Drug‐Coated Balloons Versus Other Percutaneous Coronary Intervention Strategies in De Novo Coronary Artery Disease: A Systematic Review, Meta‐Analysis With Trial Sequential Analysis

Background: Drug-coated balloons (DCBs) present a viable option distinct from drug-eluting stents (DESs) in addressing coronary artery disease (CAD), particularly when it comes to in-stent restenosis (ISR) scenarios. The utilization of DCBs marks a significant deviation from traditional DES applications. For CAD patients experiencing ISR, DCBs offer an innovative pathway to treatment. However, their efficacy and safety in de novo CAD lesions remain uncertain. This meta-analysis evaluates DCB versus other percutaneous coronary intervention (PCI) strategies, including DES, bare-metal stents (BMSs), and plain old balloon angioplasty (POBA), in de novo CAD. Methods: A comprehensive search was conducted across PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL), spanning from their inception up until November 14, 2024. Studies included were randomized controlled trials (RCTs) and cohort studies, which assessed DCB against alternative PCI strategies in patients with de novo CAD. The key outcome measures focused on major adverse cardiac events (MACEs) as well as late lumen loss (LLL). Trial sequential analysis (TSA) assessed the robustness of findings. Results: Fifty studies (19 RCTs, 31 cohort studies) involving 28,292 patients were analyzed. DCB showed a lower MACE incidence compared to noncoated devices (RR = 0.52, 95% CI: 0.40-0.69) but no significant difference versus DES (RR = 0.96, 95% CI: 0.84-1.10). DCB significantly reduced LLL compared to all controls (MD = -0.22, 95% CI: -0.29 to -0.14). Subgroup analyses confirmed DCB's safety across indications, ethnicities, comorbidities, and dual antiplatelet therapy (DAPT) durations, with reduced LLL in small vessel disease and shorter DAPT. TSA supported LLL findings but indicated inconclusive MACE results in RCTs, necessitating further research. Conclusion: DCB is a safe and effective alternative to DES in de novo CAD, with comparable safety and superior LLL reduction. However, MACE results in RCTs require further validation. Future studies should explore long-term outcomes and integrate newer-generation DCB and DES technologies to optimize clinical practice.