03251nam a2200277   4500001000800000007000300008008004100011040000800052041000800060100003400068245007400102300002300176520233500199650002502534650005202559650002402611700003402635700002502669700003502694700003302729700002602762700002702788773011002815942003102925999001702956ESSALUDta      t        pe ||||| |||| 00| 0 spa d  aBMG  aeng  aBarco, Stefano eAutor954060  aSirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease  apáginas: 561-570  aBackground: 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.   aCARDIOLOGÍA911301  aENFERMEDAD ARTERIAL PERIFÉRICA AORTICA954061  aANGIOPLASTIA937212  aEngelberger, Rolf P.  954062  aHeld, Ulrike 954063  aFumagalli, Riccardo M. 954064  aGrigorean, Alexandru 954065  aHayoz, Daniel 954066  aMünger, Mario9540670 022717922644dMassachusetts NEJM GroupoNEJM009tThe New England Journal of Medicine wESSALUDx0028-4793  cARTICULOSe2026-08-14zSQB  c22814d22814