adjunctive cilostazol versus double dose clopidogrel...

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.

Then, what is your choice?

Aspirin 100 mg Clopidogrel 75 mg

What is your choice?

+ +

Double-Dose Clopidogrel

Dual Antiplatelet Therapy

Triple Antiplatelet Therapy

(aspirin + clopidogrel + cilostazol)

TAT DDAT vs.

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

Double-Dose

Clopidogrel Dual

Antiplatelet Therapy

(DDAT)

Triple Antiplatelet

Therapy

(TAT) vs.

2x2 Factorial Design

PtCr-EES

(PromusTM

ElementTM)

CoCr-ZES

(Endeavor® -

Resolute) vs.

Platelet arm

Stent arm

Objectives

Double-Dose

Clopidogrel Dual


(DDAT)

Triple Antiplatelet

Therapy

(TAT) vs.

2x2 Factorial Design

[Hypothesis]

TAT is non-inferior to DDAT

regarding net clinical outcome at 1 month

vs. Triple Antiplatelet

Therapy

(TAT)

Double-Dose

Clopidogrel Dual


(DDAT)

Study Design

TAT arm (N=1,875)

DDAT arm (N=1,875)

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

3,750 All Comers Receiving PCI

PtCr-EES arm

(N=2,500)

CoCr-ZES arm

(N=1,250)

Percutaneous Coronary Intervention

Aspirin 300 mg + Clopidogrel 300-600 mg Loading

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

Stent Arm

2:1 Randomization

Anti-Platelet Arm

1:1 Randomization

40 Centers in Korea

2x2

Fa

cto

ria

l D

esig

n

Prospective, single-blinded, randomized multi-center trial

Enrollment Criteria

General Inclusion Criteria

Angiographic 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%

• Target lesion in coronary artery, venous

or arterial bypass graft with diameter of ≥

2.5 mm and ≤ 4.25 mm

• Target lesion amenable for PCI

• 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 <1 year

• Actively participating in another drug or

device investigational study

• LVEF <25% or cardiogenic shock

• Symptomatic heart failure

Study Endpoints

• Primary Endpoint: net clinical outcome at 1 month

(a composite of cardiac death, nonfatal MI, definite or probable ST,

stroke and PLATO major bleeding)

• Secondary Endpoints

– Cardiac death, all-cause death

– Nonfatal MI: periprocedural/spontaneous MI

– ARC-defined ST: definite or probable ST, definite ST, probable ST

– Stroke

– PLATO major/minor bleeding

– Target vessel revascularization (TVR)

– Target lesion revascularization (TLR)

• Platelet Function Test: VerifyNow P2Y12 Assay

1) At 12-24 hours after loading of clopidogrel

2) At 1-month F/U under maintenance dose

Statistical Assumption

• Assumption

– 2% in TAT group

– 3% in DDAT group

• Non-inferiority Margin: 0.75% for Primary Endpoint

– Type I error (1-sided α): 2.5%

– Attrition rate: 2.5%

– Primary Analysis: Intention-to-treat analysis

– Statistical power >90% (β<0.10)

N=3,750

Non-inferiority Design for Primary Endpoint

(net clinical outcome at 1 month)

Hyo-Soo Kim

Web-based online randomization system

Dream CIS Inc. (contract research organization)

Seung-Woo Park, Young-Jin Choi, Kwangil Kim

Yong-Seok Kim, Sang Min Park, Nae Hee Lee

(blinded to treatment allocation)

