TY - JOUR
T1 - Effects of bisoprolol transdermal patches for prevention of perioperative myocardial injury in high-risk patients undergoing non-cardiac surgery ― multicenter randomized controlled study ―
AU - Toda, Hironobu
AU - Nakamura, Kazufumi
AU - Shimizu, Kazuyoshi
AU - Ejiri, Kentaro
AU - Iwano, Takayuki
AU - Miyoshi, Toru
AU - Nakagawa, Koji
AU - Yoshida, Masashi
AU - Watanabe, Atsuyuki
AU - Nishii, Nobuhiro
AU - Hikasa, Yukiko
AU - Hayashi, Masao
AU - Morita, Hiroshi
AU - Morimatsu, Hiroshi
AU - Ito, Hiroshi
N1 - Funding Information:
This trial was supported by MAMACARI Investigators. We would like to acknowledge the people who worked with us on this project. We thank Kaoru Akazawa, Megumi Kondo and Masayo Ohmori for their excellent technical assistance and Dr. Trish Reynolds, MBBS, FRACP, from Edanz Group (www.edanzediting.com/ac) for editing a draft of this manuscript.
Funding Information:
This study was funded in part by TOA EIYO LTD. (JP).
PY - 2020
Y1 - 2020
N2 - Background: The aim of this study was to evaluate the efficacy and safety of transdermal β-blocker patches, which offer stable blood concentration and easy availability during operation, for prevention of perioperative myocardial injury (PMI) in high-risk patients. Methods and Results: In this randomized controlled trial, patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery were randomly assigned to a bisoprolol patch or control group. Primary efficacy outcome was incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT) >0.014ng/mL and relative hs-cTnT change ≥20%. Secondary efficacy outcomes were number of cardiovascular events and 30-day mortality. From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study. The incidence of PMI was 35.7% in the bisoprolol patch group and 44.5% in the control group (P=0.18). Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia was similar between the 2 groups. Tachyarrhythmia tended to be higher in the control group. There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups. Conclusions: Bisoprolol patches do not influence the incidence of PMI and cardiovascular events in high-risk patients undergoing non-cardiac surgery, but perioperative use of these patches is safe.
AB - Background: The aim of this study was to evaluate the efficacy and safety of transdermal β-blocker patches, which offer stable blood concentration and easy availability during operation, for prevention of perioperative myocardial injury (PMI) in high-risk patients. Methods and Results: In this randomized controlled trial, patients aged >60 years with hypertension and high revised cardiac risk index (≥2) undergoing non-cardiac surgery were randomly assigned to a bisoprolol patch or control group. Primary efficacy outcome was incidence of PMI, defined as postoperative high-sensitivity cardiac troponin T (hs-cTnT) >0.014ng/mL and relative hs-cTnT change ≥20%. Secondary efficacy outcomes were number of cardiovascular events and 30-day mortality. From November 2014 to February 2019, 240 patients from 5 hospitals were enrolled in this study. The incidence of PMI was 35.7% in the bisoprolol patch group and 44.5% in the control group (P=0.18). Incidence of major adverse cardiac events including non-critical myocardial infarction, strokes, decompensated heart failure and tachyarrhythmia was similar between the 2 groups. Tachyarrhythmia tended to be higher in the control group. There were no significant differences in safety outcomes including significant hypotension and bradycardia requiring any treatment between the 2 groups. Conclusions: Bisoprolol patches do not influence the incidence of PMI and cardiovascular events in high-risk patients undergoing non-cardiac surgery, but perioperative use of these patches is safe.
KW - Bisoprolol transdermal patch
KW - High-sensitivity cardiac troponin T
KW - Perioperative myocardial injury
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U2 - 10.1253/circj.CJ-19-0871
DO - 10.1253/circj.CJ-19-0871
M3 - Article
C2 - 32092717
AN - SCOPUS:85082542520
VL - 84
SP - 642
EP - 649
JO - Circulation Journal
JF - Circulation Journal
SN - 1346-9843
IS - 4
ER -