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.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Chronic Angina
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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