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

Sponsor
Euro CTO Club (Other)
Overall Status
Completed
CT.gov ID
NCT01760083
Collaborator
NHS Research and Development (Other), Biosensors International (Other), Asahi Intecc Co., Ltd. (Industry)
450
Enrollment
19
Locations
2
Arms
70
Actual Duration (Months)
23.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 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
  • Device: Biolimus-eluting stent implantation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life Seattle Angina Questionnaire (SAQ) [Baseline and 12 months]

      Seattle Angina Questionnaire and EQ-5D for health outcomes measurement

    2. Major cardiovascular events [36 months]

      Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years

    Secondary Outcome Measures

    1. Safety and efficacy endpoints [12 and 36 months]

      All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias) Repeat revascularization

    2. Procedural complications [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

    3. Protocol adherence [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)

    4. Per protocol analysis [36 months]

      primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI

    Other Outcome Measures

    1. Health-economic analysis [12 and 36 months]

      Economic assessment & cost efficacy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ≥ 18 years of age with written informed consent

    • CTO in native coronary artery

      1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Saint-Augustin Bordeaux France 33074
    2 CH de Lagny Lagny France 77405
    3 Institut Hospitalier Jacques Cartier - ICPS Massy France 91300
    4 Clinique Pasteur Toulouse France 31076
    5 Rangueil university hospital Toulouse France 31076
    6 Zentralklinik Bad Berka Bad Berka Germany 99438
    7 Herz-Zentrum Bad Krozingen Bad Krozingen Germany 79189
    8 Main Taunus Kliniken Bad Soden Germany 65812
    9 Klinikum Darmstadt Darmstadt Germany 64283
    10 Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita Catania Italy 95126
    11 Latvian Center of Cardiology Pauls Stradins Clinical University Hospital Riga Latvia 1002
    12 Unidad de Cardiología Intervencionista Hospital de Sant Pau Barcelona Spain 08025
    13 Hospital Clinic Villaroel Barcelona Spain 08036
    14 Hospital Galdakao-Usansolo Galdakao Spain 48960
    15 Cardiovascular Institute - Hospital Clinico San Carlos Madrid Spain 28040
    16 Royal Sussex County Hospital - Brighton and Sussex University Hospitals Brighton United Kingdom BN2 5BE
    17 Royal Infirmary of Edinburgh Edinburgh United Kingdom EH16 4SA
    18 Department of Cardiovascular Sciences University of Leicester Leicester United Kingdom LE3 9QP
    19 National Heart and Lung Institute Imperial College London United Kingdom SW7 2AZ

    Sponsors and Collaborators

    • Euro CTO Club
    • NHS Research and Development
    • Biosensors International
    • Asahi Intecc Co., Ltd.

    Investigators

    • Principal Investigator: Gerald S Werner, MD PhD, Klinikum Darmstadt, Darmstadt Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Euro CTO Club
    ClinicalTrials.gov Identifier:
    NCT01760083
    Other Study ID Numbers:
    • 2011-005905-64
    First Posted:
    Jan 3, 2013
    Last Update Posted:
    Jul 2, 2019
    Last Verified:
    Jun 1, 2019
    Additional relevant MeSH terms:
    Dyspnea
    Angina, Stable
    Coronary Occlusion

    Study Results

    No Results Posted as of Jul 2, 2019