TY - JOUR

T1 - Systematic review and consensus definitions for the Standardized Endpoints in Perioperative Medicine (StEP) initiative

T2 - cardiovascular outcomes

AU - Beattie, W. Scott

AU - Lalu, Manoj

AU - Bocock, Matthew

AU - Feng, Simon

AU - Wijeysundera, Duminda N.

AU - Nagele, Peter

AU - Fleisher, Lee A.

AU - Kurz, Andrea

AU - Biccard, Bruce

AU - Leslie, Kate

AU - Howell, Simon

AU - Landoni, Giovani

AU - Grocott, Hilary

AU - Lamy, Andre

AU - Richards, Toby

AU - Myles, Paul

AU - Gan, T. J.

AU - Peyton, Phil

AU - Sessler, Dan

AU - Tramèr, Martin

AU - Cyna, Alan

AU - De Oliveira, Gildasio S.

AU - Wu, Christopher

AU - Jensen, Mark

AU - Kehlet, Henrik

AU - Botti, Mari

AU - Boney, Oliver

AU - Haller, Guy

AU - Grocott, Mike

AU - Cook, Tim

AU - Fleisher, Lee

AU - Neuman, Mark

AU - Story, David

AU - Gruen, Russell

AU - Bampoe, Sam

AU - Evered, Lis

AU - Scott, David

AU - Silbert, Brendan

AU - van Dijk, Diederik

AU - Kalkman, Cor

AU - Chan, Matthew

AU - Eckenhoff, Rod

AU - Rasmussen, Lars

AU - Eriksson, Lars

AU - Landoni, Giovanni

AU - Bartlett, Richard J.

AU - McMonnies, Robert

AU - Gerstl, Jacob

AU - Moller, Ann

AU - Klein, Andy

AU - StEP COMPAC Group

N1 - Publisher Copyright: © 2020 British Journal of Anaesthesia

PY - 2021

Y1 - 2021

N2 - Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

AB - Background: Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials. Methods: We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity. Results: We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined. Conclusions: These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.

KW - cardiovascular events

KW - clinical trials

KW - MACE

KW - myocardial infarction

KW - outcome measures

KW - perioperative medicine

KW - standardised endpoint

U2 - 10.1016/j.bja.2020.09.023

DO - 10.1016/j.bja.2020.09.023

M3 - Review

C2 - 33092804

AN - SCOPUS:85092930137

VL - 126

SP - 56

EP - 66

JO - British Journal of Anaesthesia

JF - British Journal of Anaesthesia

SN - 0007-0912

IS - 1

ER -