Radial Artery Patency and Clinical Outcomes Trial

NCT00475488 | Unknown DMC

• 2 other identifiers: H2006/02690V1111-1166-3083
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary Artery Bypass Graft (CABG)Surgery is commonly used to treat patients with coronary artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart muscle function. Healthy veins or arteries, referred to as 'conduits' from elsewhere in the patient's body, are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes) coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby improving the blood supply to the myocardium (heart muscle). Over the years, a range of different veins and arteries from around the body have been used to bypass diseased coronary arteries. Typically, internal thoracic arteries from behind the breastbone and the saphenous veins from the legs are used for bypass. More recently, radial arteries from the forearm have also been used to bypass coronary arteries that are diseased (atherosclerotic). There is strong evidence to indicate that the left internal thoracic artery stays open the longest (i.e. has the highest patency) and achieves the best health outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their first choice of conduit (vessel used to bypass the blocked artery). However, many patients require multiple grafts and there is little evidence as to which grafts are the best conduits to use. It has been suggested that the radial arteries might function better than saphenous veins as conduits. The Radial Artery Patency and Clinical Outcomes Trial(RAPCO) aims to compare patency of the radial arteries with the right internal thoracic artery and also with the saphenous vein.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

radial artery; right internal thoracic artery; saphenous vein; grafts; coronary bypass surgery

Outcome Measures

Primary Outcomes (1)

• Graft patency on all surviving trial patients.

  Graft failure defined as either total occlusion, stenosis \>80% or string sign.

  Between 1-10 years from CABG surgery.

Secondary Outcomes (2)

• All cause mortality ·

  10 years from CABG surgery

• Event free Survival

  10 years from CABG surgery

Other Outcomes (4)

• [RAPCO-Extension trial] All cause mortality

  15 years from CABG Surgery

• [RAPCO-Extension trial] Event free survival

  15 years from CABG surgery

• [RAPCO-Extension trial] Myocardial infarction

  15 years from CABG surgery

Study Arms (2)

Group 1

OTHER

Radial Artery versus Right Internal Thoracic Artery when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting.

Procedure: Coronary artery bypass grafting

Group 2

OTHER

Radial Artery versus Saphenous Vein when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting.

Procedure: Coronary artery bypass grafting

Interventions

Coronary artery bypass grafting PROCEDURE

Surgery performed due to coronary artery disease.

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• The patient is scheduled for primary coronary artery bypass surgery alone ie. no reoperations, no associated procedures
• The patient requires more than 1 graft, that is, there are at least 2 coronary artery stenoses of \> 70%.

You may not qualify if:

• Renal disease with a creatinine \>0.30 mmol/L.
• Chronic heart failure (NYHA Class III or IV or ejection fraction \<35% on angiography or radionuclide ventriculography).
• Associated major illnesses e.g., malignancy.
• Body mass index (BMI) \> 35; weight (kg)/height(m2).
• Acute presentation, that is, those patients who have an acute myocardial infarct within one week prior to surgery or who present with cardiogenic shock.
• Failure to obtain informed consent.
• Off pump.
• Failure to use radial artery due to abnormal Allen Test (\>10 sec)
• Failure to be able to use the FRIMA eg. Chest trauma
• FEV1 \< 50% of expected value
• Diabetic patients (IDDM or NIDDM) ≥60 years
• Patients ≥70 years
• GROUP 2
• Failure to use radial artery due to abnormal Allen Test (\>10 sec)
• Failure to be able to use the saphenous vein eg. Varices, past trauma

Sponsors & Collaborators

• Austin Health: lead

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

• Buxton BF, Hayward PA, Raman J, Moten SC, Rosalion A, Gordon I, Seevanayagam S, Matalanis G, Benedetto U, Gaudino M, Hare DL; RAPCO Investigators*. Long-Term Results of the RAPCO Trials. Circulation. 2020 Oct 6;142(14):1330-1338. doi: 10.1161/CIRCULATIONAHA.119.045427. Epub 2020 Oct 5.

  PMID: 33017209 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• David L Hare, MB BS DPM FRACP FESC FACC

  Austin Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David L Hare

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: June 1, 1996
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2023
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)