A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy

Conditions

Acute Coronary Syndrome, Percutaneous Coronary Intervention

Keywords

Acute Coronary Syndrome, PCI, Percutaneous Coronary Intervention, Radial Access

Brief summary

This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy (PCI). The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.

Jolly SS, Cairns J, Yusuf S, Niemela K, Steg PG, Worthley M, Ferrari E, Cantor WJ, Fung A, Valettas N, Rokoss M, Olivecrona GK, Widimsky P, Cheema AN, Gao P, Mehta SR, RIVAL Investigators.

2013-11-2157 citations

10.1016/j.jacc.2013.10.052

Effect of radial versus femoral access on radiation dose and the importance of procedural volume: a substudy of the multicenter randomized RIVAL trial.

Jolly SS, Cairns J, Niemela K, Steg PG, Natarajan MK, Cheema AN, Rao SV, Cantor WJ, Džavík V, Budaj A, Sheth T, Valentin V, Fung A, Widimsky P, Ferrari E, Gao P, Jedrzejowski B, Mehta SR, RIVAL Investigators.

2013-03-0187 citations

10.1016/j.jcin.2012.10.016

Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation.

Mehta SR, Jolly SS, Cairns J, Niemela K, Rao SV, Cheema AN, Steg PG, Cantor WJ, Džavík V, Budaj A, Rokoss M, Valentin V, Gao P, Yusuf S, RIVAL Investigators.

2012-10-24231 citations

10.1016/j.jacc.2012.07.050

Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.

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.

2011-04-041,324 citations

10.1016/s0140-6736(11)60404-2

Interventions

PROCEDUREPercutaneous Coronary Intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1.1 UA/NSTEMI patients Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina \[UA\] or non-ST segment elevation myocardial infarction NSTEMI) defined as: Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy AND at least one of the following: 1. Electrocardiogram (ECG) changes compatible with new ischemia \[ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads\]. or 2. Patients \> 60 years of age with normal ECG are eligible provided there is a high degree of certainty that presenting symptoms are due to myocardial ischemia. Such patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following: * Prior MI requiring hospitalization * Prior revascularization procedure (more than 3 months ago) * Cardiac catheterization showing significant CAD * Positive exercise test * Other objective evidence of atherosclerotic vascular disease or 3. Already elevated cardiac enzymes or troponin I or T above the upper limit of normal. 1.2 STEMI patients 1. Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an invasive strategy with intent to perform a percutaneous coronary intervention (PCI) during the index hospitalization. 2. Definite ECG changes compatible with STEMI: persistent ST-elevation (\> 2 mm in two contiguous precordial leads or \> 1 mm in at least two limb leads), or new left bundle branch block, or Q-wave in 2 contiguous leads 2\) Randomized during index hospitalization for acute coronary syndrome 3) Suitable candidate for either radial or femoral artery PCI 4) Intent to perform same-sitting angiography and PCI. 5) Palpable radial artery with documented normal Allen's test 6) Acceptance by operator to use whichever route is assigned by the randomization process 7) Previous experience of the operator with at least 50 cases of radial artery access within the past year 8) Written informed consent

Exclusion criteria

1. Age \< 18 years 2. Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy. 3. Uncontrolled hypertension 4. Cardiogenic shock 5. Prior CABG surgery with use of more than one internal mammary artery 6. Documented severe peripheral vascular disease precluding a femoral approach 7. Participation in any study with an investigational drug or device within the previous 30 days 8. Medical, geographic or social factors making study participation impractical

Design outcomes

Primary

Measure	Time frame
First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days.	30 days

Secondary

Measure	Time frame
Non CABG major bleeding	within 30 days following randomization
Death, MI or stroke	within 30 days following randomization

Countries

Canada

Outcome results

None listed