Drug-coated balloons versus drug-eluting stents following coronary atherectomy in severely calcified lesions: a systematic review and meta-analysis
R Fonseca Oliveira Suruagy Motta, A dos Santos Cleto, C Rodrigues Rosa, L Dexheimer da Silva, N Schettino Samad, A Uchoa Leite Santana, D Belo Coelho Conde, E Martins Filho, A Abizaid, B Pileggi, A Colella CervoneAbstract
Background
Severely calcified coronary lesions are associated with increased procedural complications, stent underexpansion, and higher restenosis rates. While atherectomy prepares vessels for treatment, drug-eluting stents (DES) are usually preferred over drug-coated balloons (DCB). DCBs offer a stent-free alternative that may improve vessel remodeling and require shorter antiplatelet therapy. However, for severely calcified lesions, it remains unclear whether DCB or DES is more effective, as evidence is limited and studies yield conflicting results.
Purpose
To evaluate the comparative effectiveness and safety of drug-coated balloons versus drug-eluting stents following atherectomy in patients with severely calcified coronary lesions, regarding target lesion revascularization, and major adverse cardiac events.
Methods
We systematically searched PubMed, Embase, Web of Science, Scopus, and Cochrane Central databases in accordance with PRISMA guidelines, identifying randomized controlled trials and adjusted observational studies comparing drug-coated balloons versus drug-eluting stents following atherectomy in patients with severely calcified coronary lesions. We assessed major adverse cardiovascular events (MACE), all-cause death, myocardial infarction, target lesion revascularization, and major bleeding defined by BARC criteria. Random-effects models were used to estimate pooled risk ratios (RRs) with 95% confidence intervals (CIs) and 95% prediction intervals (PIs). Heterogeneity was evaluated using the I² statistic. All analyses were performed using R software (version 4.5.2).
Results
After screening 2,594 records, seven studies were included, comprising 1,497 patients, with 596 treated with DCB and 901 with DES. Drug-coated balloons were not associated with MACE compared with DES (RR 1.12; 95% CI 0.85–1.47; I²=0%), and no significant difference was observed for myocardial infarction (RR 0.94; 95% CI 0.32–2.80; I²=2.1%). Target lesion revascularization (RR 1.29; 95% CI 0.88–1.88; I²=34.6%) and all-cause mortality (RR 1.18; 95% CI 0.78–1.79; I²=0.0%) showed non-significant trends favoring DES, whereas cardiac death showed a non-significant trend favoring DCB (RR 0.65; 95% CI 0.28–1.46; I²=0%). Major bleeding was similar between groups (RR 1.11; 95% CI 0.36–3.37; I²=0%). Prediction intervals were wide for most endpoints, reflecting between-study variability.
Conclusion
In patients with severely calcified coronary lesions undergoing atherectomy, drug-coated balloons (DCBs) and drug-eluting stents (DES) were similar in MACE, myocardial infarction, or major bleeding. Although trends favored DES for target lesion revascularization and all-cause mortality, and favored DCBs for cardiac death, these differences were not statistically significant. These findings suggest that both strategies may be acceptable, but larger trials are needed to identify which patients benefit most from each approach.