Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

Gennaro Giustino; Alaide Chieffo; Tullio Palmerini; Marco Valgimigli; Fausto Feres; Alexandre Abizaid; Ricardo A. Costa; Myeong Ki Hong; Byeong Keuk Kim; Yangsoo Jang; Hyo Soo Kim; Kyung Woo Park; Martine Gilard; Marie Claude Morice; Fadi Sawaya; Gennaro Sardella; Philippe Genereux; Bjorn Redfors; Martin B. Leon; Deepak L. Bhatt; Gregg W. Stone; Antonio Colombo

doi:10.1016/j.jacc.2016.07.760

Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

Gennaro Giustino, Alaide Chieffo, Tullio Palmerini, Marco Valgimigli, Fausto Feres, Alexandre Abizaid, Ricardo A. Costa, Myeong Ki Hong, Byeong Keuk Kim, Yangsoo Jang, Hyo Soo Kim, Kyung Woo Park, Martine Gilard, Marie Claude Morice, Fadi Sawaya, Gennaro Sardella, Philippe Genereux, Bjorn Redfors, Martin B. Leon, Deepak L. BhattGregg W. Stone, Antonio Colombo

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

265 Citations (Scopus)

Abstract

Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p_interaction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p_interaction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

Original language	English
Pages (from-to)	1851-1864
Number of pages	14
Journal	Journal of the American College of Cardiology
Volume	68
Issue number	17
DOIs	https://doi.org/10.1016/j.jacc.2016.07.760
Publication status	Published - 2016 Oct 25

Bibliographical note

Funding Information:
Medtronic provided the data for the OPTIMIZE trial. No sponsor of any of the individual trials had any role in the study design, data interpretation, or drafting of the manuscript. Dr. Palmerini has received a speaker fee from Abbott Vascular; and a research grant from Eli Lilly. Dr. Valgimigli has received speaker or consultant fees from Abbott Vascular, AstraZeneca, Alvimedica, Medtronic, Terumo, and The Medicines Company. Dr. Feres has received speaker fees from Biosensors and Eli Lilly; and has been a consultant for Medtronic and Scitech. Dr. Bhatt has served on the advisory board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has served on the board of directors of the Boston VA Research Institute and Society of Cardiovascular Patient Care; is chair of the American Heart Association Quality Oversight Committee; has served on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and the Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org ), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (continuing medical education steering committees); is Deputy Editor of Clinical Cardiology; is vice chair of the NCDR-ACTION Registry Steering Committee and VA CART Research and Publications Committee; has received research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has served as site coinvestigator for Biotronik, Boston Scientific, and St. Jude Medical; is a trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, PLx Pharma, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2016 American College of Cardiology Foundation

All Science Journal Classification (ASJC) codes

Cardiology and Cardiovascular Medicine

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10.1016/j.jacc.2016.07.760

Cite this

Giustino, G., Chieffo, A., Palmerini, T., Valgimigli, M., Feres, F., Abizaid, A., Costa, R. A., Hong, M. K., Kim, B. K., Jang, Y., Kim, H. S., Park, K. W., Gilard, M., Morice, M. C., Sawaya, F., Sardella, G., Genereux, P., Redfors, B., Leon, M. B., ... Colombo, A. (2016). Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI. Journal of the American College of Cardiology, 68(17), 1851-1864. https://doi.org/10.1016/j.jacc.2016.07.760

@article{013c470e1bd44aaea19733bb10da88f6,

title = "Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI",

abstract = "Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.",

author = "Gennaro Giustino and Alaide Chieffo and Tullio Palmerini and Marco Valgimigli and Fausto Feres and Alexandre Abizaid and Costa, {Ricardo A.} and Hong, {Myeong Ki} and Kim, {Byeong Keuk} and Yangsoo Jang and Kim, {Hyo Soo} and Park, {Kyung Woo} and Martine Gilard and Morice, {Marie Claude} and Fadi Sawaya and Gennaro Sardella and Philippe Genereux and Bjorn Redfors and Leon, {Martin B.} and Bhatt, {Deepak L.} and Stone, {Gregg W.} and Antonio Colombo",

