This was a prospective, multicenter, randomized study including 130 patients with instent restenosis treated with sirolimus coated balloons (DCB S) and 128 treated with paclitaxel coated balloons (DCB P).
Primary end point was late lumen loss (LLL) at 12 months.
There were no significant differences between the groups. Mean patient age was 63, 75% were men, 36% had diabetes, 5% had prior MI, left ventricular ejection function was preserved and the most common clinical presentation was unstable angina.
At 12 months, there were no significant differences in LLL, which was 0.35±0.47 for the DCB S group and 0.31±0.36 for the DCB P (p=0.82). Neither were there differences as regards cardiac death, long term treatment failure (TLF) or ischemia driven revascularization.
Read also: TCT 2023 | T-PASS TRIAL, ASA and Ticagrelor in Acute Coronary Syndrome.
In conclusion, the study authors determined sirolimus drug coated balloons are non-inferior to paclitaxel coated balloons.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Presented by Yaling Han during TCT 2023.
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