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Clinical Trials/NCT02964975
NCT02964975CompletedPhase 4

Quality of Life Assessment in Patients With Coronary Artery Chronic Total Occlusion: Randomized Comparison of Optimal Medical Therapy and Percutaneous Coronary Intervention

Clinical Centre of Serbia1 site in 1 country100 target enrollmentStarted: September 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Health related quality of life

Study Overview

Brief Summary

Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant reduction in short-term and long-term mortality. To our knowledge till today no prospective randomized trial compared percutaneous revascularization of CTO with optimal medical therapy. For this reason quality of live improvement is one of the most important indications for revascularization 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, angina stability, angina frequency, treatment satisfaction and disease perception/quality of life.

In this open prospective study patients with CTO of coronary artery will be randomized in two groups: first - patients with percutaneous coronary intervention of chronic total occlusion 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 mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina Questionnaire before randomization and after 6 months of follow-up.

Detailed Description

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 angina symptoms unchanged in the last 3 months or evidence of silent ischemia; in case of recent acute ischemic 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. In spite of that, there is uncertainty should this lesions be revascularized and in what way. If there are symptoms or objective proof of ischemia and viability in the area of occluded artery distribution, recanalization of CTO should be considered. Several studies showed that in the presence of chronic total occlusion collateral circulation may produce supply of oxygen and preserve viability. However assessment of collateral circulation with adenosine stress test showed abnormal coronary reserve in over than 90% was reduced which means that collaterals are not enough Therapeutically uncertainties lead partially from technical complex procedures of revascularization CTO with PCI, with success rate of 60-70% which is importantly lower than revascularization rate of non-CTO lesions (98%). During last decade there has been significant improvement in technology, equipment and techniques of percutaneous revascularization procedures for CTO that increased procedural success rate (around 90%). On the other hand there are separate views regarding possibility of treating this patients with coronary artery bypass graft (CABG), and specially patients with single coronary disease Metaanalysis performed by O'Connor SA et al. showed that presence of chronic total occlusion on non infarct artery in patients with acute myocardial infarction significantly increases mortality. Furthermore several mataanalyses that analyzed the effect of PCI CTO on survival, showed significant reduction of mortality rate in short term and also long term follow up. Studies enrolled in this metaanalyses were retrospective or prospective registries which compared successful PCI CTO 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 unsuccessful probably have more serious coronary atherosclerosis and fibrosis that contribute to procedural failure and greater mortality (3).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •CTO of coronary artery (TIMI 0 flow)
  • •a) Stabile angina and/or b) evidence of ischemia in the territory of the CTO and/or c) evidence of viable myocardium in the CTO territory
  • •target coronary artery with a reference diameter of 2.5 mm

Exclusion Criteria

  • •acute myocardial infarction in past month
  • •contraindications for dual antiplatelet therapy in future 12 months
  • •contraindications for drug eluting stents (DES)
  • •informed consent not signed
  • •CTO in bypass graft
  • •EF <20 %
  • •Patient not available for follow-up
  • •CVI or TIA in past 6 months
  • •Patients with:
  • •neutropenia (<1000 /mm3) in past two weeks
  • •thrombocytopenia (<100 000/mm3)
  • •AST, ALT, alkaline phosphatase >1.5x the upper limit of normal
  • •serum creatine >2 mg/dL (>180 µmol/L)
  • •Patients with allergy to iodine contrast that cannot be treated medically
  • •Life expectancy not longer than one year
  • •Patients with bleeding diathesis or coagulopathy or will refuse transfusions.

Arms & Interventions

Percutaneous coronary intervention

Active Comparator

Percutaneous coronary intervention of chronic total occlusion

Intervention: Percutaneous coronary intervention (Procedure)

Optimal medical therapy

Active Comparator

conservative treatment

Intervention: Optimal medical therapy (Drug)

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: 6 months

Seattle Angina Questionnaire

Secondary Outcomes

  • all cause death, Major Adverse Cardiac Event (MACE) including: Acute Myocardial Infarction - AMI, repeated revascularisation(6 months)

Investigators

Sponsor
Clinical Centre of Serbia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sinisa Stojkovic

Head Deaprtment of Interventional Cardiologyand Catheter Ablation, Principal Investigator, Clinical Professor

Clinical Centre of Serbia

Study Sites (1)

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