TCT-280 Drug−Coated Balloon Versus Drug−Eluting Stent For In−Stent Restenosis: A Meta−Analysis Of Randomized Controlled Trials

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.

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Comparison of Drug-Coated Balloon Angioplasty vs. Drug-Eluting Stent Implantation for Drug-Eluting Stent Restenosis in the Routine Clinical Practice: A Meta-Analysis of Randomized Controlled Trials

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.766088 ◽

2021 ◽

Vol 8 ◽

Author(s):

Yong Zhu ◽

Kesen Liu ◽

Xiangyun Kong ◽

Jing Nan ◽

Ang Gao ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Clinical Outcomes ◽

Stent Thrombosis ◽

Cardiac Death ◽

Meta Analysis ◽

Drug Eluting Stent ◽

Controlled Trials ◽

Randomized Controlled ◽

Stent Restenosis ◽

Drug Eluting

Introduction: In-stent restenosis (ISR) remains a challenging issue despite the great advance of drug-eluting stents (DES). In addition, the consensus was lacking regarding the optimal strategy for DES-ISR. Therefore, we aimed to evaluate angiographic and clinical outcomes of the two most effective treatments DES vs. drug-eluting balloon (DCB) for patients with DES-ISR.Methods: This meta-analysis used the data from the randomized controlled trials (RCTs), which were identified by a systematic search in the databases of PubMed, Embase, and Cochrane Library. Target lesion revascularization (TLR) was regarded as the primary endpoint. In addition, the late angiographic outcomes and other clinical outcomes, namely, cardiac death, myocardial infarction (MI), target vessel revascularization, stent thrombosis, and major adverse cardiac events, were also included for analysis.Results: Five RCTs with about 1,193 patients were included in this meta-analysis for the analysis. For the primary endpoint, the overall pooled outcomes suggested repeat DES implantation was associated with a significant reduction in the term of TLR compared with DCB angioplasty (risk ratio = 1.53, 95% CI 1.15–2.04, p = 0.003). But no significant difference in angiographic outcomes and other clinical endpoints were observed between DES and DCB. In the subgroup analysis, DCB was inferior to new-generation DES (NG-DES)/everolimus-eluting stent (EES) in the term of TLR. In addition, this non-significant trend was also noted in the subgroup of the paclitaxel-eluting stent (PES) vs. DCB. For the angiographic endpoints, EES, not PES, was associated with larger minimum lumen diameter [mean difference (MD) = −0.25, 95% CI −0.38 to −0.11, p = 0.0003], lower percent diameter stenosis (MD = 7.29%, 95% CI 2.86–11.71%, p = 0.001), and less binary restenosis (OR = 2.20, 95% CI 1.18–4.11, p = 0.01). But NG-DES/EES was comparable to DCB in cardiac death, MI, and stent thrombosis.Conclusions: For the patients with DES-ISR, treatment with DES, especially NG-DES/EES could reduce the risk of TLR significantly compared to DCB at long-term follow-up.

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