Trial Design. From the a Southlake Regional Health Centre, Newmarket, Ontario, Canada, b University of Toronto, Toronto, Ontario, Canada,
|
|
- Leon Blake
- 8 years ago
- Views:
Transcription
1 Trial Design Rationale and design of the Trial of Routine ANgioplasty and Stenting After Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) Warren J. Cantor, MD, a,b David Fitchett, MD, b,c,d Bjug Borgundvaag, MD, b,e Michael Heffernan, MD, f Eric A. Cohen, MD, b,g Laurie J. Morrison, MD, b,g Anatoly Langer, MD, b,c,d Shamir Mehta, MD, h Charles Lazzam, MD, i Brian Schwartz, MD, b,g Vladimir Dzavik, MD, b,j and Shaun G. Goodman, MD b,c,d Newmarket, Toronto, Oakville, Hamilton, and Mississauga, Ontario, Canada Background Most patients with ST-elevation myocardial infarction present to hospitals without percutaneous coronary intervention (PCI) facilities and receive fibrinolysis. The role of routine early PCI after fibrinolysis, using stents and contemporary pharmacotherapy, has not been studied in a large adequately powered randomized trial. Objective To compare a pharmacoinvasive strategy of transfer for routine PCI within 6 hours after fibrinolysis with standard treatment after fibrinolysis (including predefined criteria for rescue PCI and delayed cardiac catheterization for patients who do not require rescue PCI). Methods A total of 1200 patients with high-risk ST-elevation myocardial infarction presenting to non-pci centers will be randomized to a pharmacoinvasive strategy (transfer for routine PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis. The primary end point is the 30-day composite of death, reinfarction, recurrent ischemia, heart failure, or shock. Results More than 900 patients have been enrolled as of April An interim safety analysis of the first 536 patients demonstrated no safety concerns. Enrolment is expected to be completed in late Conclusions This study will provide important data on whether routine early PCI within 6 hours after fibrinolysis is safe and superior to the standard treatment of fibrinolysis with rescue PCI or delayed cardiac catheterization. (Am Heart J 2008;155:19-25.) Patients with ST-elevation myocardial infarction (STEMI) require rapid, complete, and sustained reperfusion to minimize infarct size, morbidity, and mortality. Primary PCI, when performed in a timely manner, is associated with superior clinical outcomes compared to fibrinolysis in randomized clinical trials. 1 However, treatment delays can reduce or eliminate the benefits of primary PCI. 2,3 Patients who present to hospitals without PCI facilities often cannot undergo primary angioplasty within guideline-recommended timelines and are therefore treated with fibrinolysis. 4,5 The role of routine early PCI after fibrinolysis remains controversial. From the a Southlake Regional Health Centre, Newmarket, Ontario, Canada, b University of Toronto, Toronto, Ontario, Canada, c Terrence Donnelly Heart Centre, Division of Cardiology, St. Michael's Hospital, Toronto, Ontario, Canada, d Canadian Heart Research Centre, Toronto, Ontario, Canada, e Mount Sinai Hospital, Toronto, Ontario, Canada, f Halton Healthcare Services, Oakville, Ontario, Canada, g Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, h McMaster University and Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada, i Trillium Health Centre, Mississauga, Ontario, Canada, and j University Health Network, Toronto, Ontario, Canada. This study was supported by a grant from the Canadian Institutes of Health Research and an unrestricted grant from Hoffman La Roche, Canada. Dr Warren Cantor has received consulting fees, speaker's honoraria, and unrestricted research grants from Hoffman La Roche Canada and from Sanofi-Aventis. Dr Laurie Morrison has received speaker's honoraria from Hoffman La Roche and unrestricted research grants from Sanofi-Aventis. Dr Shaun Goodman has received consulting fees, speaker's honoraria, and research grants from Boehringer Ingelheim, Hoffmann La Roche, and Sanofi-Aventis. Dr Eric Cohen has received consulting fees and speaker's honoraria from Hoffman La Roche Canada and from Sanofi-Aventis. Dr David Fitchett has received consulting fees and speaker's honoraria from Hoffman La Roche, Bristol-Myers-Squibb, and Sanofi-Aventis. Dr Bjug Borgundvaag has received consulting fees, speaker's honoraria and/or unrestricted research grants from Hoffman La Roche Canada, Sanofi-Aventis, and Key Pharmaceuticals. Dr Shamir Mehta has received consulting fees and/or speaker's honoraria and/or unrestricted research grants from Sanofi-Aventis, Bristol-Myers-Squibb, Astra Zeneca, Eli Lilly, Boston Scientific, GlaxoSmithKline, Oryx Pharmaceuticals, Abbott, Johnson and Johnson. Dr Michael Heffernan has received speaker's honoraria from Sanofi-Aventis. Dr Anatoly Langer has received consulting fees and/or speaker's honoraria and/or unrestricted research grants from Hoffman La Roche Canada, Astra Zeneca, Bayer, Biovail, BMS, Boston Scientific, Cordis (J&J), DuPont, Eli Lilly, Fournier, GlaxoSmithKline, Guidant, Medtronic, Merck Schering, Novartis, Oryx, Pfizer, Sanofi-Aventis, and Servier. Submitted June 1, 2007; accepted August 27, Reprint requests: Warren J. Cantor, MD, Southlake Regional Health Centre, 596 Davis Drive, Newmarket, Ontario, Canada L3Y 2P9. cantorw@rogers.com /$ - see front matter 2008, Mosby, Inc. All rights reserved. doi: /j.ahj
2 20 Cantor et al American Heart Journal January 2008 Table I. Contemporary trials of systematic early PCI after fibrinolysis compared with delayed or ischemia-guided PCI Trial name Number of patients Median time from fibrinolytic to protocol PCI (h) Main results for systematic early PCI (compared with delayed or ischemia-guided PCI) Odds ratio for death/ MI with 95% CIs WEST Trend to lower death/mi at 30 d 0.48 ( ) CAPITAL AMI Less recurrent unstable ischemia and 0.47 ( ) trend to less recurrent MI at 6 m GRACIA Less revascularization and a trend 0.56 ( ) toward lower rates of death/mi at 1 y SIAM III Fewer ischemic events and higher ejection 0.50 ( ) fraction at 2 wk and at 6 m PRAGUE No difference in overall mortality; 0.51 ( ) lower cardiac mortality at 1 y for early presenters CARESS N/A N/A N/A Excludes patients randomized to primary PCI in the WEST and PRAGUE-1 trials. Clinical trials carried out before the era of coronary stenting failed to show a benefit of routine early PCI after fibrinolysis and showed increased rates of bleeding, emergency bypass surgery, and a trend toward increased mortality compared with delayed or ischemiaguided revascularization. 6,7 More recent studies involving the use of coronary stents and contemporary pharmacotherapy have suggested a benefit of routine early PCI within 24 hours after fibrinolysis (Table I), but these trials have been relatively small and underpowered to provide definitive conclusions. 