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Italian Diffuse/ Multivessel Disease ABSORB Prospective Registry under the auspices of Società Italiana di Cardiologia Invasive-GISE. IT - DISAPPEARS.
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Italian Diffuse/Multivessel Disease ABSORB Prospective Registry under the auspices of SocietàItalianadiCardiologiaInvasive-GISE
IT - DISAPPEARS Objective: Investigate short-and long-term clinical performance of Absorb in MVD (at least 2≠ epicardial vessels) or long single vessel disease (>24mm) Absorb 1000 Patients 50 Italian centres Primary Endpoint Clinical follow-up 30dy 6mo 1yr 2yr 3yr 4yr 5yr Co-PI: Dr. F Bedogni & Dr. A S Petronio Steering committee: Prof. Bartorelli, Prof. Indolfi, Prof. Richibini, Prof.Tamburino, Dr. Tomai, De. De Carlo, Dr Biondi Zoccai and Dr. Testa
Principal Investigator: Prof. Anna Sonia Petronio Dr. Francesco Bedogni Protocol Authors: Dr. LucaTesta Dr. Marco De Carlo Dr. Giuseppe Biondi-Zoccai Steeringcommittee: Prof. Bartorelli Prof. Indolfi Prof. Richibini Prof. Tamburino DSB and CEC Coordinator: Dr. Tomai e-CRF : AironTelematica CRO: GB Pharma
AIM OF THE STUDY: to investigate the procedural and the long-term clinical performance of the ABSORB technology in patients with: 1) multivessel disease (at least two significant stenosis in 2 different coronary arteries) 2) long (>24 mm) single vessel disease.
PRIMARY ENDPOINT: the cumulative hierarchical incidence of MACE defined as: • cardiac death, • non-fatal target vessel myocardial infarction (MI), or • clinically driven target lesion revascularization (TLR). • SECONDARY ENDPOINTS: • All causes mortality, • clinically driven TVR, • any revascularisation (non TLR, non TVR) • and ARC-defined stent thrombosis, at any time point.
STUDY DESIGN: multicenter (50 centers across the Italian territory aiming at 20 cases per center. Ad interim evaluation September 2014), prospective observational registry aiming to enroll a population of 1000 patients. • STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last patient in the registry. • CLINICAL FOLLOW-UP PLAN: 30 days, 6 months, 1 year, and then yearly up to 5 years after the index procedure.
INCLUSION CRITERIA: Indication to PCI for MVD or long (>24 mm) single vessel disease following: • Stable angina or evidence of myocardial ischemia with stress echocardiography/myocardial SPECT/exercise test, or • Unstable angina / non ST-elevation myocardial infarction • ST-elevation myocardial infarction with de novo culprit lesion.
EXCLUSION CRITERIA: • Known intolerance to any of the device components • Contraindication to DAPT • Lesion in a SVG • Lesion to LIMA • Unprotected LM stenosis • Woman with childbearing potential • Age < 18y/o • Concomitant indication to open heart surgery • Inability to provide written informed consent • In-stent restenosis • Enrolment in other studies\registries in the last 30 days
Procedure • Appropriate anticoagulation according to standard hospital practice. • QCA analysis is recommended for correct sizing. • IVUS, VH-IVUS, OCT techniques are encouraged (subgroup analysis). • Patients with MVD may be treated with ABSORB in one vessel and with a conventional BMS/DES in another vessel (“hybrid population”, subgroup analysis).
MVD “hybridpopulation” A “hybrid BVS-other DES” approach is acceptable under the following situations: for patients with two vessel disease at least 1 lesion must be >24 mm and must be treated with the BVS; for patients with 3 vessel disease provided that 2 vessels are treated with BVS The use of a everolimus DES is recommended in case of hybrid treatment
Follow-up Clinical Follow-up Telephone contact or office visits per the following schedule: • 30 days: office visit is encouraged • 6 months: office visit is encouraged • 1 year, and then yearly up to 5 years after the index procedure: office visit is encouraged. Angiographic follow up • The angiographic follow up will be clinically driven. • Patients undergoing angio follow up and IVUS or OCT follow up will be included in subgroup analysis.