Author + information
- Received April 19, 2016
- Revision received May 26, 2016
- Accepted June 2, 2016
- Published online August 22, 2016.
- Daniele Giacoppo, MDa,
- Salvatore Cassese, MD, PhDa,
- Yukinori Harada, MDa,
- Roisin Colleran, MBChBa,
- Jonathan Michel, MBBSa,
- Massimiliano Fusaro, MDa,
- Adnan Kastrati, MDa,b and
- Robert A. Byrne, MBChB, PhDa,∗ ()
- aDeutsches Herzzentrum München, Technische Universität München, Munich, Germany
- bDZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
- ↵∗Reprint Requests and Correspondence:
Dr. Robert Byrne, Deutsches Herzzentrum München, Lazarettstrasse 36, 80636, Munich, Germany.
Objectives This study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors which could have influenced general findings.
Background Recently several randomized trials comparing drug-coated balloon (DCB) with conventional plain balloon (PB) for the treatment of femoropopliteal artery disease have been reported, but no updated meta-analyses are available and questions remain surrounding the long-term antirestenotic effectiveness of the 2 therapies.
Methods We searched main electronic databases for randomized trials comparing DCB and PB for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months, whereas long-term TLR and death risk were assessed by mixed effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis.
Results A total of 8 eligible trials were identified. DCB was associated with a marked 12-month TLR risk reduction as compared with PB (risk ratio: 0.33; 95% confidence interval [CI]: 0.19 to 0.57). The risk of death was similar between groups (risk ratio: 0.96; 95% CI: 0.47 to 1.95). Long-term outcomes assessment showed a reduced incidence of TLR with DCB (0.35; 95% CI: 0.24 to 0.51) and a similar incidence of all-cause death (incidence rate ratio: 1.13; 95% CI: 0.60 to 2.15). Similar findings were observed in Bayesian analyses. Significant heterogeneity was present with evidence of differential efficacy across devices. Trial sequential analysis indicated that available evidence is sufficient to prove superior antirestenotic efficacy of DCB over PB.
Conclusions DCB significantly reduces the risk of TLR as compared with PB without any effect on all-cause death. Evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies.
Dr. Giacoppo has been awarded with a grant from the EAPCI (European Association Percutaneous Coronary Intervention). Dr. Kastrati has reported submission of patent applications in relation to drug-eluting stent technology. Dr. Byrne has received lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific; and institutional research grants from Boston Scientific and Heartflow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 19, 2016.
- Revision received May 26, 2016.
- Accepted June 2, 2016.
- American College of Cardiology Foundation