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. 2022 Jan 30;1(1):100004.
doi: 10.1016/j.jscai.2021.100004. eCollection 2022 Jan-Feb.

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

Kush P Patel  1   2 , Alexandra J Lansky  3   4 , Dean J Kereiakes  5 , Stephan Windecker  6 , Ecaterina Cristea  3 , Cody Pietras  3 , Ovidiu Dressler  7 , M Ozgu Issever  7 , Michael Curtis  8 , Barry Bertolet  9 , James P Zidar  10 , Pieter C Smits  11 , Victor Alfonso Jiménez Díaz  12 , Brent McLaurin  13 , David A Brogno  14 , Luc Janssens  15 , Mathias C Vrolix  16 , Iván Gómez-Blázquez  17 , Zakir H Sahul  18 , Ameer Kabour  19 , Luisa Salido  20 , Michael Cleman  3 , Shigeru Saito  21 , Martin B Leon  7   14 , Andreas Baumbach  2   3   4 ; PIONEER III Trial Investigators
Affiliations

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

Kush P Patel et al. J Soc Cardiovasc Angiogr Interv. .

Abstract

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.

Keywords: Acute coronary syndrome; Coronary artery disease; Coronary revascularization; Drug-eluting stent; Percutaneous coronary intervention.

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Figures

None
Graphical abstract
Fig. 1
Fig. 1
Target Lesion Failure Between the Supreme Drug-Eluting Stent and the Durable-Polymer Everolimus-Eluting Stent Among Patients With Complex Coronary Lesions. CI, confidence interval; DES, drug-eluting stent; DP, durable polymer; EES, everolimus-eluting stent; HR, hazard ratio.
Central Illustration
Central Illustration
Summary of Trial Findings. ACC, American College of Cardiology; AHA, American Heart Association; CI, confidence interval; DES, drug-eluting stent; DP-EES, durable polymer everolimus-eluting stent; HR, hazard ratio.
See this image and copyright information in PMC

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