Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions: The Pivotal TAXUS ATLAS Trial

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1 Polymer-Based, Paclitaxel-Eluting Stent in De Novo Lesions: The Pivotal TAXUS ATLAS Trial Mark A. Turco, John A. Ormiston, Jeffrey J. Popma, Lazar Mandinov, Charles D. O'Shaughnessy, Tift Mann, Thomas F. McGarry, Chiung-Jen Wu, Charles Chan, Mark W.I. Webster, Jack J. Hall, Gregory J. Mishkel, Louis A. Cannon, Donald S. Baim, and Joerg Koglin J. Am. Coll. Cardiol. published online Apr 3, 2007; doi: /j.jacc This information is current as of May 20, 2011 The online version of this article, along with updated information and services, is located on the World Wide Web at:

2 ARTICLE IN PRESS Journal of the American College of Cardiology Vol. 49, No. 16, by the American College of Cardiology Foundation ISSN /07/$32.00 Published by Elsevier Inc. doi: /j.jacc CLINICAL RESEARCH Interventional Cardiology Polymer-Based, Paclitaxel-Eluting Stent in De Novo Lesions The Pivotal TAXUS ATLAS Trial Mark A. Turco, MD,* John A. Ormiston, MBCHB, Jeffrey J. Popma, MD, Lazar Mandinov, MD, Charles D. O Shaughnessy, MD, Tift Mann, MD, Thomas F. McGarry, MD,# Chiung-Jen Wu, MD,** Charles Chan, MD, Mark W. I. Webster, MBCHB, Jack J. Hall, MD, Gregory J. Mishkel, MD, Louis A. Cannon, MD, Donald S. Baim, MD, Joerg Koglin, MD Takoma Park, Maryland; Auckland, New Zealand; Boston and Marlborough, Massachusetts; Elyria, Ohio; Raleigh, North Carolina; Oklahoma City, Oklahoma; Kaohsiung, Taiwan; Singapore; Indianapolis, Indiana; Springfield, Illinois; and Petoskey, Michigan Objectives Background Methods Results Conclusions The goal of this research was to assess non-inferiority of the next-generation stent (Boston Scientific Corp., Natick, Massachusetts) versus the stent (Boston Scientific Corp.). The introduction of drug-eluting stents (DES) has shifted clinical practice towards more complex lesion subsets, prompting the need for more deliverable DES. was designed to combine the established polymerbased, paclitaxel-elution TAXUS technology with the more advanced Liberté stent platform. The TAXUS ATLAS study is a global, prospective, single-arm trial evaluating outcomes in de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is an entry-criteria-matched population of patients from the TAXUS IV and V trials. The primary end point is non-inferiority of versus for 9-month target vessel revascularization. Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex for than. The primary non-inferiority end point was met with the 1-sided 95% confidence bound of 2.98% less than the pre-specified non-inferiority margin of 3% (p ). Despite the treatment of more complex lesions with, the primary end point was met, demonstrating that is non-inferior to. The successful transfer of the proven TAXUS technology to the more advanced platform was demonstrated. (TAXUS ATLAS: -SR Stent for the Treatment of De Novo Coronary Artery Lesions; 1; NCT ) (J Am Coll Cardiol 2007;49: ) 2007 by the American College of Cardiology Foundation From the *Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland; Mercy Angiography Unit, Mercy Hospital, Auckland, New Zealand; Department of Internal Medicine (Cardiovascular Division), Brigham and Women s Hospital, Boston, Massachusetts; Boston Scientific Corporation, Marlborough, Massachusetts; Elyria Memorial Hospital, Elyria, Ohio; Wake Heart Associates, Wake Medical Center, Raleigh, North Carolina; #Oklahoma Foundation for Cardiovascular Research, Oklahoma Heart Hospital, Oklahoma City, Oklahoma; **Cardiology Section, Chang-Gung Memorial Hospital, Kaohsiung, Taiwan; National Heart Centre, Singapore, Singapore; Cardiac Investigations Unit, Auckland City Hospital, Auckland, New Zealand; The Heart Center, St. Vincent s Hospital, Indianapolis, Indiana; Prairie Heart Institute, St. John s Hospital, Springfield, Illinois; and the Cardiac & Vascular Research Center, Northern Michigan Hospital, Petoskey, Michigan. This study was supported by Boston Scientific Corporation, Natick, Massachusetts. Dr. Turco has received consulting fees/honoraria, is on the Speakers Bureau, and has received research grants from Boston Scientific Corporation. Dr. Ormiston has received consulting fees/ honoraria and is on the Advisory Board of Boston Scientific Corporation. Dr. O Shaughnessy has received consulting fees/honoraria and is on the Speakers Bureau and the Advisory Board of Boston Scientific Corporation. Dr. Chan has received consulting fees/honoraria, is on the Speakers Bureau, and has received research grants from Boston Scientific Corporation. Dr. Mishkel has received consulting fees/honoraria, is on the Speakers Bureau, and has received research grants from Boston Scientific Corporation. Dr. Cannon is on the Speakers Bureau of Boston Scientific Corporation. Drs. Popma and Webster have received research grants from Boston Scientific Corporation. Dr. Ormiston is on the Advisory Board of Boston Scientific Corporation. Dr. Baim is a stockholder and full-time employee of Boston Scientific Corporation. Dr. McGarry is a stockholder of Boston Scientific Corporation. Drs. Mandinov and Koglin are full-time employees of Boston Scientific Corporation. Manuscript received October 16, 2006; revised manuscript received January 4, 2007, accepted January 9, 2007.

