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| Name | Class |
|---|---|
| Ministry of Science and Higher Education, Poland | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid revascularization | Active Comparator |
| |
| Coronary Artery Bypass Grafting | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marian Zembala, PhD | Silesian Center for Heart Disease | Principal Investigator |
| Mariusz Gasior, PhD | Silesian Center for Heart Disease | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease | Zabrze | 41-800 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9769007 | Background | 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. | |
| 10504652 | 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. |
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| Coronary Artery Bypass Grafting | Procedure | Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator. |
|
| Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups. | 1 year |
| Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease | Zabrze | 41-800 | Poland |
| 12142196 | 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. |
| 12400817 | 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. |
| 29680218 | Derived | 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. |
| 25459040 | 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. |
| 21594832 | 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. |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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