6,7 Administration of fibrinolytic agents (alone or combined with glycoprotein [GP] IIb/IIIa inhibitors) immediately before primary PCI ( facilitated PCI ) has not shown benefit in trials done to date. 12,13 A pharmacoinvasive strategy using transfer for routine early PCI after fibrinolysis may help prevent recurrent ischemia, reocclusion, and reinfarction after an initially successful fibrinolysis. Furthermore, for patients who fail to reperfuse with fibrinolysis, arranging transfer to a PCI center immediately after administration of fibrinolysis (rather than waiting minutes to determine whether fibrinolysis is successful) may expedite rescue PCI and improve outcomes. However, these potential benefits may be offset by the risk of bleeding and access site complications after fibrinolysis. Percutaneous coronary intervention may worsen coronary flow in patients who have successfully reperfused by causing distal embolization, no reflow, dissection, or abrupt closure. Furthermore, the cost-effectiveness of a strategy of routine PCI after fibrinolysis is unknown. A large randomized trial is therefore required to determine whether patients treated with fibrinolysis at non-pci centers should be transferred to undergo routine early cardiac catheterization and PCI. We therefore designed a multicenter randomized trial to compare the pharmacoinvasive strategy of transfer for routine early PCI (within 6 hours after fibrinolysis) versus the strategy of fibrinolysis with early transfer only for failed reperfusion or hemodynamic instability. The study population consists of patients with high-risk STEMI presenting to non-pci centers, for whom timely primary PCI is not possible. Study design Patient population All patients presenting with STEMI within 12 hours of symptom onset to participating non-pci centers and treated with tenecteplase will be screened for study eligibility. Only centers that use tenecteplase were included in the trial. Patients must have either 2 mm ST-segment elevation in 2 anterior leads or 1 mm ST-segment elevation in 2 inferior leads. Patients with inferior ST elevation also require at least one of the following high-risk characteristics: systolic blood pressure b100 mm Hg, heart rate N100 beats/min, Killip class II to III, 2 mm of ST-segment depression in the anterior leads, or 1 mm of ST elevation in right-sided lead V4 (V 4 R), indicative of right ventricular involvement. Key exclusion criteria include cardiogenic shock, PCI within 1 month, previous bypass surgery, or availability of primary PCI with an anticipated door-to-balloon time of b60 minutes. There was no minimum distance between the community hospital and the PCI hospital. A complete list of the exclusion criteria is provided in Appendix A. Informed consent must be obtained within 30 minutes of administering fibrinolysis. Before enrolment, participating PCI centers and emergency medical services are contacted to confirm the potential feasibility of transfer and PCI within 6 hours of fibrinolysis. The protocol was approved by the institutional research ethics committee at each participating hospital. Before initiating the randomized trial, a small nonrandomized feasibility pilot study was carried out. 14 Treatment groups After administration of fibrinolysis in the emergency department, confirmation of eligibility, obtaining of informed consent, and determination that both an
3 American Heart Journal Volume 155, Number 1 Cantor et al 21 Figure 1 Study design of TRANSFER-AMI. Reproduced with permission from Canadian Journal of Cardiology. 14 emergency medical service transfer vehicle and a potential PCI center are available, patients are randomized to one of 2 strategies (Figure 1): (i) Pharmacoinvasive strategy: Patients are transferred emergently by land or air ambulance to a participating PCI center as soon as possible and undergo coronary angiography and PCI of the infarctrelated artery within 6 hours of fibrinolysis, regardless of chest pain, ST-elevation, or coronary flow. (ii) Standard treatment: Patients have a repeat electrocardiogram 60 to 90 minutes after randomization and are transferred for rescue PCI only if they have persistent chest pain and b50% ST-segment resolution, or if they become hemodynamically unstable. Otherwise, patients remain at the enrolling hospital and do not undergo cardiac catheterization within the first 24 hours. Elective cardiac catheterization within the first 2 weeks is encouraged but not mandated. Randomization Randomization is performed through a regional coordinating center after study eligibility has been confirmed. Randomization is stratified by referring site and by age (N75 vs 75). Pharmacotherapy All patients receive standard dose tenecteplase and aspirin 160 to 325 mg. Either unfractionated heparin (UFH) or enoxaparin is used based on institutions' standard practice, using weight-adjusted dosing consistent with published STEMI guidelines. 15 However, enoxaparin use is not permitted for patients N75 years of age based on previous studies demonstrating higher rates of major bleeding and intracranial hemorrhage. 16,17 Upfront clopidogrel loading (300 mg for patients 75 years of age) is strongly encouraged in all study patients. As no safety data exist for clopidogrel doses N75 mg in elderly patients receiving thrombolysis, 75 mg is recommended for study patients N75 years of age. Glycoprotein IIb/IIIa inhibitors will not be used at enrolling centers, but may be used in the interventional centers during PCI at the discretion of the interventional cardiologist performing the procedure. Percutaneous coronary intervention procedure Patients in either treatment group who undergo urgent cardiac catheterization will undergo PCI of the presumed culprit lesion in the infarct artery if there is a 70% stenosis present, irrespective of the flow and patency status of the artery. Treatment of lesions of 50% to 70% severity with high-risk characteristics (eg, thrombus, ulceration, spontaneous dissection) will be left to the discretion of the interventional cardiologist. The use of cobalt chromium bare metal stents provided in-kind by Abbott Vascular (Markham, Ontario) Canada (Multi-Link Vision and Mini Vision) is encouraged, although other approved stents (including drug-eluting stents) are permitted. Criteria for rescue PCI in standard treatment group All patients assigned to Standard Treatment will be assessed for resolution of ST-segment elevation and of chest pain at 60 to 90 minutes after randomization. Patients are considered to have failed fibrinolysis if they have both persistent chest pain and persistent
4 22 Cantor et al American Heart Journal January 2008 ST-segment elevation (b50% resolution from electrocardiogram with peak ST-segment elevation) at 60 to 90 minutes after randomization. The coordinating center is contacted to confirm that patients meet criteria for failed fibrinolysis and to arrange transfer for rescue PCI. Early repatriation The protocol encourages routine early transfer of clinically stable study patients in either treatment group back to the enrolling hospital within 24 hours of successful PCI. End points The primary end point of the trial is the 30-day composite of death, reinfarction, recurrent ischemia, new or worsening heart failure, and cardiogenic shock. Secondary end points include death or reinfarction at 6 months and at 1 year, severe bleeding, ST-segment resolution at 6 hours, and infarct size (by electrocardiogram score). Reinfarction within the first 18 hours is defined as recurrent ST elevation and recurrent chest pain lasting at least 30 minutes. After 18 hours, the diagnosis of reinfarction requires a rise in CK-MB greater than the upper limit of normal (ULN) (N3 ULN after PCI and N5 ULN after coronary artery bypass graft) or new Q waves on the electrocardiogram. If the CK-MB has not yet normalized, then reinfarction after 18 hours requires reelevation of the CK-MB level by at least 50% over the previous value. Recurrent ischemia is defined as chest pain lasting at least 5 minutes associated with electrocardiographic ST-segment or T-wave changes consistent with acute ischemia. New or worsening heart failure is defined as heart failure requiring treatment 6 hours after enrollment and either pulmonary edema on chest x-ray, rales on chest auscultation greater than one third up the lung fields, or pulmonary capillary wedge pressure N18 mm Hg. Cardiogenic shock is defined as persistent systolic blood pressure b90 mm Hg without inotropic support, or requiring inotropic support to maintain systolic blood pressure N90 mm Hg, associated with clinical evidence of hypoperfusion. All bleeding complications will be classified using both the TIMI 18 and GUSTO 19 bleeding severity scales. Reinfarction, recurrent ischemia, new or worsening heart failure, cardiogenic shock, and major bleeding are adjudicated by a clinical events committee blinded to treatment group assignment. Follow-up All study participants will be seen in follow-up at 30 days after enrolment. Telephone