Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions - SCB vs PCB in ISR

Contribution To Literature:

The SCB vs PCB in ISR trial showed that sirolimus-coated balloon angioplasty was noninferior compared with paclitaxel-coated balloon angioplasty for coronary in-stent restenosis.

Description:

The goal of the trial was to evaluate sirolimus-coated balloon angioplasty compared with paclitaxel-coated balloon angioplasty among patients with coronary in-stent restenosis.

Study Design

  • Randomization
  • Parallel

Participants with drug-eluting stent in-stent restenosis were randomized to sirolimus-coated balloon angioplasty (sirolimus 4 μg/mm2) (n = 50) versus paclitaxel-coated balloon angioplasty (paclitaxel 3 μg/mm2) (n = 51).

This research combined two parallel randomized trials; the FIM Malaysian and German-Swiss trials.

  • Total number of enrollees: 101
  • Duration of follow-up: 6 months
  • Mean patient age: 63 years
  • Percentage female: 24%
  • Percentage with diabetes: 59%

Inclusion criteria:

  • Patients with drug-eluting stent in-stent restenosis

Principal Findings:

The primary outcome, angiographic in-lesion late lumen loss at 6 months, was 0.30 mm in the sirolimus-coated balloon angioplasty group compared with 0.30 mm in the paclitaxel-coated balloon angioplasty group (p = not significant [NS]).

Secondary outcomes: Angiographic in-segment late lumen loss at 6 months was 0.26 mm in the sirolimus-coated balloon angioplasty group compared with 0.25 mm in the paclitaxel-coated balloon angioplasty group (p = NS).

Interpretation:

Among patients with drug-eluting stent in-stent restenosis, sirolimus-coated balloon angioplasty was noninferior compared with paclitaxel-coated balloon angioplasty. Outside of the United States, paclitaxel-coated balloon angioplasty is the treatment of choice for drug-eluting stent in-stent restenosis.

References:

Presented by Dr. Bruno Scheller at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, Orlando, FL, November 6, 2021.

Keywords: Angina, Stable, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Coronary Restenosis, Drug-Eluting Stents, Myocardial Ischemia, Paclitaxel, Sirolimus, Stents, TCT21, Transcatheter Cardiovascular Therapeutics


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