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

Primary Purpose

Chronic Stable Angina, Dyspnea, Coronary Occlusion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Biolimus-eluting stent implantation
Sponsored by
Euro CTO Club
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Saint-Augustin
  • CH de Lagny
  • Institut Hospitalier Jacques Cartier - ICPS
  • Clinique Pasteur
  • Rangueil university hospital
  • Zentralklinik Bad Berka
  • Herz-Zentrum Bad Krozingen
  • Main Taunus Kliniken
  • Klinikum Darmstadt
  • Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita
  • Latvian Center of Cardiology Pauls Stradins Clinical University Hospital
  • Unidad de Cardiología Intervencionista Hospital de Sant Pau
  • Hospital Clinic Villaroel
  • Hospital Galdakao-Usansolo
  • Cardiovascular Institute - Hospital Clinico San Carlos
  • Royal Sussex County Hospital - Brighton and Sussex University Hospitals
  • Royal Infirmary of Edinburgh
  • Department of Cardiovascular Sciences University of Leicester
  • National Heart and Lung Institute Imperial College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Biolimus-eluting stent implantation

Medical therapy

Arm Description

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

Outcomes

Primary Outcome Measures

Quality of Life Seattle Angina Questionnaire (SAQ)
Seattle Angina Questionnaire and EQ-5D for health outcomes measurement
Major cardiovascular events
Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years

Secondary Outcome Measures

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

Full Information

First Posted
January 1, 2013
Last Updated
June 29, 2019
Sponsor
Euro CTO Club
Collaborators
NHS Research and Development, Biosensors International, Asahi Intecc Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01760083
Brief Title
A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Euro CTO Club
Collaborators
NHS Research and Development, Biosensors International, Asahi Intecc Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina, Dyspnea, Coronary Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biolimus-eluting stent implantation
Arm Type
Active Comparator
Arm Description
PCI of CTO using a Biomatrix drug-eluting stent system + optimal medical therapy.
Arm Title
Medical therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biolimus-eluting stent implantation
Other Intervention Name(s)
Biosensors Biolimus-eluting stents of all sizes and lengths
Intervention Description
Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents
Primary Outcome Measure Information:
Title
Quality of Life Seattle Angina Questionnaire (SAQ)
Description
Seattle Angina Questionnaire and EQ-5D for health outcomes measurement
Time Frame
Baseline and 12 months
Title
Major cardiovascular events
Description
Cumulative composite endpoint of cardiovascular death, non-fatal MI at 3 years
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Safety and efficacy endpoints
Description
All cause mortality Cardiac mortality Myocardial Infarction Any hospitalization due to cardiovascular events (angina, congestive heart failure, arrythmias) Repeat revascularization
Time Frame
12 and 36 months
Title
Procedural complications
Description
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
Time Frame
baseline upto 36 months
Title
Protocol adherence
Description
Need to cross from OMT to PCI in Group 2 (after escalation up to maximum tolerated anti-anginal therapy and persistent unequivocal symptoms)
Time Frame
36 months
Title
Per protocol analysis
Description
primary endpoint comparison in patients who did have a successful revascularization compared to those patients treated medically who had no subsequent PCI
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Health-economic analysis
Description
Economic assessment & cost efficacy
Time Frame
12 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald S Werner, MD PhD
Organizational Affiliation
Klinikum Darmstadt, Darmstadt Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint-Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
CH de Lagny
City
Lagny
ZIP/Postal Code
77405
Country
France
Facility Name
Institut Hospitalier Jacques Cartier - ICPS
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Rangueil university hospital
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Zentralklinik Bad Berka
City
Bad Berka
ZIP/Postal Code
99438
Country
Germany
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Main Taunus Kliniken
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
Klinikum Darmstadt
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Latvian Center of Cardiology Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Unidad de Cardiología Intervencionista Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic Villaroel
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Galdakao-Usansolo
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Cardiovascular Institute - Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Royal Sussex County Hospital - Brighton and Sussex University Hospitals
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Department of Cardiovascular Sciences University of Leicester
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
National Heart and Lung Institute Imperial College
City
London
ZIP/Postal Code
SW7 2AZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29722796
Citation
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.
Results Reference
result
PubMed Identifier
26434510
Citation
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.
Results Reference
derived
Links:
URL
http://eurocto.eu
Description
Sponsor European CTO Club e.V. (ECC)

Learn more about this trial

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

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