follow-up will be obtained at 6 and 12 months after enrolment. Statistical plan The primary end point event rate for the standard therapy group was estimated using a database of merged Table II. Baseline characteristics Patients enrolled to date (both treatment groups combined) (N = 841) Age (y) 57 (50, 66) Male (%) 669 (79.6 %) Prior MI (%) 91 (10.8 %) Diabetes (%) 130 (15.5 %) Hypertension (%) 289 (34.4 %) Hyperlipidemia (%) 247 (29.4 %) Prior stroke (%) 14 (1.7 %) Prior PCI (%) 46 (5.5 %) Anterior ST-elevation (%) 453 (53.9 %) Inferior ST-elevation (%) 386 (45.9 %) Killip class I (%) 770 (91.7 %) Killip class II (%) 61 (7.3 %) Killip class III (%) 9 (1.1 %) Clopidogrel use within the first 640 (76.1%) 6 h of hospitalization (%) UFH given with 402 (48.0%) tenecteplase (%) Enoxaparin given 435 (52.0%) with tenecteplase (%) Values are shown as median (25th, 75th). large acute MI trials at the Duke Clinical Research Institute. The ASSENT-3 (tenecteplase + UFH vs enoxaparin vs abciximab) and ASSENT-3 PLUS (prehospital tenecteplase + UFH vs enoxaparin) trials were used. 16,17 Of the total of 7755 patients, 3642 met the eligibility criteria for Transfer-AMI. Only patients who received fulldose tenecteplase were included. The end point definitions used in Transfer-AMI were applied for the database analysis. The 30-day event rates were as follows: death 7.8%, MI 3.9%, recurrent ischemia 9.5%, congestive heart failure 7.7%, shock 4.6%. The 30-day composite primary end point occurred in 21% of patients in the database. The expected relative risk reduction in the primary end point with routine early PCI relative to the standard therapy group was estimated as 30% based on previous studies. Based on an α of.05, and power of 80%, the required sample size is 579 patients per group, for a total sample size of 1158 patients. With an anticipated loss to follow-up of approximately 5%, the target sample size was set at 1200 patients. Comparison between the 2 treatment groups with regard to the primary combined end point will be performed with binary logistic regression. The composite secondary end points of death or reinfarction at 6 months and at 1-year follow-up will be analyzed with Cox proportional hazards models. Comparison for other event rates will be performed with Pearson χ 2 test or Fisher exact test. Exploratory prespecified subgroup analyses will be performed based on age (N75 vs 75), sex, transfer time, antithrombin agent (UFH vs enoxaparin), GP IIb/IIIa inhibitor use (including the interaction with
5 American Heart Journal Volume 155, Number 1 Cantor et al 23 timing of PCI after tenecteplase), and arterial access route (radial vs femoral). Results As of April 2007, N900 patients have been enrolled. The baseline characteristics are listed in Table II. A prespecified interim safety analysis was performed. No efficacy analysis was performed and no stopping rules were prespecified. The independent Data Safety Monitoring Committee (DSMC; see Appendix B) reviewed 30-day adjudicated data for the first 536 patients. There were no safety concerns and the DSMC strongly encouraged continuing enrolment to trial completion. Enrolment is anticipated to complete in the second half of Discussion The majority of patients with STEMI present to hospitals without PCI facilities. Transfer for primary PCI is associated with favorable clinical outcomes when performed rapidly. 20 However, most patients who require transfer for primary PCI have door-to-balloon times far exceeding the guideline-recommended 90-minute time. 4,5 Fibrinolysis therefore remains the standard-of-care in many institutions. The results of trials evaluating pharmacoinvasive strategies may depend upon the timing of PCI after fibrinolysis. In the ASSENT-4 PCI trial, patients who underwent facilitated PCI at a median of 104 minutes after fibrinolysis had higher rates of ischemic complications than patients undergoing primary PCI without fibrinolysis. 21 However, in ASSENT-4 PCI, 45% of patients were enrolled in hospitals with PCI facilities; these observed results may not be generalizable to centers that face longer delays, including hospitals without such resources that transfer patients for PCI. The timing of PCI in Transfer-AMI (within 6 hours after fibrinolysis) is similar to the strategies which appeared favorable in the WEST, SIAM-3, and GRACIA-2 trials (Table I), and may be more relevant for community hospitals without PCI facilities The longer delay between fibrinolysis and PCI may also reduce the risk of bleeding and allow for the use of GP IIb/IIIa inhibitors during PCI. The adjunct antithrombotic therapy may impact on the risk of ischemic and hemorrhagic complications when PCI is performed early after fibrinolysis. Fibrinolysis is associated with increased platelet activation and aggregation, which can be counteracted with potent antiplatelet therapy. 25 In ASSENT-4, upfront clopidogrel loading was not used, GP IIb/IIIa inhibitors were prohibited after fibrinolysis and no heparin infusion was used after the initial heparin bolus. Thus, the pharmacologic regimen used in this trial may have been suboptimal considering the prothrombotic state that exists after fibrinolytic administration, which may be amplified when coronary stenting is performed within hours after fibrinolysis. In contrast to ASSENT-4, patients in TRANS- FER-AMI receive upfront clopidogrel loading and heparin infusion (or enoxaparin use) before PCI and liberal use of GP IIb/IIIa inhibitors during PCI. Several trials and a recent meta-analysis have demonstrated the benefit of rescue PCI for failed fibrinolysis. Persistent ST-segment elevation (ST resolution b50%) 90 minutes after fibrinolysis is seen in 35% of patients. 26 However, rescue PCI has been used in b7% of patients in the fibrinolysis control groups of recent trials, 27,28 potentially biasing the results in favor of primary PCI. In TRANSFER-AMI, rescue PCI is protocol mandated for patients in the Standard Treatment group with persistent chest pain and ST-segment elevation. The pharmacoinvasive strategy is therefore being compared with a strategy of fibrinolysis followed by rescue PCI (using predefined noninvasive criteria for failed reperfusion) or delayed cardiac catheterization. Recent STEMI clinical trials have used various definitions for nonfatal end points. Severe recurrent ischemia, as defined in TRANSFER-AMI, requires electrocardiographic changes but does not require unplanned revascularization. The rates of recurrent ischemia in Transfer-AMI may be higher than in trials which documented only severe ischemia requiring urgent revascularization. The rates of new or worsening congestive heart failure may differ between treatment groups based on hemodynamic measurements performed during early cardiac catheterization. Any potential bias related to these end point definitions will be minimized with adjudication by the clinical events committee, blinded to treatment group assignment. Conclusions The TRANSFER-AMI study is designed to provide important results on whether transfer for routine early PCI within 6 hours after fibrinolysis is safe, cost-effective, and superior to the standard treatment of fibrinolysis with provisional rescue PCI or delayed cardiac catheterization. The stents are provided by Abbott Vascular Canada. All coordination of the trial, including data and site management, data analysis, are carried out by the Canadian Heart Research Centre. The steering committee convened on November 13, 2007 and reviewed the rates of enrollment, loss to followup and the blinded, aggregate adjudicated primary endpoint. Due to slowing enrollment over the past year, lack of additional trial funding, and the lower rate (b 1% vs. originally anticipated 5%) of loss to follow-up, the steering committee decided to stop enrollment at the end of December 2007, with an estimated total enrollment of 1080 patients (vs originally anticipated).
