NIPPON: Short-Term DAPT Non-Inferior to Long-Term DAPT in Patients Receiving Newer DES
Short-term dual antiplatelet therapy (DAPT) was non-inferior to longer-term DAPT in patients undergoing percutaneous coronary intervention (PCI) and placement of a newer drug-eluting stent (DES) with bioabsorbable abluminal coating, according to results of the NIPPON study presented Aug. 28 during ESC Congress 2016 in Rome.
The study randomized 3,775 patients with coronary artery disease or acute myocardial infarction from 130 Japanese institutions to receive short-term DAPT (six months) or long-term DAPT (18 months) following PCI and implantation of the Nobori bioabsorbable abluminal-coated stent. In both cases DAPT consisted of aspirin (81–162 mg/day) combined with clopidogrel (75 mg/day) or ticlopidine (200 mg/day).
Overall results showed similar rates of “net adverse clinical and cerebrovascular events” (NACCE) – the main outcome – with both six- and 18-month DAPT durations, and no significant difference in bleeding complications (0.73 percent of the long-term and 0.96 percent of the short-term DAPT group). The rate of stent thrombosis was also similar (0.07 percent in both). However, the study was terminated early due to slow enrollment and substantially lower events than expected.
“Based on these findings, a combination of short DAPT and a newer DES with bioabsorbable abluminal coating should be able to minimize the incidence of thrombotic events and bleeding complications simultaneously,” said Masato Nakamura, MD, PhD, lead author of the study. “However, the results of the present study should be interpreted with caution before trying to draw firm conclusions. The interpretation of the NIPPON trial is complicated by the fact that the event rate was lower than the expected incidence of the primary endpoint in both groups. Therefore, the statistical power may not have been adequate to fully assess the risk of primary endpoint.”
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