Misago BMS Performs Well in Multinational Trial of Patients with SFA Lesions

 A bare metal stent (BMS) for use in the superficial femoral artery (SFA) yields comparable safety and efficacy to drug-eluting stents at 12 months, according to data from a multinational trial conducted in the United States and Asia (primarily Japan). The abstract findings were presented Sunday at TCT.

For the OSPREY trial, Takao Ohki, MD, PhD, of Jikei University School of Medicine in Minato, Japan, and colleagues evaluated the self-expanding Misago nitinol stent (Terumo) in 261 patients with TransAtlantic Inter-Society Consensus (TASC) A/B SFA lesions, with a focus on whether racial differences play a role in outcome and on how the stent compares to the performance of another DES for SFA lesions.

Most of the patients (77%) were from the United States, with 50 from Japan, nine from Taiwan, and one from South Korea. Average age was 69.3 ± 10.0 years, and average lesion length was 8.38 ± 4.13 cm.

Outcomes for the Misago BMS in OSPREY were similar or slightly better than those seen for the Zilver DES (Cook Medical) in the Zilver PTX trial (see Table).

Table. Twelve-month outcomes: OSPREY vs. ZILVER PTX Trials

The OSPREY trial also found similar outcomes in patients from different racial backgrounds. U.S. patients had a primary patency rate of 82.9%, compared with 83.0% in non-U.S. patients (P=.889). Clinically driven TLR occurred in 13.4% of U.S. patients and in 11.7% of non-U.S. patients (P=.829). U.S. patients experienced a stent fracture rate of 1.5% and stent thrombosis rate of 0.5%, whereas non-U.S. patients had no instances of either event (P=1.000 for both)

“DES are generally considered superior over BMS in coronary intervention, but OSPREY shows that the new-generation BMS has potentially equal efficacy and a better safety profile compared with DES in TASC A/B lesions,” Ohki told TCT Daily. That difference between coronary and femoral disease is likely due to lesion characteristics in each setting, he added.

Though there are limitations inherent in comparing different trials head to head, Ohki said, the lower stent thrombosis rate with the Misago stent is not surprising. The BMS is a reasonable option in patients requiring an SFA stent, especially in those who cannot tolerate very long-term DAPT, he added.

Ohki also stressed the unique design of OSPREY. The lack of racial differences seen in this trial, as well as the good enrollment in both the United States and Japan, suggests the multinational approach may be able to reduce “device lag” between different parts of the world and to cut financial burdens of conducting several large trials. 

“For these reasons, I strongly believe that multinational trials will be conducted with increasing frequency,” he said, noting that a randomized controlled trial directly comparing the Misago and Zilver stents is likely.