Alfonso Ielasi1, Attilio Varricchio2, Gianluca Campo3, Massimo Leoncini4, Bernardo Cortese5, Paolo Vicinelli6, Salvatore Brugaletta7, Fortunato Scotto di Uccio8, Azeem Latib9, Maurizio Tespili1. 1. Cardiology Division, Bolognini Hospital Seriate, Seriate, BG, Italy. 2. Cardiology Division, Santa Maria della Pietà Hospital, Nola, NA, Italy. 3. Cardiovascular Section, Medical Sciences Department, Azienda Ospedaliera Universitaria Sant' Anna, Ferrara, Italy. 4. Cardiology Division, San Remo Hospital, Sanremo, IM, Italy. 5. Cardiac Department, Fatebenefratelli Hospital, Milan, Italy. 6. Fornaroli Hospital, Magenta, MI, Italy. 7. Cardiology Division, Cardiology Department, Thorax Institute; IDIBAPS, University of Barcelona, Hospital Clinic, Barcelona, Spain. 8. Ospedale Santa Maria di Loreto Mare, Napoli, Italy. 9. Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus and San Raffaele Scientific Institute, Milan, Italy.
Abstract
OBJECTIVES: To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. BACKGROUNDS: Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. METHODS: This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. RESULTS: The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. CONCLUSIONS: 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.
OBJECTIVES: To assess the feasibility and the clinical results following a prespecified bioresorbable vascular scaffold (Absorb BVS) implantation strategy in ST-elevation myocardial infarction (STEMI) patients. BACKGROUNDS: Concerns raised about the BVS safety in STEMI setting because a not negligible thrombosis rate was reported within 30 days and 12 months after implantation. Technical procedural issues related to the structural BVS features were advocated as probable causes for the thrombotic events. METHODS: This is an investigators-owned and -directed, prospective, nonrandomized, single-arm multicenter registry intended to obtain data from 500 consecutive STEMI patients undergoing primary PCI with BVS (1.1 or GT1) following a prespecified implantation protocol. The study is recorded in ClinicalTrials.gov with the identifier: NCT02601781. RESULTS: The primary endpoint is a device-oriented composite end-point (DOCE) of cardiac death, any myocardial infarction clearly attributable to the intervention culprit vessel and ischemic-driven target lesion revascularization within 30 days after the index procedure. The DOCE will be assessed even at 6-month, 1-, 3-, and 5-year follow-up. CONCLUSIONS: 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.
Authors: Elisabetta Moscarella; Alfonso Ielasi; Maria Carmen De Angelis; Fortunato Scotto di Uccio; Enrico Cerrato; Roberta De Rosa; Gianluca Campo; Attilio Varricchio Journal: J Thorac Dis Date: 2017-08 Impact factor: 2.895