Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry)

Cortese, Bernardo; Ielasi, Alfonso; Moscarella, Elisabetta; Loi, Bruno; Tarantini, Giuseppe; Pisano, Francesco; Durante, Alessandro; Pasquetto, Giampaolo; Colombo, Alessandro; Tumminello, Gabriele; Moretti, Luciano; Calabrò, Paolo; Mazzarotto, Pietro; Tespili, Maurizio; Latini, Roberto; Defilippi, G; Corrado, Donatella; Steffenino, Giuseppe

doi:10.1016/j.amjcard.2017.03.017

Cited by 10 publications

(11 citation statements)

References 18 publications

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“…This study showed the higher event rates than expected, which raised concerns about the daily use of BRS. The Registro Absorb Italiano (RAI) registry enrolled 1,505 patients (22.4% diabetes, 59.6% ACS) from 23 Italian heart centers 16) . All lesions were predilated and 96.8% lesions were post-dilated after BRS implantation.…”

Section: Current Evidencementioning

confidence: 99%

Bioresorbable Vascular Scaffold Korean Expert Panel Report

et al. 2017

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Bioresorbable vascular scaffold (BRS) is an innovative device that provides structural support and drug release to prevent early recoil or restenosis, and then degrades into nontoxic compounds to avoid late complications related with metallic drug-eluting stents (DESs). BRS has several putative advantages. However, recent randomized trials and registry studies raised clinical concerns about the safety and efficacy of first generation BRS. In addition, the general guidance for the optimal practice with BRS has not been suggested due to limited long-term clinical data in Korea. To address the safety and efficacy of BRS, we reviewed the clinical evidence of BRS implantation, and suggested the appropriate criteria for patient and lesion selection, scaffold implantation technique, and management.

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Section: Current Evidencementioning

confidence: 99%

Bioresorbable Vascular Scaffold Korean Expert Panel Report

et al. 2017

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“…The ASSURE Registry (28) (21.3% UA) reported a 5% MACE rate at 1 year, showing that a slight systematic oversizing of the BVS, followed by high pressure post-dilatation, is safe and effective. Also short-term results of the RAI registry (1,505 patients/1,969 lesions, 59% ACS) confirmed that when meticulously implanted (96.8% post-dilation rate) BVS-related events may be mitigated (29). In the ISAR-ABSORB registry (30) (39% ACS) at 12 months, the incidence of target-lesion revascularization (TLR) among these patients was 13.1%, whereas definite ScT occurred in 2.6% of patients.…”

Section: Multi-center Registriesmentioning

confidence: 70%

Are acute coronary syndromes an ideal scenario for bioresorbable vascular scaffold implantation?

Moscarella

Ielasi²,

Angelis

et al. 2017

J. Thorac. Dis.

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Bioresorbable vascular scaffolds (BRS) represent the latest innovation in the field of interventional cardiology. BRS have recently been introduced in routine clinical practice and their use has progressively extended in everyday clinical practice. The BRS use appears theoretically attractive in patients presenting with acute coronary syndromes (ACS) as they are generally young with long life expectancy, thus possibly benefiting more of the so-called vascular reparative therapy. Furthermore, "culprit" lesions are usually softer and more easily expandable by current BRS compared to stable chronic lesions. However an increased risk of BRS thrombosis has been reported in clinical trials excluding ACS patients. Therefore, concerns have been raised on the safety of BRS implantation in the ACS setting in which the risk of thrombotic recurrences is definitely higher (compared to stable lesions) independently by the device implanted. Aim of this review is to provide an overview of the available data on the BRS performance in ACS patients.

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“…The ASSURE Registry (21.3% unstable angina) showed that a slight systematic oversizing of BVS, followed by high pressure post-dilatation, is safe and effective [28]. In turn, short-term results of the RAI registry (1,505 patients, 59% ACS) confirmed that high post-dilation rate (96.8%) might mitigate BVS-related events [29]. In a pooled analysis of the BVS Expand and BVS STEMI registries (351 patients, 72.6% ACS), post-dilation in ACS group was only 41.3% [30].…”

Section: Discussionmentioning

confidence: 95%