The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis)

Verheye, Stefan; Vrolix, Mathias; Kumsārs, Indulis; Ērglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco; Cornelis, Kristoff; Janssens, Luc; Mæng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F.; Stella, Pieter R.

doi:10.1016/j.jcin.2017.06.021

Cited by 55 publications

(22 citation statements)

References 22 publications

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“…Finally, only paclitaxel‐coated balloons were used in the included studies. Newer sirolimus‐coated balloons are currently available and have shown promising results …”

Section: Discussionmentioning

confidence: 99%

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

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Background Percutaneous coronary intervention (PCI) of small‐vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug‐coated balloons (DCBs) in SVD has received limited study. Objectives To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. Methods We performed a meta‐analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. Results Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow‐up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug‐eluting stents (DES). During a mean follow‐up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04–0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08–0.37, P = <0.00001) compared with noncoated balloon angioplasty. Conclusion The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

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“…Finally, only paclitaxel‐coated balloons were used in the included studies. Newer sirolimus‐coated balloons are currently available and have shown promising results …”

Section: Discussionmentioning

confidence: 99%

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Megaly

Rofael

Saad

et al. 2018

Cathet Cardio Intervent

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“…However, due to its complicated operation, high economic cost and invasive detection, many patients have low acceptance (3). At present, coronary stent implantation is a vital interventional method in treating coronary heart disease, which mainly improves myocardial blood supply by reconstructing narrow lumen, thus achieving the purpose of treatment (4). However, in-stent restenosis after stent therapy has always been a difficult point in coronary interventional therapy.…”

Section: Introductionmentioning

confidence: 99%

lncRNA‑MALAT1 expression in patients with coronary atherosclerosis and its predictive value for in‑stent restenosis

Qiu

Sun

2020

Exp Ther Med

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This study was designed to investigate the long non-coding RNA (lncRNA)-metastasis associated lung adenocarcinoma transcript 1 (MALAT1) expression in patients with coronary atherosclerosis and its predictive value for in-stent restenosis. Ninety-five patients with coronary heart disease who came to our hospital for treatment and underwent stent implantation were selected as a research group (RG), and 95 volunteers undergoing physical examination who did not suffer from coronary heart disease during the same period were selected as a control group (CG). MALAT1 of subjects in both groups before and after treatment were detected by RT-qPCR, and N-terminal pro-brain natriuretic peptide (NT-proBNP), high sensitivity C-reactive protein (hs-CRP), lactate dehydrogenase (LDH), and creatine kinase isoenzyme (CK-MB) of them in the RG before treatment were detected. The level was evaluated and detected, and its correlation with MALAT1 was analyzed. Then, the predictive value of MALAT1 for in-stent restenosis in patients with coronary heart disease was analyzed. MALAT1 expression in patients with coronary heart disease was higher than that of normal subjects (P<0.05); after treatment, the expression levels of MALAT1, NT-proBNP, hs-CRP, LDH, and CK-MB in the serum of patients were significantly lower than those before treatment (P<0.05); MALAT1 expression was positively correlated with the expression levels of NT-proBNP, hs-CRP, LDH, and CK-MB (P<0.05). Receiver operating characteristic of MALAT1 for predicting in-stent restenosis in patients with coronary heart disease was over 0.8; the number of lesions, MALAT1, diabetes, NT-proBNP and hs-CRP were independent risk factors for in-stent restenosis. MALAT1 is highly expressed in the serum of patients with coronary heart disease, and it has high value in its diagnosis and the prediction of in-stent restenosis. It is also an independent risk factor for in-stent restenosis in patients with coronary heart disease.

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“…Most of the currently available DCBs are coated with paclitaxel and its derivatives as the antiproliferative drugs, while sirolimus and its derivatives have recently been investigated for DCB applications on the basis of their successes in stent technology. [ 28 , 29 ] However, the vascular response after DCB therapy is influenced not only by the type of antiproliferative drugs, but also by the interaction among the doses, formulations, and release kinetics of the drugs used, [ 30 ] which means there is no such thing as a “class effect” of DCBs. Additionally, differences in the study designs, types of stents, demographic and procedural characteristics (ie, the rates of patients with diabetes mellitus, the rates of complicated lesions, the rates of optimal lesion preparation and bailout stenting) among included trails may lead to a relatively high level of heterogeneity in such a meta-analysis that compared the efficacy and safety of DCB-only approach with stent approach.…”

Section: Discussionmentioning

confidence: 99%

Comparing efficacy of drug-coated balloon-only approach and stent approach in treating de novo coronary artery lesions

Cai

Wang

et al. 2020

Medicine

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Background: Drug-coated balloons (DCB) have been a novel alternative therapeutic strategy in de novo coronary artery diseases. However, the clinical feasibility of the DCB-only approach in treating small vessel disease remains controversial, while study aimed to assess the efficacy and safety of the DCB-only approach versus stent approaches in treating large vessel disease is limited. Methods: From February 2020 to May 2020, we will search Cochrane Library, PubMed, EMBASE, ScienceDirect, Scopus, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, and Chongqing VIP Database for eligible trials comparing DCB with drug-eluting stents for treatment of de novo lesions in both small vessel disease and large vessel disease. The primary endpoint is major adverse cardiac events (MACE); the secondary endpoints include in-lesion late lumen loss, binary restenosis, myocardial infarction, target lesion revascularization (TLR), mortality and target vessel thrombosis. Meta-analysis will be conducted using Review Manager software (V.5.3). Results: The results will be presented as risk ratios for dichotomous data, and weighted mean differences for continuous data. Conclusion: We will assess outcomes of the DCB-only approach in the treatment of de novo lesions compared with the stent approach. PROSPERO registration number: CRD42020164484.

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The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis)

Abstract: This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.

Cited by 55 publications

References 22 publications

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

Outcomes with drug‐coated balloons in small‐vessel coronary artery disease

lncRNA‑MALAT1 expression in patients with coronary atherosclerosis and its predictive value for in‑stent restenosis

Comparing efficacy of drug-coated balloon-only approach and stent approach in treating de novo coronary artery lesions

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