MD Conference Express ISC 2012 - (Page 11)
Figure 1. Stroke Substudy Primary Outcome.
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aspirin (n=1163). Key inclusion criteria included normal sinus rhythm, LVEF ≤35%, no defined cardioembolic source, and being on an optimal HF regimen. Baseline characteristics were similar between the two groups, as was baseline time in the therapeutic range (63%; 2 to 3.5). The mean INR was 2.5±0.95. The number of patient-years in the aspirin group was 4033; in the warfarin group, the number of patient years was 4045. The primary analysis was treatment-by-time interaction. The combined primary outcome was not significantly different between groups, occurring at a rate of 7.47% per year among warfarin patients versus 7.93% per year in those who were assigned to aspirin (HR, 0.93; 0.79 to 1.10; p=0.40; Figure 1). There was, however, a suggestive benefit of warfarin for the primary outcome at 4 years and beyond (HR, 0.894; 0.800 to 0.998; p=0.046; Figure 2). Figure 1. Primary Outcome.
Aspirin Warfarin 4033 patient years 4045 patient years (320 endpoints; 7.93% per year) (302 endpoints; 7.47% per year)
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Percent with Event
Warfarin/Prior Stroke Apixaban/Prior Stroke
6
4 Warfarin/No Prior Stroke 2 Apixaban/No Prior Stroke 0 0
1694 1742 7426 7339
6
1604 1643 7122 6977
12
1547 1564 6893 6737
Treatment Apixaban Warfarin Apixaban Warfarin
Prior Stroke Yes Yes No No
Months
18
1066 1092 4985 4880
24
560 554 2904 2851
30
263 263 1491 1505
Reproduced with permission from JD Easton, MD.
Patients with Primary Outcomes (%)
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.
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Overall HR=0.93 (0.79 to 1.10) p=0.40
40
Proportional hazards assumption violated
Aspirin
30
Warfarin
No Compelling Evidence to Use Warfarin or Aspirin in HF Patients
Written by Rita Buckley
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10
Primary Analysis: Tx by Time Interaction
0 0
No. at Risk Aspirin 1163 Warfarin 1142
1
1073 1049
2
860 852
3 Year
658 653
4
508 525
5
329 363
6
94 115
Hazard Ratio for Warfarin vs Aspirin
The Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction Trial [WARCEF; NCT00041938] found no compelling evidence to use warfarin for all patients. Shunichi Homma, MD, Columbia University College of Physicians and Surgeons, New York, New York, USA, reported outcomes from the study. WARCEF was a randomized, double-blind, multicenter, international clinical trial. The primary outcome was to determine if warfarin or aspirin was superior for preventing the combined endpoint of death, ischemic stroke, or intracerebral hemorrhage (ICH) in patients with left ventricular ejection fraction (LVEF) ≤35% in sinus rhythm. The mean follow-up was 3.5 years, ranging from 1 to 6 years. The main secondary aim was to determine if warfarin or aspirin was superior for preventing death, ischemic stroke, or ICH plus myocardial infarction or heart failure (HF) hospitalization in patients with LVEF ≤35% in sinus rhythm. A total of 2305 patients were randomized to receive either warfarin (target INR 2 to 3.5; n=1142) or 325 mg/day of
Reproduced with permission from S. Homma, MD.
Figure 2. Warfarin vs Aspirin Hazard Ratios by Year of Follow-Up (Prespecified Time-Varying Analysis).
2.0 1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0 0 Warfarin better 1
1073 1049
Aspirin better Significant Treatment by Time Interaction HR multiplier per year: 0.894 (0.800 to 0.998) p=0.046
2
860 852
3 Year
658 653
4
508 525
5
329 363
6
94 115
Aspirin Warfarin
*Estimated from time-varying model in continuous time
Reproduced with permission from S. Homma, MD.
The warfarin group (n=268) had a death rate of 6.63% per year. The death rate in the aspirin group (n=263) was 6.52% per year (HR, 1.01; 95% CI, 0.85 to 1.21; p=0.91).
Highlights from the International Stroke Conference 2012
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Table of Contents for the Digital Edition of MD Conference Express ISC 2012
MD Conference Express ISC 2012
From Neurovascular Laboratory to Clinic: A Journey Through Time
No Compelling Evidence to Use Warfarin or Aspirin in Heart Failure Patients
AXIS 2 Clinical Outcomes No Different Than Placebo
SAMMPRIS: 30-Day Outcomes After Angioplasty and Stenting
Aggressive Medical Therapy Benefits Those Who Fail Antithrombotic Therapy
Initial Clinical Results with TREVO® Mechanical Thrombectomy Device are Promising
Linking sICH Definitions to Outcomes
Solitaire™ Flow Restoration Device Achieves Successful Recanalization Free of Symptomatic Hemorrhage Transformation
FIA II Seeks Genetic Underpinnings of Familial Intracranial Aneurysm
SPS3 Study Does Not Support the Use of Combination Therapy for Stroke Prevention
Novel Agent NA-1 Proves that Ischemic Neuroprotection is Possible in Older Patients
Acute Endovascular Treatment
Neuroimaging
Stroke Guidelines: Current Recommendations in Principle and Practice
The Rising Trend of Ischemic Stroke in the Young
Advanced Neuroimaging Adds Time, Reduces Endovascular Treatment in Clinical Practice
MD Conference Express ISC 2012
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