Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI trials

Gennaro Giustino, Roxana Mehran, Sameer Bansilal, Frederick Feit, Michael Lincoff, Efthymios N. Deliargyris, Ajay J. Kirtane, Philippe Généreux, Bjorn Redfors, Jayne Prats, Debra Bernstein, Sorin J. Brener, Simona Skerjanec, Alexandra J. Lansky, Dominic P. Francese, George D. Dangas, Gregg W. Stone

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.

Original languageEnglish (US)
Pages (from-to)6-16
Number of pages11
JournalAmerican Journal of Cardiology
Volume118
Issue number1
DOIs
StatePublished - Jul 1 2016
Externally publishedYes

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Percutaneous Coronary Intervention
Diabetes Mellitus
Safety
Hemorrhage
Heparin
Mortality
Myocardial Infarction
bivalirudin
Platelet Glycoprotein GPIIb-IIIa Complex
Triage
Incidence
Catheterization
Stents
Arteries
Databases
Transplants
Drug Therapy
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Giustino, Gennaro ; Mehran, Roxana ; Bansilal, Sameer ; Feit, Frederick ; Lincoff, Michael ; Deliargyris, Efthymios N. ; Kirtane, Ajay J. ; Généreux, Philippe ; Redfors, Bjorn ; Prats, Jayne ; Bernstein, Debra ; Brener, Sorin J. ; Skerjanec, Simona ; Lansky, Alexandra J. ; Francese, Dominic P. ; Dangas, George D. ; Stone, Gregg W. / Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention : From the REPLACE-2, ACUITY and HORIZONS-AMI trials. In: American Journal of Cardiology. 2016 ; Vol. 118, No. 1. pp. 6-16.
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title = "Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI trials",
abstract = "Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7{\%}) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9{\%} vs 7.8{\%}; relative risk [RR] 0.89, 95{\%} CI 0.71 to 1.12) or without DM (7.5{\%} vs 6.7{\%}; RR 1.11, 95{\%} CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3{\%} vs 6.6{\%} RR 0.68, 95{\%} CI 0.51 to 0.89) or without DM (3.2{\%} vs 6.1{\%}; RR 0.51, 95{\%} CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7{\%} vs 3.3{\%}; RR 0.82, 95{\%} CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.",
author = "Gennaro Giustino and Roxana Mehran and Sameer Bansilal and Frederick Feit and Michael Lincoff and Deliargyris, {Efthymios N.} and Kirtane, {Ajay J.} and Philippe G{\'e}n{\'e}reux and Bjorn Redfors and Jayne Prats and Debra Bernstein and Brener, {Sorin J.} and Simona Skerjanec and Lansky, {Alexandra J.} and Francese, {Dominic P.} and Dangas, {George D.} and Stone, {Gregg W.}",
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Giustino, G, Mehran, R, Bansilal, S, Feit, F, Lincoff, M, Deliargyris, EN, Kirtane, AJ, Généreux, P, Redfors, B, Prats, J, Bernstein, D, Brener, SJ, Skerjanec, S, Lansky, AJ, Francese, DP, Dangas, GD & Stone, GW 2016, 'Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention: From the REPLACE-2, ACUITY and HORIZONS-AMI trials', American Journal of Cardiology, vol. 118, no. 1, pp. 6-16. https://doi.org/10.1016/j.amjcard.2016.04.005

Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention : From the REPLACE-2, ACUITY and HORIZONS-AMI trials. / Giustino, Gennaro; Mehran, Roxana; Bansilal, Sameer; Feit, Frederick; Lincoff, Michael; Deliargyris, Efthymios N.; Kirtane, Ajay J.; Généreux, Philippe; Redfors, Bjorn; Prats, Jayne; Bernstein, Debra; Brener, Sorin J.; Skerjanec, Simona; Lansky, Alexandra J.; Francese, Dominic P.; Dangas, George D.; Stone, Gregg W.

In: American Journal of Cardiology, Vol. 118, No. 1, 01.07.2016, p. 6-16.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and efficacy of bivalirudin in patients with diabetes mellitus undergoing percutaneous coronary intervention

T2 - From the REPLACE-2, ACUITY and HORIZONS-AMI trials

AU - Giustino, Gennaro

AU - Mehran, Roxana

AU - Bansilal, Sameer

AU - Feit, Frederick

AU - Lincoff, Michael

AU - Deliargyris, Efthymios N.

AU - Kirtane, Ajay J.

AU - Généreux, Philippe

AU - Redfors, Bjorn

AU - Prats, Jayne

AU - Bernstein, Debra

AU - Brener, Sorin J.

AU - Skerjanec, Simona

AU - Lansky, Alexandra J.

AU - Francese, Dominic P.

AU - Dangas, George D.

AU - Stone, Gregg W.

PY - 2016/7/1

Y1 - 2016/7/1

N2 - Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.

AB - Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.

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