L-RECORD: Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy
Study Details
Study Description
Brief Summary
This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Left Radial access Left Radial approach for coronary angiography in patients with prior history of CABG surgery |
Procedure: Coronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
|
| Active Comparator: Femoral access Femoral approach for coronary angiography in patients with prior history of CABG surgery |
Procedure: Coronary Angiography
Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
|
Outcome Measures
Primary Outcome Measures
- Net Procedure Time [24 hours]
The time (min) after placement of the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
Secondary Outcome Measures
- Total Procedure Time [24 hours]
The time (min) from local anesthesia at the access site until the completion of the diagnostic coronary angiography
- Fluoroscopy Time [24 hours]
Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic coronary angiography
- Dose Area Product [24 hours]
Radiation DAP (mGy*cm2) during the diagnostic coronary angiography
- Contrast Volume [24 hours]
Contrast volume (ml) used during the diagnostic coronary angiography
- Crossover access site [24 hours]
Need for crossover access site, other than this of randomization
- Major Cardiovascular Events [24 hours]
Death, stroke, acute myocardial infarction
- Vascular Complications [24 hours]
Vascular access complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age over 18 years
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Written informed consent
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Clinical indication for coronary angiography in a patient with prior history of CABG
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Left radial artery has not been used as a graft during CABG
Exclusion Criteria:
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Age over 90 years
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Patient's refusal to participate in the study
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Hemodynamic instability of the patient
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Failure to place a sheath at the randomization access site
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Arteriovenous fistula at the left upper limb
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Use of right internal mammary artery as a graft during CABG
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Creatinine clearance <30 ml/min
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Patras | Patras | Achaia | Greece | 26504 |
Sponsors and Collaborators
- University Hospital of Patras
- Korgialenio-Benakio Red Cross Hospital
- University General Hospital of Heraklion
- AHEPA University Hospital
Investigators
- Study Director: George Hahalis, Prof., University Hospital of Patras
- Study Director: Periklis Davlouros, Ass. Prof., University Hospital of Patras
- Principal Investigator: Grigorios Tsigkas, University Hospital of Patras
- Principal Investigator: Athanasios Makris, University Hospital of Patras
Study Documents (Full-Text)
None provided.More Information
Publications
- Baker NC, O'Connell EW, Htun WW, Sun H, Green SM, Skelding KA, Blankenship JC, Scott TD, Berger PB. Safety of coronary angiography and percutaneous coronary intervention via the radial versus femoral route in patients on uninterrupted oral anticoagulation with warfarin. Am Heart J. 2014 Oct;168(4):537-44. doi: 10.1016/j.ahj.2014.06.016. Epub 2014 Jul 3.
- Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1. Review.
- Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4. Erratum in: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30.
- Koltowski L, Koltowska-Haggstrom M, Filipiak KJ, Kochman J, Golicki D, Pietrasik A, Huczek Z, Balsam P, Scibisz A, Opolski G. Quality of life in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention--radial versus femoral access (from the OCEAN RACE Trial). Am J Cardiol. 2014 Aug 15;114(4):516-21. doi: 10.1016/j.amjcard.2014.05.030. Epub 2014 Jun 6.
- Koutouzis M, Matejka G, Olivecrona G, Grip L, Albertsson P. Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians. Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):79-83. doi: 10.1016/j.carrev.2009.04.107.
- Louvard Y, Lefèvre T, Allain A, Morice M. Coronary angiography through the radial or the femoral approach: The CARAFE study. Catheter Cardiovasc Interv. 2001 Feb;52(2):181-7.
- Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.
- Pancholy SB, Joshi P, Shah S, Rao SV, Bertrand OF, Patel TM. Effect of Vascular Access Site Choice on Radiation Exposure During Coronary Angiography: The REVERE Trial (Randomized Evaluation of Vascular Entry Site and Radiation Exposure). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1189-1196. doi: 10.1016/j.jcin.2015.03.026. Epub 2015 Jul 22.
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