Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

Henrik Fox,Stefan Stadler,Michael Arzt,Leonhard Bruch,Okka W Hamer,Mirko Seidel,Florian Zeman,Olaf Oldenburg,Andrea Hetzenecker,Stefan Buchner

doi:10.1186/s13063-020-4091-z

Abstract

AimsIn acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI. Adaptive servo-ventilation (ASV) can effectively treat both types of SDB (central and obstructive sleep apnoea). The Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I) will investigate the effects of ASV therapy, added to percutaneous coronary intervention (PCI) and optimal medical management of AMI, on myocardial salvage after AMI.Methods/designTEAM ASV-I is a multicentre, randomised, parallel-group, open-label trial with blinded assessment of PCI outcomes. Patients with first AMI and successful PCI within 24 h after symptom onset and SDB (apnoea–hypopnoea index ≥ 15/h) will be randomised (1:1 ratio) to PCI and optimal medical therapy alone (control) or plus ASV (with stratification of randomisation by infarct location; left anterior descending (LAD) or no LAD lesion). The primary outcome is the MSI, assessed by cardiac magnetic resonance imaging. Key secondary outcomes are change of infarct size, left ventricular ejection fraction and B-type natriuretic peptide levels and disease-specific symptom burden at 12 weeks.ConclusionTEAM ASV-I will help to determine whether treatment of SDB with ASV in the acute phase after myocardial infarction contributes to more myocardial salvage and healing.Trial registrationClinicalTrials.gov, NCT02093377. Registered on March 21, 2014.

Highlights

TEAM Adaptive servo-ventilation (ASV)-I will help to determine whether treatment of Sleep-disordered breathing (SDB) with ASV in the acute phase after myocardial infarction contributes to more myocardial salvage and healing
After acute myocardial infarction (AMI), myocardial salvage is central to limiting permanent damage to the heart because large infarct sizes result in enduring heart failure (HF) [1], which is the most important predictor of morbidity and mortality after AMI [2]
The primary objective is to evaluate the effects of 3 months of ASV therapy in addition to percutaneous coronary intervention (PCI) and optimal medical management of AMI on myocardial salvage (myocardial salvage index (MSI)), assessed by cardiac magnetic resonance imaging (CMR)

Summary

Introduction

After acute myocardial infarction (AMI), myocardial salvage is central to limiting permanent damage to the heart because large infarct sizes result in enduring heart failure (HF) [1], which is the most important predictor of morbidity and mortality after AMI [2]. Patients with AMI are affected by two main types of SDB: obstructive sleep apnoea (OSA) and central sleep apnoea (CSA) [6, 8]. Inspiratory efforts against the occluded pharynx during obstructive apnoeas generate exaggerated negative intrathoracic pressure that increases left ventricular transmural pressure and, as a result, afterload [5]. Additional acute consequences of OSA include repetitive oxygen desaturations, sympathetic nervous system activation, increased heart rate and elevated blood pressure [5, 9]. In contrast to OSA, there is no upper airway obstruction and no respiratory effort during central apnoeas [10]. Similar to OSA, CSA causes intermittent nocturnal hypoxia, arousals from sleep, repetitive sympathetic nervous system activation, and swings in heart rate and blood pressure, but does not generate negative intrathoracic pressures [10]

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