Effects of Bisoprolol Transdermal Patches for Prevention of Perioperative Myocardial Injury in High-Risk Patients Undergoing Non-Cardiac Surgery　― Multicenter Randomized Controlled Study ―

Abstract

on behalf of the MAMACARI Investigators 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.

2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery

“…8,41,101,[109][110][111]118,413,564,[636][637][638][639]641 No single intervention has yet been proven to be unequivocally beneficial in the prevention of PMI. 185,644 It is important to highlight that PMI is not a homogenous disease. Several different pathophysiologies and clinical phenotypes may underlie PMI (Figure 18).…”

“…Anecdotal evidence suggests that it is likely that the incidence is also higher than expected in the perioperative setting. 8,41,101,[109][110][111]118,413,564,[636][637][638][639]641,644…”

Long-term major adverse cardiovascular events following myocardial injury after non-cardiac surgery: meta-analysis

“…A summary of study characteristics is included in Table 1 . The majority of studies included all types of non-cardiac surgery in their eligibility criteria 2 , 15 , 22 , 30 , 33–35 , 37 , 38 , 40 , 43 , 44 , 46–49 , 51 , 56 , 58 , 60–62 , 65 . Seventeen studies focused on specific surgical subspecialties including vascular 28 , 39 , 41 , 42 , 45 , 52–54 , orthopaedic 29 , 31 , 32 , 50 , 55 , 59 , 64 , urology 36 , 63 and thoracic surgery 36 , 63 .…”

“…Seventeen studies focused on specific surgical subspecialties including vascular 28 , 39 , 41 , 42 , 45 , 52–54 , orthopaedic 29 , 31 , 32 , 50 , 55 , 59 , 64 , urology 36 , 63 and thoracic surgery 36 , 63 . Regarding surgical acuity, only two studies focused on emergency non-cardiac surgery 31 , 32 , whilst nine studies specifically included only patients undergoing elective surgery 28 , 35–38 , 52 , 53 , 58 , 63 .…”

“…For MACE rates, myocardial infarction was the most frequently reported outcome (16) 28 , 29 , 31 , 37 , 48 , 50–53 , 56 , 57 , 59–61 , 64 , 65 , followed by heart failure (9) 2 , 28 , 31 , 37 , 48 , 53 , 56 , 64 , 65 and arrhythmia (5) 31 , 36 , 48 , 56 , 65 . All three control arms from randomized controlled studies also reported rates of death or mortality, MACE and myocardial infarction 15 , 32 , 58 . None of the included studies reported outcomes for cardiac arrest or amputation.…”