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Updated: May 6, 2026

Imaging In-Stent Restenosis: An Inexpensive, Reliable, and Rapid Preclinical Model
Published on: September 14, 2009
Drug-coated balloons versus drug-eluting stents in patients with in-stent restenosis: An updated meta-analysis with
Ahmed Abdelaziz1,2, Karim Atta3,4, Abdelrahman H Hafez3,5
1Medical Research group of Egypt (MRGE), Cairo, Egypt. ahmedmhmd0144@gmail.com.
Insights
Drug-coated balloons (DCB) show comparable clinical outcomes to drug-eluting stents (DES) for in-stent restenosis (ISR). However, DCBs were associated with a higher rate of target lesion revascularization (TLR).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- In-stent restenosis (ISR) management remains a challenge.
- Drug-coated balloons (DCB) show promise for ISR, but their clinical role is not well-established.
- Evaluating DCB efficacy and safety in ISR is crucial for contemporary practice.
Purpose of the Study:
- To comprehensively appraise the efficacy and safety of DCBs versus DES in ISR patients.
- To compare primary endpoints of major adverse cardiac events (MACE) and late lumen loss (LLL).
- To assess secondary clinical and angiographic outcomes, including target lesion revascularization (TLR).
Main Methods:
- Systematic search of major databases (PubMed, Scopus, Web of Science, Ovid, Cochrane Central) until March 2023.
- Inclusion of randomized controlled trials (RCTs) comparing DCB versus DES in ISR.
- Primary endpoints: MACE and LLL; Secondary endpoints: TLR, death, MI, TVR, stent thrombosis, MLD, binary restenosis.
Main Results:
- Ten RCTs with 1977 patients were analyzed.
- No significant difference in MACE between DCB and DES (OR 1.04, 95% CI: 0.87-1.44).
- Comparable LLL (MD -0.08, 95% CI: -0.18-0.02), but increased TLR with DCB (OR 1.54, 95% CI: 1.2-1.99).
Conclusions:
- DCB is comparable to DES for ISR clinical outcomes, but with higher TLR rates.
- Further large-scale RCTs with longer follow-up are needed to validate these findings.
- DCB's role in ISR requires careful consideration due to increased TLR risk.
Background:
Drug-coated balloons (DCB) have promising results in the management of in-stent restenosis (ISR), still their role remains a major challenge, and not well established in contemporary clinical practice.
Aims:
To provide a comprehensive appraisal of the efficacy and safety of DCBs in patients with in-stent restenosis (ISR).
Methods:
We searched PubMed, Scopus, web of Science, Ovid, and Cochrane Central from inception until 30 March, 2023. We included randomized controlled trials (RCTs) that compared DCB versus DES in ISR patients. Our primary endpoints were major adverse cardiac events (MACE) and late lumen loss (LLL). Secondary clinical endpoints were all-cause death, cardiac death, MI, TLR, TVR, and stent thrombosis, and angiographic outcomes were MLD, and in-stent binary restenosis.
Results:
Ten RCTs comprising 1977 patients were included in this meta-analysis. The incidence of MACE was 15.57% in the DCB group compared to 14.13% in the DES group, with no significant difference in the risk of MACE following DCB (odds ratio [OR] 1.04, 95% confidence interval [CI]: 0.87 to 1.44). Compared with the DES intervention, the risk of LLL was comparable to the DCB intervention (mean difference [MD] -0.08, 95% CI: -0.18 to 0.02), while the incidence of TLR was increased in the DCB intervention (OR: 1.54, 95% CI: 1.2 to 1.99).
Conclusion:
DCB was comparable to DES implantation is ISR patients regarding clinical outcomes, however it showed an increase in TLR events. Moreover, a RCT with large sample size and longer follow-up duration is warrened to validate these results.
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