3 JACC Vol. 49, No. 16, 2007 April 24, 2007: ARTICLE IN PRESS Turco et al. The TAXUS ATLAS Trial 1677 The effectiveness of first-generation drug-eluting stents (DES) in reducing restenosis after percutaneous coronary intervention has been established (1 3). While reducing restenosis in all lesion and patient populations studied, the use of firstgeneration DES in more complex lesions has been limited by stent design. The next-generation (Boston Scientific Corp., Natick, Massachusetts) paclitaxel-eluting stent platform was developed to improve deliverability, conformability, and drug distribution homogeneity while maintaining the established antirestenotic properties of the TAXUS polymer-based, paclitaxel-elution technology. Since both stents use the same drug-eluting technology, we hypothesized that would be as safe and effective as (Boston Scientific Corporation) while being more deliverable. Therefore, we initiated the prospective, single-arm, non-inferiority TAXUS ATLAS trial to evaluate the safety and efficacy of versus historical controls in single, de novo coronary lesions. Methods Device description. Both 2 -SR and -SR consist of a balloon-expandable stent with a polymer coating containing 1 g/mm 2 of paclitaxel in a slow-release formulation on the Express or Liberté platforms, respectively (Fig. 1). Figure 1 Study Devices (A). (B). Abbreviations and Acronyms DES drug-eluting stent(s) ITT intention-to-treat MACE major adverse cardiac events MI myocardial infarction MLD minimum lumen diameter PP per protocol QCA quantitative coronary angiography TVR target vessel revascularization Patient selection and study flow. A total of 871 patients were enrolled at 61 centers in 7 countries in North America and Asia Pacific from August 2004 to February 2005 to receive the stent. Eligible patients were 18 years old with a single de novo lesion 10 and 28 mm in length (by visual estimate) in a native coronary artery with a reference vessel diameter of 2.5 and 4.0 mm (by visual estimate). Patients with acute ( 72 h) myocardial infarction (MI), left main disease, ostial or bifurcation lesions, total occlusion or thrombus, calcification, or tortuosity were excluded. Additional study stents were allowed in the target lesion when clinically indicated for bailout reasons. The study protocol was approved by local ethics review committees. All patients provided written informed consent. Loading doses of clopidogrel (300 mg) or ticlopidine (500 mg) and aspirin (300 mg) were administered before stent implantation. After implantation, all patients were prescribed clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) for a minimum of 6 months, and aspirin ( 100 mg daily) for at least 9 months but recommended indefinitely. Clinical follow-up was scheduled at 1, 4, and 9 months and yearly thereafter for 5 years. Follow-up quantitative coronary angiography (QCA) and intravascular ultrasound were scheduled at 9 months for a randomized subset of patients (Fig. 2A). Control group. The control group consisted of a historical population of -SR patients from the TAXUS IV and V trials (2,3); inclusion and exclusion criteria were similar to those for the TAXUS ATLAS trial (Fig. 2B). Data management and definitions. Independent monitors verified all data from case report forms. Stent thrombosis, death, and major adverse cardiac events (MACE), including cardiac death, MI, and target vessel revascularization (TVR), were adjudicated by an independent Clinical Events Committee. A data monitoring committee periodically reviewed safety data. The clinical and angiographic end point definitions were identical to those in the TAXUS IV and V trials (2,3). Blinded angiographic analysis was performed using validated quantitative methods (4). The same core lab (Brigham and Women s Hospital, Boston, Massachusetts) and procedures were used as for the TAXUS IV and V trials. Pre-specified non-inferiority end points. The primary end point was 9-month TVR. In-stent percent diameter stenosis, binary restenosis, minimum lumen diameter (MLD), and late loss were also tested for non-inferiority.

