DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity | Clinical Trial - DUTCH PEERS (TWENTE II)

Jun 16, 2015
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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:
Boston Scientific and Medtronic
Date Presented:
10/29/2013
Date Published:
06/15/2015
Date Updated:
06/16/2015
Original Posted Date:
02/11/2014
References

Description:

The goal of the trial was to evaluate treatment with the zotarolimus-eluting stent compared with the everolimus-eluting stent among patients undergoing percutaneous coronary intervention (PCI).

Contribution to the Literature: The DUTCH PEERS (TWENTE II) trial revealed similar target vessel failure with the zotarolimus-eluting stent versus the everolimus-eluting stent. 

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients ≥18 years of age undergoing PCI

    Number of screened applicants: 3,224
    Number of enrollees: 1,811
    Duration of follow-up: 1 and 2 years
    Mean patient age: 64 years
    Percentage female: 27%

Exclusions:

  • Participation in another randomized trial
  • Limited life expectancy
  • Planned surgery within the next 6 months
  • Pregnancy
  • Intolerance to aspirin, clopidogrel, heparin, or any drug-eluting stent component

Primary Endpoints:

  • Target vessel failure at 1 year; defined as cardiac death, target vessel MI, or clinically driven target vessel revascularization

Secondary Endpoints:

  • Stent thrombosis

Drug/Procedures Used:

All-comers patients undergoing PCI were randomized to the zotarolimus-eluting stent (Resolute Integrity; n = 906) versus the everolimus-eluting stent (Promus Element; n = 905).

Principal Findings:

Overall, 1,811 patients were randomized. The mean age was 64 years, 27% were women, 18% had diabetes, 23% had prior myocardial infarction, and clinical indication was non–ST-segment elevation myocardial infarction (NSTEMI) in 25%, and STEMI in 25%.

The primary outcome of target vessel failure at 1 year occurred in 6% of the zotarolimus-eluting group versus 5% of the everolimus-eluting group (p for noninferiority = 0.006). The frequency of target vessel failure was similar among all tested subgroups.

- Cardiac death: 2% vs. 1% (p = 0.31), respectively for zotarolimus vs. everolimus

- Target vessel MI: 2% vs. 1% (p = 0.15), respectively

- Clinically driven target vessel revascularization: 3% vs. 3% (p = 0.77), respectively

- Definite/probable stent thrombosis: 1% vs. 1% (p = 0.4), respectively

- Longitudinal stent deformation: 0 vs. 9 (p = 0.002), respectively. Longitudinal stent deformation did not result in any adverse events.

Target vessel failure at 2 years occurred in 8.6% of the zotarolimus-eluting group versus 7.8% of the everolimus-eluting group (p = 0.55). Definite or probable very late stent thrombosis at 2 years was 0.6% versus 0.2% (p = 0.45), respectively, for zotarolimus versus everolimus. At 2 years, >80% of patients were free from chest pain with no difference between stent type.

 

Interpretation:

Among a wide spectrum of patients undergoing PCI, including a large proportion of acute myocardial infarctions, the use of the zotarolimus-eluting stent was noninferior to the everolimus-eluting stent. Noninferiority was based on composite outcome of target vessel failure. Stent thrombosis was infrequent and similar between groups. Longitudinal stent deformation was only observed in the platinum-chromium platform of the everolimus-eluting stent; however, this was not associated with adverse events. Outcomes were similar at 2 years.

References:

Sen H, Lam MK, Löwik MM, et al. Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II). JACC Cardiovasc Interv 2015;8:889-99.

von Birgelen C, Sen H, Lam MK, et al. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet 2014;383:413-23.

Presented by Dr. Clemens von Birgelen at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2013), San Francisco, CA, October 29, 2013.

Keywords: Myocardial Infarction, Thrombosis, Sirolimus, Angioplasty, Balloon, Coronary, Diabetes Mellitus, Stents


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