Overview

This trial is active, not recruiting.

Conditions chronic stable angina, dyspnea, coronary occlusion
Treatment biolimus-eluting stent implantation
Sponsor Euro CTO Club
Collaborator NHS Research and Development
Start date March 2012
End date March 2017
Trial size 450 participants
Trial identifier NCT01760083, 2011-005905-64

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 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
biolimus-eluting stent implantation Biosensors Biolimus-eluting stents of all sizes and lengths
Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents
(No Intervention)
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.

Primary Outcomes

Measure
Quality of Life
time frame: Baseline and 12 months
Major cardiovascular events
time frame: 36 months

Secondary Outcomes

Measure
Safety and efficacy endpoints
time frame: 12 and 36 months
Prcedural complications
time frame: baseline upto 36 months
Protocol adherence
time frame: 36 months
Per protocol analysis
time frame: 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - ≥ 18 years of age with written informed consent - CTO in native coronary artery - a) Stable angina, or b) myocardial ischaemia in a territory supplied by CTO, and c) viability in akinetic myocardium (<50% transmural late enhancement on MRI or normal resting perfusion scan) - CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx) - target artery ≥2.5mm Exclusion Criteria: - AMI or NSTE-ACS within 1 month - Significant untreated coronary stenosis in a territory other than CTO - Patients with MVD and significant non-CTO stenoses where it is deemed unsafe to treat the non-CTO lesion first (e.g. Significant proximal LAD lesion with chronically occluded RCA) - Patient unsuitable for 12 month dual anti-platelet therapy - Any exclusion criteria for PCI or DES - Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure

Additional Information

Official title A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions
Principal investigator Gerald S Werner, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Euro CTO Club.