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Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial.
- Source :
-
JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2017 Jul 10; Vol. 10 (13), pp. 1332-1340. - Publication Year :
- 2017
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Abstract
- Objectives: The aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis.<br />Background: DCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy.<br />Methods: In this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year.<br />Results: Follow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year.<br />Conclusions: In patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371).<br /> (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Aged
Angioplasty, Balloon, Coronary adverse effects
Angioplasty, Balloon, Coronary mortality
Cardiovascular Agents adverse effects
Coronary Angiography
Coronary Restenosis diagnostic imaging
Coronary Restenosis etiology
Coronary Restenosis mortality
Coronary Thrombosis etiology
Female
Germany
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Infarction etiology
Neointima
Percutaneous Coronary Intervention adverse effects
Percutaneous Coronary Intervention mortality
Prosthesis Design
Therapeutics
Time Factors
Angioplasty, Balloon, Coronary instrumentation
Cardiac Catheters
Cardiovascular Agents administration & dosage
Coated Materials, Biocompatible
Coronary Restenosis therapy
Drug-Eluting Stents
Percutaneous Coronary Intervention instrumentation
Subjects
Details
- Language :
- English
- ISSN :
- 1876-7605
- Volume :
- 10
- Issue :
- 13
- Database :
- MEDLINE
- Journal :
- JACC. Cardiovascular interventions
- Publication Type :
- Academic Journal
- Accession number :
- 28683939
- Full Text :
- https://doi.org/10.1016/j.jcin.2017.04.024