Systematic Review and Meta-Analysis of the Super High-Pressure Balloon (SIS-OPN) for Percutaneous Coronary Intervention.

Introduction: The super high-pressure NC balloon (OPN NC; SIS Medical AG, Winterthur, Switzerland) is increasingly used in percutaneous coronary intervention (PCI). We performed a systematic review and meta-analysis of its efficacy and safety.

Methods: A systematic review was conducted using PubMed and the Cochrane Library to identify studies using the OPN NC balloon in PCI. Procedural success, major adverse cardiac events (MACE), coronary perforation, and other complications were pooled using weighted means, confidence intervals (CI), and I² statistics for heterogeneity assessment.

Results: Twenty-nine studies (5 prospective including 2 randomized-controlled trials, 12 retrospective, and 12 case reports) were included in the systematic review, of which 11 (3 prospective, 8 retrospective) were included in the meta-analysis. Of the 1015 meta-analysis patients, 50.7% presented with stable angina and 21.6% with an acute coronary syndrome. Mean lesion length was 22.8 ± 13.7 mm, the prevalence of moderate or severe calcification was 93.7%, and 40.4% of lesions were in-stent. Procedural success was 95.1% (95% CI 89.3%-98.8% with significant heterogeneity: I² = 84.9%). The incidence of periprocedural MACE was 1.9% (95% CI 1.1%-2.8%, I² 86.9%), and the incidence of coronary perforation was 0.6% (95% CI 0.3%-1.5%, I² 87.2%).

Conclusions: Use of the OPN NC balloon is associated with high success and acceptable complication rates. The heterogeneity of outcomes underscores the need for additional studies and standardized definitions.