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SPAF TRIAL |
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|---|---|
| Problem | Atrial fibrillation |
| Format | Multi-center RCT |
| Treatment | Warfarin or Aspirin |
| Control | Placebo |
| Population | 1300 |
| Inclusion criteria | Constant or intermittent atrial fibrillation -ECG documentation in the preceeding 12 months Inpatients or outpatients from public, private and veteran healthcare |
| Exclusion criteria | Prosthetic heart valves MI or angioplasty within previous 3 months CABG in last year Echocardiographic evidence of mitral stensosis Mitral regurgitation w/ CCF and LV diam > 5.5xm Dilated cardiomyopathy w/ CCF NYHA IV Other requirements or contraindications for/to aspirin/warfarin Life expectency less than 2 years Chronic renal failure N.B. Patients were judged ineligable for group 1 (warf/aspirin/placebo) and hence put in group 2 (aspirin/placebo) if: -Age > 75 -Lone AF complex (abandoned) -Repeated galls/unstable gait predisposing to head trauma -Positive stool for FOB -Chronic alcohol -GI/GU bleeding in last 6 months -Uncontrolled hypertension -Occupational hazards -Severe haemorrhage an anticoagulants despite previous therapeutic PT -Recurrent syncope or uncontrolled seizure disorder -Intrinsic PT prolongation > 2s beyond on 2+ occasions -Previous intracranial haemorrhage Thrombocytopoenia Alcohol abuse NSAIDs No stroke within previous 2 years -7% had prior clinical brain ischaemia |
| Follow-up | Mean 1.3 years |
| Primary endpoint | Rate of ischaemic stroke and systemic embolism |
| Secondary endpoint(s) | Composite of TIA, myocardial infarction and unstable angina |
| Details | Wanted to assess whether aspirin > placebo in ALL patients, and if warfarin > placebo in the less risky subgroup. Didn't intend to go out to compare warfarin vs. aspirin - aim for SPAF-II INR 2.0 - 4.5 target |
| Brief summary: | Aspirin or warfarin (on own) superior to placebo |
| PAPER: Stroke Prevention in Atrial Fibrillation Study. Final results. | |
|---|---|
| Date | 1 Aug 1991 |
| Journal | Circulation. 1991 Aug;84(2):527-39. |
| Information | Aimed to compare: 1) Aspirin vs. placebo in all patients -Primary events (ischaemic stroke or systemic embolism) reduced by 42% -Primary events or death reduced by 32% 2) Warfarin vs. placebo in eligible subgroup -Primary events (ischaemic stroke or systemic embolism) reduced by 67% -Primary events or death reduced by 58% N.B. So few events in warfarin/aspirin subgroup that trial did not aim to investigate relative efficacy -See SPAF-II |