Clinical trial NCT01443754: Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease
Official title: Hybrid Revascularisation by Combined CABG and PCI in Multivessel Coronary Disease. An Observational Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease (CAD)
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed description: Hybrid coronary revascularization integrates the positive features of both Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG), combining the durability of Left Anterior Descending Coronary Artery (LIMA) coronary bypass with the minimal invasiveness and lower risk of percutaneous intervention. Thereby it might represent a better option in a sizeable proportion of patients.

Candidate patients in whom hybrid revascularization would be advantageous are several subgroups of Coronary Artery Disease (CAD) patients that are increasing in numbers: the elderly patients with a high risk of mortality and/or morbidity for CABG, patients with significant disabilities and patients in whom treatment durability is important but a significantly invasive approach is not an option.

There are several potential advantages of the hybrid procedure over conventional CABG in selected patients. These advantages include the avoidance of cardiopulmonary bypass-related morbidity, no aortic manipulation with the LIMA-LAD with the beating heart procedure, less blood loss and decreased transfusions, a shorter recovery time than after conventional CABG and patient's preference for "minimally invasive" surgery.

The investigators hypothesize that in selected patients with diffuse coronary disease, a "hybrid" approach employing a staged revascularisation procedure may allow to lower the surgical risk, increase the completeness and effectiveness of revascularisation and, hopefully, to improve immediate and long term outcome.

To test this hypothesis, a well designed, properly sized, prospective, randomized study is needed. Available data, however, do not provide sufficient information to speculate on a clinically meaningful, yet achievable, effectiveness.

Aim of this observational study is therefore to collect more information on the target population, the clinical outcomes and optimal management in order to inform the design of a comparative effectiveness trial.

Eligibility criteria: Inclusion Criteria:

Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:

1. ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
2. patients amenable to a off-pump beating heart revascularization procedure;
3. non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
4. ≥ 70 years of age
5. Written informed consent for the use of personal data

Exclusion Criteria:

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

Primary outcomes:
measure: composite of major cardiac and cerebrovascular events (MACCE)
timeFrame: From date of inclusion until the date of first documented MACCE, assessed up to 12 months
Secondary outcomes:
measure: • Procedural success
timeFrame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
measure: • Procedural and post-procedural blood loss and number of transfusions
timeFrame: during index hospitalization up to discharge from the hospital ( expected average of hospital stay: 2 weeks)
measure: • Recovery time
timeFrame: from end of intervention up to discharge from the hospital (expected average of hospital stay: 2 weeks)
measure: • New York Heart Association (NYHA) class modification with respect to baseline
timeFrame: at 12 months post-procedure
measure: Quality of life (SF-12 questionnaire)
timeFrame: at 12 months post-procedure
measure: Length of time to return to work or normal activities
timeFrame: from hospital discharge (index hospitalization) up to date of return to work or normal activities assessed up to 12 months after intervention
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
Study officials:
affiliation: GVM Care & Research
name: Mauro Del Giglio, MD
role: PRINCIPAL_INVESTIGATOR
References: