Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

Abstract

Background: Acute coronary syndromes most commonly arise from thrombosis of lipid-rich coronary atheromas that have large plaque burden despite angiographically appearing mild.

Objectives: This study sought to examine the outcomes of percutaneous coronary intervention (PCI) of non-flow-limiting vulnerable plaques.

Methods: Three-vessel imaging was performed with a combination intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) catheter after successful PCI of all flow-limiting coronary lesions in 898 patients presenting with myocardial infarction (MI). Patients with an angiographically nonobstructive stenosis not intended for PCI but with IVUS plaque burden of ≥65% were randomized to treatment of the lesion with a bioresorbable vascular scaffold (BVS) plus guideline-directed medical therapy (GDMT) versus GDMT alone. The primary powered effectiveness endpoint was the IVUS-derived minimum lumen area (MLA) at protocol-driven 25-month follow-up. The primary (nonpowered) safety endpoint was randomized target lesion failure (cardiac death, target vessel-related MI, or clinically driven target lesion revascularization) at 24 months. The secondary (nonpowered) clinical effectiveness endpoint was randomized lesion-related major adverse cardiac events (cardiac death, MI, unstable angina, or progressive angina) at latest follow-up.

Results: A total of 182 patients were randomized (93 BVS, 89 GDMT alone) at 15 centers. The median angiographic diameter stenosis of the randomized lesions was 41.6%; by near-infrared spectroscopy-IVUS, the median plaque burden was 73.7%, the median MLA was 2.9 mm2, and the median maximum lipid plaque content was 33.4%. Angiographic follow-up at 25 months was completed in 167 patients (91.8%), and the median clinical follow-up was 4.1 years. The follow-up MLA in BVS-treated lesions was 6.9 ± 2.6 mm2 compared with 3.0 ± 1.0 mm2 in GDMT alone-treated lesions (least square means difference: 3.9 mm2; 95% confidence interval: 3.3 to 4.5; p < 0.0001). Target lesion failure at 24 months occurred in similar rates of BVS-treated and GDMT alone-treated patients (4.3% vs. 4.5%; p = 0.96). Randomized lesion-related major adverse cardiac events occurred in 4.3% of BVS-treated patients versus 10.7% of GDMT alone-treated patients (odds ratio: 0.38; 95% confidence interval: 0.11 to 1.28; p = 0.12).

Conclusions: PCI of angiographically mild lesions with large plaque burden was safe, substantially enlarged the follow-up MLA, and was associated with favorable long-term clinical outcomes, warranting the performance of an adequately powered randomized trial. (PROSPECT ABSORB [Providing Regional Observations to Study Predictors of Events in the Coronary Tree II Combined with a Randomized, Controlled, Intervention Trial]; NCT02171065).

Keywords: bioresorbable scaffold; coronary artery disease; prognosis; stent; vulnerable plaque.

Conflict of interest statement

Author Relationships With Industry This study was supported by Abbott Vascular, Santa Clara, California; Infraredx, Bedford, Massachusetts; and The Medicines Company, Parsippany, New Jersey. The sponsor was the Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden. The trial was funded by research grants from Abbott Vascular, Infraredx (Burlington, Massachusetts), and The Medicines Company (Parsippany, New Jersey). The funding sources were uninvolved in any study processes, including trial design, site selection and management, data collection and analysis, and manuscript preparation. The study chairs (G.W.S. and D.E.) had complete access to all study data, vouch for the trial integrity, and controlled the decision to publish. Dr. Stone has received grants to the Cardiovascular Research Foundation from Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden for core laboratory and data center analyses; has received speaker honoraria from Terumo and Cook; has served as a consultant for TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions, Matrizyme, Miracor, Neovasc, V-wave, Abiomed, Shockwave, MAIA Pharmaceuticals, Vectorious, Spectrawave, Valfix, Ancora, and Cardiomech; holds equity/options in Applied Therapeutics, the Biostar family of funds, the MedFocus family of funds, Aria, Cardiac Success, Cagent, SpectraWave, Valfix, Ancora, Orchestra Biomed, and Qool Therapeutics; and has received honoraria from Orchestra Biomed and Qool Therapeutics. Dr. Maehara has received institutional research grants and served as a consultant for Boston Scientific and Abbott Vascular. Dr. Ali has served on the Speakers Bureau for AstraZeneca; has received institutional grants from Abbott and Cardiovascular Systems Inc; has received lecture fees from Amgen; has given scientific advisory/educational lectures for Boston Scientific; and holds equity in Shockwave Medical. Dr. Held has received grants from Uppsala Clinical Research Center for the clinical endpoint adjudication committee. Mr. Matsumura has served as a consultant for Terumo. Dr. Maeng has received personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Boston Scientific, and Novo Nordisk. Dr Engstrøm has received speaker fees/served on the Advisory Boards of Novo Nordisk, Bayer, and Abbott. Dr. Persson has received an unrestricted research grant and personal fee for lecturing from Abbott Vascular. Dr. Trovik has served as a proctor on chronic total occlusion procedures for Boston Scientific. Dr. Mintz has received honoraria from Boston Scientific, Medtronic, Philips/Volcano, and Terumo. Dr. Ben-Yehuda has received grants to the Cardiovascular Research Foundation from Uppsala Clinical Research Center, Uppsala University Hospital, Uppsala, Sweden for core laboratory and data center analyses. Dr. Erlinge has received speaker fees from Amgen, AstraZeneca, Bayer, and Chiesi; and has served on the Advisory Boards of Bayer, Boehringer Ingelheim, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.