Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents: 2-Year Follow-Up From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV Trial

Jun 21, 2011
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Authors:
Stone GW, Rizvi Ali, Sudhir K, et al., on behalf of the SPIRIT IV Investigators.
Citation:
J Am Coll Cardiol 2011;58:19-25.
Summary By:
Debabrata Mukherjee, MD, FACC

Study Questions:

What are the differences in outcomes 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 longer-term follow-up?

Methods:

The investigators prospectively randomized 3,687 patients with up to three noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 US sites. Follow-up through 2 years was complete in 3,578 patents (97.0%). Survival curves were constructed for time-to-event variables using Kaplan-Meier estimates and compared by log-rank test.

Results:

Treatment with EES compared with PES reduced the 2-year rates of target lesion failure (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 two stent types.

Conclusions:

The authors concluded that 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.

Perspective:

In the SPIRIT IV trial, treatment of noncomplex lesions with EES rather than PES resulted in significant reductions in MI, stent thrombosis, and ischemia-driven TLR at 1 year, without significant differences in all-cause or cardiac mortality. The current analysis suggests that the benefits of EES present at 1 year were sustained at 2 years. The observation that the reduction in TLR with EES was durable between 1 year and 2 years with no late loss of clinical efficacy in this large-scale clinical trial is reassuring given a prior report from the SPIRIT II angiographic substudy of greater incremental late loss between 6 months and 2 years with EES compared with PES; however, longer-term (i.e., 5-year) follow-up is required to fully characterize the late differences between the two stent platforms.

Keywords: Paclitaxel, Myocardial Infarction, Follow-Up Studies, Coronary Vessels, Sirolimus, Stents


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