Italian Diffuse/Multivessel Disease

ABSORB Prospective Registry

under the auspices of

Società Italiana di Cardiologia Invasive-GISE

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IT - DISAPPEARSObjective: Investigate short-and long-term clinical performance of Absorb in MVD (at least 2≠ epicardial vessels) or long single vessel disease (>24mm)

Co-PI: Dr. F Bedogni & Dr. A S Petronio

Clinical follow-up

30dy 6mo 1yr 2yr 3yr 4yr 5yr

Primary Endpoint

Absorb

1000 Patients 50 Italian centres

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

Steering committee:

Prof. Bartorelli

Prof. Indolfi

Prof. Richibini

Prof. Tamburino

DSB and CEC Coordinator: Dr. Tomai

e-CRF : Airon Telematica

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 “hybrid population”

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 BVSThe use of a everolimus DES is recommended in case of hybrid treatment

Follow-up

Clinical Follow-upTelephone 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.