Related Experiment Video
Updated: May 11, 2026
A Murine Model of Stent Implantation in the Carotid Artery for the Study of Restenosis
Published on: May 14, 2013
Drug eluting balloons for de novo coronary lesions - a systematic review and meta-analysis
Georg M Fröhlich1, Alexandra J Lansky, Dennis T Ko
1Heart Hospital, University College London Hospital, 16-18 Westmoreland Street, London, W1G 8PH, UK.
Insights
Drug-eluting balloons (DEB) show similar outcomes to standard therapies for de novo coronary lesions. While not superior to drug-elating stents, DEB may be a viable option for patients unable to receive drug-elating stents.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The clinical efficacy of drug-eluting balloons (DEB) for de novo coronary lesions remains debated, with conflicting results from smaller trials.
- While DEB show promise for in-stent restenosis, their role in treating new coronary blockages requires further investigation.
Purpose of the Study:
- To systematically review and meta-analyze randomized controlled trials (RCTs) comparing DEB with standard stenting for de novo coronary lesions.
- To evaluate the safety and efficacy of DEB by analyzing key endpoints such as target lesion revascularization, major adverse cardiac events, and mortality.
Main Methods:
- A systematic literature search was conducted for RCTs published between 2005 and December 2012.
- Meta-analysis using a random effects model was performed to calculate pooled relative risks (RR) and 95% confidence intervals for various clinical outcomes.
- Included endpoints 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.
Main Results:
- The analysis included 8 studies with 1,706 patients, reporting follow-up durations of 6 to 12 months.
- Overall, DEB demonstrated comparable results to comparator treatments, with no significant differences in MACE (RR 0.95), mortality (RR 0.79), ST (RR 1.45), MI (RR 1.26), or TLR (RR 1.09).
- Compared to bare metal stents (BMS), DEB showed a trend towards lower late lumen loss (-0.26 mm) and reduced MACE risk (RR 0.66).
Conclusions:
- Drug-eluting balloons (+/- bare metal stent) are not superior to current standard therapies (BMS or drug-eluting stent) for de novo coronary lesions.
- DEB performance appears intermediate between DES and BMS, with a potential trend towards superiority over BMS alone.
- DEB may be considered for patients with contraindications to drug-eluting stents, though study heterogeneity is a limitation.
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.
Related Concept Videos
01:27Coronary Artery Disease V: Interprofessional Care
01:26Angina IV: Management