4 ARTICLE IN PRESS 1678 Turco et al. JACC Vol. 49, No. 16, 2007 The TAXUS ATLAS Trial April 24, 2007: Figure 2 Study Flow and Control Group Selection (A) The TAXUS ATLAS study flow. (B) Selection of the control group. Patients from the TAXUS IV and V trials were selected based on entry criteria for the TAXUS ATLAS trial. All 662 patients from the TAXUS IV trial were included. Of the 577 patients in the TAXUS V trial, 248 were excluded for reference vessel diameter (RVD) 2.5 mm, lesion length 28 mm, or 1 study stent planned for implantation. *Based on visual estimate. Angio angiography; F/U follow-up; ITT intention-to-treat population; IVUS intravascular ultrasound; PP per-protocol population. Statistical methodology. P values are 2-sided unless specified otherwise. Student t test was used to compare independent continuous variables, while chi-square or Fisher exact test was used to compare proportions. A p value of 0.05 was considered statistically significant. Kaplan-Meier analysis was used to assess time-to-event outcomes. Baseline characteristics and 9-month end points are reported for the intention-to-treat (ITT) population, while 12-month end points are reported for the per-protocol (PP) population (excludes patients without study stent). Non-inferiority testing for the primary end point was performed on both populations, but the main population of interest was PP. For the primary end point, the pre-specified, noninferiority margin of 3.0% was based on one-third of the treatment effect with versus the bare metal control observed in the TAXUS IV trial (2). Margins for

5 JACC Vol. 49, No. 16, 2007 April 24, 2007: ARTICLE IN PRESS Turco et al. The TAXUS ATLAS Trial 1679 Baseline Patient Characteristics Table 1 Baseline Patient Characteristics (n 991) (n 871) p Value Men 72.6% (719/991) 69.5% (605/871) Age (yrs) (991) (871) Cardiac history Stable angina 52.8% (523/991) 60.2% (524/871) Unstable angina 34.4% (341/991) 32.1% (280/871) Silent ischemia 12.8% (127/991) 7.6% (66/871) Previous PCI 31.4% (311/991) 30.8% (268/871) Previous CABG 10.3% (102/991) 5.5% (48/871) Cardiac risk factors Smoking, ever 64.0% (634/991) 65.9% (574/871) Diabetes, medically treated 24.6% (244/991) 25.3% (220/871) Insulin-dependent 7.7% (76/991) 7.8% (68/871) Hyperlipidemia 67.1% (665/991) 76.3% (665/871) Family history of CAD 55.2% (547/991) 50.5% (440/871) Lesion characteristics (by visual estimation) Lesion length, mm (990) (871) RVD, mm (990) (871) Numbers are % (count/sample size) or mean SD (n). Data for the intention-to-treat population are shown. CABG coronary artery bypass graft; CAD coronary artery disease; PCI percutaneous coronary intervention; RVD reference vessel diameter. non-inferiority testing of secondary QCA end points were also pre-specified based on results from the TAXUS IV trial. Assuming a non-inferiority margin of 3.0%, a Baseline Lesion Characteristics Determined by QCA Table 2 Baseline Lesion Characteristics Determined by QCA (n 991) 9-month TVR rate of 5.7% (from the TAXUS IV trial), and 10% attrition, the required enrollment for the TAXUS ATLAS trial was 822 subjects for 80% power. (n 871) p Value Target lesion vessel LAD 40.6% (400/985) 41.7% (362/869) Circumflex 27.6% (272/985) 25.7% (223/869) RCA 31.7% (312/985) 32.7% (284/869) LMCA 0.1% (1/985) 0.0% (0/869) Lesion location Ostial 3.7% (36/982) 2.4% (21/869) Proximal 37.9% (372/982) 40.3% (350/869) Mid 50.0% (491/982) 49.5% (430/869) Distal 8.5% (83/982) 7.8% (68/869) RVD (mm) (984) (869) %DS (984) (869) MLD (mm) (984) (869) Lesion length (mm) (979) (869) Eccentric lesion 46.9% (461/983) 