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

Dyspnea Clinical Trial

— EuroCTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760083
• Other study ID #: 2011-005905-64
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: Euro CTO Club
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Chronic Stable Angina
• Coronary Occlusion
• Dyspnea

Intervention

Device:
• Biolimus-eluting stent implantation
Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents

Locations

Country	Name	City	State
France	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
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen
Germany	Main Taunus Kliniken	Bad Soden
Germany	Klinikum Darmstadt	Darmstadt
Italy	Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita	Catania
Latvia	Latvian Center of Cardiology Pauls Stradins Clinical University Hospital	Riga
Spain	Hospital Clinic Villaroel	Barcelona
Spain	Unidad de Cardiología Intervencionista Hospital de Sant Pau	Barcelona
Spain	Hospital Galdakao-Usansolo	Galdakao
Spain	Cardiovascular Institute - Hospital Clinico San Carlos	Madrid
United Kingdom	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

Sponsors (4)

Lead Sponsor	Collaborator
Euro CTO Club	Asahi Intecc Co., Ltd., Biosensors International, NHS Research and Development

Countries where clinical trial is conducted

France,  Germany,  Italy,  Latvia,  Spain,  United Kingdom, 

References & Publications (1)

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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-economic analysis	Economic assessment & cost efficacy	12 and 36 months
Primary	Quality of Life Seattle Angina Questionnaire (SAQ)	Seattle Angina Questionnaire and EQ-5D for health outcomes measurement	Baseline and 12 months
Primary	Major cardiovascular events	Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years	36 months
Secondary	Safety and efficacy endpoints	All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias) Repeat revascularization	12 and 36 months
Secondary	Procedural complications	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	baseline upto 36 months
Secondary	Protocol adherence	Need to cross from OMT to PCI in Group 2 (after escalation up to maximum tolerated anti-anginal therapy and persistent unequivocal symptoms)	36 months
Secondary	Per protocol analysis	primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI	36 months

External Links

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