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Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study

Laursen, Peter Nørkjær ; Holmvang, Lene ; Lønborg, Jacob ; Køber, Lars ; Høfsten, Dan E. ; Helqvist, Steffen ; Clemmensen, Peter ; Kelbæk, Henning ; Jørgensen, Erik and Lassen, Jens Flensted , et al. (2018) In American Heart Journal 204. p.128-138
Abstract

Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI. Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was... (More)

Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI. Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality. Results: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P <.001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P <.001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all <.001). Conclusions: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.

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American Heart Journal
volume
204
pages
11 pages
publisher
Mosby
external identifiers
  • scopus:85051265826
  • pmid:30103092
ISSN
0002-8703
DOI
10.1016/j.ahj.2018.05.018
language
English
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yes
id
3d72e9e7-ed48-4e19-b0d1-92619a104ee0
date added to LUP
2018-09-06 12:15:43
date last changed
2020-04-02 02:03:55
@article{3d72e9e7-ed48-4e19-b0d1-92619a104ee0,
  abstract     = {<p>Background: The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI. Methods: In this cohort study, we compared patients with IHD who were randomized in RCTs in relation to undergoing PCI in Denmark between 2011 and 2015 were considered as RCT-participants in this study. The RCT-participants were compared with contemporary nonparticipants with IHD undergoing PCI in the same period, and they were identified using unselected national registry data. The primary end point was all-cause mortality. Results: A total of 10,317 (30%) patients were included in 10 relevant RCTs (trial participants), and a total of 23,644 (70%) contemporary patients did not participate (nonparticipants). In all the included RCTs, nonparticipants had higher hazard ratios for mortality compared to trial participants (P &lt;.001). Among all patients treated with PCI, the pooled estimates showed a significantly higher mortality rate for nonparticipants compared to trial participants (hazard ratio: 2.03, 95% CI: 1.88-2.19) (P &lt;.001). When patients were stratified according to indication for PCI, the pooled estimates showed a significantly lower mortality rate for trial participants compared to nonparticipants in all strata (P for all &lt;.001). Conclusions: Trial participants in recently performed RCTs including patients undergoing PCI were not representative of the general population of patients with IHD treated with PCI according to clinical characteristics and mortality. The difference in mortality was found irrespective of the indication for PCI. Thus, results from RCTs including patients undergoing PCI should be extrapolated with caution to the general patient population.</p>},
  author       = {Laursen, Peter Nørkjær and Holmvang, Lene and Lønborg, Jacob and Køber, Lars and Høfsten, Dan E. and Helqvist, Steffen and Clemmensen, Peter and Kelbæk, Henning and Jørgensen, Erik and Lassen, Jens Flensted and Pedersen, Frants and Høi-Hansen, Thomas and Therkelsen, Christian Juhl and Tilsted, Hans Henrik and Jensen, Lisette Okkels and Nepper-Christensen, Lars and Sadjadieh, Golnaz and Engstrøm, Thomas},
  issn         = {0002-8703},
  language     = {eng},
  month        = {10},
  pages        = {128--138},
  publisher    = {Mosby},
  series       = {American Heart Journal},
  title        = {Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study},
  url          = {http://dx.doi.org/10.1016/j.ahj.2018.05.018},
  doi          = {10.1016/j.ahj.2018.05.018},
  volume       = {204},
  year         = {2018},
}