This prospective, randomized, multicenter, investigator-initiated non-inferiority study compared the use of sirolimus-coated balloon (MagicTouch) vs paclitaxel-coated balloon in endovascular treatment.
The primary objective was to assess patency and a composite outcome of target vessel revascularization (TVR), major amputation, and procedure- or device-related death over a 12-month follow-up.
A total of 842 patients were enrolled between April 2021 and September 2022 across 25 clinics in Germany and Austria, with follow-up at one year.
Lesions averaged 84 ± 61 mm in length; 34% of them were chronic total occlusions (CTO), and 45% had grade 3 calcification per PACSS classification. Bailout stenting was required in 23% of cases.
Primary patency was assessed through Doppler ultrasound, which showed a 73.8% primary success rate (primary endpoint) for the sirolimus-coated balloon group vs 75% for the paclitaxel-coated balloon, with a difference of -1.2% (95% confidence interval [CI]: -9.7% to 7.4%, P for non-inferiority = 0.022).
Regarding safety outcomes, there was a 2.1% difference in adverse events (95% CI: -3.2% to 7.5%, P for non-inferiority = 0.003), with no mortality events. Freedom from re-intervention was 92.9% in the sirolimus group vs 95.4% in the paclitaxel group (log rank = 0.58).
The authors concluded that, in this direct comparison, sirolimus- and paclitaxel-coated balloons showed comparable results, thus achieving non-inferiority.
Presented by Ulf Teichgräber in the Late-Breaking Trials Sessions, TCT 2024, October 27-29, Washington, USA.
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