Drug-eluting balloons for coronary artery disease: A meta-analysis of randomized controlled trials.

Abstract: Background: Drug-eluting balloons (DEB) are attractive new alternatives to drug-eluting stents (DES) for percutaneous coronary interventions. We aimed to systematically review the efficacy and safety of DEB in the treatment of coronary artery disease (CAD). Methods: MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched in December 2011 for eligible randomized controlled trials. Primary outcomes were target lesion revascularization (TLR), major adverse cardiac events (MACE) and mortality. Secondary outcomes were late lumen loss, minimal lumen diameter and binary restenosis. Results: Five studies involving 349 patients were included. Compared to controls, DEB improved angiographic measures with no significant effect on clinical outcomes in the overall CAD population. There is clear superiority of DEB in patients with in-stent restenosis in TLR (OR 0.17, 95% CI 0.07 to 0.38, p<0.0001, I2 =0%), MACE (OR 0.22, 95% CI 0.10 to 0.51, p=0.0005, I2 =13%), late lumen loss (in-stent: MD −0.51, 95% CI −0.73 to −0.28, p<0.00001, I2 =60%; in-segment: MD −0.51, 95% CI −0.77 to −0.24, p=0.0002, I2 =72%;), minimal lumen diameter (in-stent: MD 0.49, 95% CI 0.05 to 0.93, p=0.03, I2 =85%; in-segment: MD 0.49, 95% CI 0.13 to 0.86, p=0.008, I2 =79%) and binary restenosis (in-stent: OR 0.15, 95% CI 0.05 to 0.47, p=0.001, I2 =37%; in-segment: OR 0.11, 95% CI 0.05 to 0.27, p<0.00001, I2 =17%). Conclusions: Our findings support the current recommendation of using DEB in in-stent restenosis. Large, well-conducted trials are essential in determining the application of DEB in other lesion types as well as exploring device-specific efficacy and safety profiles. [Copyright &y& Elsevier]