Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials

Indermuehle, Andreas; Bahl, Rahul; Lansky, Alexandra J.; Froehlich, Georg M; Knapp, Guido; Timmis, Adam; Meier, Pascal

doi:10.1136/heartjnl-2012-302945

Cited by 88 publications

(56 citation statements)

References 36 publications

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“…A meta-analysis of trials using PEB for the treatment of BMS or DES ISR showed a significant reduction in the risk of occurrence of MACE (P<0.001), TLR (P=0.006), and the recurrence of binary in-segment restenosis (P<0.001) in the group with PEB compared with an inhomogeneous control group (POBA, PES). 22 Similarly, Gao et al 23 found that the treatment of ISR with PEB significantly reduced MACE (P<0.01), death (P=0.04), TLR (P<0.01), and LLL (P<0.01) compared with POBA; however, the differences were not significant when compared with DES (PES/EES).…”

Section: Resultsmentioning

confidence: 99%

Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis

Pleva

Kukla

Kušnierová

et al. 2016

Circ: Cardiovascular Interventions

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In contrast, drug-eluting balloon (DEB) catheters allow short-term passage of the active substance into the vascular Background-The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxeleluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis. Methods and Results-A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004).

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Section: Resultsmentioning

confidence: 99%

Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis

Pleva

Kukla

Kušnierová

et al. 2016

Circ: Cardiovascular Interventions

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“…Specifically, DCB compared to DES show a significant benefit in the treatment of ISR,5, 6, 7, 8, 9, 10, 11, 12 and current guidelines recommend the use of DCB for patients with coronary ISR (class I, level of evidence A) 13. However, there are other potential indications such as coronary small vessel disease and bifurcation lesions 14, 15.…”

Section: Introductionmentioning

confidence: 99%

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population.

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“…31,32 Recently, 2 network meta-analyses were conducted comparing >2 treatments for ISR. Piccolo et al 33 compared treatments for DES-ISR using 8 randomized trials and did not account for unequal duration of follow-up.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

Sethi

Malhotra

Singh

et al. 2015

Circ: Cardiovascular Interventions

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Background— In-stent restenosis (ISR) remains a difficult problem in interventional cardiology. The relative efficacy and safety of available interventions is not clear. We aimed to perform a network meta-analysis using both direct evidence and indirect evidence to compare all available interventions. Methods and Results— We systematically searched electronic databases for randomized trials comparing ≥2 treatments for ISR. A network meta-analysis was performed using a Bayesian approach. Eleven treatments were compared in 31 studies with 8157 patient-years follow-up. Compared with balloon angioplasty, everolimus-eluting stent (hazard ratio [95% credibility interval], 0.13 [0.048–0.35]), paclitaxel-eluting balloon (0.32 [0.20–0.49]), paclitaxel-eluting cutting balloon (0.054 [0.0017–0.5]), paclitaxel-eluting stent (0.39 [0.24–0.62]), and sirolimus-eluting stent (0.32 [0.18–0.50]) are associated with lower target vessel revascularization. Balloon angioplasty is not different from cutting balloon (0.73 [0.31–1.5]), excimer laser (0.89 [0.29–2.7]), rotational atherectomy (0.96 [0.53–1.7]), and vascular brachytherapy (0.60 [0.35–1.0]). In drug-eluting stent ISR, balloon angioplasty was inferior to everolimus-eluting stent (0.19 [0.049–0.76]), paclitaxel-eluting balloon (0.43 [0.18–0.80]), paclitaxel-eluting stent (0.35 [0.13–0.76]), and sirolimus-eluting stent (0.36 [0.11–0.86]) for target vessel revascularization. There was no difference between treatments in probable or definitive stent thrombosis. The results of binary restenosis and target lesion revascularization were similar. Paclitaxel-eluting cutting balloon, everolimus-eluting stent, and paclitaxel-eluting balloon have the highest probability of being in the top 3 treatments based on low target lesion revascularization, but there was no statistical significant difference between them. Conclusions— Balloon angioplasty is inferior to all drug-eluting treatments for ISR, including drug-eluting stent ISR. Drug-eluting stent, particularly everolimus-eluting stent, or paclitaxel-eluting cutting balloon and paclitaxel-eluting balloon should be preferred for treating ISR.

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Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials

Abstract: In-stent restenosis is the bane of coronary angioplasty, and drug-eluting balloon angioplasty is a promising treatment option in this situation. It reduces the risk for MACE compared with plain balloon angioplasty or implantation of a Taxus Liberte drug-eluting stent.

Cited by 88 publications

References 36 publications

Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis

Comparison of the Efficacy of Paclitaxel-Eluting Balloon Catheters and Everolimus-Eluting Stents in the Treatment of Coronary In-Stent Restenosis

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

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