RIFLE-STEACS Published: Transradial PCI Lowers Mortality in STEMI Patients

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Percutaneous coronary intervention (PCI) via transradial access reduces mortality—specifically cardiac mortality—compared with transfemoral PCI in patients with ST-segment elevation myocardial infarction (STEMI), according to randomized trial results published online August 1, 2012, ahead of print in the Journal of the American College of Cardiology.

Results of the RIFLE-STEACS (RadIal versus FemoraL randomizEd investigation in ST-Elevation Acute Coronary Syndrome) trial were initially presented in November 2011 at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA.

For the study, researchers led by Enrico Romagnoli, MD, PhD, of Policlinico Casilino (Rome, Italy), randomized 1,001 STEMI patients undergoing primary or rescue PCI to transradial (n = 500) or transfemoral (n = 501) access at 4 high-volume Italian centers. All participating interventional cardiologists had to have performed more than 150 PCI procedures per year, with at least half of their cases via the radial approach. The crossover rate was 9.6% in the radial arm and 2.8% in the femoral arm, with the main reasons being cardiogenic shock, unknown peripheral vascular disease, and previous thrombolytic administration. The access failure rate was 6% in the radial arm and 1% in the femoral arm.

At 30 days, the primary endpoint of net adverse clinical events (NACE; cardiac death, MI, stroke, TLR, and non-CABG bleeding) was lower with transradial PCI vs. transfemoral PCI, as were MACE (cardiac death, MI, TLR, and stroke), cardiac death, and non-CABG bleeding. Other endpoints such as stroke, MI, TLR, and stent thrombosis were equivalent (table 1).

Table 1. Thirty-Day Outcomes

 

Radial
(n = 500)

Femoral
(n = 501)

P Value

NACE

13.6%

21.0%

0.003

MACE

7.2%

11.4%

0.029

Cardiac Death

5.2%

9.2%

0.020

Stroke

0.8%

0.6%

0.725

MI

1.2%

1.4%

1.000

TLR

1.2%

1.8%

0.604

Stent Thrombosis

1.2%

1.8%

0.604

Non-CABG Bleeding

7.8%

12.2%

0.026


The reduction in non-CABG bleeding was driven mainly by a 60% decrease in access-site-related bleeds (2.6% vs. 6.8%; P = 0.002) in the transradial arm, and reflected by fewer blood transfusions required with radial-access PCI (1.0% vs. 3.2%; P = 0.025).

Transradial patients also had a shorter total hospital stay (5 days vs. 6 days; P = 0.008) and spent less time in the intensive coronary care unit (3 days vs. 4 days; P < 0.001).

There was a minor trend toward an increase in door-to-balloon time with transradial PCI (60 minutes vs. 53 minutes; P = 0.175).

On multivariable analysis, transradial PCI was an independent predictor of 30-day NACE (HR 0.7; 95% CI 0.5-0.9; P = 0.028), along with female sex, chronic kidney disease, LAD as the culprit vessel, Killip class at presentation, impaired LVEF, and angiographic no reflow.

“The RIFLE-STEACS results clearly demonstrate the advantage in terms of outcome of the radial over the femoral approach in [STEMI] patients,” the authors conclude. “This net difference together with the high success rate should represent the primary reason to use the radial approach for the treatment of acute patients.”

From RIVAL to RIFLE

According to Sanjit S. Jolly, MD, MSc, of Hamilton General Hospital (Hamilton, Canada), the mortality reductions with radial-access PCI in STEMI patients are most likely due to the decreased bleeding. “It’s a similar story to what was seen with the bivalirudin data, such as from the HORIZONS trial,” he told TCTMD in a telephone interview. “It’s interesting because it was a similar effect to what was seen in the STEMI subset of RIVAL.”

In the RIVAL trial, which compared transradial and transfemoral access for angiography and PCI, the composite of death, MI, stroke, and non-CABG major bleeding was similar between the 2 groups at 30 days. However, in the subset of STEMI patients, the composite endpoint and mortality were reduced in radial patients. RIVAL was presented at the annual American College of Cardiology Scientific Session/i2 Summit in April 2011 in New Orleans, LA, and published simultaneously online in the Lancet.

Dr. Jolly, the lead investigator of RIVAL, noted that a key aspect of the RIFLE-STEACS trial is the experience level of the operators. “The message is that it’s likely you will see a benefit with radial access in STEMI with high-volume operators who are experienced with the radial technique,” he said. “I see this as quite encouraging for operators worldwide to learn radial access so that when they become quite proficient they can use it in STEMI.”

Timothy A. Sanborn, MD, of the University of Chicago School of Medicine (Chicago, IL), agreed that proficiency is the key. “The results are very encouraging and I would recommend learning more about the radial approach and gaining experience in non-STEMI cases first before tackling STEMI,” he said in a telephone interview with TCTMD. “Everybody has said don’t start learning radial with STEMI, make sure you have sufficient knowledge and experience with radial beforehand.”

Lack of ‘Bleeding Avoidance’ Cited

Dr. Sanborn did note a few key limitations of the study, such as the low use (7.6%) of bivalirudin in the trial, which was similar in both arms. In addition, there was no information regarding the use of closure devices. “In a number of studies, bivalirudin has been shown to lower the risk of bleeding, so if they’re not using ‘bleeding avoidance’ strategies of bivalirudin and closure devices, then femorals are going to look worse,” he said. “It’s like comparing apples and oranges. There are femoral cases, and then there are femoral cases where you use the best medical strategy.”

Dr. Sanborn agreed, though, that the RIFLE-STEACS study “indicates a potentially safer alternative approach” for STEMI patients, and that more physicians should learn radial access in the United States, which has lagged behind other countries in adopting the technique.

According to Dr. Jolly, the United States is approaching a “tipping point” with the procedure. “It’s often been said that if it’s just 1 person in the cath lab using a new technique like radial access, they’re often seen as different, but [the situation changes] once you see 2 or 3 people working with it,” he said. “It wouldn’t be surprising to me if within 5 years we see 25% of procedures in the United States performed via radial access.”

Dr. Jolly explained that it has taken longer for US clinicians to adopt the procedure due to the higher number of cath labs relative to the population. “There are less procedures per operator, so it does take longer to pick up a new technique,” he said.

Dr. Sanborn agreed that the tide is turning more toward radial, with an increase in US educational efforts such as didactic sessions and training courses devoted to the technique. He noted that at his own center “we have people who are experienced with radial and they will do STEMI with radial. We also have others who still aren’t comfortable with it.”

 


Source:
Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012;Epub ahead of print.

 

 

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Disclosures
  • Drs. Romagnoli, Jolly, and Sanborn report no relevant conflicts of interest.

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