Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 - ISAR-DESIRE 4
This trial sought to compare balloon angioplasty techniques prior to paclitaxel-eluting balloon (PEB) use in patients with drug-eluting stent–in-stent restenosis (DES-ISR).
Contribution to the Literature: The ISAR-DESIRE 4 trial showed that scoring balloon angioplasty results in superior intermediate-term angiographic outcomes compared with standard balloon PTCA prior to PEB use in patients with DES-ISR.
Patients with DES-ISR were randomized to scoring balloon + PEB (n = 125) or standard balloon percutaneous transluminal coronary angioplasty (PTCA) + PEB (n = 127).
- Total number of enrollees: 252
- Type of DES: everolimus-eluting stent 60%, sirolimus-eluting stent 22%
- Stenosis >50% in “limus”-eluting DES
- Symptoms/signs of ischemia
- Lesion in left main stem
- Acute ST-segment elevation myocardial infarction (STEMI)
- Cardiogenic shock
The primary endpoint was diameter stenosis at follow-up angiography for scoring balloon vs. regular balloon PTCA at 6-8 months: 35% vs. 40.4%, p = 0.047.
- Restenosis: 18.5% vs. 32%, p = 0.03
- Target-lesion revascularization: 16.8% vs. 22.6%, p = 0.25
- Death/MI: 3.3% vs. 3.4%, p > 0.99
The results of this trial indicate that scoring balloon angioplasty results in superior angiographic outcomes at 6-8 months compared with standard balloon PTCA prior to PEB use in patients with DES-ISR. The trial was underpowered for clinical differences, but event rates for death/MI were low overall with both strategies at 1 year. An earlier trial, ISAR-DESIRE 3, had compared PES PCI vs. PEB use for DES-ISR lesions, and reported similar angiographic outcomes with PEB use.
Presented by Dr. Robert A. Byrne at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 14, 2015.
Keywords: Angioplasty, Balloon, Coronary, Angioplasty, Balloon, Anterior Wall Myocardial Infarction, Constriction, Pathologic, Drug-Eluting Stents, Myocardial Ischemia, Paclitaxel, Shock, Cardiogenic, Transcatheter Cardiovascular Therapeutics
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