Revascularization in Heart Failure Trial – REHEAT 2
Recruitment status was Not yet recruiting
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.
Left Ventricular Ejection Fraction
Ischemic Heart Disease
Procedure: Percutaneous Coronary Intervention
Procedure: Coronary Artery Bypass Grafting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Myocardial Revascularization in Patients With Ischemic Cardiomyopathy: a Comparison Between Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery|
- LV ejection fraction after 1 year since the index procedure
- 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.
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388245
|Contact: Pawel E Buszman, Prof||+48 32 252 72 firstname.lastname@example.org|
|Contact: Iwona Szkrobka, MD||+48 602 457 email@example.com|
|University School of Silesia, 1-st Department of Cardiosurgery||Not yet recruiting|
|Katowice, Silesia, Poland, 40-635|
|Principal Investigator: Andrzej Bochenek, Prof|
|University School of Silesia, 3-rd Department of Cardiology, Coronary Care Unit||Not yet recruiting|
|Katowice, Silesia, Poland, 40-635|
|Principal Investigator: Pawel E Buszman, Prof|
|Sub-Investigator: Iwona Szkrobka, MD|
|Principal Investigator: Michal Tendera, Prof|
|Sub-Investigator: Aleksander Zurakowski, PhD|
|Central Clinic Hospital||Not yet recruiting|
|Warsaw, Poland, 02-507|
|Principal Investigator: Robert J Gil, Prof|
|Military Clinic Hospital||Not yet recruiting|
|Wroclaw, Poland, 50-981|
|Principal Investigator: Piotr Ponikowski, Prof|
|Study Director:||Pawel E Buszman, Prof||3-rd Division of Cardiology, University School of Silesia, Poland|
|Study Chair:||Michal Tendera, Prof||3-rd Division of Cardiology, University School of Silesia, Poland|
|Principal Investigator:||Andrzej Bochenek, Prof||1-st Division of Cardiosurgery, University School of Silesia, Poland|
|Principal Investigator:||Robert J Gil, Prof||Invasive Cardiology Department, Central Clinic Hospital, Warsaw, Poland|
|Principal Investigator:||Piotr Ponikowski, Prof||Heart Disease Department, Military Clinic Hospital, Wroclaw, Poland|