A Prospective Randomized Trial of Zotarolimus-Eluting Stents and Everolimus-Eluting Stents in Patients With Coronary Artery Disease - TWENTE

Feb 05, 2017
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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:
Abbott Vascular and Medtronic
Date Presented:
11/11/2011
Date Published:
01/18/2017
Date Updated:
02/05/2017
Original Posted Date:
02/15/2012
References

Contribution To Literature:

The TWENTE trial showed that zotarolimus-eluting stents are noninferior to everolimus-eluting stents.

Description:

The goal of the trial was to compare the zotarolimus-eluting stent versus the everolimus-eluting stent among patients with stable or unstable coronary artery disease undergoing percutaneous coronary intervention (PCI).

Study Design

  • Randomized
  • Blinded
  • Parallel
  • Stratified

Patient Populations:

  • Patients at least 18 years of age with stable coronary artery disease or non-ST-elevation acute coronary syndrome undergoing PCI

    Number of enrollees: 1,391
    Duration of follow-up: 5 years
    Mean patient age: 64 years

Exclusions:

  • ST-elevation myocardial infarction treated by primary PCI or rescue PCI
  • Planned staged revascularization
  • Hemodialysis
  • Limited life expectancy

Primary Endpoints:

  • Target vessel failure at 1 year, defined as cardiac death, target vessel myocardial infarction, and target vessel revascularization

Secondary Endpoints:

  • Individual components of target vessel failure
  • Stent thrombosis

Drug/Procedures Used:

Patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome undergoing PCI were randomized to a Resolute zotarolimus-eluting stent (n = 697) versus a Xience V everolimus-eluting stent (n = 694). Routine post-dilation was encouraged.

Patients received lifelong aspirin and 12 months of clopidogrel. Unfractionated heparin was used during PCI and glycoprotein inhibitors were used at operator discretion.

Principal Findings:

Overall 1,391 patients were randomized. The mean age was 64 years, 28% were women, 22% had diabetes, 52% presented with an acute coronary syndrome, 77% of PCI was for an off-label indication, direct stenting was employed in 39%, and post-dilation was used in 82%.

The mean lesion length was 14 mm, mean reference vessel diameter was 2.7 mm, and the mean number of stents implanted per patient was 2.

The primary outcome of target vessel failure at 1 year occurred in 8.2% of the zotarolimus group versus 8.1% of the everolimus group (pnoninferiority = 0.001, psuperiority = 0.94).

Cardiac death: 1.0% versus 1.4% (p = 0.46), myocardial infarction: 4.6% versus 4.6% (p = 0.99), clinically indicated target vessel revascularization: 3.3% versus 2.7% (p = 0.54), definite/probable cumulative stent thrombosis: 0.9% versus 1.2% (p = 0.59), definite late stent thrombosis: 0.4% versus 0 (p = 0.25), respectively for zotarolimus versus everolimus.

At 5 years, cardiac death: 3.7% versus 5.2% (p = 0.18), myocardial infarction: 6.8% versus 6.2% (p = 0.94), clinically indicated target vessel revascularization: 8.9% versus 10.5% (p = 0.41), or definite/probable cumulative stent thrombosis: 1.9% versus 2.1% (p = 0.83), respectively for zotarolimus versus everolimus.

Interpretation:

Among patients with stable or unstable coronary artery disease undergoing PCI, the zotarolimus-eluting stent was noninferior to the everolimus-eluting stent. Noninferiority was based on both efficacy and safety data at 1 year, with results sustained to 5 years. The rate of stent thrombosis was low for both stent types, including late stent thrombosis. The majority of these patients had PCI performed for off-label indications with liberal use of post-dilation. A strength of this trial was broad patient eligibility.

References:

von Birgelen C, van der Heijden LC, Basalus MW, et al. Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol 2017;Jan 18:[Epub ahead of print].

von Birgelen C, Basalus MW, Tandjung K, et al. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol 2012;59:1350-61.

Presented by Dr. Clemens von Birgelen at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2011), San Francisco, CA, November 11, 2011.

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Immunosuppressive Agents, Heparin, Ticlopidine, Sirolimus, Diabetes Mellitus, Percutaneous Coronary Intervention


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