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Table 2 Utility decrements for bleeding events during dual antiplatelet therapy from primary research studies

From: Health-related quality of life impact of minor and major bleeding events during dual antiplatelet therapy: a systematic literature review and patient preference elicitation study

Author

Country

[ref]

Study design

Patient population

Antiplatelet regime

Definition and categorisation of bleeding

Instrument used to measure QoL

Valuation method

Utility decrements for any bleed

Utility decrements for minor bleeds

Utility decrements for major bleeds

Amin

US

[10]

Prospective, multicentre cohort study (TRIUMP)

3560 AMI patients who had been hospitalised

DAPT post AMI (84.9% and 13% of patients that had a nuisance bleed at any time point received thienopyridine and warfarin respectively at discharge)

Nuisance bleeding (BARC type 1b), as the occurrence of any of the four bruising/bleeding eventsc that did not lead to: hospitalisation, blood transfusion or change of medications by a physician

EQ-5D VAS at baseline, 1, 6 and 12 months

VAS

NR

BARC type 1: − 2.81 (95% CI 1.09 to 5.64) for VAS at 1 month

NR

Amin

US

[11]

Prospective, observational, longitudinal, multicentre registry (TRANSLATE -ACS)

9,290a AMI patients treated with PCI

DAPT post PCI (clopidogrel in 68%, prasugrel in 29% and ticagrelor in 2%)

Any bleeding or severe bruising event that was patient-reported, associated with an antiplatelet medication change, or independently adjudicated bleeding rehospitalisation based on medical record review; BARCb

EQ-5D-3 L questionnaire to calculate index score and VAS at baseline and 6 months

D1 valuation model [26] for index score and direct valuation using VAS

Bleeding associated with a change of − 0.033 (95% CI -0.041 to − 0.026) in index score and − 2.5 (95% CI -3.3 to − 1.8) in VAS

BARC type 1 vs none:

− 0.0257 (95% CI -0.0365 to − 0.0148) for index score; − 2.04 (95% CI -3.15 to − 0.093) for VAS

BARC type 2–4 vs none:

− 0.0381 (95% CI -0.047 to − 0.0293) for index score;

− 2.79 (95% CI -3.70 to − 1.88) for VAS

BARC type 3–4 vs none:

− 0.0445 (95% CI -0.073 to − 0.016) for index score;

− 7.10 (95% CI -10.04 to − 4.16) for VAS

  1. AMI acute myocardial infarction, BARC Bleeding Academic Research Consortium, CI confidence interval, DAPT dual antiplatelet therapy, NR not reported, PCI percutaneous coronary intervention, QoL quality of life, TRANSLATE-ACS Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome, TRIUMP Translational Research Investigating Underlying Disparities in Acute Myocardial Infarction Patients’ Health Status, VAS visual analog scale
  2. aStarted with 11,649 patients and excluded those who died in hospital (n = 13) or by 6 months (n = 106), those with missing baseline (n = 76) or 6-month EQ-5D data (n = 1928) and those with incomplete medical records or whose hospitalisation events could not be validated (n = 236)
  3. bSee Mehran et al. [21] for the definitions of the nine BARC bleeding types (type 0, type 1, type 2, type 3a, type 3b, type 3c, type 4, type 5a and type 5b)
  4. cNuisance bleeding was assessed vis the following four questions: “Since leaving the hospital after your heart attach, have you had: 1) easy or significant bleeding?; 2) significant bruising?; 3) gum bleeds or nose bleed?; or 4) serious bleeding?”
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Health and Quality of Life Outcomes

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