ZES, EES Noninferior to PES

SAN FRANCISCO, CALIF.—Current data from two clinical trials demonstrate the clinical utility of zotarolimus-eluting stents and everolimus-eluting stents compared to paclitaxel-eluting stents.

ENDEAVOR IV data

According to 5-year follow-up results from the ENDEAVOR IV study presented by David E. Kandzari, MD, of the Piedmont Heart Institute, Atlanta, incidence of MI, the composite of cardiac death and MI, and very late stent thrombosis were considerably lower in the ZES (Endeavor, Medtronic) arm than in the PES (Taxus, Boston Scientific) arm.

“With regard to TLR compared with the PES, the event rates were higher over the initial 1 to 2 years of follow-up for the Endeavor stent, but then the curves merged and then diverged with a crossover that ultimately demonstrated a numerical excess of events with the PES compared with the Endeavor stent at 5 years,” Kandzari said.

Cumulative incidence of target vessel failure, target lesion revascularization, MI and the composite of cardiac death and MI were also lower in the ZES group vs. the PES group out to 5 years (see Table 1), although the differences were only statistically significant for the latter two endpoints. In addition, very late stent thrombosis was lower with ZES (0.4% vs. 1.8%; P=.012).

He also noted that adherence to dual antiplatelet therapy was slightly higher in the PES arm vs. the ZES arm at 5 years (47.9% vs. 41.8%; P=.03).

 “Despite initially higher late loss with Endeavor ZES, rates of TLR beyond the period of protocol-mandated angiographic surveillance remain stable with Endeavor ZES,” Kandzari said. “Late-term endothelial-independent vasodilation outcomes with Endeavor ZES parallel the consistent safety and efficacy observed across the ENDEAVOR Clinical Trials Program.”

The ENDEAVOR Clinical Trials Program includes more than 20,000 patients treated with the ZES and involves more than 6,000 patients treated with a comparison DES. For ENDEAVOR IV, 1,548 patients were randomly assigned to treatment with either PES or ZES.

SPIRIT IV results

In a presentation of the SPIRIT IV trial data, TCT Course Director Gregg W. Stone, MD, of Columbia University Medical Center, New York, discussed 3-year data comparing EES (Xience V, Abbott Vascular) with PES. The study included 3,690 patients who were randomly assigned to EES or PES in a 2:1 ratio.

Results revealed reductions in the primary endpoint of target lesion failure as well as multiple other endpoints with EES at 3 years (see Table 2).

Consistent data were observed in analyses of 11 subgroups, although nonsignificantly different rates of TLF were present in patients with diabetes vs. those without diabetes (28% reduction; P=.21).

Stone reported that follow-up is ongoing.