Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial

Wong, Yat-Wa; Kang, Do‐Yoon; Lee, Jin Bae; Rha, Seung Woon; Hong, Young Joon; Shin, Eun Seok; Her, Sung Ho; Nam, Chang Wook; Chung, Woo Young; Kim, Moo Hyun; Lee, Cheol Hyun; Lee, Pil Hyung; Ahn, Jung Min; Kang, Soo Jin; Lee, Seung Whan; Kim, Young Hak; Lee, Cheol Whan; Park, Duk‐Woo

doi:10.1016/j.ahj.2017.11.008

Cited by 37 publications

(17 citation statements)

References 26 publications

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“…Figure 1 presents in detail the study search and selection process. A er strict selection, six trials with 1134 patients were included in the present pairwise meta-analysis [4][5][6][9][10][11]. e TIS and SEDUCE trials were from a single center [6,10], and the other four trials were performed at multiple centers.…”

Section: Resultsmentioning

confidence: 99%

“…EES was a second-generation DES, which was superior to BMS and rst-generation DES in reducing the risk of stent thrombosis and repeat revascularization [1,19]. Several trials compared DCB with EES for the treatment of ISR, but they had small sample sizes and inconsistent outcomes [4,5,[8][9][10][11]. us, the clinical outcomes on the comparison of DCB and EES for the treatment of ISR were underpowered.…”

Section: Discussionmentioning

confidence: 99%

“…However, this network meta-analysis only included two head-to-head comparative trials, RIBS IV and RIBS V, to synthesize the direct result of EES versus DCB. A er this network meta-analysis, several trials compared head-tohead EES with DCB for the treatment of ISR with debated results [4][5][6]. e comparison of EES and DCB for the treatment of ISR remained controversial.…”

Section: Introductionmentioning

confidence: 99%

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Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

Peng

Liu

et al. 2020

Cardiovascular Therapeutics

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Objective. This study aimed to compare the effectiveness of drug-coated balloons (DCB) with everolimus-eluting stents (EES) in the treatment of in-stent restenosis (ISR) and the differential relative effect of DCB in patients with drug-eluting stents (DES)-ISR and bare metal stents (BMS)-ISR. Background. The efficiency and safety of DCB and EES need to be assessed for the treatment of ISR. Methods. A systematic literature search was conducted using PubMed and EMBASE to identify all relevant studies. Angiographic results and clinical events were separately assessed. Subgroup meta-analyses were performed according to the type of restenosed stent. Results. Six randomized trials with 1134 patients were included. The overall pooled outcomes indicated that DCB was associated with lower minimum lumen diameter (mean difference MD=−0.17, 95% CI = −0.29 to −0.05, P=0.006) and higher target lesion revascularization (risk ratio RR=2.38, 95% CI = 1.36 to 4.18, P=0.002) than EES. However, the subgroup meta-analyses showed that DCB was inferior to EES only in DES-ISR patients, with lower minimum lumen diameter (MD=−0.25, 95% CI = −0.37 to −0.14, P<0.001), higher percent diameter stenosis (MD=5.37, 95% CI = 1.33 to 9.42, P=0.009), more binary restenosis (RR=2.07, 95% CI = 1.20 to 3.58, P=0.009), and higher incidence of target vessel revascularization (RR=2.07, 95% CI = 1.22 to 3.50, P=0.007) and target lesion revascularization (RR=2.43, 95% CI = 1.28 to 4.22, P=0.002). No differences in angiographic results and clinical events were found between DCB and EES in BMS-ISR patients. Conclusions. DCB was inferior to EES in DES-ISR and comparable in BMS-ISR in terms of angiographic results and clinical events.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