Trial Coordination

Randomization

Data Safety

Monitoring Board

Data Management

Clinical Event

Adjudication

Committee

Principal

Investigator

Hyo-Soo Kim, In-Ho Chae, Kwang Soo Cha,

Byoung Eun Park, Jay Young Rhew, Hui-Kyung Jeon

Executive

Committee

Participating Centers 40 Hospitals in Republic of Korea

Site PI

Seoul National University Hospital Kim, Hyo-Soo

Seoul National University Bundang Hospital Chae, In-Ho

Pusan National University Hospital Cha, Kwang Soo

Dankook University Hospital Park, Byoung Eun

Presbyterian Medical Center Rhew, Jay Young

Uijeongbu St. Mary’s Hospital Jeon, Hui-Kyung

Ulsan University Hospital Shin, Eun Seok

Samsung Changwon Hospital Oh, Ju Hyeon

Chonnam National University Hospital Jeong, Myung-Ho

Chungbuk National University Hospital Hwang, Kyung-Kuk

Wonju Christian Hospital Yoon, Jung-Han

Inje University Ilsan Paik Hospital Lee, Sung Yun

Boramae Medical Center Kim, Sanghyun

Dong-A Medical Center Park, Tae-Ho

Gangnam Severance Hospital Kwon, Hyuck-Moon

St. Vincent’s Hospital Moon, Keon Woong

Daegu Catholic University Medical Center Ryu, Jae-Kean

Keimyung University Dongsan Medical Center Hur, Seung-Ho

Daegu Fatima Hospital Lee, Bong-Ryul

Gyeongsang National University Hospital Park, Yong-Whi

Site PI

Konyang University Hospital Bae, Jang-Ho

Hallym University Kangdong Sacred Heart Hospital Han, Kyoo-Rok

Ewha Womans University Mokdong Hospital Park, Si-Hoon

Korea University Guro Hospital Rha, Seung-Woon

Hallym University Sacred heart Hospital Park, Woo-Jung

Wongwang University Hospital Oh, Seok-Kyu

Korea University Anam Hospital Lim, Do-Sun

Kwangju Christian Hospital Lee, Seung-Wook

Hallym University Chuncheon Sacred Heart Hospital Yoon, Duck-Hyoung

Kyung Hee University Hospital at Gangdong Kim, Chong-Jin

Seoul Medical Center Kim, Seok-Yeon

Gachon University Gil Hospital Ahn, Taehoon

Samsung Medical Center Gwon, Hyeon-Cheol

Hallym University Kangnam Sacred Heart Hospital Lee, Namho

National Health Insurance Medical Center Jeon, Dong-Woon

Soonchunhyang University Hospital Hyun, Min-Soo

Daejun Eulji University Hospital Lee, Sang

Hanyang University Guri Hospital Lee, Jaewoong

Kangwon National University Hospital Ryu, Dong Ryeol

Kosin University Gospel Hospital Cha, Tae-Joon

3,755 Patients

Enrolled and Randomized

Allocated to TAT

(N=1,879)

Allocated to DDAT

(N=1,876)

Received TAT as Randomized

(N=1,830)

Received DDAT as Randomized

(N=1,730)

Adhered to TAT for 1 Month

(N=1,721)

Adhered to DDAT for 1 Month

(N=1,623)

107 Did not adhere to allocated treatment 4 Lost to follow-up 17 Cardiovascular events 13 Had bleeding 8 Had side effects 9 Voluntarily withdrawn or poorly compliant 23 At physicians’ discretion 33 Other reasons

109 Did not adhere to allocated treatment 4 Lost to follow-up 9 Cardiovascular events 14 Had bleeding 34 Had side effects 11 Voluntarily withdrawn or poorly compliant 18 At physicians’ discretion 19 Other reasons

1,879 Patients Analyzed

According to ITT

1,876 Patients Analyzed

According to ITT

49 Did not receive allocated treatment 4 Did not receive coronary stenting 4 Did not meet inclusion criteria 14 Patient decision 27 Other reasons

146 Did not receive allocated treatment 7 Did not receive coronary stenting 11 Did not meet inclusion criteria 97 Patient decision 31 Other reasons

Trial Flow

Baseline Characteristics

Characteristic TAT

(N=1,879) DDAT

(N=1,876)

Age 62.8±10.7 63.7±10.9

Men 1,311 (69.8) 1,257 (67.0)

Body mass index 24.7±3.2 24.6±3.1

Hypertension 1,256 (66.8) 1,286 (68.6)

Diabetes 598 (31.8) 588 (31.3)

insulin-requiring diabetes 66 (3.5) 71 (3.8)

Dyslipidemia 1,206 (64.2) 1,176 (62.7)

Current smoker 616 (32.8) 577 (30.8)

Chronic renal failure 42 (2.2) 50 (2.7)

Peripheral artery disease 44 (2.3) 24 (1.3)

Cerebrovascular disease 120 (6.4) 128 (6.8)

Previous PCI 188 (10.0) 181 (9.6)

Previous bypass surgery 11 (0.6) 15 (0.8)

Pervious MI 69 (3.7) 96 (5.1)

Previous CHF 23 (1.2) 31 (1.7)


Characteristic TAT

(N=1,879) DDAT

(N=1,876)

Clinical diagnosis

Slient ischemia 96 (5.1) 86 (4.6)

Stable angina 564 (30.0) 549 (29.3)

Unstable angina 690 (36.7) 688 (36.7)

NSTEMI 328 (17.5) 332 (17.7)

STEMI 201 (10.7) 221 (11.8)