51.4% (447/869) Bend (degrees) (983) (869) Tortuosity 8.4% (82/982) 13.1% (114/869) Calcification 23.1% (227/983) 29.8% (259/869) Aneurysm 1.7% (17/983) 4.3% (37/869) Branch vessel disease 5.0% (49/981) 10.9% (94/864) Modified ACC/AHA lesion type A 8.6% (85/983) 5.4% (47/869) B1 30.1% (296/983) 19.1% (166/869) B2 or C 61.2% (602/983) 75.5% (656/869) Numbers are % (count/sample size) or mean SD (n). Data for the intention-to-treat population are shown. ACC American College of Cardiology; AHA American Heart Association; LAD left anterior descending artery; LMCA left main coronary artery; MLD minimum lumen diameter; QCA quantitative coronary angiography; RCA right coronary artery; RVD reference vessel diameter; %DS % diameter stenosis.

6 ARTICLE IN PRESS 1680 Turco et al. JACC Vol. 49, No. 16, 2007 The TAXUS ATLAS Trial April 24, 2007: Results Baseline demographics and lesion characteristics. Both groups were well-matched for baseline patient and visually estimated lesion characteristics (Table 1). However, QCA demonstrated that lesions treated with were significantly more complex versus those treated with (Table 2). Procedural information and antiplatelet usage. Technical success was similar between groups. The average procedure time was significantly lower for (Table 3); this benefit was maintained even when groups were adjusted for geographical differences or intravascular ultrasound usage. Furthermore, the bailout rate was reduced by nearly 50% for (p ). Aspirin was prescribed at discharge to more than 99.5% of patients in both groups (Fig. 3). By 12 months, 96.1% of patients and 95.5% of patients were taking aspirin. At discharge, thienopyridines were administered to 99.9% of patients in each group; however, compliance decreased over time such that only 93% of patients were taking a thienopyridine at 6 months. At 9 and 12 months, more TAXUS Liberté than patients were taking thienopyridines (9 months: 62.6% vs. 54.2%, p ; 12 months: 51.9% vs. 47.4%, p ). Primary end point. The difference in TVR between the 2 PP populations was 0.94% (Table 4). The upper 1-sided 95% confidence bound of 2.98% was less than the prespecified non-inferiority margin of 3.0% (p ). A similar outcome was demonstrated for the ITT populations. Therefore, the primary end point was met. Additional clinical outcomes. There were no differences between the groups in any clinical outcomes analyzed at either 9 or 12 months (Table 5). Freedom from MACE or Figure 3 Procedural Characteristics and Medication Usage Table 3 Procedural Characteristics and Medication Usage (n 991) Antiplatelet Medication Usage in the Intention-to-Treat Population (n 1,862) Dual therapy: aspirin plus clopidogrel or ticlopidine. TVR through 12 months was similar between the groups (Fig. 4). By 12 months, there were 7 stent thromboses for TAXUS Express and 8 for (p 0.63) (Table 5). Two stent thromboses occurred in beyond 6 months. An 83-year-old man suffered a stent thrombosis with Q-wave MI on day 258. He was taking both aspirin and clopidogrel at the time of thrombosis. A 45-year-old man who had stent thrombosis and non Q-wave MI on day 365 had discontinued clopidogrel, but was taking aspirin. There were no sudden cardiac deaths after 30 days and out to 12 months that could possibly be attributed to additional stent thromboses in the group. (n 871) p Value Technical success* 98.9% (980/991) 99.7% (867/870) Procedure time (min) (991) (870) Patients without IVUS (706) (544) North American procedures (989) (630) Maximum stent deployment pressure (atm) (974) (866) Maximum post-dilation pressure (atm) (431) (414) Medication