Year: 2023
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: European Heart Journal
Authors: Oliver J Liakopoulos, Elmar W Kuhn, Martin Hellmich, Markus Schlömicher, Justus Strauch, Wilko Reents, Anno Diegeler, Matthias Thielmann, Daniel Wendt, Jochen Börgermann, Jan F Gummert, Christian Stoppe, Andreas Goetzenich, Sven Martens, Hermann Reichenspurner, Jens Wippermann, Hannes Reuter, Yeong-Hoon Choi, Thorsten Wahlers, for the StaRT-CABG Investigators
Institutions: Justus-Liebig-Universität Gießen, Kerckhoff Klinik, University Hospital Cologne, BG University Hospital Bergmannsheil Bochum, Ruhr University Bochum, Rhön-Klinikum, Essen University Hospital, West German Heart and Vascular Center Essen, Heart and Diabetes Center North Rhine-Westphalia, Universitätsklinikum Aachen, University of Münster, University Hospital Münster, Universität Hamburg, Otto-von-Guericke-Universität Magdeburg
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4366742796
