2-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: COMPARE (Comparison of the everolimus eluting XIENCE-V stent with the paclitaxel eluting TAXUS LIBERTÉ stent in all-comers: a randomized open label trial)

Study Questions:

What is the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared with the TAXUS LIBERTE paclitaxel-eluting stent (PES) at 2-year follow-up in daily practice?

Methods:

Patients undergoing percutaneous coronary intervention (PCI) with limited exclusion criteria were randomly allocated to EES or PES. The 2-year prespecified endpoints were composites of safety and efficacy, and stent thrombosis. The time to the prespecified endpoints was evaluated according to the Kaplan-Meier method, and the log-rank test was used to compare endpoint frequencies between groups.

Results:

Follow-up was completed in 1,795 of 1,800 patients (99.7%). The groups had similar baseline characteristics. At 2 years, significantly fewer EES patients took dual antiplatelet therapy (11.4% vs. 15.4%, p = 0.02). The primary composite of all death, nonfatal myocardial infarction (MI), and target vessel revascularization occurred in 9.0% of EES patients and 13.7% of PES patients (relative risk [RR], 0.66; 95% confidence interval [CI], 0.50-0.86) driven by a lower rate of MI (3.9% vs. 7.5 %; RR, 0.52; 95% CI, 0.35-0.77) and target vessel revascularization (3.2% vs. 8.0%; RR, 0.41; 95% CI, 0.27-0.62), in parallel with a lower rate of definite or probable stent thrombosis (0.9% vs. 3.9%; RR, 0.23; 95% CI, 0.11-0.49). Differences significantly increased between 1- and 2-year follow-up for the primary composite endpoint (p = 0.04), target vessel revascularization (p = 0.02), and definite or probable stent thrombosis (p = 0.02).

Conclusions:

The authors concluded that the substantial clinical benefit of the EES over the PES with regard to measures of both safety and efficacy is maintained at 2 years in real-life practice, with an increasing benefit in terms of safety and efficacy between 1 year and 2 years.

Perspective:

The study suggests that the demonstrated superiority at 1 year of EES over PES in terms of safety and efficacy was maintained at 2 years. Furthermore, the event curves continued to diverge in favor of the EES. This difference, at 2 years, was driven by reductions in both MI and target vessel revascularization. It should be noted that no such divergence of curves was noted in the large randomized SPIRIT IV trial. Whether these differences between the trials are due to enrollment of diverse patient populations, differences in prolonged dual antiplatelet therapy administration, or chance remains uncertain.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Paclitaxel, Myocardial Infarction, Follow-Up Studies, Thrombosis, Sirolimus, Stents, Percutaneous Coronary Intervention


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