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

Abstract

ObjectiveTo investigate whether remote ischaemic preconditioning (RIPC) prevents myocardial injury in patients undergoing hip fracture surgery.DesignPhase II, multicentre, randomised, observer blinded, clinical trial.SettingThree Danish university hospitals, 2015-17.Participants648 patients with cardiovascular risk factors undergoing hip fracture surgery. 286 patients were assigned to RIPC and 287 were assigned to standard practice (control group).InterventionThe 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 measuresThe 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.Results573 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).ConclusionsRIPC 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 registrationClinicalTrials.gov NCT02344797.

The risk of post‐operative myocardial injury after major emergency abdominal surgery: A retrospective cohort study

“…Myocardial injury occurred in 25 out of 168 patients (14.9%) in the remote ischaemic pre‐conditioning group and in 90 out of 287 patients (31.4%) in the control group, P = .002. Moreover, remote ischaemic pre‐conditioning reduced the occurrence of myocardial infarctions within 30 days of surgery 31 . Remote ischaemic pre‐conditioning is a promising, cheap and safe intervention.…”

“…Various randomised clinical trials have examined pre‐ and intra‐operative strategies to prevent myocardial injury and perioperative myocardial infarction; however, none have been effective 2,29,30 . A recent randomised clinical trial examined whether perioperative remote ischaemic pre‐conditioning could prevent myocardial injury after hip fracture surgery 31 . Myocardial injury occurred in 25 out of 168 patients (14.9%) in the remote ischaemic pre‐conditioning group and in 90 out of 287 patients (31.4%) in the control group, P = .002.…”

Delayed surgery versus nonoperative treatment for hip fractures in post-COVID-19 arena: a retrospective study of 145 patients

“…Surgical treatment, hence, tends to be the preferable treatment for hip fracture patients. In terms of surgery, operation promptness is crucial for better clinical outcomes in the elderly (Ekeloef et al 2019).…”

Effect of remote ischaemic preconditioning on mortality and morbidity after non-cardiac surgery: meta-analysis

“…Thirteen trials 23–25 , 27 , 28 , 30–36 , 40 reported on cardiovascular events and were included in the meta-analysis. They reported on cardiovascular death, myocardial infarction, myocardial injury, new arrhythmia, cardiac arrest, cardiac failure, low cardiac output syndrome, ischaemic ECG changes, stroke, hypoperfusion syndrome, transient ischaemic attack and newly ischaemic brain lesions on MRI.…”