usage Pre-procedure ASA 98.5% (976/991) 98.7% (860/871) Clopidogrel or ticlopidine 99.2% (983/991) 99.9% (870/871) ASA and clopidogrel or ticlopidine 97.7% (966/989) 98.6% (859/871) During procedure GP IIb/IIIa inhibitor 52.7% (522/990) 23.9% (208/871) Heparin/other antithrombin 97.8% (968/990) 100% (871/871) Numbers shown are mean SD (n) or % (count/sample size). Data for the intention-to-treat population are shown. *Technical success is defined as successful delivery and deployment of a study stent to the target lesion, without balloon rupture or embolization; maximum post-stent dilatation pressure for TAXUS IV control patients does not include post-dilatation performed with the stent delivery system; not all subjects underwent post-dilatation. ASA aspirin; GP glycoprotein; IVUS intravascular ultrasound.

7 JACC Vol. 49, No. 16, 2007 April 24, 2007: ARTICLE IN PRESS Turco et al. The TAXUS ATLAS Trial 1681 Non-Inferiority Testing of Primary and Pre-Specified Secondary End Points Table 4 Non-Inferiority Testing of Primary and Pre-Specified Secondary End Points Per-Protocol Population (n 980) (n 867) Difference (Upper 1-Sided 95% CI) Pre-Specified Non-Inferiority Margin p Value for Non-Inferiority Testing Primary end point 9-month TVR 7.01% (67/956) 7.95% (68/855) 0.94% (2.98%) 3.0% Secondary end points In-stent %DS (486) (448) 2.24 (4.44) 6.6% In-stent binary restenosis 8.64% (42/486) 11.38% (51/448) 2.74% (5.98%) 6.3% In-stent MLD (mm)* (486) (448) 0.09 ( 0.16) In-stent late loss (mm) (484) (446) 0.01 (0.04) Control TAXUS ATLAS Difference Pre-Specified p Value for Intention-to-Treat Population (n 991) (n 871) (Upper 1-Sided 95% CI) Non-Inferiority Margin Non-Inferiority Testing 9-month TVR 7.14% (69/967) 8.03% (69/859) 0.90% (2.94%) 3.0% Numbers shown are % (count/total) or mean SD (n). Data for per-protocol or intention-to-treat populations are shown as indicated. *Lower 1-sided 95% confidence interval (CI) is reported for in-stent minimum lumen diameter (MLD). TVR target vessel revascularization; %DS % diameter stenosis. QCA outcomes. Baseline, post-procedure, and 9-month angiographies were performed on 75% of angiographic substudy patients (Fig. 2B). Noninferiority was demonstrated for all pre-specified QCA parameters (Table 4). had a significantly lower MLD preprocedure; however, paired assessment of angiographic out- Clinical Outcomes at 9 and 12 Months in the Intention-to-Treat Population* Table 5 Clinical Outcomes at 9 and 12 Months in the Intention-to-Treat Population* (n 991) (n 871) p Value Clinical procedural success 96.7% (318/329) 96.9% (844/871) In-hospital MACE 2.6% (26/991) 2.4% (21/871) day MACE 3.3% (33/987) 2.8% (24/870) month MACE 5.4% (53/985) 3.9% (34/869) month MACE 10.5% (102/974) 11.0% (95/862) Cardiac death 0.9% (9/974) 0.8% (7/862) MI 3.9% (38/974) 3.7% (32/862) Q-wave MI 0.6% (6/974) 0.7% (6/862) Non Q-wave MI 3.3% (32/974) 3.0% (26/862) TVR, overall 7.1% (69/974) 8.0% (69/862) TLR, overall 4.5% (44/974) 5.7% (49/862) TVR remote, overall 2.7% (26/974) 3.2% (28/862) month TVF 9.8% (95/971) 10.8% (93/862) month MACE* 12.3% (118/957) 12.5% (106/851) Cardiac death* 1.0% (10/957) 0.8% (7/851) MI* 3.9% (37/957) 4.0% (34/851) Q-wave MI* 0.6% (6/957) 0.7% (6/851) Non Q-wave MI* 3.2% (31/957) 3.3% (28/851) TVR, overall* 8.9% (85/957) 9.2% (78/851) TLR, overall* 5.5% (53/957) 6.1% (52/851) TVR remote, overall* 3.8% (36/957) 4.2% (36/851) month TVF* 11.7% (112/954) 12.1% (103/851) month stent thrombosis 0.7% (7/966) 0.8% (7/858) month stent thrombosis* 0.7% (7/947) 0.9% (8/846) In-hospital 0.2% (2/991) 