Skip to main content

Table 4 On-treatment MACE (ITT population)

From: Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial

 FF/UMEC/VI
(N = 4151)
FF/VI
(N = 4134)
UMEC/VI
(N = 2070)
Total duration at risk (patient-years)3714.93457.91698.3
 n (%)Rate [#]n (%)Rate [#]n (%)Rate [#]
Narrow definition
Any MACE80 (2)22.3 [83]60 (1)18.8 [65]37 (2)22.4 [38]
 Adjudicated CV death20 (< 1)5.4 [20]27 (< 1)7.8 [27]16 (< 1)9.4 [16]
 Non-fatal CNS hemorrhages and cerebrovascular conditions (SMQ)38 (< 1)10.8 [40]21 (< 1)7.2 [25]10 (< 1)5.9 [10]
 Non-fatal MI (PT)9 (< 1)2.4 [9]6 (< 1)1.7 [6]5 (< 1)2.9 [5]
 Non-fatal acute MI (PT)13 (< 1)3.8 [14]7 (< 1)2.0 [7]7 (< 1)4.1 [7]
Broad definition
Any MACE133 (3)44.7 [166]100 (2)35.3 [122]66 (3)44.8 [76]
 Adjudicated CV death20 (< 1)5.4 [20]27 (< 1)7.8 [27]16 (< 1)9.4 [16]
 Non-fatal CNS hemorrhages and cerebrovascular conditions (SMQ)38 (< 1)10.8 [40]21 (< 1)7.2 [25]10 (< 1)5.9 [10]
 Non-fatal MI (SMQ)49 (1)14.0 [52]29 (< 1)9.3 [32]24 (1)14.7 [25]
 Non-fatal other ischemic heart disease (SMQ)41 (< 1)14.5 [54]32 (< 1)11.0 [38]25 (1)14.7 [25]
  1. #, number of events. Rates are reported as number of events per 1000 patient-years, calculated as the number of events × 1000, divided by the total duration at risk
  2. CNS Central nervous system; CV Cardiovascular; FF Fluticasone furoate; ITT Intent-to-treat; MACE Major adverse cardiac event; MedDRA Medical Dictionary for Regulatory Activities; MI Myocardial infarction; n, number of patients; PT Preferred Term; SMQ Standardized MedDRA Query; UMEC Umeclidinium; VI Vilanterol