Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI

Results from the HORIZONS-AMI trial

Timothy A. Sanborn, Matthew I. Tomey, Roxana Mehran, Philippe Genereux, Bernhard Witzenbichler, Sorin J. Brener, Ajay J. Kirtane, Thomas C. McAndrew, Ran Kornowski, Dariusz Dudek, Eugenia Nikolsky, Gregg W. Stone

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objective: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies. Background: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation. Methods: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year. Results: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84). Conclusion: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.

Original languageEnglish (US)
Pages (from-to)371-379
Number of pages9
JournalCatheterization and Cardiovascular Interventions
Volume85
Issue number3
DOIs
StatePublished - Jan 1 2015
Externally publishedYes

Fingerprint

Thigh
Angioplasty
Percutaneous Coronary Intervention
Hemorrhage
Transplants
Arteries
Platelet Glycoprotein GPIIb-IIIa Complex
Random Allocation
Coronary Artery Bypass
Heparin
Vascular Closure Devices
ST Elevation Myocardial Infarction
bivalirudin
Ischemia
Stroke

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Sanborn, Timothy A. ; Tomey, Matthew I. ; Mehran, Roxana ; Genereux, Philippe ; Witzenbichler, Bernhard ; Brener, Sorin J. ; Kirtane, Ajay J. ; McAndrew, Thomas C. ; Kornowski, Ran ; Dudek, Dariusz ; Nikolsky, Eugenia ; Stone, Gregg W. / Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI : Results from the HORIZONS-AMI trial. In: Catheterization and Cardiovascular Interventions. 2015 ; Vol. 85, No. 3. pp. 371-379.
@article{e6f45bfc43164c99918d86458dae28b8,
title = "Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: Results from the HORIZONS-AMI trial",
abstract = "Objective: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies. Background: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation. Methods: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year. Results: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30{\%}) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7{\%} vs. 10.8{\%}, HR: 0.61, 95{\%} CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0{\%} vs. 8.1{\%}, HR: 0.61, 95{\%} CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84). Conclusion: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.",
author = "Sanborn, {Timothy A.} and Tomey, {Matthew I.} and Roxana Mehran and Philippe Genereux and Bernhard Witzenbichler and Brener, {Sorin J.} and Kirtane, {Ajay J.} and McAndrew, {Thomas C.} and Ran Kornowski and Dariusz Dudek and Eugenia Nikolsky and Stone, {Gregg W.}",
year = "2015",
month = "1",
day = "1",
doi = "10.1002/ccd.25663",
language = "English (US)",
volume = "85",
pages = "371--379",
journal = "Catheterization and Cardiovascular Interventions",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "3",

}

Sanborn, TA, Tomey, MI, Mehran, R, Genereux, P, Witzenbichler, B, Brener, SJ, Kirtane, AJ, McAndrew, TC, Kornowski, R, Dudek, D, Nikolsky, E & Stone, GW 2015, 'Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: Results from the HORIZONS-AMI trial', Catheterization and Cardiovascular Interventions, vol. 85, no. 3, pp. 371-379. https://doi.org/10.1002/ccd.25663

Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI : Results from the HORIZONS-AMI trial. / Sanborn, Timothy A.; Tomey, Matthew I.; Mehran, Roxana; Genereux, Philippe; Witzenbichler, Bernhard; Brener, Sorin J.; Kirtane, Ajay J.; McAndrew, Thomas C.; Kornowski, Ran; Dudek, Dariusz; Nikolsky, Eugenia; Stone, Gregg W.

In: Catheterization and Cardiovascular Interventions, Vol. 85, No. 3, 01.01.2015, p. 371-379.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI

T2 - Results from the HORIZONS-AMI trial

AU - Sanborn, Timothy A.

AU - Tomey, Matthew I.

AU - Mehran, Roxana

AU - Genereux, Philippe

AU - Witzenbichler, Bernhard

AU - Brener, Sorin J.

AU - Kirtane, Ajay J.

AU - McAndrew, Thomas C.

AU - Kornowski, Ran

AU - Dudek, Dariusz

AU - Nikolsky, Eugenia

AU - Stone, Gregg W.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Objective: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies. Background: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation. Methods: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year. Results: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84). Conclusion: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.

AB - Objective: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies. Background: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation. Methods: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year. Results: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84). Conclusion: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy.

UR - http://www.scopus.com/inward/record.url?scp=84923008634&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84923008634&partnerID=8YFLogxK

U2 - 10.1002/ccd.25663

DO - 10.1002/ccd.25663

M3 - Article

VL - 85

SP - 371

EP - 379

JO - Catheterization and Cardiovascular Interventions

JF - Catheterization and Cardiovascular Interventions

SN - 1522-1946

IS - 3

ER -