Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy
oleh: Kush P. Patel, MBBS, Alexandra J. Lansky, MD, Dean J. Kereiakes, MD, Stephan Windecker, MD, Ecaterina Cristea, MD, Cody Pietras, BA, Ovidiu Dressler, MD, M. Ozgu Issever, MS, Michael Curtis, MD, Barry Bertolet, MD, James P. Zidar, MD, Pieter C. Smits, MD, Victor Alfonso Jiménez Díaz, MD, Brent McLaurin, MD, David A. Brogno, MD, Luc Janssens, MD, Mathias C. Vrolix, MD, Iván Gómez-Blázquez, MD, Zakir H. Sahul, MD, Ameer Kabour, MD, Luisa Salido, MD, Michael Cleman, MD, Shigeru Saito, MD, Martin B. Leon, MD, Andreas Baumbach, MD
| Format: | Article |
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| Diterbitkan: | Elsevier 2022-01-01 |
Deskripsi
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.