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. 2025 Apr 30;17(4):2101-2112.
doi: 10.21037/jtd-24-1457. Epub 2025 Apr 27.

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

Haibo Chen  1   2   3 , Jian Xu  1 , Delong Chen  1   2   3 , Feng Gao  1   2   3 , Yabin Liu  1   2   3 , Hanbin Cui  4 , Jingfeng Wang  5 , Suxia Guo  6 , Zhimin Du  7 , Jinyu Huang  8 , Xingwei Zhang  9 , Wenbing Jiang  10   11 , Zhenfeng Cheng  12 , Jun Jiang  1   2   3
Affiliations

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

Haibo Chen et al. J Thorac Dis. .

Abstract

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 vs. 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 vs. 41.14±10.63, P=0.004; 0.82±0.39 vs. 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.

Keywords: Percutaneous coronary intervention (PCI); lesion modification; scoring balloon.

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-24-1457/coif). H.C. obtained unrestricted grant support from BrosMed Medical Co., Ltd. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Schematic design of the Wedge NC scoring balloon catheter.
Figure 3
Figure 3
Cumulative frequency distribution curves of (A) MLD and (B) %DS before the procedure and post balloon dilation. %DS, percent diameter stenosis; MLD, minimal lumen diameter.
Figure 4
Figure 4
Procedure success difference between the Wedge and the ScoreFlex groups in the (A) intention-to-treat analysis, (B) per-protocol set analysis. CI, confidence interval.
See this image and copyright information in PMC

References

    1. Writing Committee Members ; Lawton JS, Tamis-Holland JE, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2022;79:e21-e129. 10.1016/j.jacc.2021.09.006 - DOI - PubMed
    1. Rheude T, Rai H, Richardt G, et al. Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial. EuroIntervention 2021;17:481-8. 10.4244/EIJ-D-20-01000 - DOI - PMC - PubMed
    1. Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 2005;45:995-8. 10.1016/j.jacc.2004.12.066 - DOI - PubMed
    1. Souteyrand G, Amabile N, Mangin L, et al. Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry. Eur Heart J 2016;37:1208-16. 10.1093/eurheartj/ehv711 - DOI - PubMed
    1. Giustino G, Colombo A, Camaj A, et al. Coronary In-Stent Restenosis: JACC State-of-the-Art Review. J Am Coll Cardiol 2022;80:348-72. 10.1016/j.jacc.2022.05.017 - DOI - PubMed

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