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Drug-eluting balloons for coronary artery disease: a meta-analysis of randomized controlled trials
Cheuk-Man Yu1, Joey S W Kwong, John E Sanderson
1Institute of Vascular Medicine, Li Ka Shing Institute of Health Sciences, S.H. Ho Cardiovascular Disease and Stroke Centre, Heart Education And Research Training (HEART) Centre, Division of Cardiology, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, China. cmyu@cuhk.edu.hk
Insights
Drug-eluting balloons (DEB) show promise for treating coronary artery disease (CAD), particularly in-stent restenosis. While DEB improved angiographic measures, further trials are needed to confirm efficacy in other lesion types.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Drug-eluting balloons (DEB) are emerging as a viable alternative to drug-eluting stents (DES) for percutaneous coronary interventions.
- Coronary artery disease (CAD) management benefits from evaluating novel treatment modalities like DEB.
Purpose of the Study:
- To systematically review the efficacy and safety of DEB in treating CAD.
- To compare DEB outcomes against control interventions in randomized controlled trials.
Main Methods:
- A systematic review of randomized controlled trials was conducted using MEDLINE, EMBASE, and CENTRAL databases (searched December 2011).
- Primary outcome measures included target lesion revascularization (TLR), major adverse cardiac events (MACE), and mortality.
- Secondary outcomes focused on angiographic parameters: late lumen loss, minimal lumen diameter, and binary restenosis.
Main Results:
- The review included five studies with 349 patients.
- DEB demonstrated significant improvements in angiographic measures compared to controls.
- DEB showed clear superiority in patients with in-stent restenosis, significantly reducing TLR, MACE, late lumen loss, minimal lumen diameter, and binary restenosis.
Conclusions:
- Findings support the current recommendation for using DEB in managing in-stent restenosis.
- Larger, well-designed trials are necessary to establish DEB's efficacy and safety in other lesion types and to explore device-specific profiles.
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, I(2)=0%), MACE (OR 0.22, 95% CI 0.10 to 0.51, p=0.0005, I(2)=13%), late lumen loss (in-stent: MD -0.51, 95% CI -0.73 to -0.28, p<0.00001, I(2)=60%; in-segment: MD -0.51, 95% CI -0.77 to -0.24, p=0.0002, I(2)=72%;), minimal lumen diameter (in-stent: MD 0.49, 95% CI 0.05 to 0.93, p=0.03, I(2)=85%; in-segment: MD 0.49, 95% CI 0.13 to 0.86, p=0.008, I(2)=79%) and binary restenosis (in-stent: OR 0.15, 95% CI 0.05 to 0.47, p=0.001, I(2)=37%; in-segment: OR 0.11, 95% CI 0.05 to 0.27, p<0.00001, I(2)=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.
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