A-CLOSE Trial: Antiplatelet Therapy After Stent Implantation Requires Personalization
核心洞察
The A-CLOSE trial found clopidogrel monotherapy was noninferior to extended DAPT for the primary net adverse clinical events endpoint (5.0% vs. 5.1%; p=0.001 for noninferiority) in high ischemic risk patients.
Extended DAPT provided greater protection against major ischemic events, including death, while clopidogrel monotherapy significantly reduced major or clinically relevant bleeding.
Key ischemic events occurred more frequently with clopidogrel monotherapy (3.7% vs. 1.6%; p<0.001), whereas BARC type 2, 3 or 5 bleeding was lower (1.8% vs. 4.1%; p<0.001).
Antiplatelet monotherapy reduced bleeding but dual antiplatelet therapy (DAPT) provided greater cardiovascular event protection in patients at high ischemic risk who had undergone stent implantation 12 months earlier. These results, from the A-CLOSE trial, were presented in a Hot Line session at ESC Congress 2026 and published simultaneously in the New England Journal of Medicine.
After stent implantation for a blocked coronary artery, current guidelines recommend 6 to 12 months of DAPT followed by long-term single antiplatelet therapy with either aspirin or clopidogrel. However, some patients remain at particularly high risk for recurrent heart attacks or blood clots due to underlying medical conditions (such as acute coronary disease, diabetes (搜索), kidney disease, heart failure (搜索) or a history of stroke (搜索)) or complex artery blockages requiring multiple or extensive stents. For those at high ischemic risk, the optimal duration of DAPT beyond 12 months remains uncertain.
The A-CLOSE trial compared two different antiplatelet strategies in high-risk patients who had undergone drug-eluting stent implantation 12 months earlier. Its Principal Investigator, Professor Byeong-Keuk Kim from Severance Cardiovascular Hospital (搜索), Yonsei University College of Medicine, Seoul, South Korea, explained: "After drug-eluting stent implantation, clinicians must balance protection from ischemic events against the bleeding risk associated with prolonged DAPT. Although clopidogrel monotherapy is increasingly used after DAPT, its efficacy and safety compared directly with extended DAPT has not been tested in patients at high ischemic risk."
Trial Design and Patient Population
The A-CLOSE trial was conducted in 19 centres in South Korea. Participants were eligible if they had undergone drug-eluting stent implantation 12 months earlier and had at least one high-risk clinical feature (acute coronary syndrome (搜索), diabetes (搜索), chronic kidney disease (搜索), heart failure (搜索), prior stroke (搜索) or peripheral artery intervention) or high-risk lesion feature (left main coronary artery lesion, a bifurcation lesion, chronic total occlusion, multivessel disease or diffuse long lesions). Participants were randomised to clopidogrel monotherapy or extended DAPT for 24 months.
The study population included 3,203 participants who had a mean age of 63 years, and 18.4% were women.
Key Findings
After 24 months, the two strategies produced similar rates of net adverse clinical events. The primary endpoint of all-cause death, myocardial infarction (搜索), stent thrombosis (搜索), stroke (搜索) or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding with clopidogrel monotherapy was noninferior to extended DAPT (5.0% vs. 5.1%; p=0.001 for noninferiority).
Of note, a key ischemic endpoint occurred more frequently with clopidogrel monotherapy than with extended DAPT (all-cause mortality, myocardial infarction (搜索), stent thrombosis (搜索) or stroke (搜索): 3.7% vs. 1.6%; p<0.001). All-cause mortality occurred in 1.3% of patients with clopidogrel monotherapy and 0.4% of patients with DAPT.
A key bleeding endpoint occurred less frequently with clopidogrel monotherapy (BARC type 2, 3 or 5 bleeding: 1.8% vs. 4.1%; p<0.001).
Clinical Implications
Concluding, Professor Kim noted that the results of the A-CLOSE trial showed a clear trade-off in patients at high ischemic risk: "Extended DAPT provided greater protection against major ischemic events, including death, whereas clopidogrel monotherapy reduced major or clinically relevant bleeding. It seems that no single strategy is best for every patient, but rather, long-term antiplatelet therapy should be individualized according to ischemic and bleeding risks, clinical characteristics and treatment preferences in a shared decision-making process between patients and physicians."