6 24 Cantor et al American Heart Journal January 2008 References 1. Keeley EC, Boura J, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomized trials. Lancet 2003;361: Nallamothu BK, Bates ER. Percutaneous coronary intervention versus fibrinolytic therapy in acute myocardial infarction: is timing (almost) everything? Am J Cardiol 2003;92: Cannon CP, Gibson CM, Lambrew CT, et al. Relationship of symptomonset-to-balloon time and door-to-balloon time with mortality in patients undergoing angioplasty for acute myocardial infarction. JAMA 2000;283: Nallamothu BK, Bates ER, Herrin J, et al. Times to treatment in transfer patients undergoing primary percutaneous coronary intervention in the United States: National Registry of Myocardial Infarction (NRMI)- 3/4 Analysis. Circulation 2005;111: Huynh T, O'Loughlin J, Joseph L, et al. Delays to reperfusion therapy in acute ST-segment elevation myocardial infarction: results from the AMI-QUEBEC Study. CMAJ 2006;175: Cantor WJ, Brunet F, Ziegler CP, et al. Immediate angioplasty after thrombolysis: a systematic review. CMAJ 2005;173: Collet JP, Montalescot G, Le MM, et al. Percutaneous coronary intervention after fibrinolysis: a multiple meta-analyses approach according to the type of strategy. J Am Coll Cardiol 2006;48: Le May MR, Wells GA, Labinaz M, et al. Combined angioplasty and pharmacological intervention versus thrombolysis alone in acute myocardial infarction (CAPITAL AMI study). J Am Coll Cardiol 2005;46: Fernandez-Aviles F, Alonso JJ, Castro-Beiras A, et al. Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial. Lancet 2004;364: Bednar F, Widimsky P, Krupicka J, et al. Interhospital transport for primary angioplasty improves the long-term outcome of acute myocardial infarction compared with immediate thrombolysis in the nearest hospital (one-year follow-up of the PRAGUE-1 study). Can J Cardiol 2003;19: di Mario C, Bolognese L, Maillard L, et al. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J 2004;148: Keeley EC, Boura JA, Grines CL. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials. Lancet 2006;367: Sinno MC, Khanal S, Al-Mallah MH, et al. The efficacy and safety of combination glycoprotein IIbIIIa inhibitors and reduced-dose thrombolytic therapy facilitated percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized clinical trials. Am Heart J 2007;153: Cantor WJ, Choi R, Heffernan M, et al. Transfer for urgent percutaneous coronary intervention immediately after thrombolysis for ST elevation myocardial infarction: the Transfer-AMI Pilot Feasibility Study. Can J Cardiol 2006;22: Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Circulation 2004;110:e82-e Wallentin L, Goldstein P, Armstrong PW, et al. Efficacy and safety of tenecteplase in combination with the low-molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction. Circulation 2003;108: The Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet 2001;358: Bovill EG, Terrin ML, Stump DC, et al. Hemorrhagic events during therapy with recombinant tissue type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial. Ann Intern Med 1991;115: The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993;329: Dalby M, Bouzamondo A, Lechat P, et al. Transfer for primary angioplasty versus immediate thrombolysis in acute myocardial infarction: a meta-analysis. Circulation 2003;108: Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet 2006;367: Armstrong PW, WEST Steering Committee. A comparison of pharmacologic therapy with/without timely coronary intervention vs. primary percutaneous intervention early after ST-elevation myocardial infarction: the WEST (Which Early ST-elevation myocardial infarction Therapy) study. Eur Heart J 2006;27: Scheller B, Hennen B, Hammer B, et al. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol 2003;42: Fernandez-Aviles F, Alonso JJ, Pena G, et al. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial. Eur Heart J 2007;28: Coulter SA, Cannon CP, Ault KA, et al. High levels of platelet inhibition with abciximab despite heightened platelet activation and aggregation during thrombolysis for acute myocardial infarction : results from TIMI (Thrombolysis In Myocardial Infarction) 14. Circulation 2000;101: de Lemos JA, Morrow DA, Gibson CM, et al. Early noninvasive detection of failed epicardial reperfusion after fibrinolytic therapy. Am J Cardiol 2001;88: Andersen HR, Nielsen TT, Rasmussen K, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med 2003;349: Widimsky P, Budesinsky T, Vorac D, et al. Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction. Final results of the randomized national multicentre trial PRAGUE-2. Eur Heart J 2003;24: Appendix A. Exclusion criteria 1. Left bundle branch block 2. Cardiogenic shock (Killip class IV requiring vasopressors or inotropic support to maintain a systolic blood pressure N90) before randomization 3. Active bleeding or known hemorrhagic diathesis
7 American Heart Journal Volume 155, Number 1 Cantor et al Availability of primary PCI with door-to-balloon time 60 minutes 5. Time from thrombolysis to initiation of consent process N30 minutes 6. Use of thrombolytic agent other than TNK for index event 7. Major surgery, biopsy of parenchymal organ, or significant trauma in the past 6 weeks 8. Systolic blood pressure N200 mm Hg or diastolic N110 mm Hg after arrival to the hospital and before enrolment 9. Concomitant use of oral anticoagulants (eg, warfarin) with international normalized ratio of N2 10. Recent noncompressible vascular puncture 11. History of central nervous system structural damage (eg, aneurysm, neoplasm, arteriovenous malformation, stroke) at any time, or transient ischemic attack within the last year 12. History of heparin-induced thrombocytopenia 13. Documented allergy to aspirin 14. Participation in other clinical research studies involving experimental therapies including drugs or devices within 7 days of enrolment or prior participation in this study 15. Inability to cooperate with the protocol or undergo cardiac catheterization 16. Other serious illness (eg, active cancer, significant hepatic disease) 17. Serum creatinine N140 μmol/l 18. Percutaneous coronary intervention within 1 month 19. Previous bypass surgery 20. Pregnancy 21. Use of enoxaparin (or other low molecular weight heparin) in the last 12 hours in patient N75 years of age 22. Inferior STEMI with none of the 5 high-risk features listed in the inclusion criteria Appendix B. Trial Organization Steering Committee: Warren Cantor (principal investigator), Shaun Goodman, David Fitchett, Anatoly Langer, Bjug Borgundvaag, Michael Heffernan, John Ducas, Eric Cohen, Vladimir Dzavik, Shamir Mehta, Charles Lazzam, Laurie Morrison, Brian Schwartz Data Safety Monitoring Committee: E. Magnus Ohman (DSMC Chair), Peter Berger, Chris Buller, Karen Pieper Coordinating Center: Canadian Heart Research Centre Sponsors: Canadian Institutes of Health Research (CIHR), Hoffman La Roche, Canada, Abbott Vascular, Canada.
