Clinical Trial: A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

Brief Summary:

CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.

Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.

While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.

Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alon

Detailed Summary:
Sponsor: Euro CTO Club

Current Primary Outcome:

  • Quality of Life [ Time Frame: Baseline and 12 months ]
    Seattle Angina Questionnaire and EQ-5D for health outcomes measurement
  • Major cardiovascular events [ Time Frame: 36 months ]
    Cumulative composite endpoint of all-cause death, non-fatal MI at 3 years


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety and efficacy endpoints [ Time Frame: 12 and 36 months ]
    All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias)
  • Prcedural complications [ Time Frame: baseline upto 36 months ]
    Incl. periprocedural enzyme leak (defined by CK increase >3 times ULN); pericprocedural MI (new Q-wave or STEMI); pericardial tamponade, need for urgent CABG, CIN, death within 30 days, proven periprocedural cerebrovascular events
  • Protocol adherence [ Time Frame: 36 months ]
    Need to cross from OMT to PCI in Group 2 (after escalation up to maximum tolerated anti-anginal therapy and persistent unequivocal symptoms)
  • Per protocol analysis [ Time Frame: 36 months ]
    primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI


Original Secondary Outcome: Same as current

Information By: Euro CTO Club

Dates:
Date Received: January 1, 2013
Date Started: March 2012
Date Completion: June 2018
Last Updated: August 29, 2016
Last Verified: August 2016