Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy.

BACKGROUND

The Supreme healing-targeted drug-eluting stent (DES) is designed to promote endothelial healing to reduce stent-related adverse events. This may be particularly relevant among complex lesions that have a higher rate of adverse events. We sought to compare 1-year outcomes of percutaneous coronary intervention in complex lesions between the Supreme DES and contemporary durable-polymer, everolimus-eluting stents (DP-EES).

METHODS

PIONEER III was a multicenter, prospective, single-blind clinical trial, randomizing 1629 patients with either an acute or chronic coronary syndrome in a 2:1 ratio to the Supreme DES or DP-EES. Complex lesions (American College of Cardiology/American Heart Association type B2/C) were found in 1137 patients. Outcomes were also compared for specific parameters of lesion complexity: severe calcification, long length (>20 ​mm), and severe tortuosity. The primary end point was target lesion failure at 1 ​year.

RESULTS

At 1 ​year, there was no difference in target lesion failure between the Supreme DES and DP-EES: (5.7% vs 5.6%; hazard ratio 1.00, 95% confidence interval 0.59-1.68, = .99). Similarly, there were no differences in the secondary end points of lesion success (99.7% vs 99.4%, = .41), device success (97.0% vs 98.5%, = .14), target vessel failure (6.5% vs 7.4%, = .50), major adverse cardiac events (7.8% vs 8.5%, = .64), or stent thrombosis (0.7% vs 1.1%, = .48). A trend was observed toward a higher rate of target lesion revascularization with the Supreme DES (2.5% vs 0.9%, = .06).

CONCLUSIONS

This study suggests that the Supreme DES is as effective and safe at 1 ​year compared with the standard DP-EES across a broad spectrum of lesion complexity.