Trial Outcomes & Findings for Radial Artery Versus Saphenous Vein Patency (RSVP) Study (NCT NCT00139399)

NCT ID: NCT00139399

Last Updated: 2019-06-25

Results Overview

Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 142 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2019-06-25

Participant Flow

Participant milestones

Measure	Saphenous Vein Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery	Radial Artery Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during coronary artery bypass graft (CABG) surgery
Overall Study STARTED	60	82
Overall Study COMPLETED	44	59
Overall Study NOT COMPLETED	16	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Saphenous Vein n=60 Participants Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery	Radial Artery n=82 Participants Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=60 Participants	0 Participants n=82 Participants	0 Participants n=142 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=60 Participants	68 Participants n=82 Participants	109 Participants n=142 Participants
Age, Categorical >=65 years	19 Participants n=60 Participants	14 Participants n=82 Participants	33 Participants n=142 Participants
Sex: Female, Male Female	2 Participants n=60 Participants	3 Participants n=82 Participants	5 Participants n=142 Participants
Sex: Female, Male Male	58 Participants n=60 Participants	79 Participants n=82 Participants	137 Participants n=142 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 5 years

Population: 103 of the patients randomized at the time of surgery agreed to return for the 5-year follow-up angiogram.

Angiographic patency rates of radial artery and long saphenous vein grafts at follow-up angiography

Outcome measures

Measure	Saphenous Vein n=44 Participants Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery	Radial Artery n=59 Participants Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery
Patency Rates Occluded graft	6 Participants	1 Participants
Patency Rates Patent graft	38 Participants	58 Participants

PRIMARY outcome

Timeframe: 5 year follow-up

Population: Intracoronary physiology investigations (diameter and intracoronary Doppler blood flow velocity measurements) were carried out in a subgroup of patients (n=27).

Diameter response of the study vessel (saphenous vein or radial artery graft) to acetylcholine, measured using quantitative coronary angiography from the coronary angiogram.

Outcome measures

Measure	Saphenous Vein n=12 Participants Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery	Radial Artery n=15 Participants Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery
Mean Diameter of the Study Graft (Saphenous Vein or Radial Artery)	3.18 mm Standard Deviation 0.67	2.7 mm Standard Deviation 0.29

SECONDARY outcome

Timeframe: 5 years

Population: 27 of the patients who returned for the 5 year angiogram were eligible for invasive measurement of blood flow.

Graft flow response to acetylcholine, calculated from vessel diameter using quantitative coronary angiography, and velocity using an intragraft Doppler wire.

Outcome measures

Measure	Saphenous Vein n=12 Participants Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery	Radial Artery n=15 Participants Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery
Blood Flow Volume	39 ml/min Standard Deviation 15	44 ml/min Standard Deviation 19

Adverse Events

Saphenous Vein

Serious events: 11 serious events

Other events: 0 other events

Deaths: 4 deaths

Radial Artery

Serious events: 13 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Saphenous Vein n=60 participants at risk Saphenous vein aortocoronary bypass graft Patients were randomized to receive a long saphenous vein graft to the left circumflex coronary artery territory during CABG surgery	Radial Artery n=82 participants at risk Radial artery aortocoronary bypass graft Patients were randomized to receive a radial artery graft to the left circumflex coronary artery territory during CABG surgery
Nervous system disorders Cerebrovascular accident (CVA)	3.3% 2/60 • Number of events 2	1.2% 1/82 • Number of events 1
Cardiac disorders Percutaneous coronary intervention (PCI)/angio post surgery	11.7% 7/60 • Number of events 7	9.8% 8/82 • Number of events 8
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	3.3% 2/60 • Number of events 2	1.2% 1/82 • Number of events 1
Infections and infestations Pneumonia	0.00% 0/60	1.2% 1/82 • Number of events 1
Cardiac disorders Myocardial infarction (MI)	0.00% 0/60	2.4% 2/82 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr Carolyn Webb

Imperial College London

Phone: 03301288860

Email: c.webb@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place