Clinical trial NCT01290952: On Versus Off Pump Myocardial Revascularization Study
Official title: ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: off-pump
bypass
coronary artery surgery
Lead sponsor: Medtronic Italia
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).

Detailed description: The initial application of off-pump coronary artery bypass in the early nineties was mainly directed to highly selected and relatively low risk surgical patients. Since then there has been a growing body of evidence suggesting many potential advantages of the OPCAB technique over the conventional cardiopulmonary bypass (CPB) technique in different groups of high-risk patients.

On-off study is a multicentre, prospective, randomized, parallel, trial.Patients indicated for elective or urgent isolated coronary artery bypass graft with additive European System for Cardiac Operative Risk Evaluation ≥ 6 were enrolled. Patients in cardiogenic shock were excluded. Patients were randomly assigned either to coronary artery bypass surgery with cardiopulmonary bypass (ON arm) or to off-pump coronary artery bypass graft (OFF arm). The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, re-operation for bleeding and adult respiratory distress syndrome, within 30 days after surgery. The total planned sample size was 693 patients; the actual number of enrolled patients was 411,according to the results of the interim analysis scheduled at 400 enrollments (alfa-spending=0.029, Pocock method).

Eligibility criteria: Inclusion Criteria:

* Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity
* EUROSCORE ≥ 6
* Pts who signed the Informed Consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump
* Patients requiring additional surgical procedures
* Porcelain Aorta
* Lack of informed consent

Primary outcomes:
measure: Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
timeFrame: 30 days
Secondary outcomes:
measure: Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)
timeFrame: 30 days
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Policlinico
city: Caserta
country: Italy
facility: S. Anna e S. Sebastiano
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Roma
country: Italy
facility: European Hospital
city: Roma
country: Italy
facility: Ospedale S. Camillo
city: Salerno
country: Italy
facility: Ospedale S. Giovanni di Dio e Ruggi d'Aragona
city: Torino
country: Italy
facility: Ospedale Molinette
city: Zurich
country: Switzerland
facility: University Hospital
Study officials:
affiliation: Ospedale Sacco-Milano
name: Massimo Lemma, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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