Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries (REVASC)

A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy

The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: revascularisation

Detailed Description

In the REVASC-study recovery of left ventricular function after recanalization of chronic total coronary occlusions (CTO) and implantation of sirolimus-eluting stents will be examined and compared to medical treatment. Extent of the scar, viable myocardium in the infarct zone and regional left ventricular function will be assessed by cardiac magnetic resonance. Patients with regional systolic left ventricular dysfunction of any degree in the supply territory of the CTO vessel will be randomized to either recanalization of the occluded coronary artery or to conservative therapy. It is of interest whether CTO patients will have an improvement in left ventricular function after late coronary reopening, regarding the high technical demands and costs of CTO recanalization.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
      • Universitäts Herzzentrum Freiburg Bad Krozingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
• chronic total occlusion has more than 4 weeks duration
• the target vessel has not previously been treated with percutaneous coronary intervention
• the target vessel must be feasible for stent implantation
• patient has stable or unstable angina pectoris or a positive functional study for ischemia
• patient must be 18 years of age or older
• female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
• patient has been informed of the nature of the study and agrees to its
• provisions ans has written informed consent as approved by the Ethics Committee
• patient complies with all required post-procedure follow-up

Exclusion Criteria:

• a documented left ventricular function < 30%
• patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
• patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
• patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
• patient has a history of bleeding diathesis or coagulopathy
• patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
• active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
• patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
• the target vessel contains intraluminal thrombus
• the target vessel or lesson shows angiographic evidence of severe calcification
• patient has contraindications to magnetic resonance imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: medical therapy; patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.
Active Comparator: revascularisation; revascularisation and stent-implantation of chronic occluded coronary artery	Device: revascularisation; revascularisation of chronic occluded coronary artery; Other Names: Cypher-stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in regional left ventricular function at 9 months	Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in global left ventricular function at 6 months	Improvement of global left ventricular function (assessed by magnetic resonance imaging at baseline and 9 months post-procedure. For global left ventricular analysis, all short-axis slices from the apex to the base will be assessed. By planimetry of all short-axis views, left ventricular end-systolic volume (in milliliters), left ventricular end-diastolic volume (in milliliters), and ejection fraction (in percent) will be determined.	6 months
Changes from baseline in left ventricular volume at 6 months	Changes in diastolic and systolic volume indices (assessed by magnetic resonance imaging at baseline and 9 months post-procedure)	6 months

Collaborators and Investigators

• Sponsor: University Heart Center Freiburg - Bad Krozingen
• Investigators: Principal Investigator: Heinz Joachim Buettner, MD, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2008
• Primary Completion (Actual): August 14, 2016
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: left ventricular function; revascularisation; chronic occlusion of coronary artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BK 1-2011