A-CLOSE finds similar composite outcomes but opposing bleeding and ischaemic risks
The A-CLOSE trial compared clopidogrel alone with continued dual antiplatelet therapy in 3,203 patients at high ischaemic risk after coronary stenting. At 24 months, the composite outcome was similar at 5.0 per cent and 5.1 per cent. Monotherapy brought less clinically relevant bleeding but more major ischaemic events. The findings call for each patient's bleeding and clotting risks to be considered together.
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Two treatment arms after the first year following a stent
A-CLOSE was a randomised trial of 3,203 patients considered at high ischaemic risk after completing the first year of dual antiplatelet therapy following implantation of a drug-eluting coronary stent. For the next 24 months, participants received either clopidogrel alone or continued dual therapy with clopidogrel and aspirin. The trial therefore compared the benefit of longer dual treatment for preventing blood clots with the bleeding risk that treatment can increase in the same patient population.[1], [2]
A near tie in the composite outcome
At the end of two years, net adverse clinical events—a composite measure combining death, cardiovascular events and bleeding—occurred in 5.0 per cent of patients receiving clopidogrel alone and 5.1 per cent of those continuing dual therapy. This met the trial's non-inferiority threshold. The near tie in the composite outcome, however, does not mean that the treatment arms moved in the same direction for each kind of harm. Their results separated clearly when bleeding and ischaemic events were examined individually.[1], [2]
Less bleeding against more ischaemic events
Major ischaemic events occurred in 3.7 per cent of the clopidogrel-alone group and 1.6 per cent of the dual-therapy group. Clinically relevant bleeding occurred in 1.8 per cent and 4.1 per cent respectively. Monotherapy reduced bleeding but was accompanied by more ischaemic events in this high-risk population. The researchers say these opposing directions require an individual assessment: treatment after stenting should reflect each patient's clotting risk alongside the risk of bleeding, rather than a universal switch to one regimen.[1], [2]
