Results of an individual patient data pooled analysis reported at RCT Connect

October 14, 2020

NEW YORK - October 14, 2020 - An individual patient data pooled analysis comparing the use of bivalirudin versus heparin in heart attack patients undergoing percutaneous coronary intervention (PCI) found that bivalirudin use was associated with similar overall rates of 30-day mortality across all heart attack patients, but lower rates of serious bleeding events. Moreover, mortality was reduced in patients with ST-segment elevation myocardial infarction (STEMI) who were treated with a post-PCI bivalirudin infusion.

Findings were reported today at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Numerous randomized trials have examined the outcomes of anticoagulation with bivalirudin vs. heparin in patients undergoing PCI. These studies have reported conflicting results given varying patient populations, study designs (including access site, use of GPIIb/IIIa inhibitors with heparin and varying regimens of post-PCI bivalirudin infusions), sample size, endpoints, and follow-up durations. Study-level meta-analyses have been unable to address these limitations, nor can they evaluate events over time, perform multivariable adjustment, or examine outcomes in important subgroups.

In this analysis, researchers pooled the individual patient data from all eight randomized clinical trials of bivalirudin vs. heparin in patients with myocardial infarction (MI) (STEMI, or non-STEMI [NSTEMI]) undergoing PCI that enrolled 1,000 or more patients: MATRIX, VALIDATE-SWEDEHEART, EUROMAX, BRIGHT, HEAT-PPCI, ISAR-REACT 4, ACUITY, and HORIZONS-AMI. The final study cohort included 27,409 patients (13,346 randomized to bivalirudin and 14,063 randomized to heparin); 15,254 had STEMI and 12,155 had NSTEMI.

The pre-specified primary effectiveness endpoint was the 30-day risk of all-cause mortality and the primary safety endpoint was the 30-day risk of serious bleeding (TIMI major or minor if available; alternatively, BARC type 3 or 5).

Overall, bivalirudin was associated with similar rates of 30-day mortality (1.9% vs. 2.1%, HR 0.91, 95% CI 0.75-1.10) and lower rates of serious bleeding (3.4% vs. 5.7%, HR 0.60, 95% CI 0.52-0.68). Further analyses were performed stratified by presentation (STEMI or NSTEMI). In STEMI patients, all-cause mortality was lower with bivalirudin use compared to heparin use (2.5% vs. 2.9%, HR 0.80, 95% CI, 0.64, 1.01). The mortality rates were substantially reduced with bivalirudin when a post-PCI bivalirudin infusion was used (HR 0.67, 95% CI, 0.50, 0.89). Serious bleeding was also lower with bivalirudin use (3.5% vs. 6.0%, HR 0.57, 95% CI, 0.47, 0.68). In NSTEMI patients, bivalirudin use and heparin use had similar rates of mortality (1.2% vs. 1.1%, HR 1.21, 95% CI, 0.84, 1.73), although bivalirudin use was also associated with lower rates of serious bleeding (3.3% vs. 5.3%, HR 0.63, 95% CI, 0.52, 0.76).

"This individual patient data pooled analysis aimed to determine the optimal anticoagulant to be used during PCI in patients with AMI," said Gregg W. Stone, MD. Dr. Stone is Director of Academic Affairs, Mount Sinai Heart Health System and Professor of Medicine at The Zena and Michael A. Wiener Cardiovascular Institute of the Icahn School of Medicine at Mount Sinai. "In patients with STEMI undergoing primary PCI, bivalirudin use was associated with reductions in the 30-day rates of mortality, serious bleeding and NACE, despite increased rates of MI and stent thrombosis compared with heparin. The mortality benefit of bivalirudin in STEMI was pronounced in patients treated with a post-PCI bivalirudin infusion (low-dose or high-dose); a high-dose infusion mitigated the MI and stent thrombosis risk."

"In patients with NSTEMI undergoing PCI, bivalirudin use was associated with a reduction in the 30-day rate of serious bleeding but similar rates of mortality, MI, and stent thrombosis compared with heparin," Dr. Stone added.
The study was funded by the Cardiovascular Research Foundation and The Medicines Company.

Dr. Stone reported the following disclosures: speaker honoraria from Cook; Consultant to Valfix, TherOx, Robocath, HeartFlow, Gore, Ablative Solutions, Miracor, Neovasc, Abiomed, Ancora, Vectorious, and Cardiomech; Equity/options from Ancora, Qool Therapeutics, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, and Valfix.

About CRF

The Cardiovascular Research Foundation (CRF) is one of the world's leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For nearly 30 years, CRF has helped pioneer medical advances and educated doctors on the latest treatments for heart disease. CRF is comprised of the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 32nd year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

For more information, visit and

Cardiovascular Research Foundation

Related Mortality Articles from Brightsurf:

Being in treatment with statins reduces COVID-19 mortality by 22% to 25%
A research by the Universitat Rovira i Virgili (URV) and Pere Virgili Institut (IISPV) led by LluĂ­s Masana has found that people who are being treated with statins have a 22% to 25% lower risk of dying from COVID-19.

Mortality rate higher for US rural residents
A recent study by Syracuse University sociology professor Shannon Monnat shows that mortality rates are higher for U.S. working-age residents who live in rural areas instead of metro areas, and the gap is getting wider.

COVID-19, excess all-cause mortality in US, 18 comparison countries
COVID-19 deaths and excess all-cause mortality in the U.S. are compared with 18 countries with diverse COVID-19 responses in this study.

New analysis shows hydroxychloroquine does not lower mortality in COVID-19 patients, and is associated with increased mortality when combined with the antibiotic azithromycin
A new meta-analysis of published studies into the drug hydroxychloroquine shows that it does not lower mortality in COVID-19 patients, and using it combined with the antibiotic azithromycin is associated with a 27% increased mortality.

Hydroxychloroquine reduces in-hospital COVID-19 mortality
An Italian observational study contributes to the ongoing debate regarding the use of hydroxychloroquine in the current pandemic.

What's the best way to estimate and track COVID-19 mortality?
When used correctly, the symptomatic case fatality ratio (sCFR) and the infection fatality ratio (IFR) are better measures by which to monitor COVID-19 epidemics than the commonly reported case fatality ratio (CFR), according to a new study published this week in PLOS Medicine by Anthony Hauser of the University of Bern, Switzerland, and colleagues.

COVID-19: Bacteriophage could decrease mortality
Bacteriophage can reduce bacterial growth in the lungs, limiting fluid build-up.

COPD and smoking associated with higher COVID-19 mortality
Current smokers and people with chronic obstructive pulmonary disease (COPD) have an increased risk of severe complications and higher mortality with COVID-19 infection, according to a new study published May 11, 2020 in the open-access journal PLOS ONE by Jaber Alqahtani of University College London, UK, and colleagues.

Highest mortality risks for poor and unemployed
Large dataset shows that income, work status and education have a clear influence on mortality in Germany.

Addressing causes of mortality in Zambia
Despite the fact that people in sub-Saharan Africa are now living longer than they did two decades ago, their average life expectancy remains below that of the rest of the world population.

Read More: Mortality News and Mortality Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to