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News

April 05 2011

ACC: Will U.S. radial PCI usage be determined by cost?

Radial access for PCI in patients with acute coronary syndromes (ACS) does not reduce death, heart attack, stroke or major bleeding compared with femoral access, according to the late-breaking RIVAL trial presented April 4 at the American College of Cardiology (ACC) scientific sessions. However, the significantly lower rate of complications at the access site and improved patient comfort might be a reason to use the radial approach.

Previous small trials have been unable to establish a clinical advantage between coronary angiography via the femoral artery in the groin or the radial artery in the wrist, and there remains considerable disagreement amongst cardiologists about the best approach, the authors wrote in the Lancet, where the study was simultaneously published. The radial procedure rate in the U.S. is 4.2 percent, according to the ACC NCDR data from the third quarter of 2010.

Therefore Sanjit Jolly, MD, of McMaster University’s Population Health Research Institute in Hamilton, Ontario, and colleagues sought to determine if radial vs. femoral access for PCI can reduce the composite of death, MI, stroke or non-CABG major bleeding in patients with acute coronary syndrome.

Between June 2006 and November 2010, they enrolled 7,021 patients from 158 hospitals in 32 countries and randomly assigned them to radial (3,507 patients) or femoral access (3,514).

The primary outcome was death, MI, stroke or non-CABG-related major bleeding at 30 days. The primary outcome occurred in 3.7 percent of 3,507 patients in the radial access group compared with 4.0 percent of 3,514 in the femoral access group.

“Both approach showed similar, very high PCI success rates, about which was uncertain prior to this trial,” Jolly said.

Dr Sanjit Jolly presenting RIVAL results

High-volume centers performed better with the transradial approach. “We know that the more you do, the better you get, particularly with the radial approach,” Jolly said. Of the six pre-specified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centers and in patients with STEMI. However, during the press conference, Jolly acknowledged that there is not a single, distinguishable number of procedures that makes an operator proficient.

The rate of death, MI or stroke at 30 days was 3.2 percent of 3,507 patients in the radial group compared with 3.2 percent of 3,514 in the femoral group—which is not statistically significant.

The rate of non-CABG-related major bleeding at 30 days was 0.7 percent of 3,507 patients in the radial group compared with 0.9 percent of 3,514 patients in the femoral group. “While there was a positive trend toward less bleeding in the radial group, it was not statistically significant,” Jolly said.

“Our results did show a more than 60 percent reduction in major vascular complication rates,” Jolly said. At 30 days, 42 of 3,507 patients in the radial group had large hematomas compared with 106 of 3,514 in the femoral group. Pseudoaneurysm needing closure occurred in seven of 3,507 patients in the radial group compared with 23 of 3,514 in the femoral group.

Also, the patients preferred the radial approach for subsequent procedures.

While there was not a cost-effectiveness analysis in this study, the researchers are following up with one, which will look at the costs to the hospital setting. However, Jolly told Cardiovascular Business News that they did examine length of hospitalization. “Our prior meta-analysis showed that the reduction in the hospital length of stay was actually half a day. While we did not detect a difference in hospital length of stay in RIVAL, one of the caveats is that we could not measure differences smaller than a whole day based on our case reports—we had hours instead of days,” he said.

Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia Medical Center in New York City, noted that “length of stay will become more of an issue in the U.S. because there is more of a trend toward performing more outpatient angioplasty in low-risk, stable patients. Therefore, the radial approach could become a more attractive option for those patients.”

Based on their findings, the researchers concluded that the “radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach.”

In the accompanying Lancet commentary, Carlo di Mario, MD, and Nicola Viceconte, MD, from the Royal Brompton Hospital in London, wrote: “After this study, there is little justification to ignore one of the main developments in interventional cardiology and stubbornly refuse to embrace a technique likely to reduce minor adverse events (but in patients with STEMI, possibly also major adverse events and mortality) and improve patient comfort.”

“Operators with a high workload of acute procedures should seriously consider re-training in radial angioplasty, and all new trainees should be taught and become proficient with this approach,” they added. “Conversely, it is important not to demonize the femoral approach, which is more suitable when large guiding catheters are required and prolonged procedural time is expected for complex lesions.

The study is funded by Sanofi-Aventis and Bristol-Myers Squibb (through CURRENT), Population Health Research Institute and Canadian Network and Centre for Trials Internationally (CANNeCTIN, an initiative of Canadian Institutes of Health Research).

The article, “Radial vs femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial” may be accessed at

 

http://www.ncbi.nlm.nih.gov/pubmed/21470671

 

Cardiovascular Business.

April 04 2011

SCAI statement on “The Rival Trial”

Patients with acute coronary syndromes who undergo angiography or angioplasty and stent procedures have similar probability of survival whether their arteries are accessed radially (via the wrist) or femorally (via the groin, or upper leg); however, when patients are suffering from a major heart attack, there is significant survival benefit if the heart arteries are accessed radially. The results of the eagerly awaited RIVAL Trial: A Randomized Comparison of Radial Versus Femoral Access for Coronary Angiography or Intervention in Patients with Acute Coronary Syndromes, were presented today at the American College of Cardiology (ACC) 60th Annual Scientific Sessions.

The RIVAL Trial is the first large North American randomized clinical trial comparing the two options for accessing the heart arteries. The findings are likely to impact practice in the United States because:

• Radial access has now been shown to be a safe and effective technique in North American patients.

• Heart attack patients had a significant survival benefit when they were treated transradially.

• The data corroborate previous studies showing that radial access is preferred by patients.

In recent years, debate has centered around which major artery should be used to insert a catheter, a thin, flexible tube used in many minimally invasive tests and procedures to diagnose and treat blocked heart arteries. Although radial access has been used abroad for some time, it remains relatively unused in the United States.

Importantly, the RIVAL Trial results showed that physicians with greater experience using the radial technique had the best outcomes. This finding underscores the need to provide high-quality physician education and training in radial-access heart procedures, as currently only 4.5 percent of coronary procedures in the United States are performed transradially.

SCAI’s Transradial Working Group has developed a series of educational programs for interventional cardiologists to be trained in the use of radial access. The demand for these programs has been high, and SCAI plans to offer at least four programs nationwide in 2011.

REMARKS FROM SCAI’S COMMITTEE ON TRANSRADIAL INTERVENTIONS:

“The data from the RIVAL trial are important because they add to the evidence showing that the technique that is more comfortable  for patients is also safe and effective,” said Kimberly A. Skelding, M.D., FSCAI, an interventional cardiologist at Geisinger Medical Center in Danville, Pa.  “These results should provide ample evidence for greater use of the radial option for many minimally invasive cardiovascular tests and procedures, especially in patients suffering from a heart attack.”

“Transradial access has been widely used and accepted in other countries, but has not yet been fully accepted in the U.S.,” said Samir Pancholy, M.D., FSCAI, an interventional cardiologist at the Commonwealth Medical College in Scranton, Pa. “The RIVAL Trial shows that our sickest patients will benefit the most if we invest in training physicians to perform the radial technique frequently and safely, hence making it available when patients need it the most.”

 

The Society for Cardiovascular Angiography and Intervention (SCAI).

 

 

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