Emergency Management Strategies for Acute Myocardial Infarction - Code R at LGH
Emergency Management Strategies for Acute Myocardial Infarction - Code R at LGH PAUL N. CASALE, M.D., F.A.C.C. Chief, Division of Cardiology and Medical Director of Cardiology, Lancaster General Hospital
More informationDATE: 29 August 2012 CONTEXT AND POLICY ISSUES
TITLE: Dual Antiplatelet Therapy and Enoxaparin or Unfractionated Heparin for patients with ST-elevation Myocardial Infarction: A Review of the Clinical Evidence DATE: 29 August 2012 CONTEXT AND POLICY
More informationDuration of Dual Antiplatelet Therapy After Coronary Stenting
Duration of Dual Antiplatelet Therapy After Coronary Stenting C. DEAN KATSAMAKIS, DO, FACC, FSCAI INTERVENTIONAL CARDIOLOGIST ADVOCATE LUTHERAN GENERAL HOSPITAL INTRODUCTION Coronary artery stents are
More informationACC/AHA 2009 STEMI Guideline Focused Update and What s New in 2012 Guideline
ACC/AHA 2009 STEMI Guideline Focused Update and What s New in 2012 Guideline David Zhao, MD, FACC, FSCAI Professor of Medicine and Cardiac Surgery Harry and Shelley Page Professor in Interventional Cardiology
More informationCopenhagen University Hospital Rigshospitalet Aarhus University Hospital Skejby Denmark
Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-elevation myocardial infarction 3 year follow-up of the randomised trial Peter Clemmensen, Henning Kelbæk,
More informationCilostazol versus Clopidogrel after Coronary Stenting
Cilostazol versus Clopidogrel after Coronary Stenting Seong-Wook Park, MD, PhD, FACC Division of Cardiology, Asan Medical Center University of Ulsan College of Medicine Seoul, Korea AMC, 2004 Background
More informationANESTHESIA FOR PATIENTS WITH CORONARY STENTS FOR NON CARDIAC SURGERY. Dr. Mahesh Vakamudi. Professor and Head
ANESTHESIA FOR PATIENTS WITH CORONARY STENTS FOR NON CARDIAC SURGERY Dr. Mahesh Vakamudi Professor and Head Department of Anesthesiology, Critical Care and Pain Medicine Sri Ramachandra University INTRODUCTION
More informationBRIGHT Trial. Bivalirudin versus Heparin and Heparin plus Tirofiban in Patients with AMI Undergoing PCI. Thirty-Day and One-Year Outcomes of the
Bivalirudin versus Heparin and Heparin plus Tirofiban in Patients with AMI Undergoing PCI Thirty-Day and One-Year Outcomes of the BRIGHT Trial Yaling Han, MD, FACC On behalf of the BRIGHT investigators
More informationAntiaggreganti. STEMI : cosa c è di nuovo? Heartline 2015. Genova 13 14 Novembre 2015
Heartline 2015 Genova 13 14 Novembre 2015 STEMI : cosa c è di nuovo? Antiaggreganti Luigi Oltrona Visconti Divisione di Cardiologia IRCCS Fondazione Policlinico S. Matteo Pavia STEMI : cosa c è di nuovo?
More informationApixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial
Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Connie N. Hess, MD, MHS, Stefan James, MD, PhD, Renato D. Lopes, MD, PhD, Daniel M. Wojdyla,
More informationCalifornia Health and Safety Code, Section 1256.01
California Health and Safety Code, Section 1256.01 1256.01. (a) The Elective Percutaneous Coronary Intervention (PCI) Pilot Program is hereby established in the department. The purpose of the pilot program
More informationSTROKE PREVENTION IN ATRIAL FIBRILLATION. TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: ABBREVIATIONS: BACKGROUND:
STROKE PREVENTION IN ATRIAL FIBRILLATION TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention
More informationJournal of the American College of Cardiology Vol. 42, No. 7, 2003 2003 by the American College of Cardiology Foundation ISSN 0735-1097/03/$30.
Journal of the American College of Cardiology Vol. 42, No. 7, 2003 2003 by the American College of Cardiology Foundation ISSN 0735-1097/03/$30.00 Published by Elsevier Inc. doi:10.1016/s0735-1097(03)00917-3
More informationAntiplatelet and Antithrombotics From clinical trials to guidelines
Antiplatelet and Antithrombotics From clinical trials to guidelines Ashraf Reda, MD, FESC Prof and head of Cardiology Dep. Menofiya University Preisedent of EGYBAC Chairman of WGLVR One of the big stories
More informationDual Antiplatelet Therapy. Stephen Monroe, MD FACC Chattanooga Heart Institute
Dual Antiplatelet Therapy Stephen Monroe, MD FACC Chattanooga Heart Institute Scope of Talk Identify the antiplatelet drugs and their mechanisms of action Review dual antiplatelet therapy in: The medical
More informationAtrial Fibrillation: A Different Perspective. Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital
Atrial Fibrillation: A Different Perspective Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital Faculty/Presenter Disclosure Faculty: Dr. Michael Heffernan Relationships with commercial
More informationAntiplatelet and anticoagulation treatment of patients undergoing carotid and peripheral artery angioplasty
Round Table: Antithrombotic therapy beyond ACS Antiplatelet and anticoagulation treatment of patients undergoing carotid and peripheral artery angioplasty M. Matsagkas, MD, PhD, EBSQ-Vasc Associate Professor
More informationRISK STRATIFICATION for Acute Coronary Syndrome in the Emergency Department
RISK STRATIFICATION for Acute Coronary Syndrome in the Emergency Department Sohil Pothiawala FAMS (EM), MRCSEd (A&E), M.Med (EM), MBBS Consultant Dept. of Emergency Medicine Singapore General Hospital
More informationCanadian Journal of Cardiology 27 (2011) 529 533. Editorial
Canadian Journal of Cardiology 27 (2011) 529 533 Editorial From Primary to Secondary Percutaneous Coronary Intervention: The Emerging Concept of Early Mechanical Reperfusion With Delayed Facilitated Stenting
More informationTreating AF: The Newest Recommendations. CardioCase presentation. Ethel s Case. Wayne Warnica, MD, FACC, FACP, FRCPC
Treating AF: The Newest Recommendations Wayne Warnica, MD, FACC, FACP, FRCPC CardioCase presentation Ethel s Case Ethel, 73, presents with rapid heart beating and mild chest discomfort. In the ED, ECG
More informationREFERRAL HOSPITAL. The Importance of Door In Door Out Time DIDO
REFERRAL HOSPITAL The Importance of Door In Door Out Time DIDO Time to Treatment is critical for STEMI patients For patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary
More informationMain Effect of Screening for Coronary Artery Disease Using CT
Main Effect of Screening for Coronary Artery Disease Using CT Angiography on Mortality and Cardiac Events in High risk Patients with Diabetes: The FACTOR-64 Randomized Clinical Trial Joseph B. Muhlestein,
More informationIs There A LIfe for DES after discontinuation of Clopidogrel
Chicago 2014 Is There A LIfe for DES after discontinuation of Clopidogrel Six-month versus 24-month dual antiplatelet therapy after implantation of drug eluting stents in patients non-resistant to aspirin:
More informationTherapeutic Approach in Patients with Diabetes and Coronary Artery Disease
Home SVCC Area: English - Español - Português Therapeutic Approach in Patients with Diabetes and Coronary Artery Disease Martial G. Bourassa, MD Research Center, Montreal Heart Institute, Montreal, Quebec,
More informationAntonio Colombo MD on behalf of the SECURITY Investigators
