Italian Absorb Registry (BVS-RAI)

Clinical Study on Absorb Polylactic, Reabsorbable Coronary Scaffold (RAI)

The investigators aim at evaluating the long-term (5-year) clinical outcome following Absorb BVS implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PCI with Absorb scaffold

Detailed Description

Long-term data after implantation of coronary BVS is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease.

Although the use of BVS is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available.

The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists who are interested in assessing the results of their interventional practice with BVS, by sharing data.

The BVS-RAI Registry has been created in joint-venture with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri Sud", and is not recipient of funding or benefits originating from the BVS manufacturer or seller. BVS devices are regularly purchased by the participating centres.

Each participating centre is willing to input data of all consecutive patients treated with BVS, with a minimum of 50, and to report on follow-up for at least 5 years. Patient recruitment is not directed per protocol, nor is it rewarded. Patients who give informed consent are included in the BVS-RAI Registry after BVS implant has been performed following the indications, techniques and protocols used in each of the participating institutions.

Baseline patient clinical data, with special attention to biochemistry and drug treatment in patients with diabetes and CKD, as well as angiographic and intravascular imaging data are entered into a web-based Case Report Form.

Follow-up data from outpatient visits or phone interviews, subsequent admissions and coronary angiograms following the protocols being used in each of the participating institutions are prospectively collected and entered into the database.

All data in the CRF is visible to all registered participants at all times. Endpoints are: target lesion and target vessel failure, BVS thrombosis, new revascularisation, myocardial infarction and death. Documentation of those events is required for adjudication by an independent committee.

• Study Type: Observational
• Enrollment (Actual): 1520

Contacts and Locations

Study Locations

• Italy
  • Cuneo, Italy
    • SSD Emodinamica Dip Cardiovasc ASO S.Croce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is an all-comers study, and includes all consecutive patients who have been treated with 1 or more BVS in the study time lapse in each participating centre

Description

Inclusion Criteria:

• Successful implantation of 1 or more coronary BVS
• Age <75 years
• Patient's informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scaffold thrombosis	acute, subacute, late and very late	1 year
Target lesion revascularization	ischemia or angiographic-driven	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Cardiac death, TLR, myocardial infarction	5 year

Collaborators and Investigators

• Sponsor: Ospedale Santa Croce-Carle Cuneo
• Collaborators: Azienda Ospedaliera di Padova; S. Andrea Hospital; San Giuseppe Moscati Hospital; Ospedale San Bortolo di Vicenza; Azienda Ospedaliera Brotzu; Fatebenefratelli and Ophthalmic Hospital; S. Giacomo Hospital; Bolognini Hospital; Ospedale Regionale di Aosta; Ospedali Riuniti di Ancona; Azienda U.L.S.S n.9 Ospedale di Treviso Ca Foncello; Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno; Ospedale Monaldi di Napoli; Ospedale della Misericordia di Grosseto; Ospedale Santa Corona di Pietra Ligure; Istituto di Ricerche Farmacologiche Mario Negri Milano
• Investigators: Principal Investigator: Alfonso Ielasi, MD, AO Seriate; Principal Investigator: Bernardo Cortese, MD, AO Fatebenefratelli; Principal Investigator: Donatella Corrado, PhD, Istituto di Ricerche Farmacologiche Mario Negri Milano

Publications and helpful links

General Publications

• Cortese B, Ielasi A, Moscarella E, Loi B, Tarantini G, Pisano F, Durante A, Pasquetto G, Colombo A, Tumminello G, Moretti L, Calabro P, Mazzarotto P, Varricchio A, Tespili M, Latini RA, Defilippi G, Corrado D, Steffenino G; RAI Investigators. Thirty-Day Outcomes After Unrestricted Implantation of Bioresorbable Vascular Scaffold (from the Prospective RAI Registry). Am J Cardiol. 2017 Jun 15;119(12):1924-1930. doi: 10.1016/j.amjcard.2017.03.017. Epub 2017 Mar 29.
• Cortese B, Ielasi A, Varricchio A, Tarantini G, LaVecchia L, Pisano F, Facchin M, Gistri R, D'Urbano M, Lucci V, Loi B, Tumminello G, Colombo A, Limbruno U, Nicolino A, Calzolari D, Tognoni G, Defilippi G, Buccheri D, Tespili M, Corrado D, Steffenino G; BVS-RAI investigators. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb BVS: study design. Cardiovasc Revasc Med. 2015 Sep;16(6):340-3. doi: 10.1016/j.carrev.2015.05.010. Epub 2015 Jun 3.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: November 15, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: RAI-Registro Absorb Italiano