A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions (EuroCTO)
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|ClinicalTrials.gov Identifier: NCT01760083|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : July 2, 2019
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 alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stable Angina Dyspnea Coronary Occlusion||Device: Biolimus-eluting stent implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2018|
Active Comparator: Biolimus-eluting stent implantation
PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
Device: Biolimus-eluting stent implantation
Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents
Other Name: Biosensors Biolimus-eluting stents of all sizes and lengths
No Intervention: Medical therapy
Optimal medical therapy. Subsequent PCI only if symptoms of angina persist despite optimal medical therapy. At least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy should be used before crossover. Medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate.
- Quality of Life Seattle Angina Questionnaire (SAQ) [ 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 cardiovascular death, non-fatal MI at 3 years
- 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) Repeat revascularization
- Procedural 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
- Health-economic analysis [ Time Frame: 12 and 36 months ]Economic assessment & cost efficacy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760083
|Principal Investigator:||Gerald S Werner, MD PhD||Klinikum Darmstadt, Darmstadt Germany|