ZES and SES Equally Effective in Long Lesion Treatment

SAN FRANCISCO, CALIF.—In the treatment of long coronary artery lesions, the next-generation zotarolimus-eluting stent (Resolute, Medtronic) and first-generation sirolimus-eluting stent (Cypher, Cordis Corporation) had similar angiographic and clinical outcomes, according to results of the LONG-DES IV study led by Seung-Jung Park, MD, PhD, of Asan Medical Center, Seoul, South Korea, and presented at TCT 2011.

“[Resolute] ZES implantation was noninferior to SES implantation as assessed by 9-month angiographic in-segment late luminal loss,” Park said. “Furthermore, both stent platforms were associated with comparable low rates of clinical endpoints for 12 months, suggesting that both stents are equally effective in the treatment of long coronary artery lesions.”

Stents with equal benefits

Multivariate analysis determined no difference in late luminal loss (see Figure 1) or binary restenosis (see Figure 2) between the 2 arms. There were no significant differences in the rates of adverse events including death (0.8% with ZES vs. 1.6% with SES; P=.41), MI (11.6% vs. 13.6%; P=.5), stent thrombosis (0% vs. 0.8%; P=.5), target-lesion revascularization (1.6% vs. 2.4%; P=.75) and MACE (14.4% vs. 16.0%; P=.65) between ZES and SES patients out to 12 months.

The prospective, multi-center study included 500 patients with de novo coronary lesions at least 25 mm long and with greater than 50% stenosis. Patients were randomized to either ZES (n=250) or SES (n=250) implantation and all patients received aspirin (100 mg daily) and clopidogrel (a loading dose of 300 mg or 600 mg and then 75 mg daily for at least 12 months). The use of glycoprotein IIb/IIIa inhibitors was at the operators’ discretion.

The average age of all patients was 63 years, with males accounting for about 73%. Almost a third of the patients had diabetes and more than a quarter of patients were smokers. About half of the patients had multivessel disease. Lesion length was 32.4±13.5 mm in the ZES group and 31.0±13.5 mm in the SES group (P=0.27).

Researchers followed up with patients at 30 days, 9 and 12 months post-procedure.

When asked about differences in stent fractures and “bendings” between the devices, Park said he saw this less than 1% of the time and determined these events were not related to clinical outcomes.

Park plans to follow up this study with another looking at differences between the Resolute Integrity (Medtronic) and the Xience Prime (Abbott Vascular) stents in even longer lesions.