STEMI-RADIAL Radial PCI Bests Femoral in STEMI Patients

MIAMI BEACH, FLA.—In the hands of experienced operators, STEMI patients benefit from undergoing PCI via the radial rather than the femoral approach. Both major bleeding and access site complications at 30 days are reduced by radial access, according to data from the randomized STEMI-RADIAL trial presented at TCT 2012.

Two other randomized trials—RIVAL and RIFLE-STEACS—have recently compared access routes in STEMI patients, said investigator Ivo Bernat, MD, PhD, of the University Hospital Pisen in Pisen, Czech Republic. Both have drawbacks, he noted. In RIVAL, slightly more than quarter of patients had STEMI, and operator experience was variable. RIFLE-STEACS enrolled patients within 24 hours of symptom onset without excluding cardiogenic shock. Both studies showed “relatively high” crossover at 7.6% and 9.6%, respectively.

STEMI-RADIAL narrows the focus

For STEMI-RADIAL, investigators randomized 707 STEMI patients slated to undergo PCI at 4 Czech centers to radial (n = 348) or femoral (n = 359) access between October 2009 and February 2012. All patients were eligible for either access route, and none presented with cardiogenic shock. Operators at each center performed more than 200 PCI procedures per year, with radial accounting for more than 80%. Baseline characteristics were largely similar between the study arms apart from hypertension, which was more common in the radial group (65% vs. 57%; P=.037).

Symptom-to-balloon time did not differ between groups, nor did procedural or fluoroscopy times. Though “very low” overall, Bernat said, the crossover rate was higher after radial vs. femoral access (3.7% vs. 0.6%; P=.003). Radial patients received lower contrast volume (170 ± 71 mL vs. 182 ± 60 mL; P=.01) and had shorter ICU stays (2.5 ± 1.7 days vs. 3.0 ± 2.9 days; P=.0016). Angiographic success was similar between groups.

At 30 days, the primary endpoint of HORIZONS-AMI bleeding and access site complications was 80% lower with radial access.

Overall MACE (death, MI, stroke) and its components all were equivalent. Consequently, the rate of net adverse events (NACE; major bleeding plus MACE) was 58% lower with radial access (see Table).

Table. Clinical Outcomes at 30 Days

“Our results support the use of the radial approach in primary PCI in experienced radial centers as a first choice,” Bernat concluded.

TCT Course Director Gregg W. Stone, MD, of Columbia University Medical Center/NewYork-Presbyterian Hospital in New York said that STEMI-RADIAL offers more reliable results than its predecessors. “The STEMI group from RIVAL was a subgroup of a negative trial . . . so you almost can discard that. And then you have RIFLE-STEACS, which was a positive study in terms of bleeding but also showed a remarkable reduction in mortality with the radial approach . . . that wasn’t consistent with what we understand from pathophysiology.”

Despite its strengths, Stone said, the current study also has limitations. He questioned the relatively high heparin dose in relation to glycoprotein IIb/IIIa inhibition, suggesting the combination “might have contributed to higher than necessary bleeding rates in the femoral group.” Results could also change if bivalirudin were used, he added.