Drug eluting balloon angioplasty for de novo coronary artery disease resulted in a similar risk of major adverse cardiac events compared with drug eluting stents (IRR 0.95; 95% CI 0.61-1.48).
Meta-Analysis
Does drug-eluting balloon angioplasty reduce major adverse cardiac events in patients with de novo coronary artery disease compared to drug-eluting stent implantation?
DEB-based PCI is associated with similar medium-term clinical outcomes compared to DES in de novo coronary artery disease, supporting its use as an alternative strategy in selected patients.
Relative Risk: 0.95 (95% CI 0.61–1.48)
Abstract Introduction In patients with de novo coronary artery disease, percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation is the gold standard therapy. New evidence from recent randomized controlled trials is now available comparing drug eluting balloon (DEB) angioplasty with DES in de novo coronary artery disease. We sought to compare the efficacy and safety of DEB-based PCI versus DES-based PCI for patients with de novo coronary artery disease with an updated meta-analysis including the most recent available evidence. Methods A systematic search of PubMed, Scopus, Web of Science, and EMBASE databases was performed from 1st January 2006 up until September 2nd, 2024. Inclusion criteria were random treatment assignment; PCI with DEB versus DES; patients with de novo coronary artery disease; clinical follow-up available for ≥1 year; and studies published in a peer-reviewed journal. After screening at title and abstract level, 181 reports were identified for full-text review. After full-text assessment, a total of 9 randomized trials met all the inclusion and exclusion criteria and were included in the primary analysis. Trial-level incidence rate ratios (IRR) with 95% confidence intervals were pooled by random effects models with inverse variance weighting. The primary outcome was major adverse cardiac events (MACE). Secondary outcomes included cardiac death, all-cause death, and target lesion revascularization. Results A total of nine clinical trials were included. See image 1. The risk of the primary compositive endpoint of MACE was comparable with DEB versus DES (IRR 0.95, 95% CI 0.61 to 1.48). Secondary endpoints including cardiac death (IRR 1.49, 95% CI 0.96 to 2.33), all-cause death (IRR 1.18, 95% CI 0.80 to 1.74), and target lesion revascularization (IRR 1.17, 95% CI 0.68 to 2.01) were comparable though confidence intervals around treatment effects were wide. Results for MACE and the main secondary endpoints of interest were consistent in a leave-one-out analysis. A sensitivity analysis for MACE showed broadly consistent treatment effects in the trials enrolling only patients with small vessel disease and those enrolling only patients with ACS. Qualitative assessment of trials showed overall a low risk of bias. According to GRADE, evidence quality was high for the primary endpoint, and moderate or high for the secondary endpoints. Conclusions DEB-based PCI for de novo coronary artery disease was associated with similar medium-term clinical outcomes compared with DES. The findings of this analysis lend some support to the concept of angioplasty with DCB as a valuable strategy in selected patients undergoing intervention for de novo coronary stenosis. Additional evidence is warranted in view of numerical trends in important secondary endpoints including cardiac death.
Callaghan et al. (Sat,) conducted a meta-analysis in de novo coronary artery disease. Drug eluting balloon (DEB) angioplasty vs. Drug eluting stent (DES) implantation was evaluated on major adverse cardiac events (MACE) (IRR 0.95, 95% CI 0.61-1.48). Drug eluting balloon angioplasty for de novo coronary artery disease resulted in a similar risk of major adverse cardiac events compared with drug eluting stents (IRR 0.95; 95% CI 0.61-1.48).