Peng

Liu

et al. 2020

Cardiovascular Therapeutics

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“…A multicenter randomized study involving 309 patients demonstrated that the rates of TLR, TVR, and MACEs at 1 year and 3 years were significantly lower in patients treated with second-generation DES (SG-DES) than those treated with DEB [ 34 , 35 ]. However, in another multicenter randomized trial enrolling 172 patients, the rates of TLR, TVR, ACD, MI, and ST at 1-year follow-up were comparable between the SG-DES group and the DEB group [ 36 ]. Recently, a meta-analysis comparing DEB versus SG-DES for the management of ISR was conducted and the subgroup analysis of DES-ISR showed that second-generation DES was associated with lower risk of TLR ( P =0.004), TVR ( P =0.012), and MACEs ( P =0.043) than DEB, but the sample size of the subgroup is so small that the statistical power to evaluate the effective size may be not enough to properly compare the efficacy and safety of DEB and SG-DES in DES-ISR patients [ 37 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis

Yang

Liu

et al. 2020

Journal of Interventional Cardiology

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Background. Although drug-eluting stents (DES) have reduced the rates of in-stent restenosis (ISR) compared with bare-metal stents (BMS), DES related ISR (DES-ISR) still occurs and outcomes of DES-ISR remain unclear. The objective of this meta-analysis was to investigate the long-term clinical outcomes of patients with DES-ISR compared with patients with BMS related ISR (BMS-ISR) after the treatment of DES or drug-eluting balloon (DEB). Methods and results. We searched the literature in the main electronic databases including PUBMED, EMBASE, Cochrane Library, and Web of Science. The primary endpoints were target lesion revascularization (TLR) and target vessel revascularization (TVR). The secondary endpoints included all cause death (ACD), cardiac death (CD), myocardial infarction (MI), stent thrombosis or re-in-stent restenosis (ST/RE-ISR), and major adverse cardiovascular events (MACEs). A total of 19 studies with 6256 participants were finally included in this meta-analysis. Results showed that the rates of TLR (P<0.00001), TVR (P<0.00001), CD (P=0.02), ST/RE-ISR (P<0.00001), and MACEs (P<0.00001) were significantly higher in the DES-ISR group than in the BMS-ISR group. No significant differences were found between the two groups in the rates of MI (P=0.05) and ACD (P=0.21). Conclusions. Our study demonstrated that patients with DES-ISR had worse clinical outcomes at the long-term follow-up than patients with BMS-ISR after the treatment of DES or DEB, suggesting that DES and DEB may be more effective for BMS-ISR than that for DES-ISR. Positive prevention of DES-ISR is indispensable and further studies concentrating on detecting the predictors of outcomes of DES-ISR are required.

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“…BMS ISR (characterized by neointimal hyperplasia) and DES ISR (characterized by neointimal hyperplasia with late neoatherosclerotic changes), 10 both benefit from PCI with DCB (Table 2 and 3). [11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] DES ISR represents a complex scenario of high-risk population, with primary failure of local drug delivery by the stent. 26,27 The potential relative efficacy of DCB versus DES, according to the underlying tissue substrate (e.g., neointimal hyperplasia versus neoatherosclerosis) may be different.…”

Section: In-stent Restenosismentioning

confidence: 99%

Clinical applications of drug-coated balloon: what have we learned and where are we going?

Dash¹,

Rohit²,

Ahmed³

et al. 2020

J Transcat Intervent

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Since the introduction of coronary stents, in-stent restenosis has been one of the main stumbling blocks for its application in coronary artery disease. The drug-eluting stents have effectively reduced and become the mainstay of the interventional therapy of coronary artery disease. However, concerns of delayed stent thrombosis, dependency on prolonged dual antiplatelet therapy, and recurrent restenosis led to a quest for new treatment modalities that could address restenosis rates without drug-eluting-stent-related drawbacks. The drug-coated balloon has emerged as an additional tool in the armamentarium of interventional cardiology. It is usually a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima, leaving no implant behind. This review highlights the rationale for drug-coated balloon use, its effectiveness in different clinical and lesion settings, and the future perspective.

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Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial

Cited by 37 publications

References 26 publications

Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

Drug-Coated Balloons versus Everolimus-Eluting Stents in Patients with In-Stent Restenosis: A Pair-Wise Meta-Analysis of Randomized Trials

Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis

Clinical applications of drug-coated balloon: what have we learned and where are we going?

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