Baseline laboratory findings

Left ventricular ejection fraction (%) 60.3±10.3 59.9±10.3

Hemoglobin (g/dL) 13.7±1.8 13.7±1.7

Platelet count (x103/mm) 227±63 227±61

Serum creatinine (mg/dL) 1.0±0.8 1.0±0.8

Total cholesterol (mg/dL) 178±44 177±44

Triglyceride (mg/dL) 143±93 136±95

HDL-cholesterol (mg/dL) 44±12 44±11

LDL-cholesterol (mg/dL) 110±42 109±38


Characteristic TAT

(N=1,879) DDAT

(N=1,876)

Medications at discharge

Aspirin 1,867 (99.4) 1,862 (99.3)

Clopidogrel 1,866 (99.3) 1,863 (99.3)

β-blocker 1,277 (68.0) 1,277 (68.1)

Calcium channel blocker 357 (19.0) 407 (21.7)

ACE inhibitor or ARB 1,215 (64.7) 1,248 (66.5)

CYP3A4-metabolized statin* 1,032 (54.9) 1,060 (56.5)

Non-CYP3A4-metabolized statin** 545 (29.0) 559 (29.8)

Proton pump inhibitor 153 (8.1) 148 (7.9)

*CYP3A4-metabolized statin: simvastatin, lovastatin, atorvastatin, etc

**Non-CYP3A4-metabolized statin: rosuvastatin, pravastatin, pitavastatin, fluvastatin

Angiographic & Procedural Characteristics

Characteristic TAT

(N=1,879) DDAT

(N=1,876) P Value

Angiographic disease extent 0.631

1-vessel disease 856 (45.6) 877 (46.7)

2-vessel disease 618 (32.9) 590 (31.4)

3-vessel disease 405 (21.6) 409 (21.8)

Number of lesions treated per patient 1.5±0.8 1.5±0.8 0.639

Stent arm – intention-to-treat 0.972

Promus-Element arm 1,253 (66.7) 1,250 (66.6)

Endeavor-Resolute arm 626 (33.3) 626 (33.4)

Type of drug-eluting stents – per protocol 0.552

No stents used 14 (0.7) 9 (0.5)

Promus-Element 1,198 (63.8) 1,202 (64.1)

Endeavor-Resolute 587 (31.2) 573 (30.5)

Others 80 (4.3) 92 (4.9)

Number of stents per patient 1.6±0.9 1.6±0.9 0.513

Use of IVUS or OCT 737 (39.2) 763 (40.7) 0.365

Treatment of left main disease 57 (3.0) 55 (2.9) 0.852

Treatment of bifurcation lesions 308 (16.4) 303 (16.2) 0.842

Use of glycoprotein IIb/IIIa inhibitors 46 (2.4) 50 (2.7) 0.673

TAT 1,879 1,855 1,845 1,832 1,763 1,538

DDAT 1,876 1,848 1,836 1,820 1,764 1,525

Cu

mu

lati

ve I

ncid

en

ce o

f

Pri

mary

En

dp

oin

t (%

)

0 7 14 21 28 35

0

1

2

3

4

TAT: 1.2%

DDAT: 1.4%

Primary Endpoint

No. at Risk

Composite of Cardiac death, nonfatal MI, stroke,

definite/probable ST, and PLATO major bleeding

Days after Randomization

Non-inferiority P<0.001

Superiority P=0.566

TAT 1,879 1,855 1,845 1,832 1,763 1,538

DDAT 1,876 1,848 1,836 1,820 1,764 1,525

Landmark Analysis

No. at Risk

Cu

mu

lati

ve I

ncid

en

ce o

f

Pri

mary

En

dp

oin

t (%

)

0 7 14 21 28 35


0.0

0.5

1.0

1.5

P=0.343

P=0.566 Overall P=0.565

Composite of Cardiac death, nonfatal MI, stroke,


TAT

DDAT

TAT (N=1,879)

23 (1.22%)

DDAT (N=1,876)

27 (1.44%)

Absolute Risk Difference: -0.22%

(standard error: 0.37%)

Upper 1-sided 97.5% CI: 0.52%

Primary Endpoint Composite of Cardiac death, nonfatal MI, stroke,


-0.5 0.5 1.0 0.0

Predefined margin

: 0.75%

Non-inferiority

P=0.005

Risk Difference with 1-sided 97.5% CI

(TAT-DDAT)

Landmark Analysis

0 7 14 21 28 35


Cu

mu

lati

ve

In

cid

en

ce

(%

) Overall P=0.178

0.0

0.5

1.0

1.5

P=0.563

P=0.179

Nonfatal MI

DDAT

TAT

0 7 14 21 28 35


Cu

mu

lati

ve

In

cid

en

ce

(%

) Overall P=0.999

0.0

0.5

1.0

1.5

P=0.999 P=0.999

PLATO Major Bleeding

DDAT

TAT

0 7 14 21 28 35


Overall P=0.797

0.0

0.5

1.0

1.5

P=0.998

P=0.801

Cardiac Death

DDAT

TAT

Cu

mu

lati

ve

In

cid

en

ce

(%

)

