Sirolimus-Coated Balloons Reduce Major Adverse Limb Events at One Year: NEJM
An open-label, prospective, large-scale trial was carried out to evaluate the benefits of coating these balloons with sirolimus, which is an antiproliferative drug. The trial followed a noninferiority approach using a superior design sequence and produced a definitive result: when compared to patients who had undergone angioplasty using plain balloons, patients who had their infrainguinal artery disease managed through angioplasty using sirolimus-coated balloons were found to have significantly fewer major adverse limb events within a year of follow-up. This trial clearly demonstrates the effectiveness of using coated drug technology in maintaining limb integrity. The study was published in The New England Journal of Medicine by Stefano B. and colleagues.
In this study, 1,252 patients with infrainguinal artery disease were selected, and each group was made up of 626 participants for either a sirolimus-coated balloon angioplasty procedure or balloon angioplasty alone. The mean age of the study participants was 75 years old, with 35.1% of the subjects being women. In addition, the investigators observed a primary composite endpoint of unplanned major amputation of the target limb or endovascular/revascularization procedure of the target lesion for critical limb ischemia within one year after enrollment. Moreover, the investigators assessed an important secondary endpoint of all unplanned amputations or revascularization procedures for critical limb ischemia and noncritical limb ischemia. To assure safety, the investigators defined a noninferiority margin of 5%, and all-cause mortality served as a primary safety endpoint.
Key findings:
The primary endpoint event was observed in 55 patients (8.8%) among the sirolimus-coated group whereas the same event occurred in 94 patients (15.0%) among the uncoated group.
Consequently, there was a median unbiased estimate of risk difference of -4.9 percentage points (95% confidence interval of -8.5 to -1.3) that led to p value of less than 0.001 in terms of non-inferiority and 0.009 for superiority.
Also, in relation to the secondary endpoint, 144 (23.0%) patients had event occurrence among the sirolimus coated group whereas 193 (30.8%) patients experienced the secondary outcome event, showing that the risk difference was -7.8 percentage points (95% confidence interval, -12.7 to -2.9; P = 0.002).
Safety issues were highly considered throughout the one year follow-up period.
There were no differences noted between the two groups in terms of the mortality rate which was noted in 74 (11.8%) among the sirolimus-coated and 80 (12.8%) among the uncoated balloon group.
It is thus evident that the use of sirolimus-coated balloon angioplasty is indeed a major improvement when it comes to the endovascular approach to treating infrainguinal artery disease. In addition to an equivalent level of safety and high efficiency, this technique could become a crucial element in managing the problem of limb loss among older patients.
Reference:
Barco, S., Engelberger, R. P., Held, U., Fumagalli, R. M., Grigorean, A., Hayoz, D., Münger, M., Sebastian, T., Stadler, R., Voci, D., Wolf, S., Baumann, F., Tritschler, T., von Stempel, C., Périard, D., Kucher, N., & SirPAD Investigators (2026). Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. The New England journal of medicine, 10.1056/NEJMoa2600360. Advance online publication. https://doi.org/10.1056/NEJMoa2600360
