Key result
A conservative enoxaparin bridging protocol for HeartMate 3 patients yielded a numerically lower primary composite outcome rate compared to routine bridging (1.5% vs 5.7%, p=0.075).
Why the study?
Bridging subtherapeutic international normalized ratios in patients with left ventricular assist devices is not well studied and may cause harm.
Does a conservative enoxaparin bridging protocol reduce major bleeding and thrombotic events in patients with HeartMate 3 devices and subtherapeutic INRs?
Cohort (n=82)
No
Does a conservative enoxaparin bridging protocol reduce major bleeding and thrombotic events in patients with HeartMate 3 devices and subtherapeutic INRs?
A conservative enoxaparin bridging protocol for subtherapeutic INRs in HeartMate 3 patients significantly reduces major bleeding without increasing thrombotic events.
May support conservative enoxaparin bridging in HM3 patients; leaves open need for prospective trials.
Bridging subtherapeutic international normalized ratios (INRs) in patients with left ventricular assist devices is not well studied and may cause harm. This retrospective, single-center, pre- and post-cohort study assessed whether a more conservative enoxaparin bridging protocol for patients with subtherapeutic INRs correlated with a reduction in major bleeding and thrombotic events in patients with HeartMate 3 devices. Eighty-two patients and 237 subtherapeutic episodes were included. The rate of the primary composite outcome was numerically lower in the post-group (5.7% vs . 1.5%, p = 0.075). The secondary composite outcome of major bleeding events or thrombotic events within 30 days was significantly reduced in the post-group (10.5% vs. 3.8%, p = 0.041). The rate of major bleeding events within 30 days was reduced in the post-group (10.5% vs. 3.0%, p = 0.019). In a subgroup of patients taking concomitant antiplatelet therapy, the primary composite outcome was significantly reduced in the post-group (5.1% vs. 0.0%, p = 0.044). Routine bridging of subtherapeutic INRs in patients with an HM3 device may be both unnecessary and harmful. A conservative bridging protocol may reduce major bleeding events without increasing the rate of thrombotic events among HM3 patients. Larger studies are necessary to confirm the results.
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McKee et al. (2025) conducted a cohort in HeartMate 3 left ventricular assist devices with subtherapeutic INRs (n=82). Conservative enoxaparin bridging protocol vs. Routine bridging protocol (pre-cohort) was evaluated on Primary composite outcome (p=0.075). A conservative enoxaparin bridging protocol for HeartMate 3 patients yielded a numerically lower primary composite outcome rate compared to routine bridging (1.5% vs 5.7%, p=0.075).
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