0.0% (0/871) Out-of-hospital to 30 days 0.3% (3/987) 0.2% (2/869) days 0.2% (2/985) 0.5% (4/867) days 0.0% (0/963) 0.1% (1/857) days* 0.0% (0/945) 0.1% (1/847) * Non-cardiac death to 12 months* 1.3% (12/951) 0.5% (4/847) Total death to 12 months* 2.3% (22/961) 1.3% (11/854) month outcomes are from the intention-to-treat population. Numbers shown are % (count/total). *12-month outcomes are based on the per-protocol population (: n 980; : n 867). MACE major adverse cardiac events; MI myocardial infarction; TLR target lesion revascularization; TVF target vessel failure; TVR target vessel revascularization.

8 ARTICLE IN PRESS 1682 Turco et al. JACC Vol. 49, No. 16, 2007 The TAXUS ATLAS Trial April 24, 2007: The TAXUS ATLAS trial evaluates the stent versus a historical control of TAXUS IV and V patients. Despite using similar inclusion and exclusion criteria, the contemporary cohort had more complex lesions when compared with the historic controls, suggesting a change in the use of DES. Despite this increase in lesion complexity, the clinical outcomes at 9 and 12 months demonstrate that is as safe and effective as TAXUS Express. Additionally, the shorter procedure time and lower bailout rate may represent a clinical surrogate for the improved deliverability and conformability of. These results demonstrate the successful transfer of the TAXUS technology to a new stent platform with optimized design. The current study compares 2 cohorts enrolled 5 to 35 months apart. Cross comparison of baseline and procedural characteristics and outcomes provides insight into the continuing change in clinical practice since the introduction of DES. Even with similar inclusion and exclusion criteria, more challenging lesions are treated now, suggesting an increased confidence in the benefits provided by DES. The duration of thienopyridine administration has increased, which may reflect the increased sensitivity to potential late thrombotic events after DES implantation. Finally, a more pronounced oculostenotic reflex (5), as suggested by the steeper decline in freedom-from-tvr during the mandated angiographic follow-up window, was observed. Decreased visual tolerance of the operator to intermediate re-narrowing within the stent segment since the introduction of DES may contribute to this development. The TAXUS ATLAS trial was designed as a prospective, non-inferiority trial with a historic control group to leverage the large amount of data available for TAXUS Express. The purpose of this trial design is to provide proof-of-concept in a patient population controlled by strict inclusion and exclusion criteria. As with the actively controlled TAXUS trials, the historically controlled TAXUS ATLAS trial has complete data monitoring: a Figure 4 Cumulative Freedom-From-Event Rates (A) Major adverse cardiac events (MACE) or (B) target vessel revascularization (TVR). Data shown are for the per-protocol population (n 1,845). comes showed comparable in-stent acute gain (p 0.68) and late loss in both groups (p 0.69) (Fig. 5). Despite the higher lesion complexity in the group, no significant differences between the groups were found in any of the QCA parameters analyzed at 9 months (Table 6). Discussion Figure 5 Angiographic Measures (A) In-stent or in-lesion minimum lumen diameter (MLD) measures over time. Data from the intention-to-treat population (n 1,862) at pre- and post-procedure, and from the angiographic subset (n 1,247) at 9 months. (B) Cumulative frequency distribution curves for in-stent late loss as determined by quantitative coronary angiography in the angiographic subset (n 1,247).

