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Unprotected left main coronary artery (ULMCA) stenting, offering restoration of a native flow to left coronary artery, is the subject of intense investigations as a potential alternative to bypass surgery. The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery.
The natural history and the results of pharmacological treatment in patients with severe narrowing of left main coronary artery show very poor prognosis (5 year survival less than 50%).
There is general agreement that surgical treatment improves 5 year survival in patients with left main coronary artery obstruction 3, however long term survival rate (15 year follow-up) is low in both groups (37% and 27% respectively in surgical and medical group). Median survival was longer in surgical group in general population (13.3 vs 6.6 years) , but there was no significant difference in patients with normal LV ejection fraction (14.7 vs 15 years).
With the advent of coronary stenting encouraging results were reported by several authors. There was high success rate 98-100% for elective procedures and in these series the mortality (for protected and non-protected left main) ranged from 0 to 3.4 %, and 6 month event free survival rate was 70-80%. Restenosis rate in stented LM varied from 10-22% for proximal LM to 40% for distal LM. Final minimal luminal area >=7mm2 post procedure, assessed by IVUS, predicted low restenosis rate of 7%, while the area below <7mm2 was connected with restenosis of 50%. Our and other experience showed that left main in-stent restenosis can be treated successfully with another percutaneous intervention (including endarterectomy and balloon angioplasty) as well as by surgical revascularization.
Six and 12-month survival rate depended on the LV function. Patients with LVEF>40% had in-hospital event free survival of 98% and 9-month event free survival of 86%, whereas patients with LVEF <40% had in-hospital and 9 month event-free survival of 67 and 22% respectively. Additionally, in patients presented with acute myocardial infarction or bail-out procedures, early and late results of LM stenting were not as good as for elective cases.
Our previously presented promising results of left main stenting is mainly related to proper technique of LM stenting (short inflations within LM, careful guiding catheter manipulation, stent selection), as well as very cautiously designed follow-up (every month visit for first six month, routine coronary angiography within 3-6 months after procedure). This initial experience gives us the backgrounds for a larger prospective randomized trial comparing elective surgical revascularisation and percutaneous intervention in patients with LM coronary artery disease. It is our impression that design and the delivery system of the new generation stent is uniquely suited to safely treat this difficult subset of patients. At the present time we would limit the study to the discrete lesions in proximal (ostial and mid) left main with reference luminal diameter >=3 mm. Based on published results of stenting under IVUS examination for such a lesion we estimate the restenosis rate to be well below 10%. As we expect, the survival and complication rate within one year in both group will be similar. Therefore our main concern is weather both treatment strategies will offer the same prevention of LV function, as well as improvement of functional capacity and coronary reserve in both groups in a period of 2-3 years.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Coronary Artery Stenosis
Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
Sharpe-Strumia Research Foundation of the Bryn Mawr Hospital, Bryn Mawr, PA, USA and Thomas Jefferson University, Philadelphia
Ministry of Science and Higher Education, Poland
Published on BioPortfolio: 2014-07-23T21:35:21-0400
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Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.
Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.
A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.
Coronary artery bypass surgery on a beating HEART without a CARDIOPULMONARY BYPASS (diverting the flow of blood from the heart and lungs through an oxygenator).
Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.
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A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body. A stent is placed in an artery as part of a procedure called angioplasty. &...