Pneumologie 2015; 69 - P144
DOI: 10.1055/s-0035-1544715

Prognostic factors of mortality and cardiovascular outcomes in the Tiotropium Safety and Performance in Respimat (TIOSPIR) trial

C Geßner 1, R Dahl 2, D Dusser 3, R Wise 4, G Pledger 5, A Anzueto 6, A Mueller 7, A Fowler 8, P Calverley 9
  • 1Praxis Leipzig
  • 2Allergy Centre, Odense University Hospital
  • 3Service de Pneumologie, Hopital Cochin, AP-HP, Université Paris Descartes, Sorbonne Paris Cité
  • 4Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine
  • 5Statistics, Independent Consultant, Hamilton
  • 6Pulmonary/Critical Care, University of Texas and South Texas Health Care System
  • 7Global Clinical Operations + Biom. and Data Man., Boehringer Ingelheim Pharma GmbH & Co KG
  • 8Medical Affairs, Boehringer Ingelheim Ltd Bracknell
  • 9Respiratory Medicine, Institute of Ageing and Chronic Disease, University of Liverpool

Background: Cardiovascular (CV) comorbidities in chronic obstructive pulmonary disease (COPD) patients are frequent. We evaluated whether baseline variables can predict mortality and CV events in the TIOSPIR trial (17,116 COPD patients receiving tiotropium Respimat 5 or 2.5µg or HandiHaler 18µg for a mean of 2.3 yrs).

Methods: Exploratory pooled analysis from TIOSPIR to determine prognostic factors for mortality, major adverse CV event (MACE), fatal MACE, myocardial infarction and stroke outcomes was performed.

Results: Patients with the following characteristics had higher risk of death and/or CV event during the study period: Male, age= 70 yrs, low FEV1, breathlessness (MMRC= 2), CV medication use and history of CV events (ischemic heart disease [IHD], cardiac arrhythmia), or exacerbation in the last year (table).

Tab. 1: Unadjusted risk ratio (RR) by baseline characteristic for all-cause mortality/CV events

Total N N = 17116

All-cause mortality RR N = 1042

MACE RR N = 697

Fatal MACE RR N = 324

Male

12237

1.45

1.29

1.75

Age= 70yrs

5651

1.96

1.83

2.13

BMI < 18.5 (kg/m2)

1098

2.49

1.45

2.29

History of

- IHD

2594

1.57

2.10

2.50

- Arrhythmia

1825

1.70

1.74

1.90

- CV medication

8753

1.33

1.34

1.94

GOLD IV

1342

2.17

1.26

1.96

MMRC = 2

9315

1.88

1.39

2.25

= 1 Exac past yr

8285

1.39

1.01

1.24

Conclusions: In TIOSPIR, prognostic factors for CV and all-cause mortality were similar, with greater risk for CV events in patients with CV medication or history (particularly IHD). High MMRC also particularly correlated with fatal CV events. Exacerbations were prognostic for both all-cause and CV death, but not for non-fatal CV events.

Funded by Boehringer Ingelheim.

Presented at the ERS congress meeting 2014