Balancing the risks of bleeding and stent thrombosis: a decision analytic model to compare durations of dual antiplatelet therapy after drug-eluting stents.

BACKGROUND: After coronary stent placement, whether dual antiplatelet therapy (DAPT) duration should be extended to prevent late stent thrombosis (ST) or adverse cardiovascular events is uncertain.

METHODS: To define the reduction in ischemic events required to outweigh increased bleeding with longer-duration DAPT, we developed a decision-analytic Markov model comparing DAPT durations of 6, 12, and 30 months after DES. Separate models were developed for patients presenting with and without an acute coronary syndrome (ACS). We used sensitivity analyses to identify the incremental benefit of longer-duration DAPT on either ST or the composite of cardiac death, myocardial infarction, and ischemic stroke (major adverse cardiovascular and cerebrovascular events [MACCEs]) required to outweigh the increased risk of bleeding associated with longer DAPT. The outcome from each strategy was quantified in terms of quality-adjusted life years.

RESULTS: In the non-ACS population, in order for 30 months of DAPT to be preferred over 12 months of therapy, DAPT would have to result in a 78% reduction in the risk of ST (relative risk [RR] 0.22, 3.1 fewer events per 1000) and only a 5% reduction in MACCE (RR 0.95, 2.2 fewer events per 1000) as compared with aspirin alone. For the ACS population, DAPT would have to result in a 44% reduction in the risk of ST (RR 0.56, 3.4 fewer events per 1000) but only a 2% reduction in MACCE (RR 0.98, 2.3 fewer events per 1000) as compared with aspirin alone, for 30 months of DAPT to be preferred for 12 months.

CONCLUSIONS: Small absolute differences in the risk of ischemic events with longer DAPT would be sufficient to outweigh the known bleeding risks.