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 (RIVAL)

• Non CABG major bleeding [ Time Frame: within 30 days following randomization ] [ Designated as safety issue: Yes ]
• Death, MI or stroke [ Time Frame: within 30 days following randomization ] [ Designated as safety issue: No ]

• Major bleeding at 48 hours and 30 days after the procedure [ Time Frame: 48 hours and 30 days post-procedure ] [ Designated as safety issue: Yes ]
• Major vascular access site complications at 48 hours and 30 days after the procedure [ Time Frame: 48 hours and 30 days post-procedure ] [ Designated as safety issue: No ]
• Composite of death, MI or stroke and each component taken separately at 48 hours and 30 days [ Time Frame: 48 hours and 30 days ] [ Designated as safety issue: No ]
• Composite of death, MI, stroke, or non-CABG related major bleeding at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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.

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention

• Active Comparator: Trans-femoral access
  Femoral artery PCI access site
  Intervention: Procedure: Percutaneous Coronary Intervention
• Active Comparator: Trans-radial access
  Radial artery PCI access site
  Intervention: Procedure: Percutaneous Coronary Intervention

• 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. Effect of radial versus femoral access on radiation dose and the importance of procedural volume: a substudy of the multicenter randomized RIVAL trial. JACC Cardiovasc Interv. 2013 Mar;6(3):258-66. doi: 10.1016/j.jcin.2012.10.016.
• 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. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490-9. doi: 10.1016/j.jacc.2012.07.050. Epub 2012 Oct 24.
• 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. Epub 2011 Apr 4. Erratum in: Lancet. 2011 Apr 23;377(9775):1408.
• Jolly SS, Niemelä K, Xavier D, Widimsky P, Budaj A, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Cairns J, Chrolavicius S, Yusuf S, Mehta SR. Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes. Am Heart J. 2011 Feb;161(2):254-260.e1-4.

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