Trial Design. From the a Southlake Regional Health Centre, Newmarket, Ontario, Canada, b University of Toronto, Toronto, Ontario, Canada,

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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.

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