Open Access Research article

Drug eluting balloons for de novo coronary lesions – a systematic review and meta-analysis

Georg M Fröhlich1, Alexandra J Lansky2, Dennis T Ko3, Olga Archangelidi4, Rodney De Palma1, Adam Timmis5 and Pascal Meier12*

Author Affiliations

1 The Heart Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK

2 Division of Cardiology, Yale Medical School, 333 Cedar Street, New Haven, CT, 06510, USA

3 Institute for Clinical Evaluative Sciences, 2075 Bayview Ave., Toronto, ON, M4N 3M5, Canada

4 Department of Epidemiology and Public Health, University College London UCL, 1-19 Torrington Place, London, WC1E 6BT, UK

5 Department of Cardiology, London Chest Hospital, Bethnal Green, London, E2 9JX, UK

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BMC Medicine 2013, 11:123  doi:10.1186/1741-7015-11-123

Published: 8 May 2013

Abstract

Background

The role of drug-eluting balloons (DEB) is unclear. Increasing evidence has shown a benefit for the treatment of in-stent restenosis. Its effect on de novo coronary lesions is more controversial. Several smaller randomized trials found conflicting results.

Methods

This is a systematic review and meta-analysis of randomized controlled trials (RCT) evaluating the effect of local Paclitaxel delivery/drug eluting balloons (DEB) (+/− bare metal stent) compared to current standard therapy (stenting) to treat de novo coronary lesions. Data sources for RCT were identified through a literature search from 2005 through 28 December 2012. The main endpoints of interest were target lesion revascularization (TLR), major adverse cardiac events (MACE), binary in-segment restenosis, stent thrombosis (ST), myocardial infarction (MI), late lumen loss (LLL) and mortality. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals.

Results

Eight studies (11 subgroups) and a total of 1,706 patients were included in this analysis. Follow-up duration ranged from 6 to 12 months. Overall, DEB showed similar results to the comparator treatment. The relative risk (RR) for MACE was 0.95 (0.64 to 1.39); P = 0.776, for mortality it was 0.79 (0.30 to 2.11), P = 0.644, for stent thrombosis it was 1.45 (0.42 to 5.01), P = 0.560, for MI it was 1.26 (0.49 to 3.21), P = 0.629, for TLR it was 1.09 (0.71 to 1.68); P = 0.700 and for binary in-stent restenosis it was 0.96 (0.48 to 1.93), P = 0.918. Compared to bare metal stents (BMS), DEB showed a lower LLL (− 0.26 mm (−0.51 to 0.01)) and a trend towards a lower MACE risk (RR 0.66 (0.43 to 1.02)).

Conclusion

Overall, drug-eluting balloons (+/− bare metal stent) are not superior to current standard therapies (BMS or drug eluting stent (DES)) in treating de novo coronary lesions. However, the performance of DEB seems to lie in between DES and BMS with a trend towards superiority over BMS alone. Therefore, DEB may be considered in patients with contraindications for DES. The heterogeneity between the included studies is a limitation of this meta-analysis; different drug-eluting balloons have been used.

Keywords:
Coronary artery disease; Stents; Drug-eluting balloon; Percutaneous coronary intervention