TCT Feature: Prolonged bivalirudin decreases bleeds, adverse events during PCI

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WASHINGTON, D.C.—A prolonged infusion of bivalirudin may decrease bleeding and adverse event rates in PCI patients pretreated with clopidogrel, Homam Ibrahim, of the Texas Heart Institute, told Cardiovascular Business News during a poster presentation Wednesday at the 2010 annual Transcatheter Cardiovascular Thereapeutics (TCT) meeting.

“Bivalirudin is a safe and effective antithrombotic therapy during PCI in patients pretreated with clopidogrel. However, clopidogrel loading is common in the cath lab and bivalirudin is stopped at the end of procedure. A prolonged bivalirudin infusion may provide extended per-procedural antithrombin therapy,” the researchers wrote.

During the study, Ibrahim and colleagues randomized 81 patients to receive either standard bivalirudin (Angiomax, The Medicines Company) therapy (31 patients), which ends at the conclusion of the procedure, or a prolonged infusion of 120 minutes to 240 minutes (51 patients) following the procedure. The mean time for standard bivalirudin therapy was 45.3 minutes and 128.1 minutes for patients receiving the prolonged dose.

The enrolled patients were undergoing either acute or elective PCI and received 325 mg of ASA, a 600 mg loading dose of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), a 0.75 mg/kg bolus of bivalirudin, followed by a 1.75 mg/kg/h bivalirudin infusion.

Patients who received the prolonged dose exhibited no signs of increased bleeding or post-procedural platelet counts. Additionally, the mean reduction in hemoglobin was 0.86 gm/dl for patients randomized to standard bivalirudin therapy and 0.98 gm/dl for those randomized to prolonged therapy.

“What we looked at in terms of safety were bleeding events and the decrease of hemoglobin,” Ibrahim said.

He noted that there were no statistically significant differences between the two groups in in-hospital MACE or cardiac enzyme levels of GUSTO scale bleeds. “We found no differences in terms of bleeding, according to the TIMI scores, or hemoglobin changes prior to and post procedure.”

For patients on standard bivalirudin therapy, there was one reported case of a TIMI minor bleed and four cases which required target lesion revascularization (TLR) within 18 months. In contrast, there were no reported cases of either TIMI minor bleeds or TLR in patients administered the prolonged bivalirudin therapy.

“Our hypothesis was that the prolonged bivalirudin infusion would protect patients until the in-lab clopidogrel loading dose took effect—almost two hours,” Ibrahim said.

“The conclusions are that patients who received the prolonged infusion had overall lower events and this therapy is safe in terms of bleeding.”