The New England journal of medicine · 2026
Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease.
СтатьяРандомизированное исследованиеEquivalence TrialМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Barco Stefano, Engelberger Rolf P, Held Ulrike, Fumagalli Riccardo M, Grigorean Alexandru, Hayoz Daniel, Münger Mario, Sebastian Tim, Stadler Roman, Voci Davide, Wolf Simon, Baumann Frédéric, Tritschler Tobias, von Stempel Conrad, Périard Daniel, Kucher Nils, SirPAD Investigators
Аннотация
BACKGROUND: Whether sirolimus-coated balloon angioplasty for infrainguinal artery disease reduces the incidence of major adverse limb events remains unknown.
METHODS: In this prospective, open-label, noninferiority trial with a prespecified sequential testing strategy for superiority and blinded outcome adjudication, we randomly assigned patients with infrainguinal artery disease in a 1:1 ratio to undergo angioplasty with a sirolimus-coated balloon or with an uncoated balloon. The primary outcome was a composite of unplanned major amputation affecting the target limb or endovascular or surgical revascularization of the target lesion for critical limb ischemia within 1 year after randomization. The key secondary outcome was a composite of any unplanned amputation affecting the target limb or revascularization of the target lesion for critical or noncritical limb ischemia within 1 year after randomization. The noninferiority margin was 5 percentage points. The primary safety outcome was death from any cause within 1 year after randomization.
RESULTS: A total of 1252 patients were enrolled in the trial: 626 patients were assigned to the sirolimus-coated-balloon group and 626 to the uncoated-balloon group. The median age of the patients was 75 years, and 35.1% were women. A primary-outcome event occurred in 55 patients (8.8%) in the sirolimus-coated-balloon group and in 94 patients (15.0%) in the uncoated-balloon group (median unbiased estimate of risk difference, -4.9 percentage points; 95% confidence interval [CI], -8.5 to -1.3; P<0.001 for noninferiority; P = 0.009 for superiority); a key secondary-outcome event occurred in 144 patients (23.0%) and 193 patients (30.8%), respectively (risk difference, -7.8 percentage points; 95% CI, -12.7 to -2.9; P = 0.002). Death occurred in 74 patients (11.8%) in the sirolimus-coated-balloon group and in 80 patients (12.8%) in the uncoated-balloon group (risk difference, -1.0 percentage points; 95% CI, -4.6 to 2.7; P = 0.67). The incidence of adverse events appeared to be similar in the two groups.
CONCLUSIONS: Among patients with infrainguinal artery disease undergoing endovascular treatment, angioplasty with sirolimus-coated balloons led to a lower incidence of major adverse limb events at 1 year than angioplasty with uncoated balloons. (Funded by Concept Medical and others; SirPAD ClinicalTrials.gov number, NCT04238546.).
METHODS: In this prospective, open-label, noninferiority trial with a prespecified sequential testing strategy for superiority and blinded outcome adjudication, we randomly assigned patients with infrainguinal artery disease in a 1:1 ratio to undergo angioplasty with a sirolimus-coated balloon or with an uncoated balloon. The primary outcome was a composite of unplanned major amputation affecting the target limb or endovascular or surgical revascularization of the target lesion for critical limb ischemia within 1 year after randomization. The key secondary outcome was a composite of any unplanned amputation affecting the target limb or revascularization of the target lesion for critical or noncritical limb ischemia within 1 year after randomization. The noninferiority margin was 5 percentage points. The primary safety outcome was death from any cause within 1 year after randomization.
RESULTS: A total of 1252 patients were enrolled in the trial: 626 patients were assigned to the sirolimus-coated-balloon group and 626 to the uncoated-balloon group. The median age of the patients was 75 years, and 35.1% were women. A primary-outcome event occurred in 55 patients (8.8%) in the sirolimus-coated-balloon group and in 94 patients (15.0%) in the uncoated-balloon group (median unbiased estimate of risk difference, -4.9 percentage points; 95% confidence interval [CI], -8.5 to -1.3; P<0.001 for noninferiority; P = 0.009 for superiority); a key secondary-outcome event occurred in 144 patients (23.0%) and 193 patients (30.8%), respectively (risk difference, -7.8 percentage points; 95% CI, -12.7 to -2.9; P = 0.002). Death occurred in 74 patients (11.8%) in the sirolimus-coated-balloon group and in 80 patients (12.8%) in the uncoated-balloon group (risk difference, -1.0 percentage points; 95% CI, -4.6 to 2.7; P = 0.67). The incidence of adverse events appeared to be similar in the two groups.
CONCLUSIONS: Among patients with infrainguinal artery disease undergoing endovascular treatment, angioplasty with sirolimus-coated balloons led to a lower incidence of major adverse limb events at 1 year than angioplasty with uncoated balloons. (Funded by Concept Medical and others; SirPAD ClinicalTrials.gov number, NCT04238546.).