Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 - ISAR-DESIRE 4

Description:

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.

Study Design

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%

Inclusion criteria:

  • Stenosis >50% in “limus”-eluting DES
  • Symptoms/signs of ischemia

Exclusion criteria:

  • Lesion in left main stem
  • Acute ST-segment elevation myocardial infarction (STEMI)
  • Cardiogenic shock

Principal Findings:

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.

Secondary outcomes:

  • 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

Interpretation:

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.

References:

Presented by Dr. Robert A. Byrne at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 14, 2015.


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