Sirolimus angioplasty balloon shows promise for in-stent restenosis treatment

A sirolimus-eluting angioplasty balloon appears to be safe and effective in the treatment of patients with in-stent restenosis, according to the results of the SABRE trial published in JACC: Cardiovascular Interventions.

“Treatment of BMS [in-stent restenosis] and, increasingly, DES [in-stent restenosis] is clinically challenging,” Stefan Verheye, MD, PhD, of the Antwerp Cardiovascular Centre at ZNA Middelheim in Antwerp, Belgium, and colleagues wrote. “Recent treatment recommendations include both paclitaxel-coated balloons and current-generation limus-eluting stents, in addition to plain balloon angioplasty.”

Verheye and colleagues conducted a prospective, single-arm feasibility study at nine centers in Europe to assess the safety and efficacy of the angioplasty balloon (Virtue, Caliber Therapeutics).

The study reported the angiographic measurements of 50 patients with in-stent restenosis at 6 months, and included a 1-year follow-up.

There was a 100% procedural success rate among the intention-to-treat population, according to the study results.

The primary safety endpoint of 30-day target lesion failure, including cardiac death, target vessel MI and clinically driven target lesion revascularization, occurred in no patients, according to the researchers.

The primary performance endpoint was 6-month in-segment late lumen loss, which was 0.31 ± 0.52 mm; in the 47 patients for whom data were available.

At 6 months, binary restenosis occurred in 19.1% of patients, MACE occurred in 10.2% and diameter stenosis was a mean of 30.3 ± 19.9%.

At 6 months, the 36-patient per-protocol population late lumen loss was 0.12 ± 0.33 mm.

The intention-to-treat population outcomes at 1 year were 12.2% for TLF and 14.3% for MACE.

Results for the per-protocol population were 2.8% for both TLF and MACE.

According to the researchers, limitations to the SABRE trial, including small sample size and single-arm design, may limit applying conclusions to a broader patient population.

“The acceptable [quantitative coronary angiography] and composite clinical outcomes for the Virtue angioplasty balloon in a challenging patient population warrant further evaluation in appropriately powered clinical trials,” they wrote. – by Dave Quaile

Disclosure s : The SABRE trial was sponsored by Caliber Therapeutics. Verheye reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.