6 months versus 18 months dual antiplatelet treatment for patients - - PowerPoint PPT Presentation

6 months versus 18 months dual antiplatelet treatment for patients underwent bioabsorbable polymer and abluminal coated DES deployment: NIPPON randomized study

Masato Nakamura, Raisuke Iijima, Junya Ako, Toshiro Shinke, Hisayuki Okada,Yoshiaki Ito, Kenji Ando, Hitoshi Anzai, Hiroyuki Tanaka, Yasunori Ueda, Shin Takiuchi, Yasunori Nishida, Hiroshi Ohira, Katsuhiro Kawaguchi, Makoto Kadotani, Hiroyuki Niinuma, Kazuto Omiya, Takashi Morita, Kan Zen, Yoshinori Yasaka, Kenji Inoue, Sugao Ishiwata, Masahiko Ochiai, Toshimitsu Hamasaki, and Hiroyoshi Yokoi, on behalf

• f the NIPPON investigators

COI Disclosure

Name of First Author : Masato Nakamura

• 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.

Objectives

• A combination of short DAPT and a newer DES

should be able to minimize the incidence of thrombotic events and bleeding complications simultaneously.

• NIPPON trial is a multi-center randomized study to

test the non-inferiority of 6 months DAPT compared with 18 months DAPT following NOBORI stent with bioabsorbable polymer and abluminal coating

• Clinical trial:NCT.01514227

Flow Chart of NIPPON trial

Randomized (N=2772) Allocation ≥18 months after enrollment (N=2772) Enrolled and Randomized (N=3775) Excluded due to follow-up <18 months (n=1003 ) Allocated to 18 months DAPT (n=1391) Allocated to 6 months DAPT (n=1381)

• Received allocated intervention

Allocation Analysis Follow-up 18 months follow-up (n=1306)

• Death (n=13)
• Declined to participate (n=2)
• Lost to FU (n=70)

18 months follow-up (n=1286)

• Death (n=16)
• Declined to participate (n=1)
• Lost to FU (n=78)

On Treatment (OT)

• n=1383

Intention-to-Treat (ITT)

• N=1391

On Treatment (OT) n=1378 Intention-to-treat (ITT) n=1381

• Received allocated intervention

(n=1391)

• Excluded (n=0)
• Received allocated intervention

(n=1381)

• Excluded (n=0)

Target lesion coronary artery Left main Left anterior descending Left circumflex Right coronary artery ACC/AHA classification A/B1 B2/C Number of treated vessel 18 months DAPT 15 (1.1) 846 (60.8) 317 (22.8) 426 (30.6) 283/523 565/335 6 months DAPT 4 (0.3) 822 (59.5) 313 (22.7) 421 (30.5) 294/489 540/348 1-vessel 2-vessel 3-vessel Number of NOBORI stent per patient Stent diameter (mean ± SD) Minimum stent diameter <3mm ≥3mm Total stent length (mean ± SD) 1189 (85.5) 179 (12.9) 23 (1.7) 1.5±0.8 3.0±0.4 491 (35.3) 897 (64.5) 20.3±5.0 1215 (88.0) 143 (10.4) 23 (1.7) 1.4±0.8 3.0±0.4 498 (36.0) 882 (63.9) 20.1±5.1

18 months DAPT n=1371 1.45 % 6 months DAPT n=1355 1.92 % Difference

• 0.46

Lower limit of 95% CI -1.48 Newcombe score method

Favor 6 months Pre-specified non inferiority margin=-2.0

Primary endpoint (NACCE)

Favor 18 months DAPT

Primary Non-Inferiority Endpoint Met

1.0

• 1
• 2
• 3
• 4

6 months of DAPT was statistically non-inferior to 18 months of DAPT in terms of net adverse clinical and cerebrovascular events, including all cause death, Q-wave or non-Q wave MI, cerebrovascular events, and major bleeding.

Conclusion

events, and major bleeding. However, the results need to be interpreted with caution given premature termination of enrollment, an open-label design with frequent crossover and a wide non-inferiority margin.

• This was not a double-blind trial, as a result, adherence of drug was

problematic in the present study.

• This trial was not adequately powered due to lower event rate than

anticipated and wide non-inferiority margin.

• Premature termination of the present study concomitant with the

enrollment of relatively low risk subject suggest that the generalization

• f our results to high-risk patients requires caution.

Study limitation

• Antiplatelet therapy was mainly limited to clopidogrel in our study, so

use of more potent antiplatelet agents may have led to different conclusions.

• The follow-up period may not have been long enough to draw

conclusions about the optimum of duration of DAPT for patients with DES, because the DAPT trial demonstrated the benefit of prolonged DAPT for 30 months