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Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients
Key result
Clopidogrel monotherapy proves noninferior to extended DAPT for net adverse clinical events in high-risk patients.
- risk difference -0.1 percentage points
- 95% CI -1.3 to 1.2
- P=0.001 for noninferiority
- n=3,203
Why the trial?
After high-risk PCI, extended dual antiplatelet therapy lowers ischaemic risk at the price of bleeding. Whether clopidogrel monotherapy can preserve ischaemic protection while reducing bleeding in this high-risk population had not been established.
Does clopidogrel monotherapy compared with extended DAPT improve net adverse clinical events in high-ischemic-risk patients 12 months after drug-eluting stent implantation?
Population
3203 high-ischemic-risk patients 12 months after drug-eluting stent implantation
Comparison
Clopidogrel monotherapy vs extended DAPT (clopidogrel + aspirin)
Design
Open-label randomized noninferiority trial in South Korea (margin 2.3 pp)
Follow-up
24 months
Authors
Discussion
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Key expert perspectives
Captured external expert commentary on this trial, strongest first. Original sources are linked where available.
The A-CLOSE trial evaluated clopidogrel monotherapy versus extended dual antiplatelet therapy after high-risk percutaneous coronary intervention, presented by Byeong-Keuk Kim.
MAMamas A. Mamas
“My @TCTMD Beyond the Data video: A-CLOSE with @Aspirinbk and dominic angillo How do we balance bleeding versus ischaemic risk in high risk pci? Did Asian paradox play chance in findings?”
“Among patients at high risk for ischemic events 12 months after drug-eluting stent implantation, clopidogrel monotherapy was noninferior to extended DAPT with respect to net adverse clinical events at 24 months.”
Implication
May support switching to clopidogrel monotherapy after 12 months to reduce bleeding; extends randomized evidence on DAPT de-escalation in high-ischemic-risk patients.
Key Points
- To evaluate whether clopidogrel monotherapy is noninferior to extended dual antiplatelet therapy (DAPT) beyond 12 months after drug-eluting stent implantation in patients at high risk for ischemic events.
- Open-label, randomized noninferiority trial conducted in South Korea enrolling 3,203 patients with high-risk clinical or lesion features 12 months after drug-eluting stent placement (A-CLOSE trial, NCT03947229).
- Participants were randomly assigned 1:1 to clopidogrel monotherapy (n=1,601) or extended DAPT with clopidogrel plus aspirin (n=1,602) and followed for 24 months.
- The primary composite endpoint of net adverse clinical events occurred in 5.0% (80/1601) of the monotherapy group versus 5.1% (81/1602) of the DAPT group (risk difference, -0.1 percentage points; 90% CI, -1.3 to 1.2; P=0.001 for noninferiority, margin 2.3 percentage points).
- Key secondary ischemic events occurred in 3.7% of monotherapy vs. 1.6% of DAPT patients (HR 2.33; 95% CI, 1.47 to 3.69; P<0.001), while BARC type 2, 3, or 5 bleeding occurred in 1.8% vs. 4.1% (HR 0.43; 95% CI, 0.27 to 0.67; P<0.001).
Evidence details
What drove the result?
| Outcome | Clopidogrel | DAPT |
|---|---|---|
| Net adverse clinical events (death, MI, ST, stroke, BARC 2/3/5) | 80 (5.0%) | 81 (5.1%) |
| Risk difference -0.1 pp (90% CI -1.3 to 1.2); P=0.001 for noninferiority | ||
| Death, MI, stent thrombosis, or stroke | 60 (3.7%) | 26 (1.6%) |
| Key secondary - higher with monotherapy (HR 2.33, 1.47-3.69; P<0.001); opposite direction from bleeding | ||
Limitations & tradeoffs
Safety
BARC 2, 3, or 5 bleeding 28 (1.8%) vs 65 (4.1%); HR 0.43 (95% CI 0.27-0.67); P<0.001.
Design limitations
open-label design, and the net composite balances ischemic and bleeding events that moved in opposite directions, so the neutral net result masks trade-offs.
Representation
conducted only in South Korea, which may limit generalizability.
Structured PICO
Does clopidogrel monotherapy compared with extended DAPT improve net adverse clinical events in high-ischemic-risk patients 12 months after drug-eluting stent implantation?
P
Population
3,203 patients with high-risk clinical or lesion characteristics 12 months after drug-eluting stent implantation, followed for 24 months.
I
Intervention
Clopidogrel monotherapy
C
Comparator
Extended dual antiplatelet therapy (DAPT) with clopidogrel plus aspirin
O
Outcome
Net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 24 monthscomposite
Main Result
Effect estimate: risk difference -0.1 percentage points (95% CI -1.3 to 1.2)
Absolute Event Rate: 5% vs 5.1%
p-value: p=0.001 for noninferiority
Clopidogrel monotherapy was noninferior to extended DAPT for net adverse clinical events at 24 months in high-risk patients 12 months post-DES, driven by reduced bleeding despite increased ischemic events.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Lee et al. (2026) conducted an RCT in High risk for recurrent ischemic events after drug-eluting stent implantation (n=3,203). Clopidogrel monotherapy vs. Extended DAPT (clopidogrel plus aspirin) was evaluated on Net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 24 months (risk difference -0.1 percentage points, 95% CI -1.3 to 1.2, p=0.001 for noninferiority). Clopidogrel monotherapy was noninferior to extended DAPT for net adverse clinical events at 24 months (5.0% vs 5.1%; risk difference -0.1 percentage points; P=0.001 for noninferiority).