Custodiol versus Plegisol: A phase 3 multicentre myocardial protection study

Abstract BACKGROUND: While considered simple and effective, crystalloid antegrade cardioplegia solutions have had few prospective multicentre comparison trials. METHODS: A commercial intracellular-type histidine-tryptophan- ketoglutarate (HTK) cardioplegia solution (Custodiol HTK; Kohler Chemie GmbH, Germany) designed for 4 h of protection after a single administration was compared with a standard extracellular multi- dose product (Plegisol [PL]; Hospira Inc, USA) in an open-label, randomized, prospective seven-institution trial. A total of 136 isolated coronary bypass patients were randomly assigned into two groups and stratified by ejection fraction into categories of 40% or greater (n=118) and 20% to 39% (n=18). RESULTS: The mean age of the study cohort was 62 years, of which 94% were men. Seventy per cent of patients had Canadian Cardiovascular Society class III angina and 75% had three-vessel disease anatomy. Cross-clamp times were nearly identical for patients in both cardioplegia groups; however, defibrillation was needed less often for patients who were treated with HTK (64% versus 91%, P