RESOLUTE US: TLF lowered at 1 year with Resolute vs. Endeavor stent

Issue: May 2011

American College of Cardiology 60th Annual Scientific Sessions

NEW ORLEANS – Compared with a historical cohort treated with the Endeavor zotarolimus-eluting stent, patients who received the Resolute zotarolimus-eluting stent had significantly improved target lesion failure at one year, according to results of the RESOLUTE US trial.

Researchers in this trial enrolled 1,402 patients from 116 sites in the United States and split them into two cohorts: clinical (n=1,242) and angiographic (n=160). Patients received revascularization with the Resolute zotarolimus-eluting stent (Medtronic) either due to stable or unstable angina, while 34.4% of the population presented with diabetes at baseline.

At 1 month, target lesion failure (TLF) of all patients, which was defined as MI, cardiac death or clinically-driven target lesion revascularization, was 1.4% with one death reported due to cardiac causes, whereas at 12 months the rate of TLF was 4.7% with 18 deaths reported (9 due to cardiac causes).

The researchers then compared the main analysis cohort of this trial (n=1,001; evaluable n=982), which utilized 2.5 mm to 3.5 mm stents in single lesions only, to historical control patients (n=1,076) that received the Endeavor zotarolimus-eluting stent (Medtronic). The primary endpoint of TLF at one year was 3.7% in the Resolute group vs. 6.5% in the Endeavor group (P-noninferiority <.001; post-hoc P-superiority=.002).

“I think this study provides interesting additional information, certainly on effectiveness, in particular on some lingering safety issues with a stent thrombosis rate of 0.1% [that included] only two episodes both occurring in patients that received 2.25 stents and in patients that did not receive dual antiplatelet therapy fairly early after treatment,” said Martin B. Leon, MD, professor of medicine, Columbia University/New York Presbyterian Hospital, and trial researcher, in a press conference. “So I think we come away feeling that the composite of the data indicates a very effective and safe device, now finally treated in a US population. Tthis will hopefully lead to an FDA consideration for availability of this stent in the United States.” – by Brian Ellis

For more information:

Leon M. LBCT III, Session 3014. Presented at:ACC 60^th Annual Scientific Sessions; April 2-5, 2011; New Orleans.

The Resolute stent is a further refinement of a second generation drug-eluting stent (DES). I think the most interesting part is that the Resolute stent changed the elution characteristics of the same drug used in the Endeavor stent. There is really no other DES that has done this iteration, so we can now understand what changing the elution profile does. What we found was that Resolute stent lowers the TLF rate as compared to the Endeaver stent. Prolonging the drug elution profile can indeed help reduce intimal proliferation resulting in better clinical outcome.

The Resolute stent, hopefully when it gets approved by the FDA, will add another new third generation DES to treat complex patients. We currently only have only two second generation DES, but adding another with a prolonged drug elution profile will help treat patients with complex disease.

– Alan Yeung, MD

Chief, Division of Cardiovascular Medicine

Stanford University School of Medicine, Palo Alto, CA

Disclosures: Drs. Leon and Yeung are co-primary investigators of the RESOLUTE-US trial. Dr. Leon reports having received consulting fees/honoraria from Medtronic, and is a nonpaid member of Medtronic's Scientific Advisory Board. Dr. Yeung reports having received consulting fees/honoraria from Medtronic and is a paid member of Medtronic's Scientific Advisory Board.

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