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Meta-Analysis
. 2024 Nov 6;19(1):624.
doi: 10.1186/s13019-024-03046-6.

Drug-coated balloons versus drug-eluting stents in patients with in-stent restenosis: An updated meta-analysis with trial sequential analysis

Ahmed Abdelaziz  1   2 , Karim Atta  3   4 , Abdelrahman H Hafez  3   5 , Hanaa Elsayed  3   6 , Ahmed A Ibrahim  3   7 , Mohamed Abdelaziz  3   5 , Hallas Kadhim  8 , Ahmed Mechi  9 , Ahmed Elaraby  3   5 , Mahmoud Ezzat  3   7 , Ahmed Fadel  3   10 , Abdullah Nouh  3   10 , Rahma AbdElfattah Ibrahim  3   11 , Mohamed Hatem Ellabban  3   5 , Ali Bakr  3   5 , Ahmed Nasr  3   12 , Mustafa Suppah  3   13
Affiliations
Meta-Analysis

Drug-coated balloons versus drug-eluting stents in patients with in-stent restenosis: An updated meta-analysis with trial sequential analysis

Ahmed Abdelaziz et al. J Cardiothorac Surg. .

Abstract

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.

Keywords: DCB; DES; In-stent restenosis; Meta-analysis; PCI.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow chart of our included studies
Fig. 2
Fig. 2
Risk of bias assessment tool-2 (ROB-2)
Fig. 3
Fig. 3
Pooled estimates from RCTs evaluating the effect of DCB on the incidence of MACE with a random-effects model. DCB: Drug-coated balloons; DES: drug-eluting stents; CI: confidence interval
Fig. 4
Fig. 4
Galbraith plot indicating the heterogeneity across studies assessing MACE. CI: confidence interval
Fig. 5
Fig. 5
Funnel plot for possible publication bias regarding MACE
Fig. 6
Fig. 6
A trial sequential analysis (TSA) for 10 RCTs illustrating that the cumulative Z-curve crossed the conventional boundary for benefit only and did not cross the trial sequential monitoring boundary for benefit, establishing sufficient but not conclusive evidence and suggesting further trials are still needed to validate our results. A diversity-adjusted required information size of 2731 patients was calculated using an alpha error of 0.05, a beta error of 0.20 (power 80%), an anticipated RR reduction of 10% in DCB, and a control event proportion of 14.13%, as calculated from the control group in this meta-analysis. RCT: randomised controlled trial; RR: risk ratio
Fig. 7
Fig. 7
Pooled estimates from RCTs evaluating the effect of DCB on the LLL with a random-effects model. DCB: Drug-coated balloons; DES: drug-eluting stents; CI: confidence interval
Fig. 8
Fig. 8
Leave-one-out analysis of LLL
See this image and copyright information in PMC

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