Abstract
BACKGROUND: Drug-eluting stents (DES) remain the standard of care for percutaneous coronary intervention in small vessel coronary artery disease (SVD). Paclitaxel-coated balloons (PCB) have emerged as an alternative, with recent trials suggesting favorable short- and mid-term outcomes, although most were limited by small sample sizes. OBJECTIVES: To compare angiographic and clinical outcomes between DES and PCB in patients with SVD. METHODS: Searches were conducted in PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for studies comparing PCB and DES in SVD, defined as a reference vessel diameter < 3.0 mm. A random-effects meta-analysis was performed, and results were reported as mean differences (MD) or risk ratios (RR). Statistical significance was set at p < 0.05. Heterogeneity was assessed using the chi-square, Tau, and Tau2 tests. The review protocol was registered in PROSPERO (CRD42024506502). RESULTS: A total of 12 studies comprising 17,441 patients (mean age of 58-73 years) were included, with clinical follow-up of 8 to 36 months. All studies evaluated PCB. No significant differences were found between PCB and DES in target lesion revascularization (RR, 1.24; 95% CI, 0.82-1.85; p = 0.30), late lumen loss (MD, -0.09 mm; 95% CI, -0.41 to 0.23; p = 0.57), major adverse cardiovascular events (RR, 1.01; 95% CI, 0.76-1.33; p = 0.95), all-cause mortality (RR, 0.81; 95% CI, 0.50-1.31; p = 0.39), cardiovascular mortality (RR, 1.74; 95% CI, 0.78-3.89; p = 0.17), and myocardial infarction (RR, 0.76; 95% CI, 0.46-1.27; p = 0.30). CONCLUSIONS: PCB angioplasty demonstrated clinical and angiographic outcomes comparable to DES in SVD, supporting its role as a safe, effective alternative in selected patients.