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

NCT ID: NCT01760083

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biolimus-eluting stent implantation

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

Group Type: ACTIVE_COMPARATOR

Biolimus-eluting stent implantation

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biolimus-eluting stent implantation

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

Intervention Type: DEVICE

Other Intervention Names

Biosensors Biolimus-eluting stents of all sizes and lengths

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Research and Development

OTHER_GOV

Sponsor Role: collaborator

Biosensors International

OTHER

Sponsor Role: collaborator

Asahi Intecc Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Euro CTO Club

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald S Werner, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Darmstadt, Darmstadt Germany

Locations

Clinique Saint-Augustin

Bordeaux, , France

CH de Lagny

Lagny, , France

Institut Hospitalier Jacques Cartier - ICPS

Massy, , France

Clinique Pasteur

Toulouse, , France

Rangueil university hospital

Toulouse, , France

Zentralklinik Bad Berka

Bad Berka, , Germany

Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Main Taunus Kliniken

Bad Soden, , Germany

Klinikum Darmstadt

Darmstadt, , Germany

Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita

Catania, , Italy

Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

Riga, , Latvia

Unidad de Cardiología Intervencionista Hospital de Sant Pau

Barcelona, , Spain

Hospital Clinic Villaroel

Barcelona, , Spain

Hospital Galdakao-Usansolo

Galdakao, , Spain

Cardiovascular Institute - Hospital Clinico San Carlos

Madrid, , Spain

Royal Sussex County Hospital - Brighton and Sussex University Hospitals

Brighton, , United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Department of Cardiovascular Sciences University of Leicester

Leicester, , United Kingdom

National Heart and Lung Institute Imperial College

London, , United Kingdom

Countries

France; Germany; Italy; Latvia; Spain; United Kingdom

References

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.

Reference Type: RESULT

PMID: 29722796 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37482940 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26434510 (View on PubMed)

Related Links

http://eurocto.eu

Sponsor European CTO Club e.V. (ECC)

Other Identifiers

2011-005905-64

Identifier Type: -

Identifier Source: org_study_id