Second Generation Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy - The SECURITY Randomized Clinical Trial Antonio Colombo MD on behalf of the SECURITY
More informationDUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania
DUAL ANTIPLATELET THERAPY Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania DUAL ANTIPLATELET THERAPY (DAPT) Dual antiplatelet regimen
More informationέΰζβν αππ έκυ,νσϊίία κν1γν πλδζέκυνβί1γ π ηία δεόμνκαλ δκζόΰκμ, θν δ υγυθ άμνγνκαλ /εάμ ΚζδθδεάμΝ υλωεζδθδεάμν
ΝΠθ ζζάθδκνσθϋ λδκν έΰκ μνεδν ιωθκ κεκη δεάμνι λδεάμ έΰζβν έκ,νσϊίί κν1γν λδζέκνβί1γ Α Α φ ; έζ δκμννένσθόμ ηί δεόμνκλ δκζόΰκμ, θν δ γθ άμνγνκλ /εάμ ΚζδθδεάμΝ λωεζδθδεάμν ένivus Scientific Director, Mediolanum
More informationESC PCI Guidelines: / Sigmund Silber et al. 1
For the first time! ESC PCI Guidelines: / Sigmund Silber et al. 1 in 2002: 649.332 in 2002: 541.964 ESC PCI Guidelines: Introduction and Definitions / Sigmund Silber et al. 2 ESC PCI Guidelines: Introduction
More informationEXAMINATION trial. Manel Sabaté Hospital Clínic, Barcelona (On behalf of the Examination Investigators)
EXAMINATION trial Manel Sabaté Hospital Clínic, Barcelona (On behalf of the Examination Investigators) EXAMINATION trial Background and Rationale (I) Acute coronary syndromes repeatedly appear as independent
More informationMission: Lifeline Recommendations for Criteria for STEMI Systems of Care
Mission: Lifeline Recommendations for Criteria for STEMI Systems of Care The Mission: Lifeline Certification Program will acknowledge STEMI Systems, EMS, Non-PCI/STEMI Referral Centers and PCI/STEMI Receiving
More informationIl punto sulla terapia antitrombotica nelle sindromi coronariche acute
Santa Margherita Ligure TIGULLIO CARDIOLOGIA 2012 16-17 Febbrajo 2012 Il trattamento dell infarto miocardico acuto ad ST spraslivellato: dal territorio al laboratorio di emodinamica Il punto sulla terapia
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationCLINICAL QUALITY MEASURES FINALIZED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS BEGINNING WITH FY 2014
CLINICAL QUALITY MEASURES FINALIZED FOR ELIGIBLE HOSPITALS AND CRITICAL ACCESS HOSPITALS BEGINNING WITH FY 2014 e 55 0495 2 Emergency Department (ED)- 1 Emergency Department Throughput Median time from
More informationSTEMI Care in WV Mission: Lifeline -AHA initiative. Christopher B. Granger, MD, FACC Mayme Lou Roettig, RN, MSN
STEMI Care in WV Mission: Lifeline -AHA initiative Christopher B. Granger, MD, FACC Mayme Lou Roettig, RN, MSN Christopher B. Granger, MD, F.A.C.C Director of Cardiac Care Unit Duke University Medical
More informationFibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction
original article or in ST-Segment Elevation Myocardial Infarction Paul W. Armstrong, M.D., Anthony H. Gershlick, M.D., Patrick Goldstein, M.D., Robert Wilcox, M.D., Thierry Danays, M.D., Yves Lambert,
More informationPRECOMBAT Trial. Seung-Whan Lee, MD, PhD On behalf of the PRECOMBAT Investigators
Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease PRECOMBAT Trial Seung-Whan Lee, MD, PhD On behalf
More informationABOUT XARELTO CLINICAL STUDIES
ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the
More informationObjectives. Preoperative Cardiac Risk Stratification for Noncardiac Surgery. History
Preoperative Cardiac Risk Stratification for Noncardiac Surgery Kimberly Boddicker, MD FACC Essentia Health Heart and Vascular Center 27 th Heart and Vascular Conference May 13, 2011 Objectives Summarize
More informationKevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013
Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness
More informationMarco Ferlini Struttura Semplice di Emodinamica, UO Cardiologia Dipartimento Cardiotoracovascolare Fondazione IRCCS, Policlinico San Matteo
Marco Ferlini Struttura Semplice di Emodinamica, UO Cardiologia Dipartimento Cardiotoracovascolare Fondazione IRCCS, Policlinico San Matteo Acute Coronary Syndromes: oral antithrombotic therapy Focus on
More informationL'aspirina è diventata obsoleta nell'era dei nuovi inbitori P2Y12? Leonardo Bolognese MD, FESC, FACC Cardiovascular Department, Arezzo, Italy ISO 9001
L'aspirina è diventata obsoleta nell'era dei nuovi inbitori P2Y12? Leonardo Bolognese MD, FESC, FACC Cardiovascular Department, Arezzo, Italy Scientific Advances and Cardiovascular Mortality Nabel and
More informationThrombosis and Hemostasis
Thrombosis and Hemostasis Wendy Lim, MD, MSc, FRCPC Associate Professor, Department of Medicine McMaster University, Hamilton, ON Overview To review the important developments in venous thromboembolism
More informationWOEST TRIAL- NO ASPIRIN IN STENTED PATIENTS REQUIRING ANTICOAGULATION. Van Crisco, MD, FACC, FSCAI First Coast
WOEST TRIAL- NO ASPIRIN IN STENTED PATIENTS REQUIRING ANTICOAGULATION Van Crisco, MD, FACC, FSCAI First Coast Conflicts of Interest I have been a paid consultant and speaker for AstraZeneca, makers of
More informationAddendum to Clinical Review for NDA 22-512
Addendum to Clinical Review for DA 22-512 Drug: Sponsor: Indication: Division: Reviewers: dabigatran (Pradaxa) Boehringer Ingelheim Prevention of stroke and systemic embolism in atrial fibrillation Division
More informationPresenter: Marco Valgimigli, MD PhD, FESC Erasmus MC, Thoraxcenter Rotterdam The Netherlands
Comparing zotarolimus-eluting and bare-metal stent efficacy in selected high bleeding risk patients treated with a short dual antiplatelet therapy duration. A pre-specified analysis from the The Zotarolimuseluting
More informationSIGN 93 Acute coronary syndromes. A national clinical guideline Updated February 2013
Help us to improve SIGN guidelines - click here to complete our survey SIGN 93 Acute coronary syndromes A national clinical guideline Updated February 2013 Evidence KEY TO EVIDENCE STATEMENTS AND GRADES
More informationNew Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013
New Treatments for Stroke Prevention in Atrial Fibrillation John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 Classification Paroxysmal atrial fibrillation (AF) Last < 7
More informationTranslating Science to Health Care: the Use of Predictive Models in Decision Making
Translating Science to Health Care: the Use of Predictive Models in Decision Making John Griffith, Ph.D., Associate Dean for Research Bouvé College of Health Sciences Northeastern University Topics Clinical
More informationReperfusion in STEMI. Pharmacoinvasive therapy The Krakow experience
Reperfusion in STEMI Pharmacoinvasive therapy The Krakow experience Dariusz Dudek Jacek Legutko,, Jarosław Zalewski, Krzysztof śmudka Institute of Cardiology Jagiellonian University Medical College Krakow,
More informationCardiac Rehabilitation An Underutilized Class I Treatment for Cardiovascular Disease
Cardiac Rehabilitation An Underutilized Class I Treatment for Cardiovascular Disease What is Cardiac Rehabilitation? Cardiac rehabilitation is a comprehensive exercise, education, and behavior modification
More informationOstial LAD: Single stent approach is the best. Antonio A. Pocoví, MD, FSCAI, MTSAC, Advisory Council Member, CACI
