Marlene Busko

May 08, 2016

ORLANDO, FL — A quality-improvement program—in which patients about to have PCI were assessed for bleeding risk to determine whether they should be anticoagulated with bivalirudin or heparin--resulted in a decline in bivalirudin use, substantial cost savings, and fewer bleeding events[1].

Specifically, during this 2-year program in a consortium of 21 hospitals with 21 cath labs, the drop in anticoagulation with bivalirudin resulted in a dramatic one-million­-dollar cost saving per year.

Importantly, with this shift to strategically use bivalirudin in high-bleeding-risk patients, overall bleeding events in patients who had PCI actually fell from 6.3% to 3.78%, Dr Jerome E Granato (Catholic Health Initiatives, Lexington, KY) reported in a late-breaking clinical-trial session and in a press briefing here at the Society for Cardiac Angiography and Interventions (SCAI) 2016 Scientific Sessions.

Dr Jerome Granato

Clinicians in the study hospitals were instructed to use the National Cardiovascular Data Registry (NCDR)–based bleeding risk calculator[2] as part of the "time-out" preprocedure checklist before a patient underwent PCI, Granato explained. The hospitals received monthly reports on how they and the other hospitals were performing in terms of assessing bleeding risk.

"The bivalirudin is $800 a dose, and the heparin is maybe $8 a dose," Granato told heartwire from Medscape. Thus, "using [bivalirudin] in 100% of patients and particularly patients who are at low risk for bleeding . . . probably isn't the best allocation of resources."

The quality initiative "started as a pharmacy cost [reduction program] to use the right drug, for the right reason, in the right patient," he explained. It was intended to steer clinicians away from using bivalirudin and toward using heparin in low-risk patients. The program also recommended using a transradial-access approach for high-risk patients, and "that caught on even more and really was the great driver of reducing complications," according to Granato.

"What a fabulous idea!" session comoderator Dr Steven R Bailey (University of Texas Health Science Center in San Antonio, Texas) told heartwire . "By making people aware and tracking what [they] do and looking at and implementing these changes, you can in fact have good patient outcomes."

Assessing Risk Before Choosing Anticoagulant, Access Approach

Administrators and physicians at the Catholic Health Initiatives consortium noted that bivalirudin anticoagulation during PCI varied a lot in their hospitals, which are located in 11 states and where more than 200 operators perform this procedure. Use of bivalirudin for PCI procedures ranged from never to always. Moreover, the use of this anticoagulant did not correlate with patient bleeding events.

Thus, starting in 2013, clinicians were asked to assess the bleeding risk of each patient coming for PCI, based on the NCDR bleeding-risk calculator.

In this scoring system, patients are given a bleeding-risk score based on points for STEMI, age, body-mass index (BMI), previous PCI, kidney disease, shock, cardiac arrest, hemoglobin, and whether the PCI was elective (0 points), urgent (20), or an emergency (40). Patients with scores <25 are classed as having a low risk of bleeding events from PCI; those with scores of 26 to 65 or >65 are classed as having an intermediate or high risk of bleeding, respectively.

For low-risk patients, clinicians were encouraged to use heparin anticoagulation. For intermediate-risk patients, they were encouraged to use radial access and heparin anticoagulation or alternatively, femoral access and bivalirudin anticoagulation. For high-risk patients, they were encouraged to use bivalirudin anticoagulation and radial access. Routine use of GP IIb/IIIa inhibitors was discouraged in all cases.

During the study, there was a progressive, significant decline in bivalirudin use from 57% of cases in 2013 to 43% of cases in 2014 to 35% of cases in 2015—an almost 40% drop. This corresponded to a saving of one million dollars in drug costs per year.

"Perhaps more important, by using a risk-directed approach to coronary intervention, we were able to cut our bleeding rate nearly in half," Granato said. In addition to the benefits to the patients, the healthcare system saved $8000 to $10,000 per 2 to 3 days of added hospital stay for each bleeding event, which corresponded to about another million dollars a year.

"By directing expensive therapies to people who benefit most you give better care and you run up fewer costs," Granato summarized to heartwire .

In addition, "in a profession that may be sometimes resistant to change, we were able to show that hundreds of physicians can clearly change their behavior," he noted. By the end of the study, 52% of PCIs were done using a transradial approach—"one of the highest rates you'll see for any system, let alone one this size," according to Granato.

Granato has reported he has no relevant financial relationships.

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