HOST-ASSURE: Promus Element stent noninferior to Resolute at 1 year

SAN FRANCISCO — Results from the HOST-ASSURE trial presented at the American College of Cardiology Scientific Sessions indicate that rates of target lesion failure were similar at 1 year with the Promus Element everolimus-eluting platinum chromium coronary stent when compared with the Resolute zotarolimus-eluting stent.

To evaluate whether the Promus Element stent (Boston Scientific) is noninferior to the Resolute stent (Medtronic), Hyo-Soo Kim, MD, PhD, of Seoul National University Hospital in Korea, and colleagues conducted a prospective, single blind, randomized trial at 40 major hospitals in South Korea.

Patients undergoing PCI (n=3,755) were randomly assigned to receive the Promus Element (n=2,503) or Resolute stent (n=1,252). Primary endpoint was target lesion failure, defined as cardiac death, target vessel MI and ischemia-driven target vessel revascularization at 1 year after the procedure. Secondary endpoints included individual components of TLF, as well as a patient-oriented composite outcome of all-cause death, all-cause MI or repeat revascularization, and stent thrombosis.

In all, 98.7% of patients completed 1-year follow-up. TLF was 2.9% (P=.0983) in both groups at 1 year, suggesting that the Promus Element stent is noninferior to the Resolute stent, Kim said. The Promus Element and Resolute stents were also similar in terms of cardiac death (1.4% for both; P=.997), target vessel-related MI (1% for both; P=.822), target lesion revascularization (1.2% for both; P=.9) and the patient-oriented composite outcome (5.4% and 4.4%; P=.187). Definite or probable stent thrombosis appeared to be higher with the Resolute stent (0.36% vs. 0.67%; P=.229), but this finding was statistically insignificant due to the low incidence of events.

The researchers noted that patients with smaller vessels favored the Promus Element stent, whereas those with larger lesions favored the Resolute stent, which is an association that the researchers were unable to explain.

The researchers also examined 5,000 lesions using visual estimation of angiography after index PCI to detect longitudinal stent deformation. They found longitudinal stent deformation in only seven patients (0.21%) in the Promus Element group and none in the Resolute group. Nominal stent length ratios were 0.92 with the Promus Element stent and 0.93 with the Resolute stent (P<.001). Post-deployment stent length ratios were 1 for both stents (P=0.352). Overall, data suggested no association between longitudinal stent deformation and future adverse clinical events or serious systemic shortening of either stent, Kim said.

“Both stents demonstrated outstanding safety as well as efficacy,” Kim said. “Longitudinal stent deformation was very rare, observed only in a few cases with the Promus Element stent, and was not associated with future adverse clinical events. There was also not a serious systematic shortening of either stent platform.”

For more information:

Kim H. Featured Clinical Research 1: Interventional. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.

Disclosure: Kim reports receiving honorarium for lectures and research grants from Boston Scientific and Medtronic.