Enoxaparin 0.3 mg/kg IV supplement for patients transitioning to PCI after subcutaneous enoxaparin therapy for NSTE ACS: a subgroup analysis from the SYNERGY trial.
OBJECTIVE: To explore clinical and bleeding outcomes in patients enrolled in the SYNERGY trial who had percutaneous coronary intervention (PCI) based on adherence to the dosing regimens of enoxaparin mandated by the protocol. BACKGROUND: In SYNERGY, 4,687 patients underwent PCI during index hospitalization. Patients in the subcutaneous (sc) enoxaparin group were to be given an 0.3 mg/kg IV bolus immediately before PCI if balloon inflation occurred > or = 8 hr after their last sc dose of enoxaparin. METHODS: The incidence of the 1 degrees efficacy end point (death/myocardial infarction [MI] post PCI and through 30 days), and the rates of post-PCI in-hospital TIMI major and GUSTO severe bleeding were compared between patients randomized to unfractionated heparin (UFH) and those randomized to sc enoxaparin who did or did not receive a supplemental IV bolus of enoxaparin in accord with protocol-mandates. RESULTS: A total of 4,687 patients had PCI; 2,323 were assigned sc enoxaparin and 1,332 received protocol-mandated IV enoxaparin bolus, while 215 enoxaparin patients received inappropriate IV therapy (either receiving IV enoxaparin before the 8-hr protocol time or not receiving the IV enoxaparin as directed after 8 hr). Death or MI occurring post PCI through 30-day follow-up tended to be lower in the enoxaparin patients who were treated according to protocol than in those who were not (12.3% vs. 14.4%; adjusted P = 0.25), as was TIMI major bleeding (3.0% vs. 4.7%, adjusted P = 0.08). CONCLUSION: These exploratory analyses show that patients in SYNERGY who received the protocol-mandated supplemental IV bolus of 0.3 mg/kg enoxaparin before PCI performed 8-12 hr after their last sc enoxaparin dose tended to have improved outcomes compared with those who did not. Strategies to ensure adherence to dosing guidelines of enoxaparin during PCI should be considered.
Cohen, M; Levine, GN; Pieper, KS; Lan, L; Antman, EM; Aylward, PE; White, HD; Kleiman, NS; Califf, RM; Mahaffey, KW; SYNERGY Trial Investigators,
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