STEMI patients treated with bivalirudin therapy during PCI had better inpatient outcomes and lower overall in-hospital costs than patients treated with heparin plus glycoprotein IIb/IIIa receptor inhibition (GPI), according to a retrospective cohort study published online Jan. 10 in Circulation: Cardiovascular Quality and Outcomes. Results from this “real world” study confirm findings in clinical trials and show use of bivalirudin therapy may provide savings of $1,300 per admission, the authors wrote.
STEMI patients commonly receive heparin and GPI when undergoing primary PCI, Duane S. Pinto, MD, MPH, of Beth Israel Deaconess Medical Center in Boston, and colleagues wrote. But the patients then are at risk of bleeding. The authors noted that randomized trials have shown reduced rates of bleeding and reduced adverse clinical events with bivalirudin (Angiomax, The Medicines Company) compared with heparin plus GPI, and that the HORIZONS-AMI also found improved 30-day outcomes.
“It is unknown whether the results of randomized trials would be similar in patients encountered in routine practice, where the risk of recurrent ischemic events, bleeding events and comorbidities are higher compared with randomized trials,” they wrote. “As such, confirmation of results from randomized trials with those from large observational databases can inform policy makers when making therapy decisions in the current economically challenged healthcare environment.”
The researchers designed the retrospective cohort study using the Premier hospital clinical and economic databases, which include more than 600 hospitals and almost five million inpatient discharges. From that database they identified 59,917 STEMI patients at 276 hospitals who underwent PCI between Jan. 1, 2004, and March 31, 2008, and who fit their inclusion criteria. Of those patients, 6,735 received bivalirudin and 53,182 received heparin and GPI.
Their primary outcome was in-hospital death. Secondary outcomes were rates of bleeding, transfusion, length of stay and in-hospital costs. Costs reflected actual costs to treat the patient—supplies, labor depreciation of equipment, laboratory, medication and procedures—calculated in 2008 dollars.
They found that the bivalirudin group had fewer deaths compared with the heparin plus GPI group, 3.2 percent vs. 4 percent, respectively; less inpatient bleeding, at 6.9 percent vs. 10.5 percent; less clinically apparent bleeding with transfusion, at 1.6 percent vs. 3 percent; and less transfusion, at 5.9 percent vs. 7.6 percent.
In the economic analyses, they found that the bivalirudin group had a shorter average length of stay, with a mean of 4.3 days compared with a mean of 4.5 days in the heparin plus GPI group. Mean in-hospital costs were $18,640 and average in-hospital costs were $14,462 for the bivalirudin group compared with $19,967 and $16,003 in the heparin plus GPI group.
“These data confirm that the findings from HORIZON-AMI translate to patients encountered in routine clinical practice and also demonstrate an association of bivalirudin use with in-hospital cost savings of approximately $1,300/admission when compared with heparin plus GPI,” Pinto and colleagues stated.
They noted that bivalirudin patients had more comorbidities and were treated more often in urban teaching hospitals. They used a propensity score matching methodology and sensitivity analyses to reduce the effect of confounding, but acknowledged residual confounding could have affected their findings.
They observed that in the period under study, the use of prasugrel (Effient, Eli Lilly/Daiichi-Sankyo) or ticagrelor (Brilinta, AstraZeneca) was not widespread, and timing of administration of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) was not known. “Whether these outcomes can be replicated with newer antiplatelet agents and broader use of bivalirudin in STEMI should be the subject of future investigations,” they concluded.