The long-term follow-up of patients in the NIPPON (Nobori dual antiplatelet therapy as appropriate duration) study Masato Nakamura, MD. Phd. Disclosures Grants from Terumo corp. Daiichi Sankyo and Sanofi KK outside the submitted work Honoraria from Terumo corp. Daiichi Sankyo KK, Astra-Zeneka KK, and Sanofi KK
Background • NIPPON study demonstrated the non-inferiority of 6 months dual antiplatelet therapy (DAPT) in terms of NACCE compared with 18 months DAPT after drug- eluting stent (DES) deployment (J Am Coll Cardiol Interv 2017; 10:1189-98). • Many previous trials comparing different durations of DAPT after DES implantation had short observation periods and lower than anticipated event rates.
• The 3-year data of the present study might provide additional insight into the risks and benefits of short- term DAPT. • Deciding the balance between risks and benefits is not easy and consensus criteria for individualizing the duration of DAPT have not been established. • CART analysis may provide some assistance when selecting the optimal duration of DAPT.
Purpose • To assess the long-term efficacy and safety of short-term DAPT by analysis of 3-year follow- up data. Key point about methods • A total of 3773 patients was randomized to 2 groups (6 month DAPT vs 18 months DAPT) • Kaplan-Meier analysis was performed to estimate the probability of the occurrence of event at 3 year. – NACCE (all-cause mortality, myocardial infarction, stroke, or major bleeding) – Efficacy end point (cardiac death, myocardial infarction, stroke, and definite or probable stent thrombosis) – Safety end point (BARC2, 3 or 5 bleeding) • CART analysis was conducted to define the subgroup benefitting from long-term DAPT
NACCE: death, MI, Stroke, major bleeding Long-term DAPT 10 Long-term DAPT 10 Short-term DAPT Short-term DAPT Cumulative Incidence (%) Cumulative Incidence (%) HR: 1.20 (95%CI: 0.87, 1.66) HR: 1.49 (95%CI: 0.97, 2.27) 8 8 Log-rank p=0.27 Log-rank p=0.06 7.03% 6 6 5.60% 4.85% 4 4 3.48% 2 2 0 0 0 6 9 12 18 24 36 0 3 6 9 12 18 24 36 Months since Enrollment Months since Enrollment No. at Risk No. at Risk 1653 1541 1488 1266 887 214 Long-term DAPT 1887 1646 1466 1213 878 210 Long-term DAPT 1654 1499 1426 1230 839 172 Short-term DAPT 1886 1684 1410 1216 833 169 Short-term DAPT
Landmark analysis (6M-3 year) Efficacy end point Safety end point CV death, MI, stroke, ST BARC 2,3, or 5 10 Long-term DAPT 10 Long-term DAPT Short-term DAPT Short-term DAPT Cumulative Incidence (%) Cumulative Incidence (%) 8 HR: 1.02 (95%CI: 0.59, 1.78) 8 HR: 1.53 (95%CI: 0.81, 2.87) Log-rank p=0.94 Log-rank p=0.17 6 6 4 4 2.22% 2.58% 2 2 1.70% 2.01% 0 0 0 6 9 12 18 24 36 0 6 9 12 18 24 36 Months since Enrollment Months since Enrollment No. at Risk No. at Risk 1653 1469 1271 937 212 1653 1527 1279 889 214 Long-term DAPT Long-term DAPT 1654 1425 1233 909 173 1654 1490 1245 845 173 Short-term DAPT Short-term DAPT
Long-term DAPT 1.0%(16/1653) Long-term DAPT 1.0%(16/1653) Short-term DAPT 1.5%(24/1654) Short-term DAPT 1.5%(24/1654) Log-rank p= Log-rank p= HR (95%CI): 1.53 (0.81, 2.87) HR (95%CI): 1.53 (0.81, 2.87) >70 <70 >70 <70 age age Long-term DAPT 0.5%(4/854) Long-term DAPT 0.5%(4/854) Long-term DAPT 1.5%(12/790) Long-term DAPT 1.5%(12/790) Short-term DAPT 0.5%(4/863) Short-term DAPT 0.5%(4/863) Short-term DAPT 2.6%(20/778) Short-term DAPT 2.6%(20/778) Log-rank p=0.96 Log-rank p=0.96 Log-rank p=0.14 Log-rank p=0.14 HR (95%CI): 1.06 (0.21, 5.26) HR (95%CI): 1.04 (0.26, 4.15) HR (95%CI): 1.68 (0.82, 3.44) HR (95%CI): 1.68 (0.82, 3.44) <77 <23.3 >23.3 >77 Syntax Age Score Long-term DAPT 1.8%(9/494) Long-term DAPT 1.5%(10/671) Long-term DAPT 1.0%(3/296) Long-term DAPT 0.0%(0/26) Short-term DAPT 1.8%(12/652) Short-term DAPT 3.5%(17/489) Short-term DAPT 18.8%(6/32) Short-term DAPT 1.0%(3/289) Log-rank p=0.10 Log-rank p=0.64 Log-rank p=0.94 Log-rank p=0.01 HR (95%CI): 1.89 (0.84, 4.23) HR (95%CI): 1.21 (0.52, 2.81) HR (95%CI): 1.06 (0.21, 5.26) HR (95%CI): 13.24 (0.59, 298.17) NO <81.429 YES >81.429 DM eGFR Long-term DAPT 1.7%(5/292) Long-term DAPT 2.0%(4/202) Long-term DAPT 1.8%(10/561) Long-term DAPT 0.0%(0/88) Short-term DAPT 2.3%(12/534) Short-term DAPT 2.0%(6/307) Short-term DAPT 6.0%(11/182) Short-term DAPT 0.0%(0/98) Log-rank p=0.81 Log-rank p=0.59 Log-rank p=0.04 HR (95%CI): 1.14 (0.35, 3.74) HR (95%CI): 1.25 (0.54, 2.90) HR (95%CI): 2.89 (0.94, 8.91)
Conclusions • Short-term and long-term DAPT showed no significant difference of net clinical benefit up to 3 years after drug-eluting stent implantation. • However, patients with a higher event risk may be candidates for long-term DAPT.
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