The STIMS trial: the ticlopidine experience and its clinical applications. Swedish Ticlopidine Multicenter Study.

The mortality in patients with intermittent claudication can be reduced by treatment with ticlopidine. This is the clinically most significant result from STIMS, the Swedish Ticlopidine Multicenter Study. During an average treatment period of 5.6 years, 153 of the 687 patients died, 26.1% in the placebo group and 18.5% in the ticlopidine group (RR0.7, p = 0.015). The incidence of fatal vascular events in the two groups was 12% and 6%. In terms of lives saved per years of treatment, STIMS showed that by treating 200 claudicants for 5 years one can save 13 from a cardiovascular death, not merely dying from something else as treatment was associated with a reduced total mortality as well. The interpretation of the on-treatment analysis is that for those who tolerate the drug the combined vascular morbidity and mortality rate is lowered from 24% to 14%. The disadvantage is that many patients do not tolerate ticlopidine. In STIMS, 22% (2.5 times as many as in the control group) had to stop medication because of gastrointestinal side-effects. Although ticlopidine is associated with an increased risk of leukopenia, the risk in absolute numbers is small: according to STIMS, 4% during 5.6 years. All events were reversible. The 1.4% incidence of thrombocytopenia did not seem to be associated with ticlopidine treatment.

RCT Entities:   Population Interventions Outcomes