Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— POL-MIDES  

Official title:

Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035567
• Other study ID #: N R13 008406/2009
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 16, 2009
• Last updated: December 1, 2013
• Start date: November 2009
• Est. completion date: October 2013

Study information

• Verified date: December 2013
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Disease
• Myocardial Ischaemia
• Myocardial Ischemia

Intervention

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
• Coronary Artery Bypass Grafting
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.

Locations

Country	Name	City	State
Poland	Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease	Zabrze
Poland	Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease	Zabrze

Sponsors (2)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year	Yes
Secondary	Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments		1 year	Yes
Secondary	Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2		1 year	No
Secondary	Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.		1 year	No