A New Strategy Regarding Discontinuation of Dual Antiplatelet
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Drug-eluting stents (DES), markedly reducing the neointimal hyperplasia after stent
      implantation compared with bare-metal stents (BMS), have improved angiographic and clinical
      outcomes in the complex lesions and patients with high risks. However, currently, the fatal
      events related with stent thrombosis still occur and are the major limitation of the use of
      DES. Especially, late or very late thrombosis after DES implantation is an uncommon but
      life-threatening fatal complication presented with sudden death or myocardial infarction (MI)
      causing heart failure. The most powerful predictor for stent thrombosis is the
      discontinuation of clopidogrel. In consideration of current data regarding stent thrombosis
      and clinical situation of discontinuation of antiplatelet, zotarolimus-eluting stent (ZES)
      [Endeavor®, Medtronic Vascular, Santa Rosa, CA] might be anticipated to be safer than other
      DES during the long-term follow-up owing to healthy endothelialization. Endeavor® stent was
      consists of zotarolimus, thin-strut, cobalt-chromium alloy stent platform (DriverTM stent;
      Medtronic Vascular, Santa Rosa, CA), and phosphorylcholine coating. The ENDEAVOR II study
      demonstrated clinically and statistically significant improvement in all of study endpoints,
      including a 47 percent reduction in the primary endpoint of target vessel failure (TVF). In
      addition, the ENDEAVOR II trial showed a 0.5 percent rate of stent thrombosis at 30 days -
      with no late thrombosis beyond 30 days and no late stent malapposition. Because
      reendothelialization after ZES implantation may occur within 3 months, 3-month dual
      antiplatelet therapy is recommended in many clinical trials and real world practice. Shorter
      maintenance of dual antiplatelet therapy might minimize the risk for stent thrombosis in
      cases of discontinuation of antiplatelet and prevent waste medications and bleeding
      complications related with dual antiplatelet therapy. However, there have been no
      non-inferior or superior data of ZES considering all these circumstances. Therefore, the
      investigators hypothesize that ZES with 3-month dual antiplatelet therapy may be safe and
      beneficial in patients with coronary artery disease during follow-up than other DES, in spite
      of higher late lumen loss. To test this hypothesis, the investigators will perform a
      multi-center, randomized, prospective trial aimed at demonstrating the efficacy of the ZES
      versus other DES in patients with coronary artery disease in real world practice.
    


Intervention name(s): Zotarolimus-eluting stent; Zotarolimus-eluting stent for ACS and DM; Everolimus-eluting stent for long lesion; Sirolimus-eluting stent for short lesion
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Zotarolimus-eluting stent; Zotarolimus-eluting stent for ACS and DM; Everolimus-eluting stent for long lesion; Sirolimus-eluting stent for short lesion
Intervention MeSH terms: Sirolimus; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment