PhD

Adjunctive Cilostazol Versus Double Dose Clopidogrel After PCI with Drug Eluting Stent : The HOST-ASSURE Randomized Trial Hyo-Soo Kim, MD/PhD Kyung-...
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Adjunctive Cilostazol Versus Double Dose

Clopidogrel After PCI with Drug Eluting Stent : The HOST-ASSURE Randomized Trial

Hyo-Soo Kim, MD/PhD Kyung-Woo Park, Si-Hyuck Kang, Kwang-Soo Cha, Byoung-Eun Park, Jay-Young Rhew, Hui-Kyung Jeon, In-Ho Chae On Behalf of The HOST-ASSURE Trial Investigators Seoul National University Hospital, Seoul, Korea

Case 66/M NSTEMI, Killip class III Left main coronary artery disease

Case Do you think DAT is enough?

Aspirin 100 mg

Clopidogrel 75 mg

Case 4 days after successful PCI with TaxusTM : Subacute stent thrombosis

DAT was not enough to protect this patient.

Aspirin 100 mg

Clopidogrel 75 mg

Then, what is your choice?

What is your choice? DDAT Double-Dose Clopidogrel Dual Antiplatelet Therapy

+

vs.

TAT Triple Antiplatelet Therapy (aspirin + clopidogrel + cilostazol)

+

cilostazol

This is theme of HOST-ASSURE-RCT.

Background • Inhibition of platelet reactivity in the first month post-PCI is critical in preventing thrombotic events. • One-week duration of doubling the dose of clopidogrel was shown to improve outcome at one month compared with conventional dose in ACS patients undergoing PCI.

• Yet in Asia, the adjunctive use of cilostazol to dual antiplatelet therapy (triple antiplatelet therapy, TAT) is used more commonly than doubling the dose of clopidogrel (double-dose dual antiplatelet therapy, DDAT) in high-risk patients. • However, there has been no large scale head-to-head comparison of TAT with DDAT to date with regard to clinical outcome.

Objectives 2x2 Factorial Design

Platelet arm

Stent arm

Triple Antiplatelet Therapy (TAT)

PtCr-EES (PromusTM ElementTM)

vs.

Double-Dose Clopidogrel Dual Antiplatelet Therapy (DDAT)

vs.

CoCr-ZES (Endeavor® Resolute)

Objectives 2x2 Factorial Design

Triple Antiplatelet Therapy (TAT)

vs.

Double-Dose Clopidogrel Dual Antiplatelet Therapy (DDAT)

[Hypothesis] TAT is non-inferior to DDAT regarding net clinical outcome at 1 month

Study Design Prospective, single-blinded, randomized multi-center trial 3,750 All Comers Receiving PCI

40 Centers in Korea

2x2 Factorial Design

Aspirin 300 mg + Clopidogrel 300-600 mg Loading

PtCr-EES arm (N=2,500)

Stent Arm 2:1 Randomization

CoCr-ZES arm (N=1,250)

TAT arm

Anti-Platelet Arm 1:1 Randomization

DDAT arm

(N=1,875)

(N=1,875)

Percutaneous Coronary Intervention 200 mg Cilostazol Loading

No Cilostazol Loading

Aspirin 100 mg QD Clopidogrel 75 mg QD Cilostazol 100mg BID

Aspirin 100 mg QD Clopidogrel 150 mg QD

Net Clinical Outcome at 1 Month Post-PCI (Intention-To-Treat Analysis)

Enrollment Criteria General Inclusion Criteria

Exclusion Criteria

• Age ≥18 years • Ability to verbally confirm understandings of risks, benefits and treatment alternatives with written informed consent prior to any study-related procedure • Significant lesion (>50% by visual estimate) in any of the coronary arteries, venous or arterial bypass grafts • Evidence of myocardial ischemia or diameter stenosis > 70%

• Known hypersensitivity/contraindication to heparin, aspirin, clopidogrel, cilostazol, everolimus, zotarolimus, or contrast media • Systemic (intravenous) Everolimus or Zotarolimus use ≤ 12 months • Female of childbearing potential • History of bleeding diathesis, known coagulopathy (including HIT), abnormal CBC (Hb < 10 g/dL or PLT < 100k /μL) or refusal of blood transfusions • GI or GU bleeding ≤ 3 months or major surgery ≤ 2 months • Life expectancy

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