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

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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.

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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).

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Authors and Affiliations

  1. Clinica Mediterranea, Naples, Italy

    Carlo Briguori

  2. Institute of Cardiology and Center of Excellence on Aging, “G. d’Annunzio” University – Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy

    Rosalinda Madonna, Marco Zimarino & Raffaele De Caterina

  3. Department of Cardiothoracic Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy

    Paolo Calabrò

  4. Department of Molecular Medicine and Medical Biotechnologies, “Federico II” University of Naples, Naples, Italy

    Cristina Quintavalle & Gerolama Condorelli

  5. Dimensione Ricerca, Milan, Italy

    Maria Salomone

  6. ES Health Science Foundation, Lugo, Italy

    Maria Salomone

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  1. Carlo Briguori
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  2. Rosalinda Madonna
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  8. Raffaele De Caterina
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Correspondence to Raffaele De Caterina.

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Briguori, C., Madonna, R., Zimarino, M. et al. Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial. Cardiovasc Drugs Ther 30, 465–472 (2016). https://doi.org/10.1007/s10557-016-6672-3

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  • DOI: https://doi.org/10.1007/s10557-016-6672-3

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