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Sirolimus-Coated Versus Paclitaxel-Coated Balloons for Coronary Artery Disease: A Grade Assessed Systematic Review
Fatima Sajjad1, Asad Iqbal Khattak2, Kanza Farhan3
1Department of Medicine, Khyber Medical College, Peshawar, Pakistan.
Insights
Sirolimus- and paclitaxel-coated balloons demonstrate comparable safety and effectiveness for treating in-stent restenosis. Angiographic results suggest personalized balloon selection may enhance patient outcomes in coronary interventions.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- In-stent restenosis (ISR) remains a significant clinical challenge despite advances in percutaneous coronary interventions.
- Drug-coated balloons (DCBs) offer potential alternatives to traditional methods for managing ISR.
- Comparative efficacy and safety data for sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) in ISR are still evolving.
Purpose of the Study:
- To conduct a meta-analysis comparing the safety and efficacy of SCBs and PCBs for treating coronary ISR.
- To evaluate primary outcomes including target lesion revascularization (TLR) and target lesion failure (TLF).
- To assess secondary outcomes such as stent thrombosis, mortality, myocardial infarction, major adverse cardiovascular events (MACE), and various angiographic parameters.
Main Methods:
- A systematic literature search of PubMed, Embase, and Cochrane databases was performed until August 2025.
- Included were 11 studies (7 RCTs, 4 observational cohorts) with 3,633 participants comparing PCBs versus SCBs.
- Primary and secondary clinical and angiographic outcomes were analyzed using Review Manager 5.4.1, with heterogeneity assessed by I2 and X2 statistics.
Main Results:
- No significant differences were observed in target lesion failure (RR 1.08, p=0.36) or target lesion revascularization (RR 1.16, p=0.08) between PCB and SCB groups.
- Secondary clinical outcomes including stent thrombosis, mortality, myocardial infarction, and MACE showed no significant variations.
- While most angiographic measures were similar, the SCB group exhibited a significantly smaller minimal lumen diameter than the PCB group (MD -0.08 mm, p=0.02).
Conclusions:
- Sirolimus- and paclitaxel-coated balloons exhibit similar overall safety and effectiveness in treating coronary ISR.
- Angiographic differences, particularly in minimal lumen diameter, suggest that lesion-specific selection of DCBs may optimize patient outcomes.
- Further research into customized DCB selection based on lesion characteristics is warranted to improve patient management in ISR.
Abstract:
Despite advances in percutaneous coronary procedures, in-stent restenosis remains a significant challenge. Although sirolimus- and paclitaxel-coated balloons are promising alternatives, their comparative safety and efficacy remain uncertain. PubMed, Embase, and Cochrane databases were searched using relevant keywords from inception until August 2025. A total of 11 studies (7 randomized controlled trials and 4 observational cohort studies) were included, comprising 3633 participants overall. The primary outcomes assessed were target lesion revascularization and target lesion failure. Meanwhile, the Secondary outcomes included stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, survival, binary restenosis, and angiographic endpoints (acute gain, diameter stenosis, in-segment late lumen loss, in-lesion late lumen loss, and in-segment minimal lumen diameter). Interstudy heterogeneity was assessed using I ² and X ² statistics ( I ²>50% = significant heterogeneity). Interstudy heterogeneity was low for most outcomes, including all primary clinical endpoints, with moderate heterogeneity observed only for select angiographic measures (notably in-segment late lumen loss and diameter stenosis). Statistical analysis was conducted using R software and RStudio (version 4.4.2), with a P value of < 0.05 indicating statistical significance. This meta-analysis examined studies that compared paclitaxel-coated balloon (PCB) versus standard balloon [sirolimus-coated balloon (SCB)] angioplasty. Regarding primary outcomes, there were no notable variations in target lesion failure [risk ratio (RR), 1.08, 95% CI, 0.90-1.29, P = 0.36] or target lesion revascularization (RR, 1.16, 95% CI, 0.98-1.37, P = 0.08). With all aggregated estimates being nonsignificant, secondary outcomes such as stent thrombosis, all-cause mortality, myocardial infarction, major adverse cardiovascular events, and survival were similar between groups. Angiographic endpoints revealed no discernible variations in late lumen loss (in-lesion and in-segment), acute gain, or diameter stenosis. Nonetheless, the SCB group's minimal lumen diameter was significantly smaller than that of the PCB group (MD, -0.08 mm, 95% CI, -0.14 to -0.01, P = 0.02). In treating coronary in-stent restenosis, SCB and PCBs show similar overall safety and effectiveness; lesion-specific angiographic variations indicate that customized selection may improve patient outcomes.
