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RIVAL TRIAL |
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| Problem | PCI for ACS |
| Format | Randomised, parallel group, multicentre trial |
| Treatment | Radial access |
| Control | Femoral access |
| Population | 7021 patients |
| Inclusion criteria | UA/NSTEMI and STEMI At least 50 cases of experience of radial access by operator Suitable for both radial and femoral access Intact dual circulation of hand required Interventionalist experienced with both (minimum 50 radial procedures in last year) |
| Exclusion criteria | Age < 18 Active bleeding or significant increased risk of bleeding (severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy) Uncontrolled hypertension Cardiogenic shock Prior CABG surgery with use of <1 internal mammary artery Documented severe peripheral vascular disease precluding a femoral approach Previously entered in the study Investigational treatment (drug or device) within the previous 30 days Medical, geographic, or social factors making study participation impractical or inability to provide written informed consent and to understand the full meaning of the informed consent |
| Follow-up | 30 days |
| Primary endpoint | Composite or death, MI, stroke or non-CABG-related Major Bleeding at 30 days |
| Secondary endpoint(s) | Death, MI, Stroke Non-CABG Major Bleeding Separate endpoints Safety: -Major Bleeding --Fatal --2 or more units blood transfused --Hypotension requiring inotropes --Leading to Hb drop of 5 g/dL or more --Requiring surgery --ICH or intraoccular bleeding leading to significant vision loss -Major vascular site complication --Large haematoma --Pseudoaneurysm requiring closure --AV fistula --Other vascular surgery needed at site |
| Details | Half of patients were from a sub-study of CURRENT/OASIS 7 |
| Brief summary: | Radial access gives similar results and fewer vascular complications |
| PAPER: Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. | |
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| Date | 23 Apr 2011 |
| Journal | Lancet. 2011 Apr 23;377(9775):1409-20. |
| Information | Radial vs. femoral access for ACS -No difference in composite of death, MI, stroke or non-CABG major bleeding -Possible adantage in --Higher volume centres --STEMI -Fewer vascular complications for radial access |