@article{97f72146617f40aaae0d43f57daa6e0e,
title = "Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study",
abstract = "Background: The SVELTE fixed-wire and rapid exchange bioresorbable-polymer sirolimus-eluting coronary stent systems (SVELTE sirolimus-eluting stent [SES]) are novel, low-profile devices designed to facilitate direct stenting, transradial access, and enhance procedural efficiencies. Methods: Eligible subjects (N=1639) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction or stable coronary artery disease were randomly assigned (1:1) to treatment with either SVELTE SES or a control durable polymer everolimus-eluting coronary stent. The primary end point was 12-month target lesion failure and a noninferiority margin was specified as 3.58% with an expected event rate of 6.5%. Results: Target lesion failure was observed in 10.3% of SVELTE SES and 9.5% of control everolimus-eluting stent subjects under intention to treat analysis (difference=0.8%; PNI=0.034). Clinically indicated target lesion revascularization and stent thrombosis were observed in 1.5% versus 1.9% (P=0.57) and 0.38% versus 0.51% (P=0.72) of SVELTE SES versus control everolimus-eluting stent-treated subjects, respectively. Protocol-defined target vessel myocardial infarction (9.4% versus 8.2%) was higher than anticipated and more frequent at sites that utilized troponin versus creatine kinase myocardial band assays. Conclusions: The SVELTE SES did not meet the prespecified threshold for noninferiority. Unexpectedly, high rates of target vessel myocardial infarction in both treatment groups contributed to higher than expected rates of target lesion failure, effectively underpowering the study. No differences between the SVELTE SES and control everolimus-eluting stent were observed for primary clinical or angiographic end point events.",
keywords = "drug-eluting stent, everolimus, percutaneous coronary intervention, polymer, sirolimus",
author = "Kereiakes, {Dean J.} and Feldman, {Robert L.} and Ijsselmuiden, {A. J.J.} and Shigeru Saito and Giovanni Amoroso and Zidar, {James P.} and Wong, {S. Chiu} and Pieter Stella and Steven Yakubov and John Lasala and Cohen, {David J.} and Gheorghe Doros and Cutlip, {Donald E.} and Rao, {Sunil V.}",
note = "Funding Information: Dr Kereiakes reports modest consulting fees from SINO Medical Sciences Technologies, Inc, significant consulting fees from Boston Scientific Corporation, Elixir Medical, Inc, Svelte Medical Systems, Inc, Caliber Therapeutics/Orchestra Biomed, Shockwave, and is a major stock shareholder/equity for Ablative Solutions, Inc. Dr Feldman is a minor stock shareholder for Boston Scientific, serves on the medical advisory board for Boston Scientific and reports modest consulting fees from Orchestra Biomed. Dr Saito reports consulting and speaking honoraria from Shockwave Medical, Elixir, TERUMO, and Japan Lifeline and speaking honoraria from Daiichi Sankyo Pharmaceuticals. Dr Zidar serves on medical advisory boards for Abbot and Medtronic. Dr Wong serves on the medical advisory boards of Abbott Vascular, Boston Scientific, and Medtronic. Dr Yakubov serves on the medical advisory boards of Boston Scientific and Medtronic. Dr Cohen reports research grant funding and consulting fees from Svelte, Inc, Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Corvia Medical. Dr Cutlip reports research funding from Celonova and Boston Scientific. The other authors report no conflicts. Funding Information: The OPTIMIZE study (The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study) was sponsored and funded by Svelte Medical Systems, Inc. Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",
year = "2021",
month = sep,
day = "1",
doi = "10.1161/CIRCINTERVENTIONS.121.010609",
language = "English",
volume = "14",
pages = "E010609",
journal = "Circulation: Cardiovascular Interventions",
issn = "1941-7640",
number = "9",
}