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Several meta analysis comparing successful CTO-PCI with unsuccessful CTO-PCI showed that there is significant reduction in short-term and long-term mortality. To our knowlege till today no prospective randomized trial compared percutaneous revascularisation of CTO with optimal medical therapy. For this reason quality of live improvement is one of the most important indications for revascularisation in elective patients with CTO. In contemporary literature Seattle Angina Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to assess the functional status of patients with angina. It comprises 19 questions that quantify five clinically relevant domains: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception/quality of life.
In this open prospective study patients with CTO of coronary arthery will be randomized in two groups: first - patients with percutaneous coronary intervention of chronic total occlusion (CTO) with optimal medical therapy and second group - patients with only optimal medical therapy (control group). Primary endpoint will be quality of life and secondary endpoints will be maior adverse cardiovascular events (MACE). All patients will complete Seattle Angina Questionaire before randomization and after 6 months of followup.
Coronary artery chronic total occlusion (CTO) is defined as complete occlusion of coronary arteries that lasts for more than three months (TIMI 0 coronary flow in occluded segment). In absence of serial angiograms , occlusion duration can be assumed based on clinical data regarding event that caused occlusion. Consensus document from the Euro CTO club suggests 3 levels of certainty:
a) Certain (angiographically confirmed): the minority of cases where a previous angiogram (for instance before a previous CABG operation, or after an acute myocardial infarction) has confirmed the presence of TIMI 0 flow for > 3 months prior to the planned procedure; b) Likely (clinically confirmed): objective evidence of an acute myocardial infarction in the territory of the occluded artery without other possible culprit arteries >3 months before the current angiogram; c) Possible (undetermined): a CTO with TIMI 0 flow and angiographic anatomy suggestive of long-standing occlusion (collateral development, no contrast staining) with stable anginal symptoms unchanged in the last 3 months or evidence of silent ischaemia; in case of recent acute ischaemic episodes (acute myocardial infarction or unstable angina or worsening effort angina), a culprit artery other than the occluded vessel should be present.
CTO is an often finding. Inspite of that there is uncertanty should this leasions be revascularized and in what way. If there are symptoms (angina pectoris) or objective proof of ischaemia and viability in the area of ocluded artery distribution, recanalisation of CTO should be considered. Several studies showed that in the presence of chronic total ocllusion colateral circulation may produce supply of oxygen and preserve viability. Howewer assessment of colateral circulation with adenosin stress test showed abnormal coronary reserve in over than 90% was reduced which means that colaterals are not enough Therapeutical uncertencies lead partialy from techinacy complexed procedures of revascularisation CTO with PCI, with success rate of 60-70% which is importantly lower than revascularisation rate of non-CTO lesions (98%). During last decade there has been significant improvement in techologies, equipment and techniques of percutaneous reavascularisation procedures for CTO that led to procedural success rate of around 90%. On the oher hand there are separate views regarding posibility of treating this patients with coronary arthery bypass graft- CABG, and specially patients with single coronary disease
Metaanalysis performed by O'Connor SA and ass. showed that presence of chronic total occlusion on non culprit lesion in patients with AMI significantly raises mortality . Furthermore several mataanalyses that investigated effect of PCI CTO on survival showed significant reduction of mortality in short term and also long term follow up . Studies analysed in this metaanalyses in most cases represent retrospective or prospective registres which compared groups with successfull PCI CTO with groups with PCI CTO failure.
There are different explanations for this clinical result (mortality reduction):
1. direct benefit of achieving coronary flow and myocardial perfusion improves ventricular function and reduces risk of malignant arrhythmias
2. patients in which PCI was unsuccessfull probably have more serious coronary atherosclerosis and fibrosis that contribute to procedural failure and greater mortality (3).
Similar to previous metaanalyses study conducted by Prasada and associates showed significantly greater mortality in the group with procedural failure .
Study conducted by Hoye and ass. showed significantly higher 5-year mortality in the group with procedural failure and greater mortality without myocardial infarction, CABG, and MACE. Authors explain difference in survival in groups with procedural success and procedural failure in different farmacological management that can be confounding factor. Also uthors state that better prognosis after successfull procedure is probably related to improved left ventricular function and reduced risk of malignant arrhythmias Till this day, to our knowlege, not one prosepctive randomised study was conducted that compared PCI CTO with optimal medical therapy. For this reason quality of life improvement is the most important indication for revascularisation CTO in elected patients. Howewer in contemporary literature there is little data regarding quality of life assessment in patients with CTO.
Quality of life assessment is important indicator of successfull revascularisation in patients with coronary artery disease. "Seattle Angina Questionnaire" (SAQ) is validated for quality of life assessment in patients with coronary artery disease . This questionare is based on five different domains : physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. So far quality of life assessment with SAQ was used in four studies. Two of them compared results of SAQ in patients with successfull recanalisation of CTO and patients with procedural failure. They proved significant improvement od SAQ score in patients with recanalised CTO . Third study compared revascularisation strategies (PCI vs CABG) with optimal medical therapy in patients with diagnosed CTO . In the group treated with medical therapy there were no changes in scores of SAQ domains after one year followup, whilw in patients that were revasculisated in CTO theritory improvement in SAQ scores were documented in three domains (Physical restraint, angina frequency and disease percepcioni). Fourth study compared quality of life after CTO PCI vs PCI in on non CTO lesion. In both groups similar improvement was documented in all domains during 6 months followup
So far no prspective randomised study was conducted that examined quality of life in patients with CTO.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Chronic Total Occlusions of Coronary Arteries
Percutaneous coronary intervention, Optimal medical therapy
Clinical Centre os Serbia
Clinical Centre of Serbia
Published on BioPortfolio: 2016-11-17T11:38:21-0500
Design: Single center, double-blind, sham-controlled trial that will randomize symptomatic patients with a coronary chronic total occlusion (CTO) to CTO percutaneous coronary intervention ...
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