Randomized Comparison of Optimal Medical Therapy and Percutaneous Recanalization for Chronic Total Occlusion (COMET-CTO)

NCT02964975 | Completed Phase 4

• 1 other identifier: OBVSS-30
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Several meta analysis comparing successful Percutaneous Coronary Intervention of Chronic Total Occlusion (PCI-CTO) with unsuccessful PCI-CTO showed that there is significant reduction in short-term and long-term mortality. To our knowledge till today no prospective randomized trial compared percutaneous revascularization of CTO with optimal medical therapy. For this reason quality of live improvement is one of the most important indications for revascularization in elective patients with CTO. In contemporary literature Seattle Angina Questionnaire (SAQ) is a psychometrically solid disease-specific instrument designed to assess the functional status of patients with angina. It comprises 19 questions that quantify five clinically relevant domains: physical limitation, angina stability, angina frequency, treatment satisfaction and disease perception/quality of life. In this open prospective study patients with CTO of coronary artery will be randomized in two groups: first - patients with percutaneous coronary intervention of chronic total occlusion with optimal medical therapy and second group - patients with only optimal medical therapy (control group). Primary endpoint will be quality of life and secondary endpoints will be mayor adverse cardiovascular events (MACE). All patients will complete Seattle Angina Questionnaire before randomization and after 6 months of follow-up.

Conditions

Chronic Total Occlusions of Coronary Arteries

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  Seattle Angina Questionnaire

  6 months

Secondary Outcomes (1)

• all cause death, Major Adverse Cardiac Event (MACE) including: Acute Myocardial Infarction - AMI, repeated revascularisation

  6 months

Study Arms (2)

Optimal medical therapy

ACTIVE COMPARATOR

conservative treatment

Drug: Optimal medical therapy

Percutaneous coronary intervention

ACTIVE COMPARATOR

Percutaneous coronary intervention of chronic total occlusion

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Recanalisation of chronic total occlusion of coronary artery

Also known as: PCI

Percutaneous coronary intervention

Optimal medical therapy DRUG

Medical threatment according to guidelines

Also known as: Angina pectoris opetimal medical therapy

Optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CTO of coronary artery (TIMI 0 flow)
• a) Stabile angina and/or b) evidence of ischemia in the territory of the CTO and/or c) evidence of viable myocardium in the CTO territory
• target coronary artery with a reference diameter of 2.5 mm

You may not qualify if:

• acute myocardial infarction in past month
• contraindications for dual antiplatelet therapy in future 12 months
• contraindications for drug eluting stents (DES)
• informed consent not signed
• CTO in bypass graft
• EF \<20 %
• Dementia
• Patient not available for follow-up
• CVI or TIA in past 6 months
• Patients with:
• neutropenia (\<1000 /mm3) in past two weeks
• thrombocytopenia (\<100 000/mm3)
• AST, ALT, alkaline phosphatase \>1.5x the upper limit of normal
• serum creatine \>2 mg/dL (\>180 µmol/L)
• Patients with allergy to iodine contrast that cannot be treated medically

Sponsors & Collaborators

• Clinical Centre of Serbia: lead

Study Sites (1)

Clinical Centre os Serbia

Belgrade, 11000, Serbia

Location

Related Publications (9)

• Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention. 2012 May 15;8(1):139-45. doi: 10.4244/EIJV8I1A21. No abstract available.

  PMID: 22580257 BACKGROUND

• Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

  PMID: 22402070 BACKGROUND

• Prasad A, Rihal CS, Lennon RJ, Wiste HJ, Singh M, Holmes DR Jr. Trends in outcomes after percutaneous coronary intervention for chronic total occlusions: a 25-year experience from the Mayo Clinic. J Am Coll Cardiol. 2007 Apr 17;49(15):1611-1618. doi: 10.1016/j.jacc.2006.12.040. Epub 2007 Apr 2.

  PMID: 17433951 BACKGROUND

• Werner GS, Bahrmann P, Mutschke O, Emig U, Betge S, Ferrari M, Figulla HR. Determinants of target vessel failure in chronic total coronary occlusions after stent implantation. The influence of collateral function and coronary hemodynamics. J Am Coll Cardiol. 2003 Jul 16;42(2):219-25. doi: 10.1016/s0735-1097(03)00624-7.

  PMID: 12875755 BACKGROUND

• Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.

  PMID: 19539251 BACKGROUND

• Saito S. Progress in angioplasty for chronic total occlusions again. Catheter Cardiovasc Interv. 2010 Nov 15;76(6):850-1. doi: 10.1002/ccd.22847. No abstract available.

  PMID: 21104774 BACKGROUND

• Godino C, Sharp AS, Carlino M, Colombo A. Crossing CTOs-the tips, tricks, and specialist kit that can mean the difference between success and failure. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1019-46. doi: 10.1002/ccd.22161.

  PMID: 19950136 BACKGROUND

• Maron DJ, Boden WE, O'Rourke RA, Hartigan PM, Calfas KJ, Mancini GB, Spertus JA, Dada M, Kostuk WJ, Knudtson M, Harris CL, Sedlis SP, Zoble RG, Title LM, Gosselin G, Nawaz S, Gau GT, Blaustein AS, Bates ER, Shaw LJ, Berman DS, Chaitman BR, Weintraub WS, Teo KK; COURAGE Trial Research Group. Intensive multifactorial intervention for stable coronary artery disease: optimal medical therapy in the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial. J Am Coll Cardiol. 2010 Mar 30;55(13):1348-58. doi: 10.1016/j.jacc.2009.10.062.

  PMID: 20338496 BACKGROUND

• Pancholy SB, Boruah P, Ahmed I, Kwan T, Patel TM, Saito S. Meta-analysis of effect on mortality of percutaneous recanalization of coronary chronic total occlusions using a stent-based strategy. Am J Cardiol. 2013 Feb 15;111(4):521-5. doi: 10.1016/j.amjcard.2012.10.034.

  PMID: 23375252 BACKGROUND

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Sinisa Stojkovic, PhD

  Clinical Centre of Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Deaprtment of Interventional Cardiologyand Catheter Ablation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: September 1, 2015
• Primary Completion: November 30, 2017
• Study Completion: December 31, 2017
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

SE (1)