The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): Phase II randomised clinical trial

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial) : Phase II randomised clinical trial. / Ekeloef, Sarah; Homilius, Morten; Stilling, Maiken; Ekeloef, Peter; Koyuncu, Seda; Münster, Anna Marie Bloch; Meyhoff, Christian S.; Gundel, Ossian; Holst-Knudsen, Julie; Mathiesen, Ole; Gögenur, Ismail.

In: The BMJ, Vol. 367, l6395, 2019.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Ekeloef, S, Homilius, M, Stilling, M, Ekeloef, P, Koyuncu, S, Münster, AMB, Meyhoff, CS, Gundel, O, Holst-Knudsen, J, Mathiesen, O & Gögenur, I 2019, 'The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): Phase II randomised clinical trial', The BMJ, vol. 367, l6395. https://doi.org/10.1136/bmj.l6395

APA

Ekeloef, S., Homilius, M., Stilling, M., Ekeloef, P., Koyuncu, S., Münster, A. M. B., ... Gögenur, I. (2019). The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): Phase II randomised clinical trial. The BMJ, 367, [l6395]. https://doi.org/10.1136/bmj.l6395

Vancouver

Ekeloef S, Homilius M, Stilling M, Ekeloef P, Koyuncu S, Münster AMB et al. The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): Phase II randomised clinical trial. The BMJ. 2019;367. l6395. https://doi.org/10.1136/bmj.l6395

Author

Ekeloef, Sarah ; Homilius, Morten ; Stilling, Maiken ; Ekeloef, Peter ; Koyuncu, Seda ; Münster, Anna Marie Bloch ; Meyhoff, Christian S. ; Gundel, Ossian ; Holst-Knudsen, Julie ; Mathiesen, Ole ; Gögenur, Ismail. / The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial) : Phase II randomised clinical trial. In: The BMJ. 2019 ; Vol. 367.

Bibtex

@article{90f48f464c6a455cbb08fe436a43502f,
title = "The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): Phase II randomised clinical trial",
abstract = "Objective To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery. Design Phase II, multicentre, randomised, observer blinded, clinical trial. Setting Three Danish university hospitals, 2015-17. Participants 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group). Intervention The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes. Main outcome measures The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere. Results 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70{\%}) women). The primary outcome occurred in 25 of 168 (15{\%}) patients in the RIPC group and 45 of 158 (28{\%}) in the control group (odds ratio 0.44, 95{\%} confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20{\%}) in the RIPC group and 90 of 287 (31{\%}) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3{\%}) in the RIPC group and 21 patients (7{\%}) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit). Conclusions RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality. Trial registration ClinicalTrials.gov NCT02344797.",
author = "Sarah Ekeloef and Morten Homilius and Maiken Stilling and Peter Ekeloef and Seda Koyuncu and M{\"u}nster, {Anna Marie Bloch} and Meyhoff, {Christian S.} and Ossian Gundel and Julie Holst-Knudsen and Ole Mathiesen and Ismail G{\"o}genur",
year = "2019",
doi = "10.1136/bmj.l6395",
language = "English",
volume = "367",
journal = "B M J",
issn = "0959-8146",
publisher = "BMJ Publishing Group",

}

RIS

TY - JOUR

T1 - The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial)

T2 - Phase II randomised clinical trial

AU - Ekeloef, Sarah

AU - Homilius, Morten

AU - Stilling, Maiken

AU - Ekeloef, Peter

AU - Koyuncu, Seda

AU - Münster, Anna Marie Bloch

AU - Meyhoff, Christian S.

AU - Gundel, Ossian

AU - Holst-Knudsen, Julie

AU - Mathiesen, Ole

AU - Gögenur, Ismail

PY - 2019

Y1 - 2019

N2 - Objective To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery. Design Phase II, multicentre, randomised, observer blinded, clinical trial. Setting Three Danish university hospitals, 2015-17. Participants 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group). Intervention The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes. Main outcome measures The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere. Results 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70%) women). The primary outcome occurred in 25 of 168 (15%) patients in the RIPC group and 45 of 158 (28%) in the control group (odds ratio 0.44, 95% confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20%) in the RIPC group and 90 of 287 (31%) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3%) in the RIPC group and 21 patients (7%) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit). Conclusions RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality. Trial registration ClinicalTrials.gov NCT02344797.

AB - Objective To investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery. Design Phase II, multicentre, randomised, observer blinded, clinical trial. Setting Three Danish university hospitals, 2015-17. Participants 648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group). Intervention The RIPC procedure was initiated before surgery with a tourniquet applied to the upper arm and consisted of four cycles of forearm ischaemia for five minutes followed by reperfusion for five minutes. Main outcome measures The original primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more caused by ischaemia. The revised primary outcome was myocardial injury within four days of surgery, defined as a peak plasma cardiac troponin I concentration of 45 ng/L or more or high sensitive troponin I greater than 24 ng/L (the primary outcome was changed owing to availability of testing). Secondary outcomes were peak plasma troponin I and total troponin I release during the first four days after surgery (cardiac and high sensitive troponin I), perioperative myocardial infarction, major adverse cardiovascular events, and all cause mortality within 30 days of surgery, length of postoperative stay, and length of stay in the intensive care unit. Several planned secondary outcomes will be reported elsewhere. Results 573 of the 648 randomised patients were included in the intention-to-treat analysis (mean age 79 (SD 10) years; 399 (70%) women). The primary outcome occurred in 25 of 168 (15%) patients in the RIPC group and 45 of 158 (28%) in the control group (odds ratio 0.44, 95% confidence interval 0.25 to 0.76; P=0.003). The revised primary outcome occurred in 57 of 286 patients (20%) in the RIPC group and 90 of 287 (31%) in the control group (0.55, 0.37 to 0.80; P=0.002). Myocardial infarction occurred in 10 patients (3%) in the RIPC group and 21 patients (7%) in the control group (0.46, 0.21 to 0.99; P=0.04). Statistical power was insufficient to draw firm conclusions on differences between groups for the other clinical secondary outcomes (major adverse cardiovascular events, 30 day all cause mortality, length of postoperative stay, and length of stay in the intensive care unit). Conclusions RIPC reduced the risk of myocardial injury and infarction after emergency hip fracture surgery. It cannot be concluded that RIPC overall prevents major adverse cardiovascular events after surgery. The findings support larger scale clinical trials to assess longer term clinical outcomes and mortality. Trial registration ClinicalTrials.gov NCT02344797.

U2 - 10.1136/bmj.l6395

DO - 10.1136/bmj.l6395

M3 - Journal article

C2 - 31801725

AN - SCOPUS:85076122173

VL - 367

JO - B M J

JF - B M J

SN - 0959-8146

M1 - l6395

ER -

ID: 239012591