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Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction (EVERZOTA)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01347554
First received: April 27, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting (PES). Although sirolimus-eluting stents (SES) have been shown to be the most efficacious drug regarding inhibition of neointima and late loss, there have been no previous head to head comparisons between EES and zotarolimus-eluting stent (ZES). Both everolimus and sirolimus are macrocyclic lactones that target the mTOR (mammalian target of rapamycin) to reduce vascular smooth muscle proliferation after vessel injury and therefore in principle may show similar results after stenting in humans. Data pooled from the EES arm that received follow up angiography in the SPIRIT III trial and the SES arm in the SIRIUS trial show similar rates of binary restenosis and late loss. However, the stent and polymer platform is not the same between the EES and ZES and it is reported that the EES system has the thinnest stent + polymer thickness (88.6um) of all of the previously KFDA-approved drug-eluting stent (DES). In addition, there are no data available on the efficacy of the EES and ZES in "real world" lesions other than the selected lesions studied in the previous trials, such as acute myocardial infarction.


Condition Intervention Phase
Myocardial Infarction
Device: Everolimus eluting stent
Device: Zotarolimus eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Stent for Coronary Lesions in Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Device-oriented Composite Outcome [ Time Frame: Two year ] [ Designated as safety issue: No ]
    defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization


Secondary Outcome Measures:
  • Device-oriented Composite Outcome [ Time Frame: Two years ] [ Designated as safety issue: No ]
    defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)

  • Stent Thrombosis [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Definite and probable stent thrombosis

  • Any Bleeding [ Time Frame: Two year ] [ Designated as safety issue: Yes ]

Enrollment: 461
Study Start Date: January 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Xience V stent group
Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
Device: Everolimus eluting stent
Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
Other Names:
  • Xience V
  • Promus or Promus element
Active Comparator: Endeavor resolute group
Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Device: Zotarolimus eluting stent
Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
Other Name: Endeavor resolute

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Chest pain duration more than 10 minutes
  • At least on of the following criteria
  • A. ECG change (T inversion, ST depression or ST elevation)
  • B. Cardiac enzyme elevation more than upper normal limit
  • Significant coronary artery stenosis (>50% by visual estimate)
  • The patient or guardian agrees to the study

Exclusion Criteria:

  • Stent thrombosis
  • Left main disease
  • Cardiogenic shock
  • Cronic kidney disease or renal failure requiring hemodialysis
  • History of bleeding diathesis or known coagulopathy
  • Gastrointestinal or genitourinary bleeding within the prior 3 months
  • History of major surgery within 2 months
  • Planned surgery requiring cessation of clopidogrel within 12 months of percutaneous coronary intervention (PCI)
  • Serious patients whose life expectancy <1 year or severe infectious status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347554

Locations
Korea, Republic of
Yonsei University Wonju College of Medicine; Wonju Severance Christian Hospital
Wonju, Korea, Republic of, 220-701
Sponsors and Collaborators
Yonsei University
Medtronic
Investigators
Principal Investigator: Seung-Hwan Lee, MD, PhD Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01347554     History of Changes
Other Study ID Numbers: EVZT_2.0
Study First Received: April 27, 2011
Results First Received: September 23, 2014
Last Updated: September 23, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
drug-eluting stent
everolimus
zotarolimus
myocardial ischemia
cardiovascular diseases
MACE
safety

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014