Nobori Dual Antiplatelet Therapy as Appropriate Duration - NIPPON

Contribution To Literature:

The NIPPON trial showed that short-term dual antiplatelet therapy was not inferior to long-term therapy.

Description:

The goal of the trial was to evaluate short-term compared with long-term dual antiplatelet therapy among patients treated with a biodegradable polymer drug-eluting stent.

Study Design

  • Randomized
  • Parallel

Patients undergoing percutaneous coronary intervention were randomized to short-term dual antiplatelet therapy (6 months; n = 1,886) versus long-term dual antiplatelet therapy (18 months; n = 1,887).

  • Total number of enrollees: 3,773
  • Duration of follow-up: 6-18 months
  • Mean patient age: 67 years
  • Percentage female: 21%
  • Percentage with diabetes: 38%

Inclusion criteria:

  • Age >20 years and <80 years
  • Patients with stable or acute coronary syndromes treated with a biodegradable polymer drug-eluting stent
  • No known contraindications to dual antiplatelet therapy

Exclusion criteria:

  • In-stent restenosis
  • Treatment of saphenous vein graft or left main lesion

Principal Findings:

The primary outcome, incidence of all-cause mortality, myocardial infarction, stroke, and major bleeding, occurred in 2.1% of the short-term dual antiplatelet therapy group versus 1.5% of the long-term dual antiplatelet therapy group (p = 0.24). The findings were the same in various tested subgroups.

Secondary outcomes:

  • Stent thrombosis: 0.1% vs. 0.1% (p = 0.99), respectively for short-term vs. long-term dual antiplatelet therapy
  • Major bleeding: 0.7% vs. 0.7% (p = 0.99), respectively for short-term vs. long-term dual antiplatelet therapy
  • From 6 months to 3 years, there was suggestion of enhanced benefit for long-term dual antiplatelet therapy among older patients with elevated SYNTAX score and among older patients with diabetes.

Interpretation:

Among patients undergoing treatment with a biodegradable polymer drug-eluting stent, short-term dual antiplatelet therapy (6 months) was noninferior to long-term therapy (18 months). The incidence of all-cause mortality, myocardial infarction, stroke, or major bleeding was similar between treatment groups. Stent thrombosis was infrequent and occurred at a similar frequency between treatment groups. There was suggestion of enhanced benefit for long-term dual antiplatelet therapy among those with increased risk.

References:

Presented by Dr. Masato Nakamura at the European Society of Cardiology Congress, Barcelona, Spain, August 28, 2017.

Nakamura M, Iijima R, Ako J, et al. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv 2017;10:1189-98.


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