Incidence of emboli with cloth-covered Starr-Edwards valve without anticoagulation and with varying forms of anticoagulation. Analysis of 183 patients followed for 3 1/2 years.
One hundred eighty-three patients with cloth-covered valves were studied from 1 1/2 to 8 years after operation, with an average follow-up time of 3 1/2 years. Over the total period, patients taking Coumadin sustained a 4 percent embolic incidence (1.2 per 100 patient-years); those taking aspirin had a 7 percent incidence (2.6 per 100 patient-years); and those taking Persantine had a 43 percent incidence (10 per 100 patient-years). Patients on no regimen of anticoagulation had a 16 percent embolic rate (four per 100 patient-years), whereas another group of patients who stopped anticoagulants after a year incurred a 13 percent embolic incidence in the subsequent 2 years (6.4 per 100 patient-years). These data showed a significantly lowered embolic rate with anticoagulation and suggest that all patients with cloth-covered valves should be taking anticoagulants. That these valves become epithelialized and do not form thrombus after a year was not borne out by this study. Persantine alone is not a satisfactory anticoagulant. Coumadin appears to be the superior anticoagulant, but if careful monitoring of its use is in question or if serious bleeding complications ensue, aspirin may provide satisfactory protection.