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

Peter Nørkjær Laursen; Lene Holmvang; Jacob Lønborg; Lars Køber; Dan E Høfsten; Steffen Helqvist; Peter Clemmensen; Henning Kelbæk; Erik Jørgensen; Jens Flensted Lassen; Frants Pedersen; Thomas Høi-Hansen; Christian Juhl Therkelsen; Hans-Henrik Tilsted; Lisette Okkels Jensen; Lars Nepper-Christensen; Golnaz Sadjadieh; Thomas Engstrøm

doi:10.1016/j.ahj.2018.05.018

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

Peter Nørkjær Laursen, Lene Holmvang, Jacob Lønborg, Lars Køber, Dan E Høfsten, Steffen Helqvist, Peter Clemmensen, Henning Kelbæk, Erik Jørgensen, Jens Flensted Lassen, Frants Pedersen, Thomas Høi-Hansen, Christian Juhl Therkelsen, Hans-Henrik Tilsted, Lisette Okkels Jensen, Lars Nepper-Christensen, Golnaz Sadjadieh, Thomas Engstrøm

Department of Clinical Medicine

4 Citations (Scopus)

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 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.

Original language	English
Journal	American Heart Journal
Volume	204
Pages (from-to)	128-138
Number of pages	11
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2018.05.018
Publication status	Published - Oct 2018

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10.1016/j.ahj.2018.05.018

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Laursen, P. N., Holmvang, L., Lønborg, J., Køber, L., Høfsten, D. E., Helqvist, S., Clemmensen, P., Kelbæk, H., Jørgensen, E., Lassen, J. F., Pedersen, F., Høi-Hansen, T., Therkelsen, C. J., Tilsted, H.-H., Jensen, L. O., Nepper-Christensen, L., Sadjadieh, G., & Engstrøm, T. (2018). Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study. American Heart Journal, 204, 128-138. https://doi.org/10.1016/j.ahj.2018.05.018

Laursen, PN, Holmvang, L, Lønborg, J, Køber, L , Høfsten, DE, Helqvist, S, Clemmensen, P, Kelbæk, H, Jørgensen, E, Lassen, JF, Pedersen, F, Høi-Hansen, T, Therkelsen, CJ, Tilsted, H-H, Jensen, LO, Nepper-Christensen, L, Sadjadieh, G & Engstrøm, T 2018, 'Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study', American Heart Journal, vol. 204, pp. 128-138. https://doi.org/10.1016/j.ahj.2018.05.018

@article{c29ac3884378489f9f36eb3bbee24135,

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

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 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.",

author = "Laursen, {Peter N{\o}rkj{\ae}r} and Lene Holmvang and Jacob L{\o}nborg and Lars K{\o}ber and H{\o}fsten, {Dan E} and Steffen Helqvist and Peter Clemmensen and Henning Kelb{\ae}k and Erik J{\o}rgensen and Lassen, {Jens Flensted} and Frants Pedersen and Thomas H{\o}i-Hansen and Therkelsen, {Christian Juhl} and Hans-Henrik Tilsted and Jensen, {Lisette Okkels} and Lars Nepper-Christensen and Golnaz Sadjadieh and Thomas Engstr{\o}m",

note = "Copyright {\textcopyright} 2018. Published by Elsevier Inc.",

year = "2018",

month = oct,

doi = "10.1016/j.ahj.2018.05.018",

language = "English",

volume = "204",

pages = "128--138",

journal = "American Heart Journal",

issn = "0002-8703",

publisher = "Mosby Inc.",

}

TY - JOUR

T1 - Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study

AU - Laursen, Peter Nørkjær

AU - Holmvang, Lene

AU - Lønborg, Jacob

AU - Køber, Lars

AU - Høfsten, Dan E

AU - Helqvist, Steffen

AU - Clemmensen, Peter

AU - Kelbæk, Henning

AU - Jørgensen, Erik

AU - Lassen, Jens Flensted

AU - Pedersen, Frants

AU - Høi-Hansen, Thomas

AU - Therkelsen, Christian Juhl

AU - Tilsted, Hans-Henrik

AU - Jensen, Lisette Okkels

AU - Nepper-Christensen, Lars

AU - Sadjadieh, Golnaz

AU - Engstrøm, Thomas

PY - 2018/10

Y1 - 2018/10

N2 - 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.

AB - 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.

U2 - 10.1016/j.ahj.2018.05.018

DO - 10.1016/j.ahj.2018.05.018

M3 - Journal article

C2 - 30103092

SN - 0002-8703

VL - 204

SP - 128

EP - 138

JO - American Heart Journal

JF - American Heart Journal

ER -

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

Abstract

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