Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention

The SMART-CHOICE Randomized Clinical Trial

Joo Yong Hahn, Young Bin Song, Ju Hyeon Oh, Woo Jung Chun, Yong Hawn Park, Woo Jin Jang, Eul Soon Im, Jin Ok Jeong, Byung Ryul Cho, Seok Kyu Oh, Kyeong Ho Yun, Deok Kyu Cho, Jong Young Lee, Young Youp Koh, Jang Whan Bae, Jae Woong Choi, Wang Soo Lee, Hyuck Jun Yoon, Seung Uk Lee, Jang Hyun Cho & 9 others Woong Gil Choi, Seung-Woon Rha, Joo Myung Lee, Taek Kyu Park, Jeong Hoon Yang, Jin Ho Choi, Seung Hyuck Choi, Sang Hoon Lee, Hyeon Cheol Gwon

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Importance: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. Objective: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. Design, Setting, and Participants: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. Interventions: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). Main Outcomes and Measures: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%. Results: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95% CI, -∞% to 1.3%]; P =.007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95% CI, 0.63-2.21; P =.61), myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95% CI, 0.31-1.40; P =.28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95% CI, 0.78-6.43; P =.14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P =.02). Conclusions and Relevance: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.

Original languageEnglish
Pages (from-to)2428-2437
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume321
Issue number24
DOIs
Publication statusPublished - 2019 Jun 25

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Percutaneous Coronary Intervention
Randomized Controlled Trials
Group Psychotherapy
Therapeutics
Hemorrhage
Cause of Death
Stroke
Myocardial Infarction
Drug-Eluting Stents
Korea
Research
Population
Aspirin
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Medicine(all)

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Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention : The SMART-CHOICE Randomized Clinical Trial. / Hahn, Joo Yong; Song, Young Bin; Oh, Ju Hyeon; Chun, Woo Jung; Park, Yong Hawn; Jang, Woo Jin; Im, Eul Soon; Jeong, Jin Ok; Cho, Byung Ryul; Oh, Seok Kyu; Yun, Kyeong Ho; Cho, Deok Kyu; Lee, Jong Young; Koh, Young Youp; Bae, Jang Whan; Choi, Jae Woong; Lee, Wang Soo; Yoon, Hyuck Jun; Lee, Seung Uk; Cho, Jang Hyun; Choi, Woong Gil; Rha, Seung-Woon; Lee, Joo Myung; Park, Taek Kyu; Yang, Jeong Hoon; Choi, Jin Ho; Choi, Seung Hyuck; Lee, Sang Hoon; Gwon, Hyeon Cheol.

In: JAMA - Journal of the American Medical Association, Vol. 321, No. 24, 25.06.2019, p. 2428-2437.

Research output: Contribution to journalArticle

Hahn, JY, Song, YB, Oh, JH, Chun, WJ, Park, YH, Jang, WJ, Im, ES, Jeong, JO, Cho, BR, Oh, SK, Yun, KH, Cho, DK, Lee, JY, Koh, YY, Bae, JW, Choi, JW, Lee, WS, Yoon, HJ, Lee, SU, Cho, JH, Choi, WG, Rha, S-W, Lee, JM, Park, TK, Yang, JH, Choi, JH, Choi, SH, Lee, SH & Gwon, HC 2019, 'Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial', JAMA - Journal of the American Medical Association, vol. 321, no. 24, pp. 2428-2437. https://doi.org/10.1001/jama.2019.8146
Hahn, Joo Yong ; Song, Young Bin ; Oh, Ju Hyeon ; Chun, Woo Jung ; Park, Yong Hawn ; Jang, Woo Jin ; Im, Eul Soon ; Jeong, Jin Ok ; Cho, Byung Ryul ; Oh, Seok Kyu ; Yun, Kyeong Ho ; Cho, Deok Kyu ; Lee, Jong Young ; Koh, Young Youp ; Bae, Jang Whan ; Choi, Jae Woong ; Lee, Wang Soo ; Yoon, Hyuck Jun ; Lee, Seung Uk ; Cho, Jang Hyun ; Choi, Woong Gil ; Rha, Seung-Woon ; Lee, Joo Myung ; Park, Taek Kyu ; Yang, Jeong Hoon ; Choi, Jin Ho ; Choi, Seung Hyuck ; Lee, Sang Hoon ; Gwon, Hyeon Cheol. / Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention : The SMART-CHOICE Randomized Clinical Trial. In: JAMA - Journal of the American Medical Association. 2019 ; Vol. 321, No. 24. pp. 2428-2437.
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abstract = "Importance: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. Objective: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. Design, Setting, and Participants: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. Interventions: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). Main Outcomes and Measures: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8{\%}. Results: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6{\%}]), 2912 (97.3{\%}) completed the trial. Adherence to the study protocol was 79.3{\%} of the P2Y12 inhibitor monotherapy group and 95.2{\%} of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9{\%} vs 2.5{\%}; difference, 0.4{\%} [1-sided 95{\%} CI, -∞{\%} to 1.3{\%}]; P =.007 for noninferiority). There were no significant differences in all-cause death (21 [1.4{\%}] vs 18 [1.2{\%}]; hazard ratio [HR], 1.18; 95{\%} CI, 0.63-2.21; P =.61), myocardial infarction (11 [0.8{\%}] vs 17 [1.2{\%}]; HR, 0.66; 95{\%} CI, 0.31-1.40; P =.28), or stroke (11 [0.8{\%}] vs 5 [0.3{\%}]; HR, 2.23; 95{\%} CI, 0.78-6.43; P =.14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0{\%} vs 3.4{\%}; HR, 0.58; 95{\%} CI, 0.36-0.92; P =.02). Conclusions and Relevance: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.",
author = "Hahn, {Joo Yong} and Song, {Young Bin} and Oh, {Ju Hyeon} and Chun, {Woo Jung} and Park, {Yong Hawn} and Jang, {Woo Jin} and Im, {Eul Soon} and Jeong, {Jin Ok} and Cho, {Byung Ryul} and Oh, {Seok Kyu} and Yun, {Kyeong Ho} and Cho, {Deok Kyu} and Lee, {Jong Young} and Koh, {Young Youp} and Bae, {Jang Whan} and Choi, {Jae Woong} and Lee, {Wang Soo} and Yoon, {Hyuck Jun} and Lee, {Seung Uk} and Cho, {Jang Hyun} and Choi, {Woong Gil} and Seung-Woon Rha and Lee, {Joo Myung} and Park, {Taek Kyu} and Yang, {Jeong Hoon} and Choi, {Jin Ho} and Choi, {Seung Hyuck} and Lee, {Sang Hoon} and Gwon, {Hyeon Cheol}",
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TY - JOUR

