期刊
JACC-CARDIOVASCULAR INTERVENTIONS
卷 14, 期 12, 页码 1337-1348出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jcin.2021.04.015
关键词
coronary artery disease; patient-level pooled analysis; calcification
资金
- Amgen
- Behring
- Chiesi
- DaiichiSanyo
- Edwards Lifesciences
- Medtronic
- Shockwave
- Volcano Philips
- National Heart, Lung, and Blood Institute
- Abbott Vascular
- Cardiovascular Systems
- Boston Scientific
- Abiomed
- Shockwave Medical
The pooled analysis of coronary intravascular lithotripsy (IVL) demonstrated high safety and effectiveness in severely calcified coronary lesions. Results showed that 92.7% of patients achieved the primary safety endpoint and 92.4% achieved the primary effectiveness endpoint within 30 days. The study concluded that IVL successfully facilitated stent implantation with a low rate of complications in this patient population.
OBJECTIVES The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). BACKGROUND The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]). METHODS Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis #30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days. RESULTS Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 +/- 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow. CONCLUSIONS In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success. (J Am Coll Cardiol Intv 2021;14:1337-48) (c) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
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