Statin loading before coronary artery bypass grafting: a randomized trial
European Heart Journal, vol. 44, pp. 2322–2331
Abstract
AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.
Authors 19
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Oliver Joannis Liakopoulos corresponding
Justus-Liebig-Universität Gießen · Kerckhoff Klinik · University Hospital Cologne
Affiliation as printed
Department of Cardiac Surgery, Kerckhoff-Clinic, Campus Kerckhoff, Justus-Liebig-University of Giessen , Benekestr. 2-8, 61231 Bad Nauheim , Germany
Department of Cardiothoracic Surgery, University Hospital Cologne , Kerpener Str. 62, 50937 Cologne , Germany
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Affiliation as printed
Department of Cardiothoracic Surgery, University Hospital Cologne , Kerpener Str. 62, 50937 Cologne , Germany
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Affiliation as printed
Institute of Medical Statistics and Computational Biology, University Hospital Cologne , Cologne , Germany
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BG University Hospital Bergmannsheil Bochum · Ruhr University Bochum
Affiliation as printed
Department of Cardiothoracic Surgery, Ruhr-University Hospital Bergmannsheil , Bochum , Germany
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BG University Hospital Bergmannsheil Bochum · Ruhr University Bochum
Affiliation as printed
Department of Cardiothoracic Surgery, Ruhr-University Hospital Bergmannsheil , Bochum , Germany
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Affiliation as printed
Department of Cardiac Surgery , Bad Neustadt a. d. Saale , Germany
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Affiliation as printed
Department of Cardiac Surgery , Bad Neustadt a. d. Saale , Germany
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Essen University Hospital · West German Heart and Vascular Center Essen
Affiliation as printed
Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital Essen , Essen , Germany
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Essen University Hospital · West German Heart and Vascular Center Essen
Affiliation as printed
Department of Thoracic and Cardiovascular Surgery, West German Heart and Vascular Center Essen, University Hospital Essen , Essen , Germany
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Heart and Diabetes Center North Rhine-Westphalia · Ruhr University Bochum
Affiliation as printed
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum , Bad Oeynhausen , Germany
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Heart and Diabetes Center North Rhine-Westphalia · Ruhr University Bochum
Affiliation as printed
Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum , Bad Oeynhausen , Germany
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Affiliation as printed
Department of Thoracic and Cardiovascular Surgery, University Hospital Aachen , Aachen , Germany
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Affiliation as printed
Department of Thoracic and Cardiovascular Surgery, University Hospital Aachen , Aachen , Germany
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University of Münster · University Hospital Münster
Affiliation as printed
Department of Cardiac and Thoracic Surgery, University Hospital Münster , Münster , Germany
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Affiliation as printed
Department of Cardiovascular Surgery, University Heart Center Hamburg , Hamburg , Germany
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Otto-von-Guericke-Universität Magdeburg
Affiliation as printed
Department of Cardiothoracic Surgery, Otto-von Guericke University , Magdeburg , Germany
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Affiliation as printed
Department of Cardiology, University Hospital Cologne , Cologne , Germany
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Justus-Liebig-Universität Gießen · Kerckhoff Klinik · University Hospital Cologne
Affiliation as printed
Department of Cardiac Surgery, Kerckhoff-Clinic, Campus Kerckhoff, Justus-Liebig-University of Giessen , Benekestr. 2-8, 61231 Bad Nauheim , Germany
Department of Cardiothoracic Surgery, University Hospital Cologne , Kerpener Str. 62, 50937 Cologne , Germany
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Affiliation as printed
Department of Cardiothoracic Surgery, University Hospital Cologne , Kerpener Str. 62, 50937 Cologne , Germany
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