The Supreme drug-eluting stent resulted in a similar rate of target lesion failure at 1 year compared with durable-polymer everolimus-eluting stents in patients with complex coronary lesions.
RCT (n=1,137)
Single-blind
2:1
Yes
Does the Supreme healing-targeted drug-eluting stent reduce target lesion failure at 1 year compared to durable-polymer everolimus-eluting stents in patients with complex coronary lesions?
The Supreme healing-targeted drug-eluting stent demonstrated comparable 1-year efficacy and safety to contemporary durable-polymer everolimus-eluting stents in patients with complex coronary lesions.
Effect estimate: HR 1.00 (95% CI 0.59-1.68)
Absolute Event Rate: 5.7% vs 5.6%
p-value: p=.99
BackgroundThe 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).MethodsPIONEER 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.ResultsAt 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, P = .99). Similarly, there were no differences in the secondary end points of lesion success (99.7% vs 99.4%, P = .41), device success (97.0% vs 98.5%, P = .14), target vessel failure (6.5% vs 7.4%, P = .50), major adverse cardiac events (7.8% vs 8.5%, P = .64), or stent thrombosis (0.7% vs 1.1%, P = .48). A trend was observed toward a higher rate of target lesion revascularization with the Supreme DES (2.5% vs 0.9%, P = .06).ConclusionsThis 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.
Patel et al. (Sat,) conducted a rct in Complex coronary lesions (n=1,137). Supreme drug-eluting stent vs. Durable-polymer everolimus-eluting stent (DP-EES) was evaluated on Target lesion failure at 12 months (HR 1.00, 95% CI 0.59-1.68, p=.99). The Supreme drug-eluting stent resulted in a similar rate of target lesion failure at 1 year compared with durable-polymer everolimus-eluting stents in patients with complex coronary lesions.