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March 29, 2011 -- 4:30pm EDT

Will a Heart Stent from the Wrist RIVAL One from the Leg?
Transradial angioplasty from the wristAt Angioplasty.Org, we are about to mark the fourth anniversary of our Transradial Access Center, where we have been evangelizing an approach used around the world for catheter-based diagnostic and interventional procedures: using the radial artery in the wrist for catheterizations and PCI (angioplasty and stents) instead of the femoral artery in the leg. It's an approach that is used 50% or more of the time in other countries, but is still in the single digits (pun intended) here in the United States. You can read why the U.S. has been behind the curve in our many articles on the subject of the transradial approach.

But all this soon may be changing, if the results of an important study, being presented at this year's American College of Cardiology meeting, support the investigators' hypothesis:

"...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.

The study is dubbed RIVAL (RadIal Vs. FemorAL Access for Coronary Intervention Study) and, as of last month, had enrolled over 7,000 patients. It's actually a sub-study of the CURRENT-OASIS 7 trial, which tested double-dose clopidogrel after PCI.

But RIVAL will be looking at the incidence within 30 days of death, heart attack, stroke and non-CABG major bleeding in Acute Coronary Syndrome (ACS) patients who are experiencing unstable angina or heart attack (either NSTEMI or STEMI) and who are going to be treated with angioplasty and/or stents. Included in the definition of non-CABG major bleeding is access-site hemorrhage requiring intervention, retroperitoneal bleeding, where significant blood loss into the retroperitoneal space occurs, often undetected right away, large hematomas or any significant reduction in hemoglobin where there is no overt source of bleeding. And RIVAL will compare the 30-day results of those patients where femoral access was used vs. those who were treated via the transradial wrist approach.

As Sunil V. Rao, MD, FACC, Assistant Professor of Medicine at Duke University Medical Center and Director of the Cardiac Cath Lab at the Durham VA Medical Center in North Carolina, told Angioplasty.Org in his exclusive interview :

  Sunil V. Rao, MD, FACC

"...this will be the largest multicenter randomized trial worldwide ever done in the radial approach with hard clinical endpoints: death or MI. This will be a huge addition to our knowledge base and what the role of radial is in a high-risk patient population."

Previous smaller studies have shown a significant reduction in bleeding complications with the transradial approach, and some have posited that mortality and bleeding complications are related.

Speaking of complications, if you take a look at just two topics in our Patient Forum (Complications from Femoral Caths and Complications from Vascular Closure Devices) you'll find over 1,300 posts from patients who have suffered from bleeding complications with the femoral approach, not to mention trauma to the femoral nerve or complications from various vascular closure devices (which are not used in radial procedures).

It's not that the femoral approach is terrible. Quite the contrary. Over 90% of patients do perfectly well with femoral caths -- and the radial approach is not possible in all patients. But when less than 7% of all procedures in the U.S. are done via the wrist, and the vast number of U.S. interventional cardiologists don't even know how to do radial procedures, something has to change.

And on Monday morning, April 4, 2011, when the RIVAL results have been presented to the ACC/i2 Joint Session at ACC.11 in New Orleans, that change may well be accelerated.

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