Journal of the Society for Cardiovascular Angiography & Interventions (Jan 2022)

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

  • 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

Journal volume & issue
Vol. 1, no. 1
p. 100004

Abstract

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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.

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