Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction

Stefan James; Sasha Koul; Jonas Andersson; Oskar Angerås; Pallonji Bhiladvala; Fredrik Calais; Mikael Danielewicz; Ole Fröbert; Per Grimfjärd; Matthias Götberg; Loghman Henareh; Dan Ioanes; Jens Jensen; Rikard Linder; Pontus Lindroos; Elmir Omerovic; Georgios Panayi; Truls Råmunddal; Giovanna Sarno; Anders Ulvenstam; Sebastian Völtz; Henrik Wagner; Helena Wikström; Ollie Östlund; David Erlinge

doi:10.1161/CIRCINTERVENTIONS.120.008969

Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction

Stefan James^*, Sasha Koul, Jonas Andersson, Oskar Angerås, Pallonji Bhiladvala, Fredrik Calais, Mikael Danielewicz, Ole Fröbert, Per Grimfjärd, Matthias Götberg, Loghman Henareh, Dan Ioanes, Jens Jensen, Rikard Linder, Pontus Lindroos, Elmir Omerovic, Georgios Panayi, Truls Råmunddal, Giovanna Sarno, Anders UlvenstamSebastian Völtz, Henrik Wagner, Helena Wikström, Ollie Östlund, David Erlinge

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

13 Citationer (Scopus)

Abstract

Background: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y₁₂-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). Methods: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. Results: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y₁₂-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). Conclusions: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y₁₂-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.

Originalsprog	Engelsk
Tidsskrift	Circulation. Cardiovascular Interventions
Vol/bind	14
Nummer	12
Sider (fra-til)	E008969
ISSN	1941-7640
DOI	https://doi.org/10.1161/CIRCINTERVENTIONS.120.008969
Status	Udgivet - 1 dec. 2021
Udgivet eksternt	Ja

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10.1161/CIRCINTERVENTIONS.120.008969

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James, S., Koul, S., Andersson, J., Angerås, O., Bhiladvala, P., Calais, F., Danielewicz, M., Fröbert, O., Grimfjärd, P., Götberg, M., Henareh, L., Ioanes, D., Jensen, J., Linder, R., Lindroos, P., Omerovic, E., Panayi, G., Råmunddal, T., Sarno, G., ... Erlinge, D. (2021). Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction. Circulation. Cardiovascular Interventions, 14(12), E008969. https://doi.org/10.1161/CIRCINTERVENTIONS.120.008969

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title = "Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction",

abstract = "Background: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). Methods: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. Results: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). Conclusions: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.",

keywords = "bivalirudin, heparin, myocardial infarction, stent, thrombosis",

author = "Stefan James and Sasha Koul and Jonas Andersson and Oskar Anger{\aa}s and Pallonji Bhiladvala and Fredrik Calais and Mikael Danielewicz and Ole Fr{\"o}bert and Per Grimfj{\"a}rd and Matthias G{\"o}tberg and Loghman Henareh and Dan Ioanes and Jens Jensen and Rikard Linder and Pontus Lindroos and Elmir Omerovic and Georgios Panayi and Truls R{\aa}munddal and Giovanna Sarno and Anders Ulvenstam and Sebastian V{\"o}ltz and Henrik Wagner and Helena Wikstr{\"o}m and Ollie {\"O}stlund and David Erlinge",

year = "2021",

month = dec,

day = "1",

doi = "10.1161/CIRCINTERVENTIONS.120.008969",

language = "English",

volume = "14",

pages = "E008969",

journal = "Circulation. Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins Ltd.",

number = "12",

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James, S, Koul, S, Andersson, J, Angerås, O, Bhiladvala, P, Calais, F, Danielewicz, M, Fröbert, O, Grimfjärd, P, Götberg, M, Henareh, L, Ioanes, D, Jensen, J, Linder, R, Lindroos, P, Omerovic, E, Panayi, G, Råmunddal, T, Sarno, G, Ulvenstam, A, Völtz, S, Wagner, H, Wikström, H, Östlund, O & Erlinge, D 2021, 'Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction', Circulation. Cardiovascular Interventions, bind 14, nr. 12, s. E008969. https://doi.org/10.1161/CIRCINTERVENTIONS.120.008969

