[Safety and effectiveness of a novel spiral-scored balloon catheter in percutaneous coronary intervention]

Objective: Evaluate the short-term safety and effectiveness of a novel helical scoring balloon catheter in the treatment of coronary lesions during percutaneous coronary intervention (PCI). Methods: This study employed a multicenter, prospective, randomized controlled non-inferiority trial design. Led by the General Hospital of Northern Theater Command, it enrolled 207 patients scheduled for PCI across three centers between October 2021 and March 2022. Patients were randomized 1∶1 to the spiral-scored balloon group (n=104) or the ScoreFlex balloon group (n=103) with 30-day follow-up. The primary endpoint was device success rate, defined as successful delivery to the target lesion, normal inflation and deflation, successful withdrawal, and residual stenosis ≤50.0% after pre-ballooning. The non-inferiority margin was set at -9.0%. Secondary endpoints included procedure success rate, 30-day target lesion failure, and patient-oriented cardiovascular clinical composite endpoint. The incidence of non-device-related adverse events and device-related complications was also assessed in both groups. Results: The spiral-scored balloon group had an average age of (60.1±9.3) years, with 69 males (66.3%). The ScoreFlex balloon group had an age of (61.2±9.0) years, with 74 males (71.8%). For the primary endpoint, the device success rate was 98.1% (102/104) in the spiral-scored balloon group and 100.0% (103/103) in the ScoreFlex balloon group. The lower limit of the 95%CI for the rate difference was -4.6%, exceeding the non-inferiority margin of -9.0%, confirming non-inferiority (P<0.001). For secondary endpoints, the procedure success rates were 100.0% in both groups. Neither group experienced the 30-day target lesion failure or patient-reported cardiovascular clinical composite endpoint. Safety analysis showed the incidence of non-device-related adverse events was 1.9% (2/104) in the spiral-scored balloon group and 2.9% (3/103) in the ScoreFlex balloon group, with no statistically significant difference (P=0.683). No device-related complications occurred in either group. Conclusions: The novel spiral scoring balloon catheter was noninferior to the ScoreFlex scoring balloon for device success and demonstrated favorable 30-day safety and effectiveness, supporting its use as an option for coronary lesion preparation during PCI.