Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents

• Published in: Journal of the American College of Cardiology 2011-06, Vol.58 (1), p.19-25
• Main Authors: Stone, Gregg W., MD, Rizvi, Ali, MD, Sudhir, Krishnankutty, MD, PhD, Newman, William, MD, Applegate, Robert J., MD, Cannon, Louis A., MD, Maddux, James T., MD, Cutlip, Donald E., MD, Simonton, Charles A., MD, Sood, Poornima, MD, Kereiakes, Dean J., MD
• Format: Article
• Language: English
• Subjects: angioplasty; Cardiovascular; Internal Medicine; prognosis; stent
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.02.022

Objectives We sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up. Background In the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis. Methods We prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%). Results Treatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types. Conclusions In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years. (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System; NCT01016041 )