9 JACC Vol. 49, No. 16, 2007 April 24, 2007: ARTICLE IN PRESS Turco et al. The TAXUS ATLAS Trial Month Angiographic Outcomes* Table 6 9-Month Angiographic Outcomes* (n 704) (n 543) p Value Pre-procedure RVD (486) (449) MLD, in-lesion (486) (449) %DS (486) (449) Post-procedure RVD (mm) (484) (447) MLD, in-stent (mm) (484) (446) MLD, analysis segment (mm) (484) (447) %DS, in-stent (484) (446) %DS, analysis segment (484) (447) month RVD (mm) (486) (449) MLD, in-stent (mm) (486) (448) MLD, analysis segment (mm) (486) (449) %DS, in-stent (486) (448) %DS, analysis segment (486) (449) Binary restenosis, in-stent (%) 8.6 (486) 11.4 (448) Binary restenosis, analysis segment (%) 12.1 (486) 14.3 (449) Acute gain In-stent (695) (539) Analysis segment (696) (541) Late loss, mm In-stent (484) (446) Analysis segment (484) (447) Loss index In-stent (484) (446) Analysis segment (484) (447) Numbers shown are mean SD (n) or % (n). The analysis segment consists of the stented segment and the 5 mm immediately proximal and distal to the stent. *Data shown is for paired analysis subset, including patients for whom pre-procedure, post-procedure, and 9-month quantitative coronary angiography data were available. MLD minimum lumen diameter; RVD reference vessel diameter; %DS % diameter stenosis. Clinical Events Committee to adjudicate clinical events, and an independent core lab to perform QCA analysis. Nevertheless, a limitation of a historically controlled trial is the potential for bias due to changes in practice patterns or lack of blinding. The TAXUS ATLAS trial shows the successful transfer of a proven drug/polymer combination from the stent to the next-generation TAXUS Liberté stent with an optimized platform design. Despite increased lesion complexity in patients treated with, procedural characteristics suggest improved deliverability and conformability of the new TAXUS stent while the clinical and angiographic outcomes demonstrate non-inferiority of versus. Acknowledgments The authors thank Leslie E. Stolz, PhD, and Katherine H. Lewis, MA (both of Boston Scientific Corp.), for their assistance in drafting this manuscript. Reprint requests and correspondence: Dr. Mark A. Turco, Center for Cardiac & Vascular Research, Washington Adventist Hospital, 7600 Carroll Avenue, Takoma Park, Maryland MTurco@ahm.com. REFERENCES 1. Moses JW, Leon MB, Popma JJ, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349: Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxeleluting stent in patients with coronary artery disease. N Engl J Med 2004;350: Stone GW, Ellis SG, Cannon L, et al. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005;294: van der Zwet PM, Reiber JH. A new approach for the quantification of complex lesion morphology: the gradient field transform; basic principles and validation results. J Am Coll Cardiol 1994;24: Cohn JN. Efficacy and safety in clinical trials in cardiovascular disease. J Am Coll Cardiol 2006;48:430 3.

10 Polymer-Based, Paclitaxel-Eluting Stent in De Novo Lesions: The Pivotal TAXUS ATLAS Trial Mark A. Turco, John A. Ormiston, Jeffrey J. Popma, Lazar Mandinov, Charles D. O'Shaughnessy, Tift Mann, Thomas F. McGarry, Chiung-Jen Wu, Charles Chan, Mark W.I. Webster, Jack J. Hall, Gregory J. Mishkel, Louis A. Cannon, Donald S. Baim, and Joerg Koglin J. Am. Coll. Cardiol. published online Apr 3, 2007; doi: /j.jacc This information is current as of May 20, 2011 Updated Information & Services Supplementary Material References Citations Rights & Permissions Reprints including high-resolution figures, can be found at: 9v1 Supplementary material can be found at: 9/DC1 This article cites 5 articles, 3 of which you can access for free at: 9v1#BIBL This article has been cited by 20 HighWire-hosted articles: 9v1#otherarticles Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: Information about ordering reprints can be found online: