Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs

Jeehoon Kang, Kyung Woo Park, Tullio Palmerini, Gregg W. Stone, Michael S. Lee, Antonio Colombo, Alaide Chieffo, Fausto Feres, Alexandre Abizaid, Deepak L. Bhatt, Marco Valgimigli, Myeong Ki Hong, Yangsoo Jang, Martine Gilard, Marie Claude Morice, Duk Woo Park, Seung Jung Park, Young Hoon Jeong, Jiesuck Park, Bon Kwon KooHyo Soo Kim

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background ?Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods ?We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results ?Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001). Conclusion ?We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.

Original languageEnglish
Pages (from-to)149-162
Number of pages14
JournalThrombosis and Haemostasis
Volume119
Issue number1
DOIs
Publication statusPublished - 2019 Jan 1

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Meta-Analysis
Blood Platelets
Ischemia
Randomized Controlled Trials
Hemorrhage
Therapeutics
Percutaneous Coronary Intervention
Confidence Intervals
Group Psychotherapy
Proportional Hazards Models
Odds Ratio

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Kang, Jeehoon ; Park, Kyung Woo ; Palmerini, Tullio ; Stone, Gregg W. ; Lee, Michael S. ; Colombo, Antonio ; Chieffo, Alaide ; Feres, Fausto ; Abizaid, Alexandre ; Bhatt, Deepak L. ; Valgimigli, Marco ; Hong, Myeong Ki ; Jang, Yangsoo ; Gilard, Martine ; Morice, Marie Claude ; Park, Duk Woo ; Park, Seung Jung ; Jeong, Young Hoon ; Park, Jiesuck ; Koo, Bon Kwon ; Kim, Hyo Soo. / Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy : Individual Patient Level Landmark Meta-Analysis from Seven RCTs. In: Thrombosis and Haemostasis. 2019 ; Vol. 119, No. 1. pp. 149-162.
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abstract = "Background ?Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods ?We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results ?Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8{\%} vs. 1.8{\%}, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6{\%} vs. 0.3{\%}, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95{\%} confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95{\%} CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3{\%} vs. 0.4{\%}, p < 0.001). Conclusion ?We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.",
author = "Jeehoon Kang and Park, {Kyung Woo} and Tullio Palmerini and Stone, {Gregg W.} and Lee, {Michael S.} and Antonio Colombo and Alaide Chieffo and Fausto Feres and Alexandre Abizaid and Bhatt, {Deepak L.} and Marco Valgimigli and Hong, {Myeong Ki} and Yangsoo Jang and Martine Gilard and Morice, {Marie Claude} and Park, {Duk Woo} and Park, {Seung Jung} and Jeong, {Young Hoon} and Jiesuck Park and Koo, {Bon Kwon} and Kim, {Hyo Soo}",
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language = "English",
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Kang, J, Park, KW, Palmerini, T, Stone, GW, Lee, MS, Colombo, A, Chieffo, A, Feres, F, Abizaid, A, Bhatt, DL, Valgimigli, M, Hong, MK, Jang, Y, Gilard, M, Morice, MC, Park, DW, Park, SJ, Jeong, YH, Park, J, Koo, BK & Kim, HS 2019, 'Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs', Thrombosis and Haemostasis, vol. 119, no. 1, pp. 149-162. https://doi.org/10.1055/s-0038-1676545

Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy : Individual Patient Level Landmark Meta-Analysis from Seven RCTs. / Kang, Jeehoon; Park, Kyung Woo; Palmerini, Tullio; Stone, Gregg W.; Lee, Michael S.; Colombo, Antonio; Chieffo, Alaide; Feres, Fausto; Abizaid, Alexandre; Bhatt, Deepak L.; Valgimigli, Marco; Hong, Myeong Ki; Jang, Yangsoo; Gilard, Martine; Morice, Marie Claude; Park, Duk Woo; Park, Seung Jung; Jeong, Young Hoon; Park, Jiesuck; Koo, Bon Kwon; Kim, Hyo Soo.

In: Thrombosis and Haemostasis, Vol. 119, No. 1, 01.01.2019, p. 149-162.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy

T2 - Individual Patient Level Landmark Meta-Analysis from Seven RCTs

AU - Kang, Jeehoon

AU - Park, Kyung Woo

AU - Palmerini, Tullio

AU - Stone, Gregg W.

AU - Lee, Michael S.

AU - Colombo, Antonio

AU - Chieffo, Alaide

AU - Feres, Fausto

AU - Abizaid, Alexandre

AU - Bhatt, Deepak L.

AU - Valgimigli, Marco

AU - Hong, Myeong Ki

AU - Jang, Yangsoo

AU - Gilard, Martine

AU - Morice, Marie Claude

AU - Park, Duk Woo

AU - Park, Seung Jung

AU - Jeong, Young Hoon

AU - Park, Jiesuck

AU - Koo, Bon Kwon

AU - Kim, Hyo Soo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background ?Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods ?We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results ?Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001). Conclusion ?We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.

AB - Background ?Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischaemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischaemia/bleeding risk trade-off. Methods ?We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischaemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). Results ?Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischaemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischaemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001). Conclusion ?We suggest that the ischaemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischaemic risk, while significantly increases the bleeding risk.

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