ISAR-TRIPLE
Trial question
What is the optimum duration of triple therapy in patients requiring oral anticoagulation after drug-eluting stent implantation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 614
614 patients (143 female, 471 male).
Inclusion criteria: patients who underwent drug-eluting stent implantation and are receiving concomitant aspirin and oral anticoagulation.
Key exclusion criteria: age ≤ 18 years, previous ST, DES implantation in the left main stem, active bleeding or bleeding diathesis, or a history of intracranial bleeding.
Interventions
N=307 clopidogrel treatment for 6 weeks (75 mg daily for 6 weeks; aspirin 75 to 200 mg once daily; and a VKA with either phenprocoumon or warfarin).
N=307 clopidogrel treatment for 6 months (75 mg daily for 6 months; aspirin 75 to 200 mg once daily; and a VKA with either phenprocoumon or warfarin).
Primary outcome
Death, MI, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months
9.8%
8.8%
9.8 %
7.4 %
4.9 %
2.5 %
0.0 %
Clopidogrel treatment for 6
weeks
Clopidogrel treatment for 6
months
No significant
difference ↔
No significant difference in death, MI, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months (9.8% vs. 8.8%; HR 1.14, 95% CI 0.68 to 1.91).
Secondary outcomes
No significant difference in cardiac death, MI, definite stent thrombosis, or ischemic stroke (4% vs. 4.3%; HR 0.93, 95% CI 0.43 to 2.05).
No significant difference in TIMI major bleeding (5.3% vs. 4%; HR 1.35, 95% CI 0.64 to 2.84).
Conclusion
In patients who underwent drug-eluting stent implantation and are receiving concomitant aspirin and oral anticoagulation, clopidogrel treatment for 6 weeks were not superior to clopidogrel treatment for 6 months with respect to death, MI, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months.
Reference
Fiedler KA, Maeng M, Mehilli J et al. Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial. J Am Coll Cardiol. 2015 Apr 28;65(16):1619-1629.
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