Revascularization in Heart Failure Trial - REHEAT 2

Study Overview
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Brief Summary
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REHEAT 2 study is designed as a prospective, randomised trial comparing two strategies of myocardial revascularisation (PCI vs CABG) in patients with ischemic cardiomyopathy and low left ventricular ejection fraction.Patients will undergo in random way PCI or CABG procedure. The aim the study is to assess the improvement of left ventricle systolic function and comparing recent (30 days) and late (12 months) results of surgical (CABG) and percutaneous (PCI) revascularization.

Detailed Description
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Heart failure constitutes one of basic problems of contemporary cardiology. It is most commonly caused by ischaemic heart disease, which as an etiologic factor, has a negative impact on prognosis. On the other hand, decreased left ventricular ejection fraction is the most important prognostic factor in patients with ischaemic heart disease. Annual mortality among patients with ejection fraction below 35% accounts for 17%, and in a group with ejection fraction below 25% reaches 24%. Most of multicenter studies (e.g. ARTS, BARI, ERACI) comparing results of percutaneous and surgical revascularisation in ischemic heart disease pertain to patients with normal or minimally decreased left ventricular ejection fraction, excluding patients with left ventricular ejection fraction lower than 35%. Current medical standards indicate the surgical way as a method of choice in treatment of patients with ischemic cardiomyopathy. In early nineties the procedures of percutaneous angioplasty in patients with depressed left ventricular function were connected with comparable to CABG risk of death (5-10%). The intensive progress of percutaneous procedures contributed PCI is competitive method of revasularization to CABG. Our knowledge about the efficacy of above mentioned methods in patients with ischemic heart failure is scarce until now. It was proved, that patients with viable myocardium assessed in dobutamine stress echocardiography or MRI benefit mostly from myocardial revascularization. Repeat revascularization during follow up occurred more frequently in patients after PCI, so that introduction of coronary stents, especially drug eluting stents (DES) could significantly improve the clinical outcome after PCI procedures. The administration of antiplatelet drugs (IIb/IIIa platelet receptor inhibitors) have considerably improved the short and long-term results of PCI so that it is interesting if they could have beneficial effect on clinical outcome of patients with ischemic heart failure. In the field of cardiac surgery the method of left ventricle reconstruction in patients with ischemic cardiomyopathy (STICH Trial) seems to be promising. Therefore, the comparison of innovative methods of percutaneous and surgical revascularization may influence current medical standards concerning patients with ischemic heart disease.

Official Title
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Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery

Conditions
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Left Ventricular Ejection Fraction, Myocardial Revascularization, Ischemic Heart Disease

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Procedure: Coronary Artery Bypass Grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic coronary artery disease (angina CCS class 1) left ventricle ejection fraction <40% coronary artery lesions suitable for percutaneous or surgical myocardial revascularisation evidence for viability of the myocardium written inform consent for the study Exclusion Criteria: age <18 years acute myocardial infarct with ST elevation within 30 days concomitant congenital heart disease mitral regurgitation required surgical intervention history of bleeding diathesis, coagulopathy or abnormal bleeding within the previous 30 days. major surgery within the previous 6 weeks stroke or transient ischemic attack (TIA) within the previous 6 weeks history of hemorrhagic stroke uncontrolled hypertension chronic renal insufficiency with creatinine >2.0 mg/dl platelet count <100.000/mm3 hematocrit <30% PT >1,2 times control positive pregnancy test any disease that may shorten the life expectancy of the patient the patient is currently participating in another research study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous Coronary Intervention|nan|
|Procedure: Coronary Artery Bypass Grafting|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV ejection fraction after 1 year since the index procedure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital and 30 day major adverse events (MAE) and major adverse cardiovascular events (MACE) defined as: death, AMI, stroke, acute heart failure, re-CABG, re-PTCA; |  |  | 
| major adverse coronary and cerebrovascular events during 1 year follow-up (MACCE): death, repeat revascularisation, AMI, unstable angina, heart transplantation, heart failure stroke; |  |  | 
| long term survival; |  |  | 
| severity of angina, exercise and functional capacity along with assessment of quality of life in one year observation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, CABG, Ejection Fraction, Myocardial Revascularization