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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NHS Research and Development
Biosensors International
Asahi Intecc Co., Ltd.
Information provided by (Responsible Party):
Euro CTO Club
ClinicalTrials.gov Identifier:
NCT01760083
First received: January 1, 2013
Last updated: April 7, 2016
Last verified: April 2016
  Purpose

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 Intervention
Chronic Stable Angina
Dyspnea
Coronary Occlusion
Device: Biolimus-eluting stent implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Euro CTO Club:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Seattle Angina Questionnaire and EQ-5D for health outcomes measurement

  • Major cardiovascular events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Cumulative composite endpoint of all-cause death, non-fatal MI at 3 years


Secondary Outcome Measures:
  • Safety and efficacy endpoints [ Time Frame: 12 and 36 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Health-economic analysis [ Time Frame: 12 and 36 months ] [ Designated as safety issue: No ]
    Economic assessment & cost efficacy


Enrollment: 450
Study Start Date: March 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760083

Locations
France
Clinique Saint-Augustin
Bordeaux, France, 33074
CH de Lagny
Lagny, France, 77405
Institut Hospitalier Jacques Cartier - ICPS
Massy, France, 91300
Clinique Pasteur
Toulouse, France, 31076
Rangueil university hospital
Toulouse, France, 31076
Germany
Zentralklinik Bad Berka
Bad Berka, Germany, 99438
Herz-Zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Main Taunus Kliniken
Bad Soden, Germany, 65812
Klinikum Darmstadt
Darmstadt, Germany, 64283
Italy
Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita
Catania, Italy, 95126
Latvia
Latvian Center of Cardiology Pauls Stradins Clinical University Hospital
Riga, Latvia, 1002
Spain
Unidad de Cardiología Intervencionista Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Clinic Villaroel
Barcelona, Spain, 08036
Hospital Galdakao-Usansolo
Galdakao, Spain, 48960
Cardiovascular Institute - Hospital Clinico San Carlos
Madrid, Spain, 28040
United Kingdom
Royal Sussex County Hospital - Brighton and Sussex University Hospitals
Brighton, United Kingdom, BN2 5BE
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Department of Cardiovascular Sciences University of Leicester
Leicester, United Kingdom, LE3 9QP
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Euro CTO Club
ClinicalTrials.gov Identifier: NCT01760083     History of Changes
Other Study ID Numbers: 2011-005905-64 
Study First Received: January 1, 2013
Last Updated: April 7, 2016
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Angina, Stable
Coronary Occlusion
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Coronary Disease
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on May 05, 2016