Triple Versus Dual Antiplatelet Therapy After ABT578-Eluting Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate whether the cilostazol reduce neointimal hyperplasia after ZES
      (Zotarolimus-eluting stents) implantation, the investigators performed
      double-blind,randomized, multicenter, prospective study compared triple antiplatelet therapy
      (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet therapy (aspirin plus
      clopidogrel) for 8 months in patients with long coronary lesion treated with ZES.
    

Detailed description: 
      Use of drug-eluting stent (DES) has reduced the incidence of restenosis rate and the need for
      repeat revascularization compared to using bare metal stents. DES implantation also
      significantly reduced the angiographic restenosis in patients with long coronary
      lesions.However, although the use of DES has decreased the effect of lesion length on
      restenosis, the restenosis after DES implantation of long coronary lesions remain at a higher
      risk of restenosis.

      Cilostazol, a phosphodiesterase III inhibitor, has been known to reduce smooth muscle
      proliferation and intimal hyperplasia after endothelial injury and restenosis after balloon
      angioplasty and bare-metal stent (BMS) implantation when compared with aspirin and
      clopidogrel or ticlopidine. Recently, the impact of 6-month cilostazol treatment in addition
      to aspirin and clopidogrel on neointimal hyperplasia after sirolimus-(SES) or
      paclitaxel-eluting stent (PES) implantation for long-coronary lesions has been evaluated in
      our institution. It reported that cilostazol treatment achieved primary end point (in-stent
      late loss) and reduced need of target lesion revascularization without significant adverse
      drug-side effects with open-label design, which suggest that 6-month treatment of cilostazol
      effectively inhibits the neointimal hyperplasia after DES implantation and can be safely
      applied to the patients or lesions with higher risk of restenosis such as diabetes and long
      lesions.However, our study was done in unblinded manner and might underestimate the
      angiographic results due to relatively short-term follow-up angiographic follow-up(6-month.

      Recently commercially available new-DES, zotarolimus-eluting stent (ZES) demonstrated
      significant reduction of restenosis and cardiac events during 9-month. However, it has not
      been tested that 8-month treatment of cilostazol also effectively inhibits the neointimal
      hyperplasia after ZES implantation in patients with long coronary lesions. Therefore, to
      evaluate whether the cilostazol reduce neointimal hyperplasia after ZES implantation, the
      investigators performed double-blind, randomized, multicenter, prospective study compared
      triple antiplatelet therapy (aspirin plus clopidogrel plus cilostazol) and dual antiplatelet
      therapy (aspirin plus clopidogrel) for 8 months in patients with long coronary lesion treated
      with ZES.
    

Intervention name(s): cilostazol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): cilostazol 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months; placebo 200mg loading dose within 1 hours after successful stenting, followed by 100mg bid for 8 months
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stents; cilostazol