TOPLINE: 

A sirolimus drug-eluting balloon performed similarly to a usual care strategy (mostly drug-eluting stents and balloon angioplasty used in fewer cases) in patients with coronary in-stent restenosis with one or two prior bare metal or drug-eluting stents at 1 year. However, it did not match the performance of drug-eluting stents alone in patients with single-layer in-stent restenosis.

METHODOLOGY:

• A multicenter randomized controlled trial evaluated the efficacy and safety of a novel sirolimus-eluting balloon for coronary in‑stent restenosis.
• The study enrolled 418 patients with myocardial ischemia who underwent percutaneous coronary intervention for a single lesion within a prior bare metal or drug‑eluting stent in a native coronary artery between July 2020 and July 2024. The median age was 69 years, and 22% were women.
• Participants were randomly assigned to receive a sirolimus drug-eluting balloon (n = 210) or usual care control treatment (n = 208), which included any approved drug-eluting stent in 80% of patients and balloon angioplasty in up to 20%. A total of 390 patients (197 in the drug-eluting balloon group, 193 in usual care group) were included in the per protocol analysis. Participants were followed up for 12 months.
• The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) assessed at 12 months in the per protocol group). Noninferiority was established if the upper bound of the two-sided 95% credible interval (CrI) for the difference between sirolimus-eluting balloon and usual care control treatment was smaller than 10%.

TAKEAWAY:

• At 12 months, target lesion failure occurred in 16.2% of patients in the sirolimus‑eluting balloon group and in 14.5% of those in the control group (difference, 1.7%; 95% CrI, -5.5% to 8.9%; posterior probability of noninferiority, 98.80%), meeting the prespecified noninferiority criterion.
• Among patients with single-layer in-stent restenosis, target lesion failure occurred in 14.2% of patients who received a sirolimus‑eluting balloon vs 6.5% of patients who received drug-eluting stents (difference, 7.7%; 95% CrI, 0.6%–14.6%; posterior probability of noninferiority, 76.07%), failing to meet the noninferiority criterion.
• Target lesion failure according to operator-selected control was higher with sirolimus-eluting balloon than with drug-eluting stents (15.3% vs 7.1%; difference, 8.1%) but lower with sirolimus-eluting balloon than with balloon angioplasty (23.6% vs 43.6%; difference, -23.7%; P for interaction = .0026).
• Overall safety outcomes (rates of mortality, myocardial infarction, stent thrombosis, and bleeding) were comparable between treatment groups at 12 months.

IN PRACTICE:

“The secondary comparison of DEB [drug-eluting balloon] vs DES [drug-eluting stent] is especially important. Even though, as expected, selection of DES was limited almost exclusively to single-layer ISR [in-stent restenosis], the outstanding performance of DES in this subgroup has clinical implications for treatment of initial ISR,” the researchers wrote.

SOURCE:

The study was led by Donald E. Cutlip, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston. It was published online April 15 in Journal of the American College of Cardiology.

LIMITATIONS: 

The study excluded patients with more than two stent layers, limiting the generalizability of the findings. The researchers used a blended control group to reflect US practice, which limited balloon angioplasty to 20% of the study group. Outcomes were reported through 1 year, and potential longer‑term differences could not be ruled out.

DISCLOSURES:

The study received funding and research contract support from Cordis through its affiliate, MA MedAlliance SA. Some authors disclosed receiving research funding/contracted research funding paid to their institutions, salary support, research funding, honoraria, and consulting fees from multiple organizations and industries.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.