MedStar Authors catalog › Details for: Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The Disrupt CAD III Study.
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Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease: The Disrupt CAD III Study.

by Waksman, Ron.
Citation: Journal of the American College of Cardiology. 76(22):2635-2646, 2020 12 01.; .Journal: Journal of the American College of Cardiology.Published: 2020; ; ; ISSN: 0735-1097.Full author list: Bachinsky W; Herrmann HC; Hill JM; Kereiakes DJ; Klein AJ; Price MJ; Riley RF; Shlofmitz RA; Stone GW; Waksman R.UI/PMID: 33069849.Subject(s): *Coronary Artery Disease | *Coronary Stenosis | *Endovascular Procedures | *Equipment Design | *Lithotripsy | *Percutaneous Coronary Intervention | *Vascular Calcification | Aged | Coronary Angiography/mt [Methods] | Coronary Artery Disease/di [Diagnosis] | Coronary Artery Disease/su [Surgery] | Coronary Stenosis/dg [Diagnostic Imaging] | Coronary Stenosis/su [Surgery] | Endovascular Procedures/is [Instrumentation] | Endovascular Procedures/mt [Methods] | Female | Humans | Lithotripsy/is [Instrumentation] | Lithotripsy/mt [Methods] | Male | Percutaneous Coronary Intervention/is [Instrumentation] | Percutaneous Coronary Intervention/mt [Methods] | Severity of Illness Index | Stents | Tomography, Optical Coherence/mt [Methods] | Treatment Outcome | Vascular Calcification/dg [Diagnostic Imaging] | Vascular Calcification/su [Surgery]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: (Click here) Abbreviated citation: J Am Coll Cardiol. 76(22):2635-2646, 2020 12 01; .Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007.Abstract: BACKGROUND: Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment.Abstract: CONCLUSIONS: Coronary IVL safely and effectively facilitated stent implantation in severely calcified lesions. Copyright (c) 2020 The Authors. Published by Elsevier Inc. All rights reserved.Abstract: METHODS: Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter study designed for regulatory approval of coronary IVL. The primary safety endpoint was freedom from major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success. Both endpoints were compared to a pre-specified performance goal (PG). The mechanism of calcium modification was assessed in an optical coherence tomography (OCT) sub-study.Abstract: OBJECTIVE: To assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions.Abstract: RESULTS: Patients (n=431) were enrolled at 47 sites in four countries. The primary safety endpoint of the 30-day freedom from MACE was 92.2%; the lower bound of the 95% confidence interval (CI) was 89.5% which exceeded the PG of 84.4% (P<0.0001). The primary effectiveness endpoint of procedural success was 92.4%; the lower bound of the 95% CI was 90.2% which exceeded the PG of 83.4% (P<0.0001). Mean calcified segment length was 47.9+/-18.8 mm, calcium angle was 292.5+/-76.5degree and calcium thickness was 0.96+/-0.25 mm at the site of maximum calcification. OCT demonstrated multi-plane and longitudinal calcium fractures after IVL in 67.4% of lesions. Minimum stent area was 6.5 +/- 2.1mm2 and was similar regardless of demonstrable fractures on OCT.

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