Author + information
- Received March 24, 2011
- Revision received June 30, 2011
- Accepted July 7, 2011
- Published online November 1, 2011.
- Bimmer E. Claessen, MD, PhD⁎,
- Pieter C. Smits, MD†,
- Dean J. Kereiakes, MD‡,
- Helen Parise, ScD⁎,
- Martin Fahy, MSc⁎,
- Elvin Kedhi, MD†,
- Patrick W. Serruys, MD, PhD§∥,
- Alexandra J. Lansky, MD¶,
- Ecaterina Cristea, MD⁎,
- Krishnankutty Sudhir, MD, PhD∥,
- Poornima Sood, MD∥,
- Charles A. Simonton, MD∥ and
- Gregg. W. Stone, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022
Objectives The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES).
Background Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention.
Methods Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905).
Results The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C.
Conclusions Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041)
Dr. Smits has received travel and speaking fees from Abbott Vascular and has served as a consultant to Blue Medical. Dr. Kereiakes has served as a consultant for Boston Scientific and Abbott Vascular. Drs. Sudhir and Simonton are full-time employees of Abbott Vascular. Dr. Sood is a salaried employee of Abbott Vascular. Dr. Stone has served on the scientific advisory boards for and received honoraria from Boston Scientific and Abbott Vascular and has served as a consultant to Medtronic.
All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 24, 2011.
- Revision received June 30, 2011.
- Accepted July 7, 2011.
- American College of Cardiology Foundation