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Cardiovascular Drugs and Therapy

, Volume 30, Issue 5, pp 465–472 | Cite as

Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial

  • Carlo Briguori
  • Rosalinda Madonna
  • Marco Zimarino
  • Paolo Calabrò
  • Cristina Quintavalle
  • Maria Salomone
  • Gerolama Condorelli
  • Raffaele De CaterinaEmail author
ORIGINAL ARTICLE

Abstract

Background

Periprocedural myocardial infarction (MI) is a frequent complication of percutaneous coronary intervention (PCI). Statins might reduce its incidence. The aims of the present study are to assess whether such benefit is a class-effect or whether differences exist between various lipid-lowering strategies and whether cardioprotection is exerted by increasing circulating endothelial progenitor cells (EPCs).

Methods

The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and - in a subset of diabetic patients - at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI.

Keywords

Percutaneous coronary intervention PCI Statins Cardioprotection Periprocedural myocardial infarction Endothelial progenitor cells 

Notes

Acknowledgments

The REMEDY Study is partially funded by AstraZeneca Italy (to RDC) and a Programma Operativo Nazionale (PON) Ricerca e Competitività 2007-2013 PON01_02342 (to CB and GC).

Supplementary material

10557_2016_6672_MOESM1_ESM.pdf (725 kb)
ESM 1 (PDF 724 kb)

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Carlo Briguori
    • 1
  • Rosalinda Madonna
    • 2
  • Marco Zimarino
    • 2
  • Paolo Calabrò
    • 3
  • Cristina Quintavalle
    • 4
  • Maria Salomone
    • 5
    • 6
  • Gerolama Condorelli
    • 4
  • Raffaele De Caterina
    • 2
    Email author
  1. 1.Clinica MediterraneaNaplesItaly
  2. 2.Institute of Cardiology and Center of Excellence on Aging“G. d’Annunzio” University – Chieti, C/o Ospedale SS. AnnunziataChietiItaly
  3. 3.Department of Cardiothoracic Sciences, Monaldi HospitalSecond University of NaplesNaplesItaly
  4. 4.Department of Molecular Medicine and Medical Biotechnologies“Federico II” University of NaplesNaplesItaly
  5. 5.Dimensione RicercaMilanItaly
  6. 6.ES Health Science FoundationLugoItaly

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