The MD Conference Express ISTH Special Collection - (Page 8)
CLINICAL TrIAL HIGHLIGHTS
In the hazard ratio outcomes, all p values were
nonsignificant, demonstrating comparable benefit in the
Prior Stroke/TIA and No Prior Stroke/TIA groups. Efficacy
outcomes also had nonsignificant interaction p values,
indicating a consistent benefit between the two groups
(Table 1). The safety outcomes showed that the benefit
always accrued to apixaban. Nonsignificant interaction
p values indicated that the results in both groups were
equally beneficial.
Summary data showed that treatment with apixaban
compared with warfarin in patients with AF and prior stroke
or TIA reduced stroke and SE by 24%, major bleeding by
27%, intracranial bleeding by 63%, and mortality by 11%.
Overall, the trial demonstrated that in patients with AF
and prior stroke or TIA, apixaban is superior to warfarin
in preventing stroke or SE; causes less bleeding, especially
intracranial bleeding; and results in lower mortality.
These outcomes are consistent with those of the main
ARISTOTLE trial.
The HOST-ASSURE Randomized Trial
ACC 2012, Written by Maria Vinall
Hyo-Soo Kim, MD, Seoul National University Hospital,
Seoul, South Korea, reported results from a study that
compared double- with triple-dose antiplatelet therapy
(DAPT vs TAPT) in acute coronary syndrome patients who
were undergoing percutaneous coronary intervention (PCI),
which showed no difference in net clinical outcomes between
the two treatment regimens after 1 month.
The Harmonizing Optimal Strategy for Treatment of
Coronary Artery Stenosis – Safety & Effectiveness of Drug-
Eluting Stents & Antiplatelet Regimen [HOST-ASSURE;
NCT01267734] trial was a 2x2 factorial design trial that
compared the safety and long-term effectiveness of
coronary stenting, the everolimus-eluting stenting system,
and the zotarolimus-eluting stenting system, as well as the
short-term efficacy and safety of TAPT, adding cilostazol to
standard aspirin plus clopidogrel dosing, versus DAPT with
aspirin plus higher-dose clopidogrel. The presentation by
Prof. Kim focused only on the results of the comparison of
the two antiplatelet regimens.
The HOST-ASSURE study comprised 3750 subjects
who were undergoing PCI with drug-eluting stents (DES)
at 40 centers in South Korea. Subjects were randomized
in a 1:1 fashion to either TAPT (aspirin 100 mg QD,
clopidogrel 75 mg QD, cilostazol 200 mg loading-dose
followed by 100 mg BID) or DAPT (aspirin 100 mg QD,
clopidogrel 150 mg QD). All patients were loaded with
300 mg of aspirin and 300 to 600 mg of clopidogrel prior
to PCI. Patients with a left ventricular ejection fraction
<25%, cardiogenic shock, or symptomatic heart failure
were excluded from the study. The hypothesis that was
being tested was that the net clinical outcome at 1 month
with TAPT would be noninferior to that with DAPT. The
net clinical outcome was defined as a composite of cardiac
death, nonfatal myocardial infarction (periprocedural
or spontaneous), definite or probable stent thrombosis,
stroke, or PLATO major bleeding. The noninferiority
margin was set at 0.75% absolute. In other words, the study
had 90% power to show that the rate of the net clinical
outcome in patients who were assigned TAPT was not
more than 0.75% higher than with DAPT, assuming that no
difference in rates between the regimens truly existed.
Table 1. Stroke Substudy Efficacy Outcomes.
Prior Stroke or TIA
No Prior Stroke or TIA
p Value
(interaction)
Apixaban
Warfarin
HR (95% CI)
Apixaban
Warfarin
HR (95% CI)
n (Rate*)
n (Rate*)
Apixaban vs
Warfarin
n (Rate*)
n (Rate*)
Apixaban vs
Warfarin
Primary Efficacy Outcome
(Stroke or Systemic
Embolism)
73 (2.46)
98 (3.24)
0.76 (0.56-1.03)
139 (1.01)
167 (1.23)
0.82 (0.65-1.03)
0.71
Stroke
67 (2.26)
96 (3.17)
0.71 (0.52-0.98) 132 (0.96)
154 (1.14)
0.84 (0.67-1.06)
0.40
Hemorrhagic
12 (0.40)
31 (1.00)
0.40 (0.21-0.78)
28 (0.20)
47 (0.34)
0.59 (0.37-0.94)
0.35
Ischemic or uncertain
57 (1.92)
68 (2.23)
0.86 (0.60-1.22) 105 (0.76)
107 (0.79)
0.97 (0.74-1.26)
0.61
Disabling or fatal
39 (1.31)
46 (1.49)
0.87 (0.57-1.34)
46 (0.33)
76 (0.56)
0.60 (0.41-0.86)
0.18
Myocardial infarction
17 (0.57)
28 (0.91)
0.62 (0.34-1.14)
73 (0.53)
74 (0.54)
0.97 (0.70-1.34)
0.20
Cardiovascular death
72 (2.35)
76 (2.41)
0.98 (0.71-1.35)
236 (1.68)
268 (1.94)
0.87 (0.73-1.03)
0.53
Death from any cause
129 (4.22)
150 (4.77)
0.89 (0.70-1.12)
474 (3.37)
519 (3.75)
0.90 (0.79-1.02)
0.89
*Rate per 100 patient/years of follow-up; Reproduced with permission from JD Easton, MD.
8
May 2013
www.mdconferencexpress.com
http://www.mdconferencexpress.com
Table of Contents for the Digital Edition of The MD Conference Express ISTH Special Collection
The MD Conference Express ISTH Special Collection
Table of Contents
New Oral Anticoagulants and Antiplatelet Drugs
SPS3 Study Does Not Support the Use of Combination Therapy for Stroke Prevention
Apixaban Superior to Warfarin in Patients with Atrial Fibrillation as Well as Prior Stroke or TIA
The HOST-ASSURE Randomized Trial
Oral Rivaroxaban Alone for Symptomatic Pulmonary Embolism
Moderate PE Treated with Thrombolysis (MOPETT Study)
Results of the WOEST Trial
Genetic Determinants of Variability in Dabigatran Exposure
Rivaroxaban of Benefit in STEMI: ATLAS ACS 2-TIMI 51
Hyporesponsiveness to Clopidogrel Does Not Predict 1-Year Mortality
First Large-Scale Platelet Function Evaluation in an Acute Coronary Syndrome Trial: The Trilogy ACS-Platelet Function Substudy
ASPIRE: Using Aspirin to Prevent Recurrence of VTE
ARCTIC: Randomized Trial of Bedside Platelet Function Monitoring
Long-Term Dabigatran Extension Study for Stroke Prevention in Treatment for Atrial Fibrillation
Clopidogrel Plus Aspirin Reduces Risk of Recurrent Stroke: The CHANCE Trial
Anticoagulation and Antithrombotic Therapy in Atrial Fibrillation
Balancing Bleeding and Ischemic Risk in the Acute and Long-Term Setting
Safety and Efficacy of Anticoagulants
The MD Conference Express ISTH Special Collection
https://www.nxtbook.com/nxtbooks/md_conference_express/ISTH
https://www.nxtbookmedia.com