Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy: An Individual Participant Data Analysis

Raffaele Piccolo, Fausto Feres, Alexandre Abizaid, Martine Gilard, Marie Claude Morice, Myeong Ki Hong, Hyo Soo Kim, Antonio Colombo, Deepak L. Bhatt, Tullio Palmerini, Gregg W. Stone, Stephan Windecker, Marco Valgimigli

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Abstract

Objectives The study sought to evaluate the presence of a clinically relevant rebound phenomenon after dual antiplatelet therapy (DAPT) discontinuation in randomized trials. Background It is currently unknown whether clopidogrel discontinuation after short-term DAPT is associated with an early hazard of ischemic events. Methods The authors performed an individual participant data analysis and aggregate meta-analysis. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction (MI), or stroke. Results The study included 11,473 PCI patients with individual participant data from 6 randomized trials comparing short-term DAPT (3 or 6 months) versus long-term DAPT (12 months or more). During the first 90 days following clopidogrel discontinuation, there was no significant increase in the risk of MACCE between patients randomized to short-term DAPT compared with long-term DAPT (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 0.71 to 1.98; p = 0.52; absolute risk difference 0.10%; 95% CI: −0.16% to 0.36%). The risk of MI or stent thrombosis was similar among patients randomized to short-term DAPT versus long-term DAPT (HR: 0.93; 95% CI: 0.46 to 1.90; p = 0.85). In the aggregate data meta-analysis of 11 trials including 38,919 patients, a higher risk of early MACCE was observed after long-term (≥12 months) DAPT duration (HR: 2.28; 95% CI: 1.69 to 3.09; p < 0.001) but not short-term (<12 months) DAPT duration (HR: 1.08; 95% CI: 0.67 to 1.74; p for interaction = 0.036). Conclusions Among patients undergoing PCI with predominantly new-generation DES, discontinuation of clopidogrel after 3 or 6 months DAPT duration was not associated with an early increase in adverse clinical events. An early increase in MACCE was observed after long-term (≥12 months) DAPT exposure.

Original languageEnglish
Pages (from-to)1621-1630
Number of pages10
JournalJACC: Cardiovascular Interventions
Volume10
Issue number16
DOIs
Publication statusPublished - 2017 Aug 28

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clopidogrel
Confidence Intervals
Therapeutics
Meta-Analysis
Myocardial Infarction
Implosive Therapy

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Piccolo, Raffaele ; Feres, Fausto ; Abizaid, Alexandre ; Gilard, Martine ; Morice, Marie Claude ; Hong, Myeong Ki ; Kim, Hyo Soo ; Colombo, Antonio ; Bhatt, Deepak L. ; Palmerini, Tullio ; Stone, Gregg W. ; Windecker, Stephan ; Valgimigli, Marco. / Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy : An Individual Participant Data Analysis. In: JACC: Cardiovascular Interventions. 2017 ; Vol. 10, No. 16. pp. 1621-1630.
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title = "Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy: An Individual Participant Data Analysis",
abstract = "Objectives The study sought to evaluate the presence of a clinically relevant rebound phenomenon after dual antiplatelet therapy (DAPT) discontinuation in randomized trials. Background It is currently unknown whether clopidogrel discontinuation after short-term DAPT is associated with an early hazard of ischemic events. Methods The authors performed an individual participant data analysis and aggregate meta-analysis. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction (MI), or stroke. Results The study included 11,473 PCI patients with individual participant data from 6 randomized trials comparing short-term DAPT (3 or 6 months) versus long-term DAPT (12 months or more). During the first 90 days following clopidogrel discontinuation, there was no significant increase in the risk of MACCE between patients randomized to short-term DAPT compared with long-term DAPT (hazard ratio [HR]: 1.18; 95{\%} confidence interval [CI]: 0.71 to 1.98; p = 0.52; absolute risk difference 0.10{\%}; 95{\%} CI: −0.16{\%} to 0.36{\%}). The risk of MI or stent thrombosis was similar among patients randomized to short-term DAPT versus long-term DAPT (HR: 0.93; 95{\%} CI: 0.46 to 1.90; p = 0.85). In the aggregate data meta-analysis of 11 trials including 38,919 patients, a higher risk of early MACCE was observed after long-term (≥12 months) DAPT duration (HR: 2.28; 95{\%} CI: 1.69 to 3.09; p < 0.001) but not short-term (<12 months) DAPT duration (HR: 1.08; 95{\%} CI: 0.67 to 1.74; p for interaction = 0.036). Conclusions Among patients undergoing PCI with predominantly new-generation DES, discontinuation of clopidogrel after 3 or 6 months DAPT duration was not associated with an early increase in adverse clinical events. An early increase in MACCE was observed after long-term (≥12 months) DAPT exposure.",
author = "Raffaele Piccolo and Fausto Feres and Alexandre Abizaid and Martine Gilard and Morice, {Marie Claude} and Hong, {Myeong Ki} and Kim, {Hyo Soo} and Antonio Colombo and Bhatt, {Deepak L.} and Tullio Palmerini and Stone, {Gregg W.} and Stephan Windecker and Marco Valgimigli",
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Piccolo, R, Feres, F, Abizaid, A, Gilard, M, Morice, MC, Hong, MK, Kim, HS, Colombo, A, Bhatt, DL, Palmerini, T, Stone, GW, Windecker, S & Valgimigli, M 2017, 'Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy: An Individual Participant Data Analysis', JACC: Cardiovascular Interventions, vol. 10, no. 16, pp. 1621-1630. https://doi.org/10.1016/j.jcin.2017.06.001

Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy : An Individual Participant Data Analysis. / Piccolo, Raffaele; Feres, Fausto; Abizaid, Alexandre; Gilard, Martine; Morice, Marie Claude; Hong, Myeong Ki; Kim, Hyo Soo; Colombo, Antonio; Bhatt, Deepak L.; Palmerini, Tullio; Stone, Gregg W.; Windecker, Stephan; Valgimigli, Marco.

In: JACC: Cardiovascular Interventions, Vol. 10, No. 16, 28.08.2017, p. 1621-1630.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Risk of Early Adverse Events After Clopidogrel Discontinuation in Patients Undergoing Short-Term Dual Antiplatelet Therapy

T2 - An Individual Participant Data Analysis

AU - Piccolo, Raffaele

AU - Feres, Fausto

AU - Abizaid, Alexandre

AU - Gilard, Martine

AU - Morice, Marie Claude

AU - Hong, Myeong Ki

AU - Kim, Hyo Soo

AU - Colombo, Antonio

AU - Bhatt, Deepak L.

AU - Palmerini, Tullio

AU - Stone, Gregg W.

AU - Windecker, Stephan

AU - Valgimigli, Marco

PY - 2017/8/28

Y1 - 2017/8/28

N2 - Objectives The study sought to evaluate the presence of a clinically relevant rebound phenomenon after dual antiplatelet therapy (DAPT) discontinuation in randomized trials. Background It is currently unknown whether clopidogrel discontinuation after short-term DAPT is associated with an early hazard of ischemic events. Methods The authors performed an individual participant data analysis and aggregate meta-analysis. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction (MI), or stroke. Results The study included 11,473 PCI patients with individual participant data from 6 randomized trials comparing short-term DAPT (3 or 6 months) versus long-term DAPT (12 months or more). During the first 90 days following clopidogrel discontinuation, there was no significant increase in the risk of MACCE between patients randomized to short-term DAPT compared with long-term DAPT (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 0.71 to 1.98; p = 0.52; absolute risk difference 0.10%; 95% CI: −0.16% to 0.36%). The risk of MI or stent thrombosis was similar among patients randomized to short-term DAPT versus long-term DAPT (HR: 0.93; 95% CI: 0.46 to 1.90; p = 0.85). In the aggregate data meta-analysis of 11 trials including 38,919 patients, a higher risk of early MACCE was observed after long-term (≥12 months) DAPT duration (HR: 2.28; 95% CI: 1.69 to 3.09; p < 0.001) but not short-term (<12 months) DAPT duration (HR: 1.08; 95% CI: 0.67 to 1.74; p for interaction = 0.036). Conclusions Among patients undergoing PCI with predominantly new-generation DES, discontinuation of clopidogrel after 3 or 6 months DAPT duration was not associated with an early increase in adverse clinical events. An early increase in MACCE was observed after long-term (≥12 months) DAPT exposure.

AB - Objectives The study sought to evaluate the presence of a clinically relevant rebound phenomenon after dual antiplatelet therapy (DAPT) discontinuation in randomized trials. Background It is currently unknown whether clopidogrel discontinuation after short-term DAPT is associated with an early hazard of ischemic events. Methods The authors performed an individual participant data analysis and aggregate meta-analysis. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of cardiac death, myocardial infarction (MI), or stroke. Results The study included 11,473 PCI patients with individual participant data from 6 randomized trials comparing short-term DAPT (3 or 6 months) versus long-term DAPT (12 months or more). During the first 90 days following clopidogrel discontinuation, there was no significant increase in the risk of MACCE between patients randomized to short-term DAPT compared with long-term DAPT (hazard ratio [HR]: 1.18; 95% confidence interval [CI]: 0.71 to 1.98; p = 0.52; absolute risk difference 0.10%; 95% CI: −0.16% to 0.36%). The risk of MI or stent thrombosis was similar among patients randomized to short-term DAPT versus long-term DAPT (HR: 0.93; 95% CI: 0.46 to 1.90; p = 0.85). In the aggregate data meta-analysis of 11 trials including 38,919 patients, a higher risk of early MACCE was observed after long-term (≥12 months) DAPT duration (HR: 2.28; 95% CI: 1.69 to 3.09; p < 0.001) but not short-term (<12 months) DAPT duration (HR: 1.08; 95% CI: 0.67 to 1.74; p for interaction = 0.036). Conclusions Among patients undergoing PCI with predominantly new-generation DES, discontinuation of clopidogrel after 3 or 6 months DAPT duration was not associated with an early increase in adverse clinical events. An early increase in MACCE was observed after long-term (≥12 months) DAPT exposure.

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