An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention

Rahman Shah, Kelly Rogers, Khalid Matin, Raza Askari, Sunil V. Rao

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Background Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI. Methods and Results Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P =.800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P =.089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P =.122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P =.069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P =.041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P =.009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P <.001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P =.012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P =.009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P =.252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P =.114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P =.049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P =.226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P =.018). Conclusions In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.

Original languageEnglish (US)
Pages (from-to)14-24
Number of pages11
JournalAmerican Heart Journal
Volume171
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Percutaneous Coronary Intervention
Heparin
Meta-Analysis
Odds Ratio
Hemorrhage
Randomized Controlled Trials
Mortality
clopidogrel
bivalirudin
Platelet Glycoprotein GPIIb-IIIa Complex
Anticoagulants
Stents
Thrombosis

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention. / Shah, Rahman; Rogers, Kelly; Matin, Khalid; Askari, Raza; Rao, Sunil V.

In: American Heart Journal, Vol. 171, No. 1, 01.01.2016, p. 14-24.

Research output: Contribution to journalArticle

@article{351814ff7f1c4a9cafc64bd561502cc6,
title = "An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention",
abstract = "Background Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI. Methods and Results Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95{\%} CI 0.87-1.19, P =.800), myocardial infarction (RR 1.41, 95{\%} CI 0.94-2.11, P =.089), target vessel revascularization (RR 1.37, 95{\%} CI 0.91-2.04, P =.122), and net adverse clinical events (RR 0.81, 95{\%} CI 0.64-1.01, P =.069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95{\%} CI 0.67-0.99, P =.041) and cardiac mortality (RR 0.68, 95{\%} CI 0.51-0.91, P =.009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95{\%} CI 1.79-6.10, P <.001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37{\%} (RR 0.63, 95{\%} CI 0.44-0.90, P =.012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95{\%} CI 0.23-0.81, P =.009) vs bailout (RR 0.73, 95{\%} CI 0.42-1.25, P =.252), predominantly radial access (RR 0.54, 95{\%} CI 0.25-1.15, P =.114) vs non-radial access (RR 0.60, 95{\%} CI 0.36-0.99, P =.049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95{\%} CI 0.40-1.24, P =.226) vs clopidogrel use (RR 0.39, 95{\%} CI 0.18-0.85, P =.018). Conclusions In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.",
author = "Rahman Shah and Kelly Rogers and Khalid Matin and Raza Askari and Rao, {Sunil V.}",
year = "2016",
month = "1",
day = "1",
doi = "10.1016/j.ahj.2015.10.006",
language = "English (US)",
volume = "171",
pages = "14--24",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "1",

}

TY - JOUR

T1 - An updated comprehensive meta-analysis of bivalirudin vs heparin use in primary percutaneous coronary intervention

AU - Shah, Rahman

AU - Rogers, Kelly

AU - Matin, Khalid

AU - Askari, Raza

AU - Rao, Sunil V.

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI. Methods and Results Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P =.800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P =.089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P =.122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P =.069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P =.041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P =.009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P <.001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P =.012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P =.009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P =.252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P =.114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P =.049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P =.226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P =.018). Conclusions In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.

AB - Background Despite several randomized controlled trials and meta-analyses, the ideal anticoagulant for patients undergoing primary percutaneous coronary intervention (PCI) remains controversial. We performed an updated meta-analysis including recently reported randomized clinical trials that compare bivalirudin and heparin with or without provisional administration of a glycoprotein IIb/IIIa inhibitor (GPI) for primary PCI. Methods and Results Scientific databases and Web sites were searched for randomized clinical trials. Data from 6 trials involving 14,095 patients were included. The pooled risk ratios (RRs) were calculated using random-effects models. Moderator analyses examined the impact of routine use of GPI, radial access, and P2Y12 inhibitors on safety outcomes. At 30 days, patients receiving bivalirudin had rates of major adverse cardiac events similar to those receiving heparin with or without provisional GPI (RR 1.02, 95% CI 0.87-1.19, P =.800), myocardial infarction (RR 1.41, 95% CI 0.94-2.11, P =.089), target vessel revascularization (RR 1.37, 95% CI 0.91-2.04, P =.122), and net adverse clinical events (RR 0.81, 95% CI 0.64-1.01, P =.069). However, bivalirudin use decreased the risk of all-cause mortality (RR 0.81, 95% CI 0.67-0.99, P =.041) and cardiac mortality (RR 0.68, 95% CI 0.51-0.91, P =.009) at 30 days, There were higher rates of acute stent thrombosis (RR 3.31, 95% CI 1.79-6.10, P <.001) in patients receiving bivalirudin. Bivalirudin use also decreased the risk of major bleeding at 30 days by 37% (RR 0.63, 95% CI 0.44-0.90, P =.012), but bleeding risk varied depending on routine GPI use with heparin (RR 0.44, 95% CI 0.23-0.81, P =.009) vs bailout (RR 0.73, 95% CI 0.42-1.25, P =.252), predominantly radial access (RR 0.54, 95% CI 0.25-1.15, P =.114) vs non-radial access (RR 0.60, 95% CI 0.36-0.99, P =.049), and second-generation P2Y12 inhibitor use with bivalirudin (RR 0.70, 95% CI 0.40-1.24, P =.226) vs clopidogrel use (RR 0.39, 95% CI 0.18-0.85, P =.018). Conclusions In primary PCI, relative to heparin, bivalirudin reduces the risk for all-cause mortality, cardiac mortality, and major bleeding but yields similar rates of major adverse cardiac event and net adverse clinical event at 30 days. However, the benefit of a reduction in bleeding with bivalirudin appears to be modulated by the concurrent administration of second-generation P2Y12 inhibitors with bivalirudin, using radial access, and avoiding routine GPI use with heparin.

UR - http://www.scopus.com/inward/record.url?scp=84951753046&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84951753046&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2015.10.006

DO - 10.1016/j.ahj.2015.10.006

M3 - Article

VL - 171

SP - 14

EP - 24

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 1

ER -