TY - JOUR

T1 - Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction

AU - James, Stefan

AU - Koul, Sasha

AU - Andersson, Jonas

AU - Angerås, Oskar

AU - Bhiladvala, Pallonji

AU - Calais, Fredrik

AU - Danielewicz, Mikael

AU - Fröbert, Ole

AU - Grimfjärd, Per

AU - Götberg, Matthias

AU - Henareh, Loghman

AU - Ioanes, Dan

AU - Jensen, Jens

AU - Linder, Rikard

AU - Lindroos, Pontus

AU - Omerovic, Elmir

AU - Panayi, Georgios

AU - Råmunddal, Truls

AU - Sarno, Giovanna

AU - Ulvenstam, Anders

AU - Völtz, Sebastian

AU - Wagner, Henrik

AU - Wikström, Helena

AU - Östlund, Ollie

AU - Erlinge, David

PY - 2021/12/1

Y1 - 2021/12/1

N2 - Background: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). Methods: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. Results: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). Conclusions: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.

AB - Background: Bivalirudin was not superior to unfractionated heparin in patients with myocardial infarction (MI) treated with percutaneous coronary intervention and no planned use of GPI (glycoprotein IIb/IIIa inhibitors) in contemporary clinical practice of radial access and potent P2Y12-inhibitors in the VALIDATE-SWEDEHEART randomized clinical trial (Bivalirudin Versus Heparin in STEMI and NSTEMI Patients on Modern Antiplatelet Therapy-Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies Registry). Methods: In this prespecified separately powered subgroup analysis, we included patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with the primary composite end point of all-cause death, MI, or major bleeding event within 180 days. Results: Among the 6006 patients enrolled in the trial, 3005 patients with ST-segment-elevation MI were randomized to receive bivalirudin or heparin. The mean age was 66.8 years. According to protocol recommendations, 87% were treated with potent oral P2Y12-inhibitors before start of angiography and radial access was used in 90%. GPI was used in 51 (3.4%) and 74 (4.9%) of patients randomized to receive bivalirudin and heparin, respectively. The primary end point occurred in 12.5% (187 of 1501) and 13.0% (196 of 1504; hazard ratio [HR], 0.95 [95% CI, 0.78-1.17], P=0.64) with consistent results in all major subgroups. All-cause death occurred in 3.9% versus 3.9% (HR, 1.00 [0.70-1.45], P=0.98), MI in 1.7% versus 2.2% (HR, 0.76 [0.45-1.28], P=0.30), major bleeding in 8.3% versus 8.0% (HR, 1.04 [0.81-1.33], P=0.78), and definite stent thrombosis in 0.5% versus 1.3% (HR, 0.42 [0.18-0.96], P=0.04). Conclusions: In patients with ST-segment-elevation MI undergoing primary percutaneous coronary intervention with radial access and receiving current recommended treatments with potent P2Y12-inhibitors rate of the composite of all-cause death, MI, or major bleeding was not lower in those randomized to receive bivalirudin as compared with heparin. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02311231.

KW - bivalirudin

KW - heparin

KW - myocardial infarction

KW - stent

KW - thrombosis

UR - http://www.scopus.com/inward/record.url?scp=85122903628&partnerID=8YFLogxK

U2 - 10.1161/CIRCINTERVENTIONS.120.008969

DO - 10.1161/CIRCINTERVENTIONS.120.008969

M3 - Journal article

C2 - 34903034

AN - SCOPUS:85122903628

SN - 1941-7640

VL - 14

SP - E008969

JO - Circulation. Cardiovascular Interventions

JF - Circulation. Cardiovascular Interventions

IS - 12

ER -

Bivalirudin Versus Heparin Monotherapy in ST-Segment-Elevation Myocardial Infarction

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