Phase 4
N=479
Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction
Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01347554 ↗Enrolled (actual)
479
Serious AEs
—
Results posted
Sep 2014
Primary outcome: Primary: Device-oriented Composite Outcome — 12; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus eluting stent (Device); Zotarolimus eluting stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yonsei University
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device-oriented Composite Outcome |
20; 24 | — |
| SECONDARY Device-oriented Composite Outcome |
20; 24 | — |
| SECONDARY Stent Thrombosis |
0; 7 | — |
| SECONDARY Any Bleeding |
7; 11 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01347554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.