Clinical trial NCT01760083: A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stable Angina
Dyspnea
Coronary Occlusion
Lead sponsor: Euro CTO Club
Sponsor class: OTHER
Collaborators: name: NHS Research and Development
name: Biosensors International
name: Asahi Intecc Co., Ltd.
First posted: 2013-01-03
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Quality of Life Seattle Angina Questionnaire (SAQ)
timeFrame: Baseline and 12 months
measure: Major cardiovascular events
timeFrame: 36 months
Secondary outcomes:
measure: Safety and efficacy endpoints
timeFrame: 12 and 36 months
measure: Procedural complications
timeFrame: baseline upto 36 months
measure: Protocol adherence
timeFrame: 36 months
measure: Per protocol analysis
timeFrame: 36 months
Other outcomes:
measure: Health-economic analysis
timeFrame: 12 and 36 months
Locations:
city: Bordeaux
country: France
facility: Clinique Saint-Augustin
city: Lagny
country: France
facility: CH de Lagny
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier - ICPS
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Rangueil university hospital
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Bad Soden
country: Germany
facility: Main Taunus Kliniken
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Catania
country: Italy
facility: Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita
city: Riga
country: Latvia
facility: Latvian Center of Cardiology Pauls Stradins Clinical University Hospital
city: Barcelona
country: Spain
facility: Unidad de Cardiología Intervencionista Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic Villaroel
city: Galdakao
country: Spain
facility: Hospital Galdakao-Usansolo
city: Madrid
country: Spain
facility: Cardiovascular Institute - Hospital Clinico San Carlos
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital - Brighton and Sussex University Hospitals
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Leicester
country: United Kingdom
facility: Department of Cardiovascular Sciences University of Leicester
city: London
country: United Kingdom
facility: National Heart and Lung Institute Imperial College
Study officials:
affiliation: Klinikum Darmstadt, Darmstadt Germany
name: Gerald S Werner, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.