One-year outcomes of two RCTs of sirolimus-coated and paclitaxel-coated balloons in coronary in-stent restenosis lesions

Key Points:

• Patients undergoing PCI for in-stent restenosis (ISR) were treated with either SeQuent paclitaxel-coated balloons (the current standard of care) or SeQuent sirolimus-coated balloons. Only patients with stable angina, unstable angina, or a positive functional study were included (ie, not acute STEMI patients). Two parallel multicenter trials were performed and pooled for this analysis.
• The primary outcome was late luminal loss at 6 months. Important secondary outcomes included target lesion revascularization, stent thrombosis, all-cause death, and MI.
• Treatment with sirolimus-coated balloons was noninferior to paclitaxel-coated balloons in the primary endpoint, and there were no significant differences in the secondary outcomes. Further evidence with long-term outcomes and larger studies for clinical endpoints will be required.

Paclitaxel-coated balloons (PCB) are the current standard-of-care for the treatment of coronary in-stent restenosis (ISR) lesions. The role of other drug-coated balloons has remained unclear. The “One-year Outcomes of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions” study combined two parallel trials investigating the impact of sirolimus-coated and paclitaxel-coated balloons in cases of coronary ISR. In a breaking presentation at the 2021 Transcatheter Cardiovascular Therapeutics Conference today, Dr. Bruno Scheller and his team presented the results of these trials.

Two parallel multicenter, randomized, prospective non-inferiority clinical trials with identical study protocols were performed simultaneously across 5 centers in Malaysia and 5 in Germany and Switzerland. Patients undergoing PCI for ISR in drug-eluting stents (DES) were included. Patients were either treated with a SeQuent SCB (sirolimus-coated balloon) or SeQuent Please Neo (PCB). Adults with up to ISR lesions after DES who presented with either a) stable angina, b) unstable angina, or c) a positive functional study were included. Relevant exclusions were: a) STEMI within 72 hours, b) intolerance to either sirolimus of paclitaxel, c) CKD with Cr >2mg/dL, d) LVEF <30%, e) lesion length >3.5cm or reference vessel <2.5mm, and f) contraindication to any required post-balloon medication.

A total of 101 patients were randomized, of whom 50 received a SCB and 51 received a PCB. The number and characteristics of ISR lesions were similar between the two groups. The non-inferiority primary endpoint was late luminal loss at 6 months. Use of SCB was non-inferior to PCB at this timepoint. Relevant secondary outcomes included targeted lesion revascularization, stent thrombosis, death, MI, and MACE at one year. There was no significant difference between the SCB and PCB groups in any secondary outcomes.

When discussing the implications of the study at TCT, Dr. Scheller stated: “The SeQuent sirolimus-coated balloon was noninferior to paclitaxel-coated balloon in the primary outcome of luminal loss at 6 months…however, these findings are not applicable to other SCBs…we need longer follow-up and larger trials powered for clinical endpoints to better investigate sirolimus-coated balloons. For now, paclitaxel-coated balloons remain the standard of care.”