Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease

NCT01443754 | Terminated

• 1 other identifier: ESREFO04
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is designed as a prospective, single centre, open label, observational trial. The study will collect information about the medical care patients receive during their planned procedure(s). No new testing or procedures will be done. Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data. Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization. After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• composite of major cardiac and cerebrovascular events (MACCE)

  composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: * Death from any cause * From cardiovascular causes * From noncardiovascular causes * Stroke * MI * hospitalization for repeat revascularization procedure

  From date of inclusion until the date of first documented MACCE, assessed up to 12 months

Secondary Outcomes (6)

• • Procedural success

  during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)

• • Procedural and post-procedural blood loss and number of transfusions

  during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)

• • Recovery time

  from end of intervention up to discharge from the hospital (expected average of hospital stay: 2 weeks)

• • New York Heart Association (NYHA) class modification with respect to baseline

  at 12 months post-procedure

• Quality of life (SF-12 questionnaire)

  at 12 months post-procedure

Study Arms (1)

Hybrid group

Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization (LIMA-LAD surgical revascularization followed by PCI)

Procedure: LIMA-LAD surgical revascularization; Procedure: PCI

Interventions

LIMA-LAD surgical revascularization PROCEDURE

Off-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon: * use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device; * minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another.

Hybrid group

PCI PROCEDURE

State of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines. Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites.

Hybrid group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to participating sites with clinical indication to revascularization and with clinical characteristics and multi-vessel disease amenable to hybrid revascularization

You may qualify if:

• Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:
• ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
• patients amenable to a off-pump beating heart revascularization procedure;
• non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
• ≥ 70 years of age
• Written informed consent for the use of personal data

You may not qualify if:

• patients hemodynamically unstable;
• acute or recent (\< 1 month) myocardial infarction;
• severe heart failure (NYHA Class IV);
• creatinine \> 2.2 mg/dl;
• allergy to radiographic contrast;
• contraindication to double antiaggregation therapy (DAT) for at least 12 months;
• previous cardiac surgery of any type;
• previous thoracic surgery involving left pleural space;
• previous coronary stenting: within one month for BMS, within 6 months for DES;
• disabling stroke within previous 6 months;
• need for concomitant cardiac surgery during index hospitalization;

Sponsors & Collaborators

• Ettore Sansavini Health Science Foundation: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mauro Del Giglio, MD

  GVM Care & Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 30, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)