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Table 3 Utility decrements for bleeding events during dual antiplatelet therapy from decision analytic models

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 [ref]

Hypothetical patient population modelled

Antiplatelet regime

Definition and categorisation of bleeding

Instrument and population used to measure QoL

Valuation method

Utility decrements for minor bleeds

Utility decrements for major bleeds

Utility decrements for other bleeds

Greenhalgh [27]

Four subgroups:

ACS with PCI for STEMI with and without T2DM; and ACS with PCI for UA or NSTEMI with and without T2DM

DAPT – prasugrel plus low-dose aspirin compared to clopidogrel plus low-dose aspirin

MS model definition for bleed does not exclude CABG-related bleeds; non-fatal bleeds not treated as on-going health states within model [such events incur only temporary reduction (14 days) in HRQoL]

MS: EQ-5D-3 L; UK population norms

MS: Time trade-off techniques

NR

MS: 25% decrement to UK population norms (free of disease) for 14 days; equal to a disutility of − 0.007

NR

Garg [28]

ACS with PCI (i.e., DES)

DAPT - clopidogrel plus low-dose aspirin; durations of 12 and 30 months

Major and minor bleeds based on TIMI bleeding risk score [disutility applied during the year in which event occurred]

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

−0.002

− 0.025

NR

Kazi [29]

ACS with PCI

Five strategies:

1) generic clopidogrel; 2) prasugrel; 3) ticagrelor; 4) CYP2C19 carriers ticagrelor and noncarriers clopidogrel; 5) CYP2C19 carriers prasugrel and noncarriers clopidogrel

Minor haemorrhage and CABG-related bleeding based on TIMI bleeding risk score and extracranial haemorrhage based on TIMI score

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

0.2 for 2 days (− 0.004)

NR

Extra-cranial: 0.2 for 14 days (− 0.0308)

CABG-related bleed: 0.5 for 7 days (− 0.01)

Liew [30]

ACS (trial data used included patients scheduled to undergo medical or invasive management (e.g., PCI or CABG)

DAPT – ticagrelor plus aspirin compared to clopidogrel plus aspirin

No clinical definitions reported [disutilities applied during the cycle (1-year cycle length) in which the event occurred]

EQ-5D-3 L

NR

−0.02

− 0.05

NR

Gupta [31]

CAS with PCI receiving either DES or BMS

DAPT - clopidogrel plus aspirin

GI bleeding

Based on the average duration of hospitalisation

NA

NR

NR

GI haemorrhage: toll of 6 days (− 0.016)

Schleinitz [32]

High-risk ACS: unstable angina and electrocardiographic changes or non-Q-wave MI

DAPT – clopidogrel plus aspirin compared to aspirin alone

GI bleeding

Assumption

NA

NR

NR

GI bleeding: − 0.005

Latour-Perez [33]

NSTEMI ACS with hospital admission

DAPT - clopidogrel plus aspirin compared to aspirin alone

GI bleeding [disutility only counted in the cycle (1-month cycle length) in which it occurred]

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

NR

NR

Serious haemorrhage disutility − 0.13; GI bleeding referred to in methods section, but no associated disutility value reported

Jiang [34]

ACS with PCI

DAPT –

Three strategies:

1) clopidogrel plus aspirin; 2) prasugrel or ticagrelor plus aspirin; and 3) CYP2C19 LOF/GOF allele prasugrel or ticagrelor plus aspirin and wild type clopidogrel plus aspirin

Nonfatal bleeding

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

NR

NR

Nonfatal bleeding: −0.250

Wang [35]

60-year old Chinese (North Asian) ACS patients who underwent PCI

DAPT –

Three strategies:

1) clopidogrel plus aspirin; 2) ticagrelor plus aspirin; and 3) CYP2C19*2 allele carriers receive ticagrelor plus aspirin and wild type clopidogrel plus aspirin

Bleeding

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

NR

NR

Bleeding: − 0.02

Jiang [36]

60-year old ACS patients undergoing PCI

DAPT –

Four strategies:

1) clopidogrel plus aspirin; 2) prasugrel or ticagrelor plus aspirin; 3) CYP2C19 LOF/GOF allele prasugrel or ticagrelor plus aspirin and wild type clopidogrel plus aspirin; and 4) low responders (PRU > 208) clopidogrel loading dose followed by prasugrel or ticagrelor plus aspirin and normal responders (PRU ≤ 208) clopidogrel plus aspirin.

Nonfatal bleeding

NR – see Additional file 1: Appendix E for more details

NR – see Additional file 1: Appendix E for more details

NR

NR

Nonfatal bleeding: −0.250

  1. ACS acute coronary syndrome, AF atrial fibrillation, AG assessment group, BMS bare metal stent, CABG coronary artery by-pass grafting, CAS coronary artery stenosis, DAPT dual antiplatelet therapy, DES drug-eluting stent, GI gastrointestinal, GOF gain-of-function, HRQoL health-related quality of life, ICD-9 International Statistical Classification of Diseases and Related Health Problems Version 9, LOS loss-of-function, MI myocardial infarction, MS manufacturer’s submission, NA not applicable, NR not reported, NSTEMI non-ST segment elevation myocardial infarction, PAD peripheral arterial disease, PCI percutaneous coronary intervention, PRU P2Y12 reaction units, QoL quality of life, SD standard deviation, SG standard gamble, STEMI ST segment elevation myocardial infarction, T2DM type 2 diabetes mellitus, TIMI [28], UA unstable angina