Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction
EVERZOTA
Comparison of the Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Stent for Coronary Lesions in Acute Myocardial Infarction
1 other identifier
interventional
461
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
September 29, 2014
CompletedSeptember 29, 2014
September 1, 2014
4.2 years
April 27, 2011
September 23, 2014
September 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Device-oriented Composite Outcome
defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization
Two year
Secondary Outcomes (3)
Device-oriented Composite Outcome
Two years
Stent Thrombosis
Two years
Any Bleeding
Two year
Study Arms (2)
Xience V stent group
ACTIVE COMPARATORXience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
Endeavor resolute group
ACTIVE COMPARATOREndeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
Interventions
Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yonsei Universitylead
- Medtroniccollaborator
Study Sites (1)
Yonsei University Wonju College of Medicine; Wonju Severance Christian Hospital
Wŏnju, 220-701, South Korea
Related Publications (1)
Ahn SG, Choi HH, Lee JH, Lee JW, Youn YJ, Yoo SY, Cho BR, Lee SH, Yoon J. The impact of initial and residual thrombus burden on the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction. Coron Artery Dis. 2015 May;26(3):245-53. doi: 10.1097/MCA.0000000000000197.
PMID: 25503419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Relatively small number of sample size. Therefore, our result may be underpowerd. The incidence of clinical events were low. And we did not record the compliance of dual antiplatelet therapy for at least 1 year.
Results Point of Contact
- Title
- Dr. Seung-Hwan Lee
- Organization
- Yonsei University Wonju College of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Hwan Lee, MD, PhD
Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2011
First Posted
May 4, 2011
Study Start
January 1, 2009
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
September 29, 2014
Results First Posted
September 29, 2014
Record last verified: 2014-09