Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Everolimus eluting stent; Zotarolimus eluting stent
Intervention description: 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
Intervention MeSH terms: Everolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 461.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug-eluting stent; everolimus; zotarolimus; myocardial ischemia; cardiovascular diseases; MACE; safety

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