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

NCT01035567 | Completed Phase 2 DMC

• 1 other identifier: N R13 008406/2009
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments

  1 year

• Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2

  1 year

• Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.

  1 year

Study Arms (2)

Hybrid revascularization

ACTIVE COMPARATOR

Procedure: Hybrid revascularization

Coronary Artery Bypass Grafting

ACTIVE COMPARATOR

Procedure: Coronary Artery Bypass Grafting

Interventions

Hybrid revascularization PROCEDURE

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

Hybrid revascularization

Coronary Artery Bypass Grafting PROCEDURE

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

Coronary Artery Bypass Grafting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (2)

Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease

Zabrze, 41-800, Poland

Location

Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease

Zabrze, 41-800, Poland

Location

Related Publications (7)

• 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.

  PMID: 9769007 BACKGROUND

• 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.

  PMID: 10504652 BACKGROUND

• 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.

  PMID: 12142196 BACKGROUND

• 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.

  PMID: 12400817 BACKGROUND

• 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.

  PMID: 29680218 DERIVED

• 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.

  PMID: 25459040 DERIVED

• 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.

  PMID: 21594832 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease; Coronary Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Marian Zembala, PhD

  Silesian Center for Heart Disease

  PRINCIPAL INVESTIGATOR

• Mariusz Gasior, PhD

  Silesian Center for Heart Disease

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of the Cardiosurgery and Transplantology Department

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 18, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

PL (2)