Clinical trial NCT01035567: Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease
Official title: Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Disease
Myocardial Ischaemia
Coronary Disease
Coronary Artery Disease
Keywords: Multivessel coronary artery disease
Hybrid revascularization
Coronary Artery Bypass Grafting
Percutaneous Coronary Interventions
Drug eluting stents
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2009-12-18
Enrollment: 200
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: 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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
timeFrame: 1 year
measure: Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
timeFrame: 1 year
measure: Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
city: Zabrze
country: Poland
facility: Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
Study officials:
affiliation: Silesian Center for Heart Disease
name: Marian Zembala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Silesian Center for Heart Disease
name: Mariusz Gasior, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1016/s0003-4975(98)00714-0.
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. doi: 10.1016/S0022-5223(99)70035-8. No abstract available.
citation: 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. doi: 10.1016/s1010-7940(02)00262-2.
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. doi: 10.1016/s0003-4975(02)03889-4.
citation: Tajstra M, Hrapkowicz T, Hawranek M, Filipiak K, Gierlotka M, Zembala M, Gasior M, Zembala MO; POL-MIDES Study Investigators. Hybrid Coronary Revascularization in Selected Patients With Multivessel Disease: 5-Year Clinical Outcomes of the Prospective Randomized Pilot Study. JACC Cardiovasc Interv. 2018 May 14;11(9):847-852. doi: 10.1016/j.jcin.2018.01.271. Epub 2018 Apr 18.
citation: Gasior M, Zembala MO, Tajstra M, Filipiak K, Gierlotka M, Hrapkowicz T, Hawranek M, Polonski L, Zembala M; POL-MIDES (HYBRID) Study Investigators. Hybrid revascularization for multivessel coronary artery disease. JACC Cardiovasc Interv. 2014 Nov;7(11):1277-83. doi: 10.1016/j.jcin.2014.05.025. Epub 2014 Nov 17.
citation: Zembala M, Tajstra M, Zembala M, Filipiak K, Knapik P, Hrapkowicz T, Gierlotka M, Hawranek M, Polonski L, Gasior 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.