T1 - Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention

T2 - The SMART-CHOICE Randomized Clinical Trial

AU - Hahn, Joo Yong

AU - Song, Young Bin

AU - Oh, Ju Hyeon

AU - Chun, Woo Jung

AU - Park, Yong Hawn

AU - Jang, Woo Jin

AU - Im, Eul Soon

AU - Jeong, Jin Ok

AU - Cho, Byung Ryul

AU - Oh, Seok Kyu

AU - Yun, Kyeong Ho

AU - Cho, Deok Kyu

AU - Lee, Jong Young

AU - Koh, Young Youp

AU - Bae, Jang Whan

AU - Choi, Jae Woong

AU - Lee, Wang Soo

AU - Yoon, Hyuck Jun

AU - Lee, Seung Uk

AU - Cho, Jang Hyun

AU - Choi, Woong Gil

AU - Rha, Seung-Woon

AU - Lee, Joo Myung

AU - Park, Taek Kyu

AU - Yang, Jeong Hoon

AU - Choi, Jin Ho

AU - Choi, Seung Hyuck

AU - Lee, Sang Hoon

AU - Gwon, Hyeon Cheol

PY - 2019/6/25

Y1 - 2019/6/25

N2 - Importance: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. Objective: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. Design, Setting, and Participants: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. Interventions: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). Main Outcomes and Measures: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%. Results: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95% CI, -∞% to 1.3%]; P =.007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95% CI, 0.63-2.21; P =.61), myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95% CI, 0.31-1.40; P =.28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95% CI, 0.78-6.43; P =.14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P =.02). Conclusions and Relevance: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.

AB - Importance: Data on P2Y12 inhibitor monotherapy after short-duration dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention are limited. Objective: To determine whether P2Y12 inhibitor monotherapy after 3 months of DAPT is noninferior to 12 months of DAPT in patients undergoing PCI. Design, Setting, and Participants: The SMART-CHOICE trial was an open-label, noninferiority, randomized study that was conducted in 33 hospitals in Korea and included 2993 patients undergoing PCI with drug-eluting stents. Enrollment began March 18, 2014, and follow-up was completed July 19, 2018. Interventions: Patients were randomly assigned to receive aspirin plus a P2Y12 inhibitor for 3 months and thereafter P2Y12 inhibitor alone (n = 1495) or DAPT for 12 months (n = 1498). Main Outcomes and Measures: The primary end point was major adverse cardiac and cerebrovascular events (a composite of all-cause death, myocardial infarction, or stroke) at 12 months after the index procedure. Secondary end points included the components of the primary end point and bleeding defined as Bleeding Academic Research Consortium type 2 to 5. The noninferiority margin was 1.8%. Results: Among 2993 patients who were randomized (mean age, 64 years; 795 women [26.6%]), 2912 (97.3%) completed the trial. Adherence to the study protocol was 79.3% of the P2Y12 inhibitor monotherapy group and 95.2% of the DAPT group. At 12 months, major adverse cardiac and cerebrovascular events occurred in 42 patients in the P2Y12 inhibitor monotherapy group and in 36 patients in the DAPT group (2.9% vs 2.5%; difference, 0.4% [1-sided 95% CI, -∞% to 1.3%]; P =.007 for noninferiority). There were no significant differences in all-cause death (21 [1.4%] vs 18 [1.2%]; hazard ratio [HR], 1.18; 95% CI, 0.63-2.21; P =.61), myocardial infarction (11 [0.8%] vs 17 [1.2%]; HR, 0.66; 95% CI, 0.31-1.40; P =.28), or stroke (11 [0.8%] vs 5 [0.3%]; HR, 2.23; 95% CI, 0.78-6.43; P =.14) between the 2 groups. The rate of bleeding was significantly lower in the P2Y12 inhibitor monotherapy group than in the DAPT group (2.0% vs 3.4%; HR, 0.58; 95% CI, 0.36-0.92; P =.02). Conclusions and Relevance: Among patients undergoing percutaneous coronary intervention, P2Y12 inhibitor monotherapy after 3 months of DAPT compared with prolonged DAPT resulted in noninferior rates of major adverse cardiac and cerebrovascular events. Because of limitations in the study population and adherence, further research is needed in other populations. Trial Registration: ClinicalTrials.gov Identifier: NCT02079194.

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