OBJECTIVE: To evaluate the efficacy of drug-coated balloon (DEB) for the treatment of drug-eluting stent (DES) in-stent restenosis (ISR). METHODS: A comprehensive literature search was performed. The primary outcome was the composite of death, myocardial infarction (MI), and target-lesion revascularization (TLR) at longest available follow-up (range, 12-36 months). Outcomes for DEB vs balloon angioplasty (BA) and DEB vs DES were analyzed separately using a random-effect Mantel-Haenszel model, as per an a priori protocol. RESULTS: The study cohort comprised 1526 patients (746 DEB, 537 DES, 243 BA). DEB was associated with lower composite outcome compared with BA alone (19% vs 47%; risk ratio [RR], 0.31; 95% confidence interval [CI], 0.11-0.84; P=.02), driven primarily by lower TLR (17% vs 34%; RR, 0.66; 95% CI, 0.46-0.95; P=.03), with no difference in death or MI. There was no difference in the composite outcome between DEB and DES (20% vs 17%; RR, 1.2; 95% CI, 0.82-1.74; P=.35); DEB was associated with higher TLR (17.4% vs 11.3%; RR, 1.48; 95% CI, 1.08-2.03; P=.01), but lower all-cause mortality (2.2% vs 5.7%; RR, 0.43; 95% CI, 0.22-0.82; P=.01), with no difference in MI or stent thrombosis. CONCLUSIONS: DEB was associated with a lower TLR rate than BA alone, but associated with a higher TLR rate than implantation of another DES. However, additional DES use was associated with an increase in mortality, a finding that requires further investigation.
OBJECTIVE: To evaluate the efficacy of drug-coated balloon (DEB) for the treatment of drug-eluting stent (DES) in-stent restenosis (ISR). METHODS: A comprehensive literature search was performed. The primary outcome was the composite of death, myocardial infarction (MI), and target-lesion revascularization (TLR) at longest available follow-up (range, 12-36 months). Outcomes for DEB vs balloon angioplasty (BA) and DEB vs DES were analyzed separately using a random-effect Mantel-Haenszel model, as per an a priori protocol. RESULTS: The study cohort comprised 1526 patients (746 DEB, 537 DES, 243 BA). DEB was associated with lower composite outcome compared with BA alone (19% vs 47%; risk ratio [RR], 0.31; 95% confidence interval [CI], 0.11-0.84; P=.02), driven primarily by lower TLR (17% vs 34%; RR, 0.66; 95% CI, 0.46-0.95; P=.03), with no difference in death or MI. There was no difference in the composite outcome between DEB and DES (20% vs 17%; RR, 1.2; 95% CI, 0.82-1.74; P=.35); DEB was associated with higher TLR (17.4% vs 11.3%; RR, 1.48; 95% CI, 1.08-2.03; P=.01), but lower all-cause mortality (2.2% vs 5.7%; RR, 0.43; 95% CI, 0.22-0.82; P=.01), with no difference in MI or stent thrombosis. CONCLUSIONS: DEB was associated with a lower TLR rate than BA alone, but associated with a higher TLR rate than implantation of another DES. However, additional DES use was associated with an increase in mortality, a finding that requires further investigation.