0 7 14 21 28 35


Overall P=0.365

0.0

0.5

1.0

1.5

P=0.256

P=0.391

Definite/Probable ST

DDAT

TAT

Cu

mu

lati

ve

In

cid

en

ce

(%

) 0 7 14 21 28 35


0.0

0.5

1.0

1.5

P=0.343

P=0.566

Overall P=0.565

Primary Endpoint

DDAT

TAT

Cu

mu

lati

ve

In

cid

en

ce

(%

)

0 7 14 21 28 35


Overall P=0.654

0.0

0.5

1.0

1.5

P=0.157 P=0.659

Stroke

DDAT

TAT

Cu

mu

lati

ve

In

cid

en

ce

(%

)

Clinical Outcomes

End point

Event Rates at D/C Event Rates at 1 Month Hazard Ratio

(95% CI) P TAT

(N=1,879) DDAT

(N=1,876) TAT

(N=1,879) DDAT

(N=1,876)

Primary end point 16 (0.9) 17 (0.9) 23 (1.2) 27 (1.4) 0.85 (0.49-1.48) 0.566

Secondary end points

Cardiac death 6 (0.3) 5 (0.3) 8 (0.4) 7 (0.4) 1.14 (0.41-3.15) 0.798

Nonfatal MI 6 (0.3) 8 (0.4) 7 (0.4) 13 (0.7) 0.54 (0.21-1.35) 0.185

Periprocedural MI 6 (0.3) 8 (0.4) 6 (0.3) 8 (0.4) 0.75 (0.26-2.16) 0.591

Spontaneous MI 0 (0.0) 0 (0.0) 1 (0.1) 5 (0.3) 0.20 (0.02-1.71) 0.141

Stroke 2 (0.1) 3 (0.2) 2 (0.1) 3 (0.2) 0.67 (0.11-3.99) 0.656

Ischemic stroke 2 (0.1) 3 (0.2) 2 (0.1) 3 (0.2) 0.67 (0.11-3.99) 0.656

ST, definite or probable 2 (0.1) 2 (0.1) 4 (0.2) 7 (0.4) 0.57 (0.17-1.95) 0.371

ST, definite 1 (0.1) 0 (0.0) 2 (0.1) 4 (0.2) 0.50 (0.09-2.73) 0.423

ST, probable 1 (0.1) 2 (0.1) 2 (0.1) 3 (0.2) 0.67 (0.11-3.99) 0.656

PLATO major bleeding 3 (0.2) 4 (0.2) 8 (0.4) 8 (0.4) 1.00 (0.38-2.66) 0.999

Other events

All-cause death 6 (0.3) 8 (0.4) 9 (0.5) 11 (0.6) 0.82 (0.34-1.97) 0.654

PLATO minor bleeding 9 (0.5) 1 (0.1) 12 (0.6) 6 (0.3) 2.00 (0.75-5.34) 0.165

TLR 3 (0.2) 1 (0.1) 4 (0.2) 5 (0.3) 0.80 (0.22-2.98) 0.739

TVR 3 (0.2) 1 (0.1) 7 (0.4) 5 (0.3) 1.40 (0.44-4.41) 0.567

*Primary endpoint

: a composite of cardiac death, nonfatal MI, stent thrombosis, stroke and PLATO major bleeding at 1 month

Secondary Endpoints at 1 Month

Cardiac Death

p=0.798

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

Nonfatal MI

p=0.185

Periprocedural MI

p=0.591

Spontaneous MI

p=0.141

0.43% 0.37%

0.37%

0.69%

0.32%

0.43%

0.05%

0.27%

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876


Definite/Probable ST

p=0.371

Definite ST

p=0.423

Probable ST

p=0.656

ARC Stent Thrombosis

0.21%

0.37%

0.11%

0.21%

0.11% 0.16%


TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

Stroke

p=0.656

PLATO

Major Bleeding

p=0.999

0.11% 0.16%

0.43% 0.43%

Other Events at 1 Month

All-Cause Death

p=0.654

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

TAT N=1,879

DDAT N=1,876

PLATO

Minor Bleeding

p=0.165

Target Lesion

Revascularization

p=0.739

Target Vessel

Revascularization

p=0.567

0.48% 0.59%

0.64%

0.32%

0.21% 0.27%

0.37%

0.27%

Per-Protocol Analysis

End point TAT

(N=1,773) DDAT

(N=1,637)

