Impact of Bleeding and Bivalirudin Therapy on Mortality Risk in Women Undergoing Percutaneous Coronary Intervention (from the REPLACE-2, ACUITY, and HORIZONS-AMI Trials)

Ng, Vivian G.; Baumbach, Andreas; Grinfeld, Liliana; Lincoff, A. Michael; Mehran, Roxana; Stone, Gregg W.; Lansky, Alexandra J.

doi:10.1016/j.amjcard.2015.10.029

Cited by 31 publications

(22 citation statements)

References 30 publications

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“…In addition, the risk of smoking and alcohol consumption leading to GIB was also proportional to age (Tabiri, Akanbong, & Abubakari, ). Women have been shown to have a near two‐fold increase in bleeding complications compared with men after PCI (Ng et al, ) and worse outcomes including mortality (Feit et al, ), consistent with the conclusions of this review. It is important to have a comprehensive understanding of these factors, so as to supported initiation of preventive action.…”

Section: Discussionsupporting

confidence: 86%

“…In contrast, bivalirudin remained associated with less bleeding risk but higher stent thrombosis risk (Perez et al, ). While men and women were seen to experience similar safety benefits of bivalirudin therapy in reducing bleeding complications, women experienced a more pronounced benefit of bivalirudin in reducing 12‐month mortality than men, so selective bivalirudin therapy may offer the best therapeutic option for women (Ng et al, ).…”

Section: Discussionmentioning

confidence: 99%

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Meta‐analysis of risk and protective factors for gastrointestinal bleeding after percutaneous coronary intervention

Wang

Ouyang

et al. 2018

Int J of Nursing Practice

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Aim To quantitatively analyse factors related to gastrointestinal bleeding after percutaneous coronary intervention and provide evidence for the prevention of gastrointestinal bleeding. Data Sources and Review Methods Cochrane Library, Pubmed, Embase, and Ovid databases were searched from inception to 31 May 2018; case‐control and cohort studies published in English were included. The methodological quality of each study was assessed by two independent reviewers using the Newcastle‐Ottawa Scale. Meta‐analysis was performed using Revman version 5.3. Results A total of 16 publications yielded data about risk factors. It was found that age older than 70 years, age (per 10‐year increase), female sex, baseline anaemia, history of smoking, history of using alcohol, history of peptic ulcer disease, chronic renal failure, previous bleeding, shock, congestive heart failure, acute myocardial infarction, prior use of inotropic medications, and prior use of antithrombotic medications were positively associated with gastrointestinal bleeding. Four articles yielded data about protective factors. It was found that proton‐pump inhibitor and bivalirudin therapy were negatively associated with gastrointestinal bleeding after percutaneous coronary intervention. Conclusion This research found risk and protective factors which can assist in effective management of this potentially fatal complication.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Meta‐analysis of risk and protective factors for gastrointestinal bleeding after percutaneous coronary intervention

Wang

Ouyang

et al. 2018

Int J of Nursing Practice

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“…The findings of this meta-analysis concured with a patient-level meta-analysis[34] showing a more pronounced clinical benefit of bivalirudin in women undergoing PCI including a significant reduction in major bleeding and a significant reduction in mortality rates at 1 year. Further studies are needed to definitively confirm the benefit of bivalirudin in women.…”

Section: Discussionsupporting

confidence: 84%

“…When comparing bivalirudin and heparin plus GPI, we found no difference in 30-day mortality overall. The similar result was obsreved in a patient-level pooled analysis in women [34]. Given only two studies reported the 1-year mortality, we did not perform a pooled analysis of 1-year mortality between bivalirudin arm and heparin plus GPI arm.…”

Section: Discussionsupporting

confidence: 67%

Bivalirudin versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in Women Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials

Xu¹,

Wang²,

Yang³

et al. 2017

PLoS ONE

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Bivalirudin has been shown to be safe and efficacious compared with heparin plus glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI). Whether bivalirudin would have the beneficial effects in female patients undergoing PCI remains unknown. We searched the literature for randomized controlled trials that assessed bivalirudin versus heparin plus GPI therapy in female patients undergoing PCI. The primary efficacy end point was major adverse cardiovascular events (MACE) within 30 days. The secondary efficacy end points were 30-day incidence of all-cause mortality, myocardial infarction (MI), urgent/ischemia-driven revascularization of target vessel. The safety end point was major bleeding up to 30 days. A total of 4,501 female patients were included in five randomized trials. No significant difference in MACE emerged between bivalirudin and heparin plus GPI at 30 days (8.15% vs 8.76%, RR 0.94, 95% CI 0.77–1.16, P = .57). There were no significant differences in rates of mortality (1.28% vs 1.91%, RR 0.74, 95% CI 0.45–1.20, P = .22), MI (5.46% vs 5.25%, RR 1.02, 95% CI 0.79–1.32, p = .88), or target vessel revascularization (2.13% vs 1.65%, RR 1.43, 95% CI 0.88–2.30, P = .15). Compared with heparin plus GPI, bivalirudin was associated with a significant reduction in 30-day major bleeding (5.32% vs 9.20%, RR 0.58, 95% CI 0.47–0.72, P < .0001). In conclusion, bivalirudin is associated with a significant reduction in 30-day major bleeding without increased ischemic events compared with heparin plus GPI in female patients undergoing PCI.

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“…The reasons are likely multi‐factorial including older age at time of PCI and more frequent co‐morbidities including renal failure, diabetes, anemia, hypertension, as well as, smaller body surface area, and lower body weight. Even after correction for differences in baseline characteristics, women have higher bleeding complications and 30‐day major bleeding is the strongest independent predictor of 1‐year mortality in women .…”

mentioning

confidence: 99%

If you prick us, do we not bleed?

Ahmed¹,

Henry²

2017

Cathet Cardio Intervent

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Women have higher post PCI bleeding complications which in turn contributes to higher post PCI mortality. Bivalirudin decreases bleeding events in both men and women when compared to use of both heparin and GPI but bleeding avoidance strategies such as radial artery access or avoiding GPI may modify that benefit. The NCDR bleeding risk score incorporates gender and is predictive of both bleeding complications and mortality. The ideal strategy to reduce bleeding will depend on the specific patient, local practice patterns, and ideally cost effectiveness.

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Impact of Bleeding and Bivalirudin Therapy on Mortality Risk in Women Undergoing Percutaneous Coronary Intervention (from the REPLACE-2, ACUITY, and HORIZONS-AMI Trials)

Cited by 31 publications

References 30 publications

Meta‐analysis of risk and protective factors for gastrointestinal bleeding after percutaneous coronary intervention

Meta‐analysis of risk and protective factors for gastrointestinal bleeding after percutaneous coronary intervention

Bivalirudin versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in Women Undergoing Percutaneous Coronary Intervention: A Meta-Analysis of Randomized Controlled Trials

If you prick us, do we not bleed?

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