Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial

Arroyo, Diego; Gendre, Gregoire; Schukraft, Sara; Kallinikou, Zacharenia; Müller, Olivier; Baeriswyl, Gérard; Stauffer, Jean‐Christophe; Goy, Jean‐Jácques; Togni, Mario; Cook, Stéphane; Puricel, Serban

doi:10.1016/j.ijcard.2017.05.053

Cited by 27 publications

(14 citation statements)

References 22 publications

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“…Considering the complexity of the patient group, Absorb BVS demonstrated acceptable efficacy and safety, with the rate of TVF comparable to other studies. 12–14,18 The rate and timing of scaffold (BVS) thrombosis was also similar to previously reported rates. 19,20 Predictors of TVF and BVS thrombosis were associated primarily with complexity of the patients and lesions, including patients with heart failure, worse ejection fraction, and extensive CAD that required multi-vessel and multi-lesion long scaffolding.…”

Section: Discussionsupporting

confidence: 86%

“…The practice of prolonging DAPT beyond one year following implantation varied between different studies, and was only 16% in the EVERBIO trial, 18 36.2% in the ABSORB II trial, 12 and up to 50% in the ABSORB Japan study. 7 In the present study, more than 50% of patients were receiving DAPT after 1 years following PCI, which most probably reflects the complex and high-risk nature of the patients in the present registry, and might be also be associated with the acceptable clinical outcome.…”

Section: Discussionmentioning

confidence: 99%

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Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population

et al. 2018

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Objectives To evaluate long-term clinical outcomes of the Absorb bioresorbable vascular scaffold (BVS) system (Abbott Vascular) in an all-comers Middle East population. Methods This prospective registry study included an initial set of patients with coronary lesions treated using Absorb BVS. Patients were followed for target vessel failure (TVF) including cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization. Results A total of 217 patients (age, 55 ± 11 years; male, 169) with 300 treated lesions were included (median follow-up, 36 months [range, 26–41 months]; complete follow-up, 201 patients). Diabetes mellitus and acute coronary syndrome were present in 50% and 57% of patients, respectively. TVF rate was 32/201 (15.9%), including cardiac death in 10 (5%), target vessel MI in 13 (6.5%), and target lesion revascularization in 22 patients (10.9%). Definite or probable device thrombosis occurred in 11/201 patients (5.5%). TVF was associated with heart failure, worse ejection fraction, multi-vessel BVS, multi BVS in lesion, and total BVS length >50 mm. Conclusions Long-term outcome following Absorb BVS implantation in a population with high prevalence of high-risk and complex patients is acceptable, but heart failure, worse ejection fraction, and multi-vessel or long BVS implantation were associated with worse outcomes.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population

et al. 2018

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“…Finally, the preliminary 30 day results of the most up to date and most populous ABSORB IV study revealed lower acute device success rate (94.6% vs. 99.0% (P < 0.0001)), greater risk of TLF (5.0% vs. 3.7%; p = 0.02) and greater ischemia-driven target vessel revascularization rate (ID-TVR) (1.2% vs. 0.2%; p = 0.003) [68]. Simultaneously, cumulative meta-analyses embracing ABSORB II, III, AIDA, EVERBIO II and TROFI II trials indicated the superiority of DES in the terms of both TLF and overall ST [9,10,69,70]. So far, only two country-specific trials (ABSORB JAPAN and ABSORB CHINA) demonstrated superiority of ABSORB BVS over Xience V DES [71,74].…”

Section: Real-world Bvs Performance-outcomes and Evaluationmentioning

confidence: 98%

“…Figure presents data from ABSORB, AIDA, EVERBIO II and TROFI II trials. The circle diameter represents the number of patients in respective trials[17,19,[66][67][68][69][70].…”

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confidence: 99%

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Jeżewski

Kubisa

Eyileten

et al. 2019

JCM

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Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS.

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“…Bioresorbable scaffolds (BRS) were introduced to offer transient vessel support after coronary angioplasty while avoiding long-term risks associated with permanent metallic stents [1]. However, the BRS with by far the most clinical experience, the everolimus-eluting Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), showed an unexpectedly high incidence of scaffold thrombosis (ScT) both early and late after implantation in a number of single- and multicentre observational studies [2,3,4,5,6] and was ultimately removed from the market. Incomplete expansion of the BRS is believed to convey the highest risk of early ScT and implantation techniques aimed to achieve full expansion of the device were shown to reduce the incidence of early ScT [7].…”

Section: Introductionmentioning

confidence: 99%

Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds

Boeder

Weissner²,

Blachutzik

et al. 2019

JCM

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Malapposition is a common finding in stent and scaffold thrombosis (ScT). Evidence from studies with prospective follow-up, however, is scarce. We hypothesized that incidental observations of strut malapposition might be predictive of late ScT during subsequent follow-up. One hundred ninety-seven patients were enrolled in a multicentre registry with prospective follow-up. Optical coherence tomography (OCT), performed in an elective setting, was available in all at 353 (0–376) days after bioresorbable scaffold (BRS) implantation. Forty-four patients showed evidence of malapposition that was deemed not worthy of intervention. Malapposition was not associated with any clinical or procedural parameter except for a higher implantation pressure (p = 0.0008). OCT revealed that malapposition was associated with larger vessel size, less eccentricity (all p < 0.01), and a tendency for more uncovered struts (p = 0.06). Late or very late ScT was recorded in seven of these patients 293 (38–579) days after OCT. OCT-diagnosed malapposition was a predictor of late and very late scaffold thrombosis (p < 0.001) that was independent of the timing of diagnosis. We provide evidence that an incidental finding of malapposition—regardless of the timing of diagnosis of the malapposition—during an elective exam is a predictor of late and very late ScT. Our data provide a rationale to consider prolonged dual antiplatelet therapy if strut malapposition is observed.

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Comparison of everolimus- and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds: Two-year clinical outcomes of the EVERBIO II trial

Cited by 27 publications

References 22 publications

Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population

Long-term outcome of first 300 implanted Absorb bioresorbable vascular scaffolds in an all-comers Middle East population

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Incidental Finding of Strut Malapposition Is a Predictor of Late and Very Late Thrombosis in Coronary Bioresorbable Scaffolds

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