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SPAF-II TRIAL |
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|---|---|
| Problem | Atrial fibrillation |
| Format | Multi-center RCT |
| Treatment | Warfarin |
| Control | Aspirin (325mg) |
| Population | 715 patients <75yr; 385 patients > 75yr |
| Inclusion criteria | Age >18 AF in the previous 12 month Patient with history of ischemic stroke or TIA more than 2 years before entry were eligible |
| Exclusion criteria | Prosthetic heart valves Mitral stenosis Requirement or contraindication to aspirin or warfarin Patient younger than 60 without overt cardiovascular disease(with lone AF). |
| Follow-up | Mean 2.0 years |
| Primary endpoint | Ischaemic stroke and systemic embolism |
| Secondary endpoint(s) | Composite of TIA, myocardial infarction and unstable angina |
| Details | Therapeutic INR 2.0 - 4.5 N.B. 61.9% (681) of patients are from SPAF-I study |
| Brief summary: | Aspirin sufficient in young & healthy. Warfarin may be necessary for higher risk patients. |
| PAPER: Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II Study. | |
|---|---|
| Date | 19 Mar 1994 |
| Journal | Lancet. 1994 Mar 19;343(8899):687-91. |
| Information | Two parallel trials 1) Patients < 75 - Warfarin vs. aspirin -Primary endpoint (ischaemic stroke or systemic embolism) --Warfarin decreased the absolute rate of primary events by 0.7% per year --(1.3% vs. 1.9%) -Only 0.5%/yr risk on aspirin without HTN/recent CCF/previous thromboembolism 2) Patients > 75 - Warfarin vs. aspirin -Primary endpoint (ischaemic stroke or systemic embolism) --Warfarin decreased the absolute rate of primary events by 1.2% per year --(3.6% vs. 4.8%) -Rate of all stroke with residual deficit (ischaemic or haemorrhagic): --4.3% per year with aspirin and 4.6% per year with warfarin (RR 1.1) ==> -Warfarin may be more effective than aspirin -Younger patients with no RFs had low rate of stroke with aspirin -In older patients risk fo stroke was substantial with both treatments -Age and inherent risk should be considered |