Key result
Long-term phosphodiesterase-5 inhibitor therapy after LVAD implantation was associated with a higher rate of bleeding at 12 months compared to no PDE5I therapy (23% vs. 6%, P=0.03).
Why the study?
PDE5 inhibitor therapy after LVAD implantation has been associated with lower mortality and device thrombosis but higher risk for post-operative and gastrointestinal bleeding, leaving its impact on overall bleeding risk unclear.
Does long-term oral phosphodiesterase-5 inhibitor therapy increase bleeding risk in patients with continuous-flow LVADs?
Cohort (n=109)
No
Does long-term oral phosphodiesterase-5 inhibitor therapy increase bleeding risk in patients with continuous-flow LVADs?
Absolute Event Rate: 23% vs 6%
p-value: p=0.03
Long-term use of phosphodiesterase-5 inhibitors after continuous-flow LVAD implantation is associated with a significantly increased risk of bleeding at 12 months.
May warrant bleeding vigilance with PDE5Is in LVAD patients; leaves open causal confirmation in prospective trials.
AIMS: Therapy with phosphodiesterase-5 inhibitors (PDE5Is) after left ventricular assist device (LVAD) implantation has been associated with lower mortality and device thrombosis but increased risk for post-operative and gastrointestinal bleeding. We aimed to evaluate the impact of long-term PDE5Is on the overall bleeding risk after LVAD implantation. METHODS AND RESULTS: We retrospectively included patients who received a continuous-flow LVAD at our site and were prescribed with long-term oral PDE5Is after discharge from the index hospitalization. The primary endpoint was the occurrence of bleeding at 12 month follow-up. Secondary endpoints were all-cause death and the combination of bleeding and all-cause death. Our analysis included 109 patients of whom 75 (69%) received long-term PDE5Is. Mean age was 56 years, and 85% were male. At 12 months, 19 (17%) patients experienced at least one bleeding event. Patients on PDE5Is had higher bleeding rates (23% vs. 6%, P = 0.03) and more bleeding events per patient-year (0.32 vs. 0.06, P = 0.03) compared with patients not on PDE5Is. While overall bleeding incidence was excessively higher in the PDE5I group, there were no significant differences in the incidence of major bleeding (19% vs. 6%, P = 0.08) and gastrointestinal bleeding (11% vs. 3%, P = 0.18). Kaplan-Meier analysis revealed higher cumulative incidence of bleeding for the PDE5I group (log rank = 0.04) with no difference on all-cause death (log rank = 0.67) and the combination of bleeding and all-cause death (log rank = 0.13). Hospitalizations for bleeding and their duration were numerically higher in the PDE5I group (0.28 vs. 0.03, P = 0.07 and 2.4 vs. 0.2, P = 0.07, respectively). CONCLUSIONS: Phosphodiesterase-5 inhibitor treatment after LVAD implantation is associated with increased bleeding risk after LVAD implantation. The safety of long-term PDE5Is in LVAD patients remains unclear and needs to be further clarified in prospective studies with randomized study design.
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Jakstaite et al. (2021) conducted a cohort in Left ventricular assist device (LVAD) implantation (n=109). Phosphodiesterase-5 inhibitors (PDE5Is) vs. No PDE5Is was evaluated on Occurrence of bleeding at 12 month follow-up (p=0.03). Long-term phosphodiesterase-5 inhibitor therapy after LVAD implantation was associated with a higher rate of bleeding at 12 months compared to no PDE5I therapy (23% vs. 6%, P=0.03).
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