Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease - Full Text View

Purpose

The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.

Condition	Intervention	Phase
Heart Disease Myocardial Ischaemia Coronary Disease Coronary Artery Disease	Procedure: Hybrid revascularization Procedure: Coronary Artery Bypass Grafting	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Silesian Centre for Heart Diseases:

Primary Outcome Measures:

Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2009
Estimated Study Completion Date:	June 2013
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Hybrid revascularization	Procedure: Hybrid revascularization First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery
Active Comparator: Coronary Artery Bypass Grafting	Procedure: Coronary Artery Bypass Grafting Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 or more
Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
Patient is willing to comply with all follow-up visits
Patient signed an Informed Consent

Exclusion Criteria:

Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
Prior surgery with the opening of pericardium or pleura
Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
One or more chronic total occlusions in major coronary territories
Left main stenosis (at least 50% diameter stenosis)
Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
Concurrent enrollment in another clinical trial
Patient inaccessible for follow-up visits required by protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035567

Locations

Poland
Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, Poland, 41-800
Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, Poland, 41-800

Sponsors and Collaborators

Silesian Centre for Heart Diseases

Ministry of Science and Higher Education, Poland

Investigators

Principal Investigator:	Marian Zembala, PhD	Silesian Center for Heart Disease
Study Chair:	Mariusz Gasior, PhD	Silesian Center for Heart Disease

More Information

Publications:

Riess FC, Schofer J, Kremer P, Riess AG, Bergmann H, Moshar S, Mathey D, Bleese N. Beating heart operations including hybrid revascularization: initial experiences. Ann Thorac Surg. 1998 Sep;66(3):1076-81.

Wittwer T, Cremer J, Klima U, Wahlers T, Haverich A. Myocardial "hybrid" revascularization: intermediate results of an alternative approach to multivessel coronary artery disease. J Thorac Cardiovasc Surg. 1999 Oct;118(4):766-7. No abstract available.

Cisowski M, Morawski W, Drzewiecki J, Kruczak W, Toczek K, Bis J, Bochenek A. Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization. Eur J Cardiothorac Surg. 2002 Aug;22(2):261-5.

Stahl KD, Boyd WD, Vassiliades TA, Karamanoukian HL. Hybrid robotic coronary artery surgery and angioplasty in multivessel coronary artery disease. Ann Thorac Surg. 2002 Oct;74(4):S1358-62.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zembala M, Tajstra M, Zembala M, Filipiak K, Knapik P, Hrapkowicz T, Gierlotka M, Hawranek M, Polo?ski L, G?sior M. Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI-vessel coronary artery DisEaSe (POLMIDES) - study design. Kardiol Pol. 2011;69(5):460-6.

Responsible Party:	Marian Zembala, MD, PhD, Head of the Cardiosurgery and Transplantology Department, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier:	NCT01035567 History of Changes
Other Study ID Numbers:	N R13 008406/2009
Study First Received:	December 16, 2009
Last Updated:	January 25, 2013
Health Authority:	Poland: Ministry of Science and Higher Education

Keywords provided by Silesian Centre for Heart Diseases:

Multivessel coronary artery disease
Hybrid revascularization
Coronary Artery Bypass Grafting
Percutaneous Coronary Interventions
Drug eluting stents

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease (POL-MIDES)