Ostial LAD: Single stent approach is the best Antonio A. Pocoví, MD, FSCAI, MTSAC, Advisory Council Member, CACI Chair, Interventional Cardiology Sanatorio San Lucas Instituto Alexander Fleming Buenos
More informationManagement of acute coronary syndromes in patients presenting without persistent ST-segment elevation
Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation Recommendations of the European Society of Cardiology Updated version December 2002 Task Force on management
More informationFailure or significant adverse effects to all of the alternatives: Eliquis and Xarelto
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics
More informationEuropean Resuscitation Council Guidelines for Resuscitation 2005 Section 5. Initial management of acute coronary syndromes
Resuscitation (2005) 67S1, S87 S96 European Resuscitation Council Guidelines for Resuscitation 2005 Section 5. Initial management of acute coronary syndromes Hans-Richard Arntz, Leo Bossaert, Gerasimos
More informationImplementing a Prehospital 12-Lead Program
Implementing a Prehospital 12-Lead Program Corey M. Slovis, M.D. Professor and Chairman Department of Emergency Medicine Vanderbilt University Medical Center Medical Director, Metro Nashville Fire Department
More informationAcute Myocardial Infarction (the formulary thrombolytic for AMI at AAMC is TNK, please see the TNK monograph in this manual for information)
ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Alteplase (Tissue Plasminogen Activator (t-pa)), Activase in the Treatment
More informationThe 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012
The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era CCRN State of the Heart 2012 June 2, 2012 Disclosures I have I have been involved in trials of new anticoagulants and have received
More informationThe FINESSE Trial. (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) Stephen Ellis, MD For the FINESSE Investigators
The FINESSE Trial (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) Stephen Ellis, MD For the FINESSE Investigators ESC Vienne 2007 Rational for FINESSE Time is muscle: early reperfusion
More informationBayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com. News Release. Not intended for U.S. and UK Media
News Release Not intended for U.S. and UK Media Bayer Pharma AG 13342 Berlin Germany Tel. +49 30 468-1111 www.bayerpharma.com Bayer Forms Collaboration with Academic and Governmental Institutions for Rivaroxaban
More informationDabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM
Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM This report was commissioned by the NIHR HTA Programme as project number 12/78
More informationREGIONAL SYSTEMS OF CARE DEMONSTRATION PROJECT: MISSION: LIFELINE STEMI SYSTEMS ACCELERATOR
REGIONAL SYSTEMS OF CARE DEMONSTRATION PROJECT: MISSION: LIFELINE STEMI SYSTEMS ACCELERATOR Version 5.0 July 2012 2012 Duke Center for Educational Excellence Edited by Daniel Muñoz, MD, MPA Duke University
More informationBayer Extends Clinical Investigation of Rivaroxaban into Important Areas of Unmet Medical Need in Arterial Thromboembolism
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Bayer Extends Clinical Investigation of Rivaroxaban into Important Areas of
More informationBayer Initiates Rivaroxaban Phase III Study to Support Dose Selection According to Individual Benefit-Risk Profile in Long- Term VTE Prevention
Investor News Not intended for U.S. and UK Media Bayer AG Investor Relations 51368 Leverkusen Germany www.investor.bayer.com Long-term prevention of venous blood clots (VTE): Bayer Initiates Rivaroxaban
More information6/5/2014. Objectives. Acute Coronary Syndromes. Epidemiology. Epidemiology. Epidemiology and Health Care Impact Pathophysiology
Objectives Acute Coronary Syndromes Epidemiology and Health Care Impact Pathophysiology Unstable Angina NSTEMI STEMI Clinical Clues Pre-hospital Spokane County EMS Epidemiology About 600,000 people die
More informationSTROKE PREVENTION IN ATRIAL FIBRILLATION
STROKE PREVENTION IN ATRIAL FIBRILLATION OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention of ischemic stroke and arterial thromboembolism in patients
More informationBios 6648: Design & conduct of clinical research
Bios 6648: Design & conduct of clinical research Section 1 - Specifying the study setting and objectives 1. Specifying the study setting and objectives 1.0 Background Where will we end up?: (a) The treatment
More informationTHE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT
THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT Stroke Prevention in Atrial Fibrillation Gregory Albers, M.D. Director Stanford Stroke Center Professor of Neurology and Neurological
More informationHow to manage a patient who needs thrombolysis in acute stroke, ablation or angioplasty/stenting? Janet M McComb Freeman Hospital Newcastle upon Tyne
How to manage a patient who needs thrombolysis in acute stroke, ablation or angioplasty/stenting? Janet M McComb Freeman Hospital Newcastle upon Tyne What do the guidelines say? What happens with warfarin
More informationThe author has no disclosures
Mary Bradbury, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Surgery September 18, 2012 Mary.bradbury@inova.org This presentation will discuss unlabeled and investigational use of products The author
More informationMedical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South
Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains
More informationNAME OF THE HOSPITAL: 1. Coronary Balloon Angioplasty: M7F1.1/ Angioplasty with Stent(PTCA with Stent): M7F1.3
1. Coronary Balloon Angioplasty: M7F1.1/ Angioplasty with Stent(PTCA with Stent): M7F1.3 1. Name of the Procedure: Coronary Balloon Angioplasty 2. Select the Indication from the drop down of various indications
More informationACTION Registry - GWTG: Defect Free Care for Acute Myocardial Infarction Specifications and Testing Overview
Measure Purpose Numerator To provide defect free AMI care to all patients. Meaning all of the ACC/AHA endorsed performance measures are followed for eligible patients. Count of Care patients that received
More informationNone. Dual Antiplatelet Therapy Plus Systemic Anticoagulation: Bleeding Risk and Management. 76 year old male LINGO 1/5/2015
Financial Disclosure Information Dual Antiplatelet Therapy Plus Systemic Anticoagulation: Bleeding Risk and Management Robert D. McBane, M.D. Division of Cardiology Mayo Clinic Rochester Dual Antiplatelet
More informationHow can registries contribute to guidelines? Nicolas DANCHIN, HEGP, Paris
How can registries contribute to guidelines? Nicolas DANCHIN, HEGP, Paris Pros and cons of registers Prospective randomised trials constitute the cornerstone of "evidence-based" medicine, and they therefore
More informationRivaroxaban for acute coronary syndromes
Northern Treatment Advisory Group Rivaroxaban for acute coronary syndromes Lead author: Nancy Kane Regional Drug & Therapeutics Centre (Newcastle) May 2014 2014 Summary Current long-term management following
More informationNovel OAC s : How should we use them?
