Adjunctive cilostazol versus double-dose clopidogrel after drug-eluting stent implantation: the HOST-ASSURE randomized trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Safety & Effectiveness of Drug-Eluting Stents & Anti-platelet Regimen).
OBJECTIVE
This study sought to test the noninferiority of triple antiplatelet therapy (TAT) versus double-dose clopidogrel dual antiplatelet therapy (DDAT) in patients undergoing percutaneous coronary intervention (PCI).


BACKGROUND
Antiplatelet regimen is an integral component of medical therapy after PCI. A 1-week duration of doubling the dose of clopidogrel was shown to improve outcome at 1 month compared with the conventional dose in patients with acute coronary syndrome undergoing PCI. Yet in Asia, the addition of cilostazol is used more commonly than DDAT in high-risk patients.


METHODS
We randomly assigned 3,755 all-comers undergoing PCI to either TAT or DDAT, which was continued for 1 month, to test the noninferiority of TAT versus DDAT. The primary outcome was the cumulative incidence of net clinical outcome at 1 month post-PCI defined as the composite of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO (Platelet Inhibition and Patient Outcomes) major bleeding.


RESULTS
TAT was noninferior to DDAT with respect to the primary outcome, which occurred in 1.2% and 1.4% of patients, respectively (-0.22% absolute difference, 0.34% 1-sided 97.5% confidence interval, p = 0.0007 for noninferiority; hazard ratio: 0.85; 95% confidence interval: 0.49 to 1.48; p = 0.558 for superiority). The individual risks of cardiac death, nonfatal myocardial infarction, stent thrombosis, stroke, and PLATO major bleeding did not differ significantly between the 2 groups. There were no significant between-group differences in the treatment effect with regard to the rate of the primary outcome.


CONCLUSIONS
The adjunctive use of cilostazol was noninferior to doubling the dose of clopidogrel for 1 month in all-comers undergoing PCI with exclusively drug-eluting stents. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST-ASSURE]; NCT01267734).
Seoul National University Hospital, Seoul, Republic of Korea.
Kyung Woo
KW
Park
Si-Hyuck
SH
Kang
Jin Joo
JJ
Park
Han-Mo
HM
Yang
Hyun-Jae
HJ
Kang
Bon-Kwon
BK
Koo
Byoung-Eun
BE
Park
Kwang Soo
KS
Cha
Jay Young
JY
Rhew
Hui-Kyoung
HK
Jeon
Eun Seok
ES
Shin
Ju Hyeon
JH
Oh
Myung-Ho
MH
Jeong
Sanghyun
S
Kim
Kyung-Kuk
KK
Hwang
Jung-Han
JH
Yoon
Sung Yun
SY
Lee
Tae-Ho
TH
Park
Keon Woong
KW
Moon
Hyuck-Moon
HM
Kwon
In-Ho
IH
Chae
Hyo-Soo
HS
Kim
D000368:Aged; D001241:Aspirin / Q000008:administration & dosage; D000077407:Cilostazol; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003328:Coronary Thrombosis / Q000209:etiology; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011474:Prosthesis Design; D056910:Republic of Korea; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D013777:Tetrazoles; D000077144:Clopidogrel; D000077407:Cilostazol; D013988:Ticlopidine; D001241:Aspirin
ACS; CI; DDAT; HOPR; MI; OPR; PCI; TAT; acute coronary syndromes; antiplatelet therapy; cliostazol; clopidogrel; confidence interval; double-dose clopidogrel dual antiplatelet therapy; high on-treatment platelet reactivity; myocardial infarction; on-treatment platelet reactivity; percutaneous coronary intervention; randomized controlled trial; triple antiplatelet therapy