6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial

Hahn, Joo‐Yong; Song, Young Bin; Oh, Ju‐Hyeon; Cho, Deok-Kyu; Lee, Jin Bae; Doh, Joon‐Hyung; Kim, Sang-Hyun; Jeong, Jin‐Ok; Bae, Jang–Ho; Kim, Byung-Ok; Cho, Jang Hyun; Suh, Il-Woo; Kim, Doo-Il; Park, Hoon Ki; Park, Jong Seon; Choi, Woong; Lee, Wang Soo; Kim, Jihoon; Choi, Ki Hong; Park, Taek Kyu; Lee, Joo Myung; Yang, Jeong Hoon; Choi, Jin‐Ho; Choi, Seung–Hyuk; Gwon, Hyeon‐Cheol; Lee, Jong‐Young; Park, Hun Sik; Hwang, Jin‐Yong; Hur, Seung‐Ho; Rha, Seung Woon; Cho, Sang‐Cheol; Kang, Won You; Lim, Sung Mook; Kim, Moo Hyun; Soo, Kwang; Choi, Rak Kyung; Chae, In‐Ho; Jang, Woo Jin; Park, Yong Hawn; Chun, Woo Jung; Choi, Jae Woong; Jeong, Myung Ho; Kang, Seung Ho; Ahn, Kyung-Ju

doi:10.1016/s0140-6736(18)30493-8

Cited by 271 publications

(242 citation statements)

References 29 publications

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“…In a recent large‐scale randomized controlled trial that exclusively enrolled ACS patients, 6 months of DAPT were associated with an increased risk of MI in comparison to standard 12‐month duration of DAPT . In this study, landmark analysis at 6 months after the index PCI demonstrated a 5‐fold higher risk of MI (hazard ratio 5.06; 95% confidence interval 1.46‐17.5; P = 0.01) associated with short‐term DAPT . These recent findings along with our meta‐analysis results raise concerns about adopting a short‐term DAPT strategy in the ACS cohort.…”

Section: Discussionsupporting

confidence: 56%

“…However, these subgroup analyses were not adequately powered to detect differences for relatively rare events such as MI or ST. In a recent large‐scale randomized controlled trial that exclusively enrolled ACS patients, 6 months of DAPT were associated with an increased risk of MI in comparison to standard 12‐month duration of DAPT . In this study, landmark analysis at 6 months after the index PCI demonstrated a 5‐fold higher risk of MI (hazard ratio 5.06; 95% confidence interval 1.46‐17.5; P = 0.01) associated with short‐term DAPT .…”

Section: Discussionmentioning

confidence: 52%

“…The baseline characteristics of included studies are shown in Table . Among the 10 trials, 3 trials exclusively enrolled ACS patients . The other seven trials enrolled both stable angina and ACS patients with reported outcomes for the ACS subgroup .…”

Section: Resultsmentioning

confidence: 99%

“…Several studies reported comparable outcomes between short‐term vs long‐term DAPT in the ACS cohort . In contrast, a recent large‐scale randomized controlled trial that exclusively enrolled ACS patients showed that 6 months of DAPT was associated with an increased risk of MI in comparison to standard 12 month of DAPT . A recent comprehensive meta‐analysis in the ACS cohort was conducted prior to the publication of recent randomized controlled trials .…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Misumida

Abo-Aly

Kim

et al. 2018

Clinical Cardiology

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Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 52%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Misumida

Abo-Aly

Kim

et al. 2018

Clinical Cardiology

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“…The authors stated that the increased risk of MI with 6 month DAPT and the wide non-inferiority margin prevented them from concluding that short-term DAPT was safe in this setting, and suggested that prolonged DAPT should remain the standard of care in patients with ACS without excessive risk of bleeding. 715 In specific clinical scenarios, this standard DAPT duration can be shortened (<12 months) or extended (>12 months). Further on, switching and especially a de-escalation of DAPT (switching from potent P2Y 12 -inhibitors to clopidogrel) was subject to a number of randomized clinical trials.…”

Section: Peri-interventional Treatmentmentioning

confidence: 99%

2018 ESC/EACTS Guidelines on myocardial revascularization

Neumann¹,

Ahlsson²,

Alfonso³

et al. 2018

European Heart Journal

4,654

1,698

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

Hahn

Song

et al. 2019

JAMA

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452

378

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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,-ϱ% 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.

show abstract

6-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial

Cited by 271 publications

References 29 publications

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

Efficacy and safety of short‐term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta‐analysis of randomized controlled trials

2018 ESC/EACTS Guidelines on myocardial revascularization

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

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