
Sirolimus-eluting balloon (SEB) failed to show noninferiority to paclitaxel-eluting balloon (PEB) for in-stent restenosis (ISR). In a randomized study (145 patients, 158 lesions), SEB did not meet the noninferiority margin for late lumen loss, except in bare-metal stent ISR. Binary ISR (31.6% vs. 30.4%) and major cardiac events (31% each) were similar. SEB's efficacy remains uncertain compared to PEB.
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