Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:76

Article

Stone, Gregg W.^1,2  Maehara, Akiko^2,3  Ali, Ziad A.^2,3  Held, Claes^4,5  Matsumura, Mitsuaki²  Kjoller-Hansen, Lars⁶  Botker, Hans Erik⁷  Maeng, Michael⁷  Engstrom, Thomas⁸  Wiseth, Rune⁹  Persson, Jonas¹⁰  Trovik, Thor¹¹  Jensen, Ulf¹²  James, Stefan K.^4,5  Mintz, Gary S.²  Dressler, Ovidiu²  Crowley, Aaron²  Ben-Yehuda, Ori^2,13  Erlinge, David¹⁴ 

[1] Icahn Sch Med Mt Sinai, Zena & Michael A Wiener Cardiovasc Inst, New York, NY 10029 USA

[2] Cardiovasc Res Fdn, New York, NY USA

[3] Columbia Univ, NewYork Presbyterian Hosp, Irving Med Ctr, New York, NY USA

[4] Uppsala Univ, Uppsala, Sweden

[5] Uppsala Clin Res, Uppsala, Sweden

[6] Zealand Univ Hosp, Roskilde, Denmark

[7] Aarhus Univ Hosp, Aarhus, Denmark

[8] Univ Copenhagen, Copenhagen, Denmark

[9] Trondheim Reg & Univ Hosp, St Olavs Hosp, Trondheim, Norway

[10] Karolinska Inst, Danderyd Hosp, Stockholm, Sweden

[11] Univ Hosp North Norway, Tromso, Norway

[12] Sodersjukhuset AB, Stockholm, Sweden

[13] Univ Calif San Diego, San Diego, CA 92103 USA

[14] Lund Univ, Clin Sci, Lund, Sweden

关键词: bioresorbable scaffold;    coronary artery disease;    prognosis;    stent;    vulnerable plaque;   

DOI  :  10.1016/j.jacc.2020.09.547

来源: Elsevier

【 摘 要 】

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 mm(2), 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 mm(2) compared with 3.0 +/- 1.0 mm(2) in GDMT alone-treated lesions (least square means difference: 3.9 mm(2); 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. (C) 2020 by the American College of Cardiology Foundation.

【 授权许可】

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