ArticlesDual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial
Introduction
The recommended duration of dual antiplatelet treatment (DAPT) for elective coronary implantation of a bare-metal stent is at least 1 month on the basis of observational data.1 Concerns about a potential increased risk of stent thrombosis with drug-eluting stents (DESs)2, 3, 4 led to extension of DAPT from 2 months to 6–12 months.5, 6 However, new analyses of data from randomised trials7 and data from studies of the newer generations of DESs have not substantiated any increased risk, but have instead shown a lower risk of stent thrombosis in higher risk clinical situations such as in ST-elevation myocardial infarction.8, 9, 10
Findings from several randomised studies and large observational registries have challenged the recommendation of 6–12 months of DAPT treatment after implantation of a DES in stable patients, although duration in the control groups of these studies was variable and not always reflecting the 12-month recommendation of DAPT duration after DES implantation.11, 12, 13, 14, 15, 16, 17, 18, 19, 20
The ARCTIC (Assessment by a double Randomisation of a Conventional antiplatelet strategy versus a monitoring-guided strategy for drug-eluting stent implantation and, of Treatment Interruption versus Continuation 1 year after stenting)-Interruption trial is the second phase of the previously published ARCTIC-Monitoring study,21, 22 in which we randomly allocated 2440 patients to either platelet function testing with antiplatelet treatment adjustment or conventional antiplatelet treatment after coronary stenting with a DES. After 1 year of follow-up, we invited patients without major events and who were treated with clopidogrel or prasugrel in addition to aspirin to enrol in a second randomisation to either interruption of DAPT as recommended by international guidelines or continuation of DAPT for a further 6–18 months.6, 23 All patients participated in the first phase of the ARCTIC study, which served as a screening log book for the second randomisation 1 year later to assess this second hypothesis about DAPT duration.
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Study design and population
ARCTIC was a multicentre, prospective open-label study with parallel trial arms and double randomisation. Between Jan 26, 2009, and Jan 5, 2011, we recruited patients (aged ≥18 years) scheduled for planned DES implantation at 38 centres in France.21 We excluded patients with primary percutaneous coronary intervention for ST-elevation myocardial infarction, planned use of glycoprotein IIb/IIa inhibitors, chronic anticoagulation treatment, or bleeding diathesis. Results from the first phase
Results
Of the 2440 patients originally enrolled in the ARCTIC-TRIAL, 1259 were enrolled into the ARCTIC-Interruption study, of whom 624 were assigned to the interruption group and 635 were assigned to the continuation group (figure 1). The baseline risk of the non-randomised study population (n=1181) differed from the ARCTIC-Interruption population with a higher proportion of diabetes (469 [40%] of 1181 patients vs 420 [33%] of 1259 patients; p=0·0011), peripheral artery disease (167 [14%] patients vs
Discussion
Findings from ARCTIC-Interruption show no benefit with DAPT continuation beyond 1 year after coronary stenting, rather a harm of continued DAPT, with patients in the continuations group having more major or minor bleeding. They also show that 1 year after stenting, only half of patients are eligible for randomisation to thienopyridine interruption or continuation leading to the selection of a low risk population, and that strict adherence to the open-label treatment assignment of both single
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