Hazard Ratio

(95% CI) P

Primary end point 21 (1.2) 27 (1.6) 0.73 (0.42-1.30) 0.287

Secondary end points

Cardiac death 7 (0.4) 7 (0.4) 0.92 (0.33-2.70) 0.918

Nonfatal MI 6 (0.3) 13 (0.8) 0.44 (0.17-1.15) 0.092

Periprocedural MI 6 (0.3) 8 (0.5) 0.71 (0.25-2.04) 0.522

Spontaneous MI 0 (0.0) 5 (0.3) - 0.021

Stroke 1 (0.1) 3 (0.2) 0.32 (0.03-3.03) 0.317

Ischemic stroke 1 (0.1) 3 (0.2) 0.32 (0.03-3.03) 0.317

ST, definite or probable 3 (0.2) 7 (0.4) 0.41 (0.11-1.57) 0.191

ST, definite 1 (0.1) 4 (0.2) 0.24 (0.03-2.12) 0.198

ST, probable 2 (0.1) 3 (0.2) 0.63 (0.11-3.78) 0.614

PLATO major bleeding 8 (0.5) 8 (0.5) 0.95 (0.36-2.52) 0.912

*Primary endpoint

: a composite of cardiac death, nonfatal MI, stent thrombosis, stroke and PLATO major bleeding at 1 month

TAT 1,733 1,714 1,708 1,697 1,637 1,427

DDAT 1,637 1,618 1,607 1,598 1,548 1,337

Cu

mu

lati

ve I

ncid

en

ce o

f

Pri

mary

En

dp

oin

t (%

)

0 7 14 21 28 35

0

1

2

3

4

TAT: 1.2%

DDAT: 1.6%

No. at Risk Days after Randomization

Primary Endpoint – Per Protocol Composite of Cardiac death, nonfatal MI, stroke,


HR: 0.73 (0.42-1.30)

P=0.287

Subgroup Analysis

Subgroups Pt No. Δ Absolute Risk at 1 Month

(95% CI) P Int P

Age ≥ 65 years 1,797 0.722 0.933

< 65 years 1,958 0.717

Sex Men 2,568 0.295 0.319

Women 1,187 0.675

Acute coronary syndrome Yes 2,460 0.907 0.513

No 1,295 0.393

Diabetes mellitus Yes 1,186 0.834 0.506

No 2,569 0.390

renal dysfunction Yes 92 0.663 0.756

No 3,663 0.645

Concomittant use of statin Yes 3,196 0.768 0.649

No 559 0.410

Concomittant use of CCBs Yes 764 0.890 0.902

No 2,991 0.558

Allocated stent arm Promus-Element 2,503 0.725 0.829

Endeavor-Resolute 1,252 0.615

Multivessel stenting Yes 2,022 0.466 0.696

No 1,733 0.966

Total 3,755 0.566

Favors TAT Favors DDAT

-4.0 -3.0 -2.0 -1.0 0.0 1.0 1.5

On-Clopidogrel Platelet Reactivity

At Baseline (12-24 hours after the loading dose)

0

100

200

300

400

500

TAT DDAT

173±97 213±93

P<0.001

P2Y

12 R

eacti

on

Un

its

At 1 Month (after maintenance dose)

0

100

200

300

400

500

TAT DDAT

169±80 192±80

P<0.001

Limitations

1. Event rates were lower than expected

- Expected rate of primary endpoint in DDAT group: 3.0%

- Based on previous study (3.7% at 1 mo in CURRENT study)

- Actual event rate: 1.4% (ITT) & 1.6% (PP)

Possibility of being underpowered ?

2. Chance of under-reporting

- Dedicated periodic on-site monitoring was performed

- Event rates after PCI are known to be lower in Asian population

3. Low rates of peri-procedural MI

- Cardiac enzyme measurement was not mandated unless significant sx or sign

- The clinically-significant events are all counted

4. Non-adherence to allocated treatment may have affected outcomes

- Adherence rate: 91.6% (TAT group) and 86.5% (DDAT group)

- However, PP analysis yielded consistent results with ITT

• The adjunctive use of cilostazol in addition to

conventional dual antiplatelet therapy was noninferior to

doubling the maintenance dose of clopidogrel in this all-

comer PCI population receiving exclusively drug-eluting

stents with regard to net clinical outcome at 1 month.

• Both potent antiplatelet regimens for 1 month were safe,

effective, and widely applliable to the daily practice to

improve clinical outcome after DES implantation.

Conclusions

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

adjunctive cilostazol versus double dose clopidogrel...

Documents