Shorter DAPT appears safe, effective long-term

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.

Photo by Sage Ross

BARCELONA—Three-year follow-up of the NIPPON study showed no significant difference in net clinical benefit with short-term or long-term dual antiplatelet therapy (DAPT).

Overall, there was no significant difference in safety or efficacy outcomes between patients who received 6 months of DAPT or 18 months of DAPT after placement of a drug-eluting stent (DES).

However, the data did suggest certain patients may benefit from long-term DAPT.

Details of this study were presented at ESC Congress 2017 (abstract 3831).

“These findings support and strengthen the evidence for short-term DAPT after DES deployment and may help confirm that clinical benefits of extended DAPT are reduced in patients with newer-generation DES,” said study investigator Masato Nakamura MD, PhD, of Toho University Ohashi Medical Center in Tokyo, Japan.

“The findings are important because shorter duration of therapy is less expensive and could theoretically reduce the risk of side effects.”

NIPPON enrolled 3775 patients with coronary artery disease or acute myocardial infarction who had undergone percutaneous coronary intervention and DES placement at 130 Japanese institutions.

All patients had received the Nobori bioabsorbable abluminal-coated stent. They then received DAPT—consisting of aspirin (81–162 mg/day) and clopidogrel (75 mg/day) or ticlopidine (200 mg/day)—for 6 months or 18 months.

Initial results from this trial were presented last year at ESC Congress.

The 3-year follow-up included 3307 patients—1887 who received long-term DAPT and 1886 who received short-term DAPT.

Dr Nakamura first reported the net adverse clinical and cerebrovascular events (NACCEs)—which included all-cause mortality, myocardial infarction, stroke, and major bleeding—in each arm.

Three years from the start of the study, the cumulative incidence of NACCE was 7.03% in the short-term DAPT arm and 4.85% in the long-term DAPT arm (hazard ratio [HR]=1.20, P=0.27).

In the landmark analysis, which only included data from 6 months to 3 years, the incidence of NACCE was 5.60% in the short-term DAPT arm and 3.48% in the long-term DAPT arm (HR=1.49, P=0.06).

The investigators also looked at efficacy and safety endpoints separately.

The efficacy endpoint included cardiovascular death, myocardial infarction, stroke, and definite or probable stent thrombosis. The safety endpoint included BARC 2, 3, or 5 bleeding.

In the landmark analysis, the incidence of the efficacy endpoint was 2.58% in the short-term DAPT arm and 1.70% in the long-term DAPT arm (HR=1.53, P=0.17). The incidence of the safety endpoint was 2.22% and 2.01%, respectively (HR=1.02, P=0.94).

Although there were no significant differences between the arms in the overall cohort, the investigators did identify patients with a high risk of ischemic events who might benefit from long-term DAPT.

In patients older than 70 who had a SYNTAX score above 23.3, the rate of efficacy events was 0% in those on long-term DAPT and 18.8% in those on short-term DAPT (HR=13.24, P=0.01).

In patients age 70 to 76 who had diabetes, the rate of efficacy events was 2.0% in those on long-term DAPT and 6.0% in those on short-term DAPT (HR=2.89, P=0.04)

“In real-world practice, it is not easy to find the balance between risks and benefits of DAPT duration, and consensus criteria for individualization therapy have not been established,” Dr Nakamura said.

“The present findings may provide some assistance, although it is essential to obtain confirmation by further investigation.”

This study was sponsored by the Association for Establishment of Evidence in Interventions. Dr Nakamura disclosed research expert witness payment from Terumo Corporation, grant support from Daiichi Sankyo and Sanofi, and honoraria from Terumo Corporation, Daiichi Sankyo, and Sanofi.