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

NCT01760083 | Completed DMC

• 1 other identifier: 2011-005905-64
• Study Type: interventional
• Target: 450
• Locations: 6 countries
• Sites: 19

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

Conditions

Chronic Stable Angina; Dyspnea; Coronary Occlusion

Outcome Measures

Primary Outcomes (2)

• Quality of Life Seattle Angina Questionnaire (SAQ)

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

  Baseline and 12 months

• Major cardiovascular events

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

  36 months

Secondary Outcomes (4)

• Safety and efficacy endpoints

  12 and 36 months

• Procedural complications

  baseline upto 36 months

• Protocol adherence

  36 months

• Per protocol analysis

  36 months

Other Outcomes (1)

• Health-economic analysis

  12 and 36 months

Study Arms (2)

Biolimus-eluting stent implantation

ACTIVE COMPARATOR

PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.

Device: Biolimus-eluting stent implantation

Medical therapy

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.

Interventions

Biolimus-eluting stent implantation DEVICE

Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents

Also known as: Biosensors Biolimus-eluting stents of all sizes and lengths

Biolimus-eluting stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure

Sponsors & Collaborators

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

Study Sites (19)

Clinique Saint-Augustin

Bordeaux, 33074, France

Location

CH de Lagny

Lagny, 77405, France

Location

Institut Hospitalier Jacques Cartier - ICPS

Massy, 91300, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Rangueil university hospital

Toulouse, 31076, France

Location

Zentralklinik Bad Berka

Bad Berka, 99438, Germany

Location

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Main Taunus Kliniken

Bad Soden, 65812, Germany

Location

Klinikum Darmstadt

Darmstadt, 64283, Germany

Location

Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita

Catania, 95126, Italy

Location

Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Unidad de Cardiología Intervencionista Hospital de Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic Villaroel

Barcelona, 08036, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, 48960, Spain

Location

Cardiovascular Institute - Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Royal Sussex County Hospital - Brighton and Sussex University Hospitals

Brighton, BN2 5BE, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Department of Cardiovascular Sciences University of Leicester

Leicester, LE3 9QP, United Kingdom

Location

National Heart and Lung Institute Imperial College

London, SW7 2AZ, United Kingdom

Location

Related Publications (3)

• Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.

  PMID: 29722796 RESULT

• Werner GS, Hildick-Smith D, Martin Yuste V, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, Di Mario C, Teruel L, Bufe A, Lauer B, Galassi AR, Louvard Y. Three-year outcomes of A Randomized Multicentre Trial Comparing Revascularization and Optimal Medical Therapy for Chronic Total Coronary Occlusions (EuroCTO). EuroIntervention. 2023 Sep 18;19(7):571-579. doi: 10.4244/EIJ-D-23-00312.

  PMID: 37482940 DERIVED

• Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11.

  PMID: 26434510 DERIVED

Related Links

• Sponsor European CTO Club e.V. (ECC)

MeSH Terms

Conditions

Angina, Stable; Dyspnea; Coronary Occlusion

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Coronary Disease

Study Officials

• Gerald S Werner, MD PhD

  Klinikum Darmstadt, Darmstadt Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2013
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-06

Locations

FR (5); GB (4); DE (4); IT (1); LA (1); ES (4)