Effects of Routine Early Treatment with PCSK-9 inhibitor in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: A randomized, double-blind, sham-controlled trial

EuroIntervention 2022;18:e-e. DOI: 10.4244/EIJ-D-22-00735

Shamir R. Mehta
Shamir R. Mehta1,2,2, MD, MSc; Guillaume Pare1,2,3,4, MD, MSc; Eva M Lonn1,2,3, MD, MSc; Sanjit S Jolly1,2,3, MD; Madhu K Natarajan1,2,3, MD; Natalia Pinilla-Echeverri1,2,3, MD, MSc; Jon-David Schwalm1,2,3, MD, MSc; Tej N. Sheth1,2,3, MD; Matthew Sibbald2,3, MD, PhD; Michael Tsang2,3, MD; Nicholas Valettas2,3, MD, MASc; James L Velianou2,3, MD; Shun Fu Lee1, PhD; Tahsin Ferdous1, MSc; Sadia Nauman3, MBBS, MSc; Helen Nguyen1, BSc; Tara McCready1, PhD, MBA; Matthew J McQueen1,2,3,4, MBChB, PhD
1. Population Health Research Institute, Hamilton, Ontario, Canada; 2. Department of Medicine, McMaster University, Hamilton, Ontario, Canada; 3. Hamilton Health Sciences, Hamilton, Ontario, Canada; 4. Department of Pathology and Molecular Medicine, Hamilton, Ontario, Canada
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Abstract

Background: In patients with STEMI, early initiation of high-intensity statin, regardless of LDL-cholesterol levels, is the standard of practice worldwide.   Aims: To determine the effect of a similar early initiation strategy using PCSK9 inhibitor added to high-intensity statin on LDL-cholesterol in acute STEMI. Methods: In a randomized, double-blind trial we assigned 68 patients with STEMI undergoing primary PCI to early treatment with alirocumab 150mg subcutaneously or matching sham-control. The first injection was given before primary PCI regardless of baseline LDL level, then at 2 and 4 weeks. The primary outcome was percent reduction in direct LDL-cholesterol up to 6 weeks, analyzed using a linear-mixed model.    Results: High-intensity statin use was 97% and 100% in the alirocumab/sham-control groups, respectively. At a median of 45 days, the primary outcome of LDL-cholesterol decreased by 72.9% with alirocumab (2.97mmol/L to 0.75mmol/L) versus 48.1% with sham-control (2.87mmol/L to 1.30mmol/L), for a mean between-group difference of -22.3% (P<0.001). More patients achieved ESC/EAS dyslipidemia guideline target LDL≤1.4 mmol/L in the alirocumab group (92.1% v 56.7%, P<0.001). Within the first 24 hours, LDL declined slightly more rapidly in the alirocumab group then sham-control (-0.01 mmol/L/hour, P=0.03) with similar between-group mean values.   Conclusion: In this randomized trial of routine early initiation of PCSK9 inhibitor in patients undergoing primary PCI for STEMI, alirocumab reduced LDL-cholesterol by 22% compared with sham-control on a background on high-intensity statin. A large trial is needed to determine if this simplified approach followed by long term therapy improves cardiovascular outcomes in patients with acute STEMI.

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