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News
Three new studies presented at VIVA 2026 bolster the case for sirolimus drug-coated balloons (DCBs) in treating peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI). The data show clear biological efficacy, fewer amputations, and lower rates of repeat procedures compared to uncoated balloons — and raise the prospect of sirolimus becoming a leading alternative to paclitaxel as the go-to DCB drug.
Three studies presented at the VIVA 2026 meeting in Las Vegas are strengthening the case for sirolimus-eluting drug-coated balloons (DCBs) as a frontline treatment for lower-extremity peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI). The data — drawn from the SirPAD trial, the SELUTION4SFA trial, and a large international postmarket registry — collectively show that sirolimus DCBs outperform uncoated balloons on both efficacy and safety endpoints, including hard outcomes like amputation rates.
One of the more intriguing findings: sirolimus doesn't appear to show the ~10% year-over-year drop-off in patency rates typically seen with paclitaxel, which experts say could be a meaningful long-term advantage. Meanwhile, paclitaxel's position is weakening in Europe following renewed safety concerns and updated guidelines that now limit its use to select cases only.
By the Numbers:
Why it matters: With paclitaxel facing safety scrutiny and supply challenges in Europe, sirolimus DCBs are emerging as a credible — and potentially superior — alternative. These findings could accelerate regulatory approvals and reshape treatment algorithms for millions of patients with PAD and CLTI worldwide.
