Resolute All Comers - Resolute All Comers

Jun 16, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medtronic CardioVascular
Date Published:
01/01/2010
Date Updated:
06/16/2010
Original Posted Date:
06/16/2010
References

Description:

The goal of the trial was to evaluate treatment with the Resolute zotarolimus-eluting stent compared with the Xience V everolimus-eluting stent in patients with stable angina or an acute coronary syndrome.

Hypothesis:

The Resolute stent would be noninferior to the Xience V stent in regard to efficacy.

Study Design

  • Randomized
  • Blinded
  • Parallel

Patient Populations:

  • Enrollees: 2,292
  • Duration of Follow-up: 12 months
  • Age Range: Mean 64 years
  • Percentage Female: 23%

Exclusions:

  • Known intolerance to a study medication, metal alloy, or contrast media
  • Planned surgery within 6 months
  • Pregnant or ability to become pregnant
  • Participation in another clinical trial

Primary Endpoints:

Cardiovascular death, any target-vessel myocardial infarction, or clinically indicated target-lesion revascularization within 12 months

Secondary Endpoints:

  • All-cause mortality
  • Individual components of the composite outcome
  • Stent thrombosis

Drug/Procedures Used:

Patients with stable angina or acute coronary syndromes were randomized to the zotarolimus-eluting stent (n = 1,140) versus the everolimus-eluting stent (n = 1,152).

Unfractionated heparin was used for percutaneous coronary intervention (PCI), and glycoprotein IIb/IIIa inhibitors were administered according to operator discretion. Patients were discharged with aspirin and at least 6 months of clopidogrel.

Principal Findings:

Overall, 2,292 patients were randomized. The mean age was 64 years, 23% were women, 23% had diabetes, and 34% presented with an acute myocardial infarction. The mean lesion length was 12 mm, mean reference vessel diameter was 2.6 mm, number of lesions treated per patient was 1.5, mean SYNTAX score was 15 (range is 0-115), and off-label stent use was 67%. The mean number of stents per patient was 1.9 in the zotarolimus group and 2.0 in the everolimus group (p = 0.02) and the mean total stent length was 34 mm versus 37 mm (p = 0.02), respectively.

At 1 year, the primary outcome had occurred in 8.2% of the zotarolimus group versus 8.3% of the everolimus group (p for superiority = 0.94; p for noninferiority <0.001). All-cause mortality was 1.6% versus 2.8% (p = 0.08), cardiovascular mortality was 1.3% versus 1.7% (p = 0.61), any target-vessel myocardial infarction was 4.2% versus 4.1% (p = 0.92), and any target-lesion revascularization was 3.9% versus 3.4% (p = 0.50), respectively, for the zotarolimus versus everolimus-eluting stent.

Definite stent thrombosis at 1 year was 1.2% versus 0.3% (p = 0.01). This was due to more thrombotic events within 30 days (9 vs. 1; p = 0.01) and 31 days to 1 year (5 vs. 2; p = 0.29).

Angiographic follow-up was performed in a subset of patients at 13 months. In-segment late loss was 0.15 mm versus 0.06 mm (p = 0.04) and in-stent late loss was 0.27 mm versus 0.19 mm (p = 0.08), respectively, for the zotarolimus versus everolimus-eluting stent.

Interpretation:

Among patients with stable coronary disease and acute coronary syndromes, the Resolute zotarolimus stent was noninferior to the Xience V everolimus stent for the composite outcome of cardiovascular death, target-vessel myocardial infarction, or target-lesion revascularization.

The Resolute stent was designed to have enhanced properties compared to the Endeavor stent by using a proprietary polymer called BioLinx, which has hydrophilic and hydrophobic properties that extend the duration of drug exposure in the vessel.

The individual components of the primary outcome were also similar between the two groups. Angiography was performed at 13 months and after assessment of the primary outcome; therefore, all revascularizations were clinically driven. In these patients, in-segment late loss was significantly lower, while in-stent late loss was nonsignificantly lower with the everolimus-eluting stent.

The zotarolimus-eluting stent was associated with more definite stent thromboses within 1 year. This appeared to be influenced by more stent thromboses within 30 days; however, there was still a numerical excess of stent thromboses from 31 days to 1 year, although mortality was nonsignificantly lower. Ongoing research is needed to provide more insight into this important safety outcome to determine the relative incidence of early and late stent thrombosis between the current generation drug-eluting stents.

References:

Serruys PW, Silber S, Garget S, al. Comparison of Zotarolimus-Eluting and Everolimus-Eluting Coronary Stents. N Engl J Med 2010;Jun 16:[Epub ahead of print].

Keywords: Coronary Artery Disease, Myocardial Infarction, Acute Coronary Syndrome, Follow-Up Studies, Angina, Stable, Drug-Eluting Stents, Heparin, Ticlopidine, Sirolimus, Percutaneous Coronary Intervention, Stents, Thrombosis, Polymers, Diabetes Mellitus


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