Paclitaxel- and Sirolimus-Coated Drug-Coated Balloons versus Drug-Eluting Stents in Acute Myocardial Infarction: A Comprehensive Systematic Review and Meta-Analysis.

CONTEXT: Acute myocardial infarction (AMI) requires rapid yet durable coronary reperfusion. Drug-eluting stents (DES) are the standard for percutaneous coronary intervention (PCI) but pose long-term challenges such as late stent thrombosis and extended dual antiplatelet therapy (DAPT). Drug-coated balloons (DCBs), using paclitaxel or newer sirolimus formulations, deliver antiproliferative therapy without leaving a permanent scaffold, offering a potentially safer, stent-free option.

OBJECTIVES

To evaluate the efficacy and safety of DCBs versus DES in AMI, with emphasis on drug platform (paclitaxel vs. sirolimus) and specific outcomes.

METHODS

This systematic review and meta-analysis followed PRISMA 2020 guidelines. Databases including PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov were searched from inception through 15 January 2025, according to a prospectively archived protocol on the Open Science Framework. Thirty-four eligible studies (14 randomized controlled trials (RTCs), 20 observational cohorts) comprising 19,642 participants and 2,313 major adverse cardiovascular events (MACE) were analyzed. Dichotomous outcomes were synthesized as pooled risk ratios (RRs) with 95% confidence intervals (CIs) using a random-effects (DerSimonian-Laird) model; heterogeneity was quantified by I², τ², and H² statistics.

RESULTS

Drug-coated balloons were associated with a 15% relative reduction in MACE compared with DES (RR = 0.85, 95% CI: 0.73 - 0.99, I² = 63.2%). Rates of myocardial infarction (MI) (RR = 0.93, 95% CI: 0.78 - 1.11), target lesion revascularization (TLR) (RR = 0.88, 95% CI: 0.71 - 1.07), and cardiovascular mortality (RR = 0.97, 95% CI: 0.81 - 1.16) were comparable between groups. Late stent thrombosis was significantly lower with DCBs (RR = 0.64, 95% CI: 0.42 - 0.97). Most pooled evidence involved paclitaxel-coated balloons, while sirolimus-coated DCB data, though directionally consistent, remain limited by smaller sample size and shorter follow-up.

CONCLUSIONS

This meta-analysis suggests that DCBs represent a feasible, stent-free PCI strategy in AMI, providing comparable safety and efficacy to DES with a potential advantage in reducing late thrombosis. Device selection should be guided by lesion complexity, bleeding risk, and DAPT tolerance. Further large-scale, head-to-head randomized trials, particularly involving sirolimus-coated DCBs, are warranted to validate these findings.