Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide

Jeffrey S. Mandak, James C. Blankenship, Laura H. Gardner, Scott D. Berkowitz, Frank V. Aguirre, Kristina N. Sigmon, Gerald C. Timmis, Ian C. Gilchrist, Michael McIvor, Jon Resar, Bonnie H. Weiner, Barry S. George, J. David Talley, A. Michael Lincoff, James E. Tcheng, Robert M. Califf, Eric J. Topol

Research output: Contribution to journalArticle

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Abstract

Objectives. This study was designed to identify potential predictors of vascular access site (VAS) complications in the largescale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). Background. GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. Methods. A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-μg/kg body weight eptifibatide bolus/0.5-μg/kg per min eptifibatide infusion; or 135-μg/kg eptifibatide bolus/0.75-μg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. Results. VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. Conclusions. VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.

Original languageEnglish (US)
Pages (from-to)1518-1524
Number of pages7
JournalJournal of the American College of Cardiology
Volume31
Issue number7
DOIs
StatePublished - Jun 1 1998

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Coronary Thrombosis
Platelet Aggregation
Angioplasty
Blood Vessels
Percutaneous Coronary Intervention
Heparin
Platelet Glycoprotein GPIIb-IIIa Complex
Placebos
Stents
eptifibatide
Thrombolytic Therapy
Dissection
Multivariate Analysis
Logistic Models
Body Weight
Weights and Measures

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Mandak, Jeffrey S. ; Blankenship, James C. ; Gardner, Laura H. ; Berkowitz, Scott D. ; Aguirre, Frank V. ; Sigmon, Kristina N. ; Timmis, Gerald C. ; Gilchrist, Ian C. ; McIvor, Michael ; Resar, Jon ; Weiner, Bonnie H. ; George, Barry S. ; Talley, J. David ; Lincoff, A. Michael ; Tcheng, James E. ; Califf, Robert M. ; Topol, Eric J. / Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide. In: Journal of the American College of Cardiology. 1998 ; Vol. 31, No. 7. pp. 1518-1524.
@article{b82a4915b6c944bbb852308307b9c3cd,
title = "Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide",
abstract = "Objectives. This study was designed to identify potential predictors of vascular access site (VAS) complications in the largescale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). Background. GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. Methods. A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-μg/kg body weight eptifibatide bolus/0.5-μg/kg per min eptifibatide infusion; or 135-μg/kg eptifibatide bolus/0.75-μg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. Results. VAS complications were more common in patients treated with eptifibatide (9.9{\%} vs. 5.9{\%} placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. Conclusions. VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.",
author = "Mandak, {Jeffrey S.} and Blankenship, {James C.} and Gardner, {Laura H.} and Berkowitz, {Scott D.} and Aguirre, {Frank V.} and Sigmon, {Kristina N.} and Timmis, {Gerald C.} and Gilchrist, {Ian C.} and Michael McIvor and Jon Resar and Weiner, {Bonnie H.} and George, {Barry S.} and Talley, {J. David} and Lincoff, {A. Michael} and Tcheng, {James E.} and Califf, {Robert M.} and Topol, {Eric J.}",
year = "1998",
month = "6",
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doi = "10.1016/S0735-1097(98)00130-2",
language = "English (US)",
volume = "31",
pages = "1518--1524",
journal = "Journal of the American College of Cardiology",
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Mandak, JS, Blankenship, JC, Gardner, LH, Berkowitz, SD, Aguirre, FV, Sigmon, KN, Timmis, GC, Gilchrist, IC, McIvor, M, Resar, J, Weiner, BH, George, BS, Talley, JD, Lincoff, AM, Tcheng, JE, Califf, RM & Topol, EJ 1998, 'Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide', Journal of the American College of Cardiology, vol. 31, no. 7, pp. 1518-1524. https://doi.org/10.1016/S0735-1097(98)00130-2

Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide. / Mandak, Jeffrey S.; Blankenship, James C.; Gardner, Laura H.; Berkowitz, Scott D.; Aguirre, Frank V.; Sigmon, Kristina N.; Timmis, Gerald C.; Gilchrist, Ian C.; McIvor, Michael; Resar, Jon; Weiner, Bonnie H.; George, Barry S.; Talley, J. David; Lincoff, A. Michael; Tcheng, James E.; Califf, Robert M.; Topol, Eric J.

In: Journal of the American College of Cardiology, Vol. 31, No. 7, 01.06.1998, p. 1518-1524.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Modifiable risk factors for vascular access site complications in the IMPACT II trial of angioplasty with versus without eptifibatide

AU - Mandak, Jeffrey S.

AU - Blankenship, James C.

AU - Gardner, Laura H.

AU - Berkowitz, Scott D.

AU - Aguirre, Frank V.

AU - Sigmon, Kristina N.

AU - Timmis, Gerald C.

AU - Gilchrist, Ian C.

AU - McIvor, Michael

AU - Resar, Jon

AU - Weiner, Bonnie H.

AU - George, Barry S.

AU - Talley, J. David

AU - Lincoff, A. Michael

AU - Tcheng, James E.

AU - Califf, Robert M.

AU - Topol, Eric J.

PY - 1998/6/1

Y1 - 1998/6/1

N2 - Objectives. This study was designed to identify potential predictors of vascular access site (VAS) complications in the largescale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). Background. GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. Methods. A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-μg/kg body weight eptifibatide bolus/0.5-μg/kg per min eptifibatide infusion; or 135-μg/kg eptifibatide bolus/0.75-μg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. Results. VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. Conclusions. VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.

AB - Objectives. This study was designed to identify potential predictors of vascular access site (VAS) complications in the largescale Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis (IMPACT) II trial, which studied angioplasty with versus without a new glycoprotein (GP) IIb/IIIa receptor inhibitor (eptifibatide). Background. GP IIb/IIIa receptor inhibition during coronary interventions has been associated with excess VAS complications. If other predictors of VAS complications could be identified, they might be manipulated to reduce complications. Methods. A total of 4,010 patients undergoing percutaneous transluminal coronary revascularization (PTCR) were randomized into one of three bolus/20- to 24-h infusion arms: placebo bolus/placebo infusion; 135-μg/kg body weight eptifibatide bolus/0.5-μg/kg per min eptifibatide infusion; or 135-μg/kg eptifibatide bolus/0.75-μg/kg per min eptifibatide infusion. Heparin during the procedure was weight adjusted and stopped 4 h before sheaths were removed. Logistic regression modeling was used to identify independent predictors of VAS complications. Results. VAS complications were more common in patients treated with eptifibatide (9.9% vs. 5.9% placebo-treated patients, p < 0.001). Multivariate analysis identified eptifibatide therapy (p < 0.0001), advanced age (p = 0.0001), longer time to sheath removal (p = 0.0002), stent placement (with intense post-stent anticoagulation) (p = 0.0004), female gender (p = 0.0006), PTCR within 24 h of thrombolytic therapy (p = 0.002), larger heparin doses during PTCR (p = 0.009), major coronary dissection (p = 0.03) and placement of a venous sheath (p = 0.04) as independent predictors of VAS complications. Conclusions. VAS complications may be reduced by early sheath removal, by avoiding placement of venous sheaths and by limiting heparin dosing to avoid excessive activated clotting times. Early sheath removal during inhibition of platelet aggregation by eptifibatide is feasible.

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