Novel OAC s : How should we use them? Jean C. Grégoire MD, FRCP(c), FACC, FACP Associate Professor, Université de Montréal, IntervenJonal Cardiologist, InsJtut de cardiologie de Montréal Disclosures Speaker
More informationNational Medicines Information Centre
National Medicines Information Centre VOLUME 11 NUMBER 4 2005 ST. JAMES S HOSPITAL DUBLIN 8 TEL 01-4730589 or 1850-727-727 FAX 01-4730596 www.nmic.ie For personal use only. Not to be reproduced without
More informationGetting smart about dyspnea and life saving drug therapy in ACS patients. Kobi George Kaplan Medical Center Rehovot
Getting smart about dyspnea and life saving drug therapy in ACS patients Kobi George Kaplan Medical Center Rehovot 78 year old female Case description Presented with resting chest pain and dyspnea Co morbidities:
More informationHow To Treat A Heart Attack
Reperfusion therapy, reocclusion and disease progression in acute myocardial infarction ISBN/EAN 978-90-9025678-8 Drukwerk: Ipskamp Drukkers B.V., Enschede Ontwerp: O8 grafische vormgeving i.s.m. www.formatters.nl
More informationWhat s New in Stroke?
5 th McMaster University Review Course in INTERNAL MEDICINE What s New in Stroke? Robert Hart, M.D. HHS / McMaster Stroke Program Department of Medicine (Neurology) McMaster University Hamilton, Ontario
More informationNetworking for optimal treatment of STEMI and NSTEMI. European Stent for life Project
Networking for optimal treatment of STEMI and NSTEMI European Stent for life Project Dariusz Dudek on behalf of Department of Interventional Cardiology, Institute of Cardiology, Krakow, Poland The European
More informationStent for Life Initiative How can we improve system delay and patients delay in STEMI
Stent for Life Initiative How can we improve system delay and patients delay in STEMI Z. Kaifoszova SFL Initiative Europe 2011 Stent for Life Initiative 10 countries participate in the program Declaration
More informationGuidelines for Use of Clopidogrel (Plavix )
East Lancashire Medicines Management Board representing East Lancashire Hospitals NHS Trust, Lancashire Care Trust, Blackburn with Darwen PCT, East Lancs PCT Licensed Indications Guidelines for Use of
More informationCDEC FINAL RECOMMENDATION
CDEC FINAL RECOMMENDATION RIVAROXABAN (Xarelto Bayer Inc.) New Indication: Pulmonary Embolism Note: The Canadian Drug Expert Committee (CDEC) previously reviewed rivaroxaban for the treatment of deep vein
More informationRenovascular Hypertension
Renovascular Hypertension Philip Stockwell, MD Assistant Professor of Medicine (Clinical) Warren Alpert School of Medicine Cardiology for the Primary Care Provider September 28, 201 Renovascular Hypertension
More informationDERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) MANAGEMENT of Atrial Fibrillation (AF)
DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) MANAGEMENT of Atrial Fibrillation (AF) Key priorities Identification and diagnosis Treatment for persistent AF Treatment for permanent AF Antithrombotic
More informationPrevention of stroke in patients with atrial fibrillation
www.sign.ac.uk Prevention of stroke in patients with atrial fibrillation A guide for primary care January 2014 Evidence Contents 1 Introduction... 1 2 Detection...2 3 Risk stratification... 3 4 Treatment
More informationAktuelle Literatur aus der Notfallmedizin
05.02.2014 Aktuelle Literatur aus der Notfallmedizin prä- und innerklinisch Aktuelle Publikationen aus 2012 / 2013 PubMed hits zu emergency medicine 12,599 Abstract OBJECTIVES: Current American Heart
More informationRisk stratification for patients who present to the
CLINICAL INVESTIGATIONS Application of the TIMI Risk Score for Unstable Angina and Non-ST Elevation Acute Coronary Syndrome to an Unselected Emergency Department Chest Pain Population Charles V. Pollack
More informationThe largest clinical study of Bayer's Xarelto (rivaroxaban) Wednesday, 14 November 2012 07:38
Bayer HealthCare has announced the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto (rivaroxaban) to date, investigating the prevention of major adverse cardiac
More informationB etween 30% and 50% of patients with acute myocardial
330 ORIGINAL ARTICLE Rescue percutaneous coronary intervention for failed thrombolysis: results from a district general hospital K P Balachandran, J Miller, ACHPell, B D Vallance, K G Oldroyd... Postgrad
More informationDr. Samir. B. Pancholy. M.D. FACC. Program Director, Cardiology. WCGME (Principal investigator)
Measurement of the Anti-Xa Activity of Rivaroxaban Submitted by: Dr. Samir. B. Pancholy. M.D. FACC. Program Director, Cardiology. WCGME (Principal investigator) Dr. Michael Kondash. D.O. Director of Medical
More informationAnticoagulation For Atrial Fibrillation
Anticoagulation For Atrial Fibrillation New Agents In A New Era Arjun V Gururaj, MD Arrhythmia and Electrophysiology Nevada Heart and Vascular Center Disclosures Biotronik Speaker Clinical investigator
More informationACTION Registry GWTG Version 2.4
ACTION Registry GWTG Version 2.4 Dr. Joanne Foody Kim Hustler The following relationships exist: Dr. Foody:Janssen, Sanofi, Genzyme, Aegerion, Amarin, BristolMeyersSquibb, Abbott, Gilead, ACC, Pfizer,
More informationLevel III Stroke Center Data Collection Requirements
Who? Level III Stroke Center Data Collection Requirements All LERN Level III Stroke Centers. LERN Level I and II Stroke Centers have reporting requirements to The Joint Commission or other Board approved
More informationCardiac Assessment for Renal Transplantation: Pre-Operative Clearance is Only the Tip of the Iceberg
Cardiac Assessment for Renal Transplantation: Pre-Operative Clearance is Only the Tip of the Iceberg 2 nd Annual Duke Renal Transplant Symposium March 1, 2014 Durham, NC Joseph G. Rogers, M.D. Associate
More informationREPORT OF A PILOT STUDY OF CMS. Objectives. We evaluated a telephone-based Care Management System (CMS) designed to
REPORT OF A PILOT STUDY OF CMS Page 1 Objectives. We evaluated a telephone-based Care Management System (CMS) designed to streamline the care for 30 pts previously hospitalized with ACS. Background. Many
More informationCardiac Rehabilitation The Best Medicine for Your CAD Patients. James A. Stone
James A. Stone BPHE, BA, MSc, MD, PhD, FRCPC, FAACVPR, FACC Clinical Professor of Medicine, University of Calgary Total Cardiology, Calgary Acknowledgements and Disclosures Acknowledgements Jacques Genest
More information6.3. Management 6.3.1. Routine Measures
ACC/AHA 2004 Practice Guidelines for STEMI 6.3. Management 6.3.1. Routine Measures 6.3.1.1. Oxygen Supplemental oxygen should be administered to patients with arterial oxygen desaturation (SaO2 less than
More information