Abstract
Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.
Highlights
Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard of care for prevention of stent thrombosis [1]
Values are presented as mean ± SD or absolute numbers (%) OCT optical coherence tomography, PCI percutaneous coronary intervention
The NIPPON OCT sub-study was a multicenter, randomized control trial to evaluate the difference of intra-stent thrombus (IS-Th) formation between shorter and prolonged DAPT duration after biolimus A9 eluting stent (BES) implantation and was first to demonstrate that the incidence of IS-Th formation at mid-term follow-up was equivalent between the two groups
Summary
Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard of care for prevention of stent thrombosis [1]. Extended author information available on the last page of the article. NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) is an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT after biolimus A9 eluting stent (BES) implantation. This NIPPON main study demonstrated that 6 months of DAPT was not inferior to 18 months of DAPT following implantation of BES in terms of net adverse clinical and cerebrovascular events (all-cause mortality, myocardial infarction, stroke, and major bleeding) [9].
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