Abstract

Introduction: TIMI Major and Minor bleeding, reflecting large bleeds of >5 and >3g/dl, respectively, are routinely tracked as outcomes of PCI. Lesser degrees of bleeding, called ‘nuisance’ bleeding (NB), can occur as a result of chronic dual antiplatelet therapy (DAPT). NB has never been reported in clinical trials of PCI or DAPT. The frequency of patient-reported NB after PCI and its association with patients’ quality of life (QOL) is therefore unknown. Methods: We assessed the incidence of NB in a 9-center prospective PCI registry, the PRISM study, at 1 and 6 months after the index PCI. NB was defined by patients who responded positively, via telephone interviews, to the following question: ‘Since leaving the hospital after your heart procedure have you had easy bleeding?” QOL was assessed with the EuroQOL-5D visual analogue scale (EQ5D VAS) score (range 0-100, higher = better). Hierarchical linear regression models was used to assess the association of NB at 6 months with QOL (EQ5D VAS) at 6 months, after adjustment for socio-demographic and clinical factors (age, gender, race, insurance status, warfarin use, atrial fibrillation and baseline EQ5D VAS score). Results: Among 2,630 patients enrolled in the PRISM trial, NB occurred in 1085 (41.25%) at 6 months. Compliance with DAPT was 98.6% at 1 month and 93.3% at 6 months, precluding an assessment of its association with NB. NB was associated with a significant decrement in QOL, even after adjusting for baseline EQ5D-VAS score and other confounders (EQ5D VAS estimate -1.41, 95%CI -2.79 to -0.03, P-value 0.045, Figure) Conclusions: In this multicenter study of PCI, we found NB to be very common and to be independently associated with worse QOL. These results suggest that NB should be quantified in future outcomes studies and interventions to minimize its occurrence should be explored.

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