Treatment of coronary artery disease with sirolimus- versus paclitaxel-coated balloons

Abstract

Abstract Background Percutaneous coronary interventions (PCI) with paclitaxel-coated balloons (PCB) represent an established treatment for in-stent restenosis (ISR) and small coronary arteries. Lately sirolimus-coated balloons (SCB) have been introduced. Yet, studies comparing SCBs to PCBs are lacking. Purpose We sought to assess clinical outcomes at 12 months of an all-comer population presenting with acute or chronic coronary artery disease (CAD) treated with either a novel SCB or an established PCB. Methods We analyzed consecutive patients from the ongoing prospective SIROOP registry (NCT:04988685). Outcomes of interest included, target lesion failure (TLF), target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiac-death (cv-death). All angiograms and outcomes were independently adjudicated. Results A total of 359 patients were included in this analysis, 220 (61%) and 139 (39%) patients were treated with SCBs and PCBs, respectively. Diabetes was present in 108 (30%) of patients and 145 (40%) patients presented with an acute coronary syndrome. The mean Syntax score of the overall population was 17.8±11, 95 (26%) of the lesions were ISR, 30 (8.4%) chronic total occlusions (CTOs) and 211 (59%) had moderate to severe calcifications. All lesions were treated with a DCB-only approach in both groups. Mean DCB diameter was 2.8±0.56 mm and the maximal mean dilatation pressure was 8.1±4.7 atm. We encountered no relevant coronary artery perforations or acute vessel closures. Further baseline and procedural characteristics can be found in Figure 1. At 1-year follow-up, there was no statistically significant difference in the TLF rate between patients treated with SCBs versus PCBs (14 (7.4%) versus 12 (10%), respectively, (p=0.5)), with TLR being the leading cause for TLF (13 (6.8%) in the SCB and 10 (8.8%) in the PCB group, p=0.7). Figure 2 depicts the Kaplan-Meier curve of TLF over time. The leading TLF cause appeared to be lesion recoil/ collapse in both groups. Comparing ISR lesions treated with SCBs versus PCBs, there was also no significant difference with regards to the TLF rate (3 (9.1%) versus 4 (8.2%), respectively, p=1.00). Conclusions To our best knowledge, this is one of the first studies comparing SCBs to PCBs for treatment of CAD. At 1-year follow-up, there was no significant difference in outcomes between the two groups. Moreover, there was a numerically lower number of adverse events among patients treated with SCBs. These findings warrant further investigation in a dedicated randomized trial.Baseline and procedural characteristicsKaplan-Meier curve of TLF