Journal of the Society for Cardiovascular Angiography & Interventions · 2022
Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy.
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Patel Kush P, Lansky Alexandra J, Kereiakes Dean J, Windecker Stephan, Cristea Ecaterina, Pietras Cody, Dressler Ovidiu, Issever M Ozgu, Curtis Michael, Bertolet Barry, Zidar James P, Smits Pieter C, Jiménez Díaz Victor Alfonso, McLaurin Brent, Brogno David A, Janssens Luc, Vrolix Mathias C, Gómez-Blázquez Iván, Sahul Zakir H, Kabour Ameer, Salido Luisa, Cleman Michael, Saito Shigeru, Leon Martin B, Baumbach Andreas, PIONEER III Trial Investigators
Аннотация
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, 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).
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.
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, 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).
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.