note = "Funding Information: Medtronic provided the data for the OPTIMIZE trial. No sponsor of any of the individual trials had any role in the study design, data interpretation, or drafting of the manuscript. Dr. Palmerini has received a speaker fee from Abbott Vascular; and a research grant from Eli Lilly. Dr. Valgimigli has received speaker or consultant fees from Abbott Vascular, AstraZeneca, Alvimedica, Medtronic, Terumo, and The Medicines Company. Dr. Feres has received speaker fees from Biosensors and Eli Lilly; and has been a consultant for Medtronic and Scitech. Dr. Bhatt has served on the advisory board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has served on the board of directors of the Boston VA Research Institute and Society of Cardiovascular Patient Care; is chair of the American Heart Association Quality Oversight Committee; has served on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and the Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org ), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today{\textquoteright}s Intervention), the Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (continuing medical education steering committees); is Deputy Editor of Clinical Cardiology; is vice chair of the NCDR-ACTION Registry Steering Committee and VA CART Research and Publications Committee; has received research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald{\textquoteright}s Heart Disease); has served as site coinvestigator for Biotronik, Boston Scientific, and St. Jude Medical; is a trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, PLx Pharma, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2016 American College of Cardiology Foundation",

year = "2016",

month = oct,

day = "25",

doi = "10.1016/j.jacc.2016.07.760",

language = "English",

volume = "68",

pages = "1851--1864",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

number = "17",

}

Giustino, G, Chieffo, A, Palmerini, T, Valgimigli, M, Feres, F, Abizaid, A, Costa, RA, Hong, MK, Kim, BK, Jang, Y, Kim, HS, Park, KW, Gilard, M, Morice, MC, Sawaya, F, Sardella, G, Genereux, P, Redfors, B, Leon, MB, Bhatt, DL, Stone, GW & Colombo, A 2016, 'Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI', Journal of the American College of Cardiology, vol. 68, no. 17, pp. 1851-1864. https://doi.org/10.1016/j.jacc.2016.07.760

TY - JOUR

T1 - Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

AU - Giustino, Gennaro

AU - Chieffo, Alaide

AU - Palmerini, Tullio

AU - Valgimigli, Marco

AU - Feres, Fausto

AU - Abizaid, Alexandre

AU - Costa, Ricardo A.

AU - Hong, Myeong Ki

AU - Kim, Byeong Keuk

AU - Jang, Yangsoo

AU - Kim, Hyo Soo

AU - Park, Kyung Woo

AU - Gilard, Martine

AU - Morice, Marie Claude

AU - Sawaya, Fadi

AU - Sardella, Gennaro

AU - Genereux, Philippe

AU - Redfors, Bjorn

AU - Leon, Martin B.

AU - Bhatt, Deepak L.

AU - Stone, Gregg W.

AU - Colombo, Antonio

N1 - Funding Information: Medtronic provided the data for the OPTIMIZE trial. No sponsor of any of the individual trials had any role in the study design, data interpretation, or drafting of the manuscript. Dr. Palmerini has received a speaker fee from Abbott Vascular; and a research grant from Eli Lilly. Dr. Valgimigli has received speaker or consultant fees from Abbott Vascular, AstraZeneca, Alvimedica, Medtronic, Terumo, and The Medicines Company. Dr. Feres has received speaker fees from Biosensors and Eli Lilly; and has been a consultant for Medtronic and Scitech. Dr. Bhatt has served on the advisory board of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has served on the board of directors of the Boston VA Research Institute and Society of Cardiovascular Patient Care; is chair of the American Heart Association Quality Oversight Committee; has served on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and the Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org ), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (guest editor; associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), the Society of Cardiovascular Patient Care (secretary/treasurer), and WebMD (continuing medical education steering committees); is Deputy Editor of Clinical Cardiology; is vice chair of the NCDR-ACTION Registry Steering Committee and VA CART Research and Publications Committee; has received research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); has served as site coinvestigator for Biotronik, Boston Scientific, and St. Jude Medical; is a trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, PLx Pharma, and Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2016 American College of Cardiology Foundation

PY - 2016/10/25

Y1 - 2016/10/25

N2 - Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

AB - Background Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. Objectives This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. Methods The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Results Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; pinteraction = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (pinteraction = 0.96). Results were consistent by per-treatment landmark analysis. Conclusions Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT.

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Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI

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