A prospective evaluation of a standardized strategy for the use of a polymeric everolimus‐eluting bioresorbable scaffold in ST‐segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY‐IT study

Ielasi, Alfonso; Varricchio, Attilio; Campo, Gianluca; Leoncini, Massimo; Cortese, Bernardo; Vicinelli, Paolo; Brugaletta, Salvatore; Uccio, Fortunato Scotto di; Latib, Azeem; Tespili, Maurizio

doi:10.1002/ccd.26801

Cited by 10 publications

(5 citation statements)

References 30 publications

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“…However, bigger studies and registries enrolling patients receiving BRS with a standardized implantation technique are clearly on demand, especially in complex settings such as acute coronary syndrome or long lesions requiring overlap (30).…”

Section: Discussionmentioning

confidence: 99%

BRS implantation in long lesions requiring device overlapping: myth or reality?

et al. 2017

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Dealing with bioresorbable vascular scaffolds (BVS) implantation in long lesions requiring device overlapping in this particular moment might seem a little provocative for several reasons. First, most studies testing BVS have focused on their safety and efficacy profile in simple patients with simple lesions. Second, ABSORB II did not meet its primary endpoint, while ABSORB III showed a higher rate of target vessel-myocardial infarction (TV-MI) at 2 years. Third, data on porcine model showed that overlapping zone has delayed but greater neointimal proliferation with consequent higher risk for scaffold thrombosis in the short-term and of in-scaffold restenosis in the long-term. Fourth, recently published data showed higher risk of TVF in patients treated with ≥60 mm BVS. Given all these premises, it may seem right to put aside this technology, while it may seem inappropriate to hypothesize the use of BVS in long lesions. The aim of the present review is precisely to critically review the available evidences regarding BVS with particular regard to overlapping BVS in order to understand whether this technology has a future per se and especially in long coronary lesions requiring overlap.

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Section: Discussionmentioning

confidence: 99%

BRS implantation in long lesions requiring device overlapping: myth or reality?

et al. 2017

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“…As for the ideal patient for BVS, 31% considered patients younger than 75 years and admitted for ST-segment elevation myocardial infarction as good candidates for scaffold implantation, while 35% of them preferred patients with target vessel diameter between 3 and 3.6 mm, and 9% of them preferred patients in whom left anterior descending artery is involved (12). A minority of the operators (18%) did not consider scaffold implantation a possible choice in patients admitted to hospital for ST-segment elevation myocardial infarction (Figure 3).…”

Section: Future Perspectives On Bvsmentioning

confidence: 99%

The impact of the 3-year ABSORB II trial results on my clinical practice: an Italian survey

Serenelli¹,

Biscaglia²,

Tonet³

et al. 2017

J. Thorac. Dis.

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Background: To evaluate how the 3-year results from the "A clinical evaluation to compare the safety, efficacy and performance of ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) system against XIENCE everolimus eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions" (ABSORB II) trial have influenced clinical practice among Italian interventional cardiologists.Methods: We performed a survey among 95 interventional cardiologists sending a brief questionnaire by electronic mail. We collected 65 replies and analysed the data.Results: The opinion of the operators regarding the two main endpoints of the study ABSORB II was conflicting. However, 66% of the operators considered at least one of the two co-primary endpoints (late lumen loss or vasomotion) unreliable and not reflecting clinical practice. Asking about an explanation for the negative results of the study, we found that the 91% of the operators considered the implantation technique the main limit of the ABSORB II. Furthermore, 74% of the operators affirmed that the results from the study did not decrease the number of scaffold implanted in their cath-lab.Conclusions: Absorb II trial did not influence clinical practice among Italian interventional cardiologists mainly due to the overall idea that the co-primary endpoints were not adequate to provide a robust evidence on device clinical safety and also because the lack of experience on device implantation may have influenced the outcomes.

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“…In addition to the primary endpoint, the authors include sundry secondary endpoints: rates of procedural success; DOCE at extended follow‐up; definite or probable BVS thrombosis; bleeding; cardiac death; target vessel myocardial infarction; and ST‐segment resolution within 60 min of PPCI. The authors dictate specifics of patient care including antiplatelet regimen (dual antiplatelet therapy must be continued for 1 year and preferably with prasugrel or ticagrelor); use of thrombus aspiration (recommended if baseline TIMI flow is 0 or 1 or baseline TIMI flow of 2–3 with high thrombus burden on initial angiography); appropriate sizing of BVS (intracoronary imaging is not a requirement in this study); and how pre‐dilation and post‐dilation is to be performed . Notably these recommendations parallel Abbott's Instruction for Use (IFU).…”

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confidence: 99%

“…They quote a recent meta‐analysis which showed that following a BVS‐implantation protocol could significantly reduce the early and 12‐month incidence of device thrombosis . Ielasi et al are also strong believers in the theoretical advantages of BVS over traditional metallic stents. They point to the caging of the coronary wall at the site of drug‐eluting stent (DES) implantation and the loss of vasomotion associated with metallic stent implantation.…”

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confidence: 99%

The invisible scaffold…with invisible benefits?

Krishnan

Dean

2017

Cathet Cardio Intervent

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Authors suggest the use of an investigator-owned and directed, prospective, non-randomized, single-arm multicenter registry at 23 Italian hospitals to follow 500 STEMI patients who receive BVS. Follow-up of patients is out to 5 years to determine how a BVS which has been deployed according to the IFU performs in these ACS patients. There is no comparator arm. Mandate that patients included in this registry follow a strict BVS implantation protocol which is felt to mitigate the not insignificant stent thrombosis rates noted with BVS to date.

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A prospective evaluation of a standardized strategy for the use of a polymeric everolimus‐eluting bioresorbable scaffold in ST‐segment elevation myocardial infarction: Rationale and design of the BVS STEMI STRATEGY‐IT study

Abstract: This will be the first study investigating the feasibility and the early- and long-term clinical impact of a prespecified BVS implantation protocol in thrombotic lesions causing STEMI. Here, we describe the rationale and the design of the study. © 2016 Wiley Periodicals, Inc.

Cited by 10 publications

References 30 publications

BRS implantation in long lesions requiring device overlapping: myth or reality?

BRS implantation in long lesions requiring device overlapping: myth or reality?

The impact of the 3-year ABSORB II trial results on my clinical practice: an Italian survey

The invisible scaffold…with invisible benefits?

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