When bivalirudin first came on the market, one institution (which wishes to remain unnamed here) did a retrospective analysis of all 475 patients who had a percutaneous coronary intervention (PCI) procedure between the months of November 2002 and June 2003.

The study was conducted to present supporting data for the use of bivalirudin in the cardiac cath lab. The institution looked at three variables:
Access site complications, which included pseudoaneurysm, access site bleeding, and arteriovenous (AV) fistulas
Peri-procedural MIs
Cost

The definitions utilized for the above variables were taken from the American College of Cardiology NCDR national database registry.

Conclusions:
1. The patients who had the highest incidence of vascular access site complications were the patients who received heparin and IIb/IIIa inhibitors (9/328).
2. The patients with the lowest incidence of vascular access site complications were the patients who received bivalirudin (2/147).
3. Peri-procedural MIs were higher in the patients who received bivalirudin, but not by a great margin (2.7% compared to 2.1% in the IIb/IIIa group).
4. The most expensive drugs to use (per the institution's pricing) was the combination of bivalirudin and IIb/IIIa inhibitors, but only 39 out of 147 patients received both bivalirudin and IIb/IIIa inhibitors.
5. The least expensive drug to use was heparin alone, followed by bivalirudin alone.
6. Bivalirudin and IIb/IIIa inhibitors were more expensive than heparin and IIb/IIIa inhibitors; however, the majority of patients receiving bivalirudin do not get IIb/IIIa inhibitors, whereas the majority of patients receiving heparin also received IIb/IIIa inhibitors.

The conclusion from this analysis (which was a small number of patients, n=475) was that not only was it more cost-effective to use bivalirudin, there were less bleeding complications, which resulted in decreased length of stay and increased patient and physician satisfaction.

Our facility has utilized bivalirudin since this study, and guidelines for use are currently according to MD preference. Generally, however, if the patient comes in through the emergency room and gets started on a GP IIb/IIIa inhibitor in the ER, then they usually will stay with that drug in the cath lab. If it is an acute MI patient, the cath lab will use a IIb/IIIa and sometimes will use bivalirudin and a IIb/IIIa. We use mostly bivalirudin alone on our PCI patients, especially those who come in for an elective cath and then proceed to PCI. For the more acute patients with STEMI, our facility tends to use IIb/IIIas, or a IIb/IIIa with bivalirudin.

About the institution: We are a non-profit institution with over 450 acute care beds. Greater than 90 of these beds are critical care. We have programs in Cardiac, Pulmonary, Women™s Health, Rehabilitation, and Transplant. The facility has four cardiac catheterization labs. We perform diagnostic caths, PCIs, EPS, RFA, AICD and pacemaker implantation, diagnostic and interventional peripheral vascular procedures, cardiac biopsies, and placement of dialysis access catheters. Our facility has a device program for bridge to transplantation and these patients, as well as the heart transplant patients, have their follow-up in the cardiac cath lab. In 2004, the cath lab performed 1967 diagnostic procedures and 622 interventional cardiac procedures.

Annie Ruppert can be contacted at:
cathlabdigest@aol.com.