Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial.

Background: Scoring balloon angioplasty catheters are designed to induce high focal stress at low inflation pressure for better lesion modification. We aimed to assess the effectiveness and safety of a newly developed Wedge NC scoring balloon catheter compared to the ScoreFlex coronary dilatation catheter for treating coronary artery lesions.

Methods: The Wedge NC trial was a prospective, multicenter, open-label, randomized controlled non-inferiority trial conducted during August 2021 and February 2022. There were 198 patients with indication for percutaneous coronary intervention (PCI) enrolled at nine centers in China. Patients undergoing angioplasty were randomly assigned to treatment with the Wedge NC scoring balloon or the ScoreFlex scoring balloon. The primary endpoint was procedure success, defined as the residual stenosis of the target lesion ≤30% immediately after PCI procedure, without complications (limited to death, Q-wave or non-Q-wave myocardial infarction, or emergent coronary artery bypass grafting during postoperative hospitalization). The secondary endpoints included rate of clinical success, device procedural success, balloon slippage, and angiographic traits measured by quantitative coronary analysis.

Results: Baseline parameters showed no differences between the two groups. Procedure success was achieved in 98 of 99 patients in both groups. The mean difference between the Wedge group and the ScoreFlex group was 0 (95% confidence interval: -2.79% to 2.79%, 1-sided P<0.001 with both Wald method and minimum risk weights method). Noninferiority at a predefined margin of 7% was established. Immediately after the balloon inflation, minimal lumen diameter in the Wedge group was significantly larger than that of the ScoreFlex group (1.71±0.39 1.56±0.36 mm, P=0.02), resulting in a lower percent diameter stenosis and a higher acute lumen gain (36.04±11.43 41.14±10.63, P=0.004; 0.82±0.39 0.69±0.37 mm, P=0.02, respectively). There was comparable and low rate of procedural complications for both treatment groups.

Conclusions: In patients undergoing PCI, the Wedge NC scoring balloon dilatation catheter was noninferior to the ScoreFlex coronary dilatation catheter regarding procedure success and had comparably low procedural complication rate. (Sponsored by BrosMed Medical.).

Trial Registration: The trial was registered at clinicaltrials.gov with the identifier NCT06214247.