The following is a summary of “Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials,” published in the November 2023 issue of Cardiology by Scalamogna et al.
The efficacy of using modified balloons, particularly cutting and scoring balloons, to prepare severely calcified lesions in patients undergoing percutaneous coronary intervention (PCI) remains a subject of ongoing discussion. Researchers performed a retrospective study to assess the clinical and imaging outcomes of patients undergoing PCI with modified balloon therapy for severely calcified coronary lesions.
The analysis aggregated study-level data from trials that enrolled invasively treated patients who were randomly assigned to receive either modified balloon or control therapy for the preparation of severely calcified lesions before stenting. The primary outcome under investigation was major adverse cardiac events (MACE), which included death, myocardial infarction (MI), and repeat revascularization. Secondary outcomes comprised the constituent parts of the primary outcome and outcomes related to coronary perforation and the final minimal stent area (MSA) assessed through intracoronary imaging.
About 648 participants from six trials were divided into two groups: modified balloon therapy (n=335) and control therapy (semi-compliant, non-compliant, or super high-pressure balloon, n=313). Over a median follow-up of 11 months, MACE occurred in 8.96% of the modified balloon group and 12.78% of the control group (RR=0.70, 95% CI 0.35–1.39; P=0.24). Notably, a significant treatment effect was observed in patients assigned to cutting balloon therapy compared to control therapy [RR=0.40 (0.28–0.56), P for interaction (Pint) <0.001]. No clinically meaningful differences were observed in other secondary outcomes or the final minimal stent area (MSA) between patients treated with modified balloon therapy and control therapy[standardized mean difference = 0.67 (−0.71, 2.06); P = 0.26].
The study found that modified balloon therapy does not improve clinical or imaging outcomes in patients with severely calcified coronary artery disease undergoing PCI, but the performance of cutting and scoring balloons warrants further investigation.