C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study
Background: C-reactive protein (CRP) is a well-known marker of inflammation. It is less known that CRP mediates tissue damage in acute myocardial infarction (AMI) thus potentially worsening prognosis. A newly developed specific CRP adsorber allows efficient lowering of CRP levels and may improve sur...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2021-03-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2021.591714/full |
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| author | Wolfgang Ries Jan Torzewski Franz Heigl Christian Pfluecke Sebastian Kelle Sebastian Kelle Sebastian Kelle Harald Darius Hueseyin Ince Steffen Mitzner Peter Nordbeck Christian Butter Horst Skarabis Ahmed Sheriff Christoph D. Garlichs |
| author_facet | Wolfgang Ries Jan Torzewski Franz Heigl Christian Pfluecke Sebastian Kelle Sebastian Kelle Sebastian Kelle Harald Darius Hueseyin Ince Steffen Mitzner Peter Nordbeck Christian Butter Horst Skarabis Ahmed Sheriff Christoph D. Garlichs |
| author_sort | Wolfgang Ries |
| collection | DOAJ |
| description | Background: C-reactive protein (CRP) is a well-known marker of inflammation. It is less known that CRP mediates tissue damage in acute myocardial infarction (AMI) thus potentially worsening prognosis. A newly developed specific CRP adsorber allows efficient lowering of CRP levels and may improve survival.Objectives: Aim of this multi-center, controlled, non-randomized first-in-man CRP apheresis in Acute Myocardial Infarction study (CAMI-1) was to investigate the relationship between CRP levels (CRP gradient), myocardial infarct size and function as well as safety and efficacy of CRP apheresis in the setting of acute ST-segment Elevation Myocardial Infarction (STEMI) in humans.Methods: Eighty-three patients (45 apheresis, 38 controls) were recruited. CRP apheresis was performed 24 ± 12, 48 ± 12, and optionally 72 ± 12 h after onset of symptoms. First aphereses were performed at a median CRP concentration of 23.0 mg/L (range 9–279). In each apheresis session, 5,900 ± 400 mL plasma was processed via peripheral venous access. Primary study endpoint was a reduction in myocardial infarct size after STEMI as determined by cardiovascular magnetic resonance (CMR).Results: In controls, the CRP concentration significantly correlated with infarct size (p = 0.002) and decreased myocardial function (p ≤ 0.001). The CRP concentration in apheresis patients did not correlate with infarct size (p = 0.66) or left ventricular (LV) function (p = 0.79) and global strains and therefore significantly differed from controls (p = 0.03 and p = 0.002). Three major adverse cardiac events occurred in the control group after 12 months, none occurred in the apheresis group. Mean CRP depletion achieved over all apheresis procedures was 53.0 ± 15.1%. Apheresis sessions were well-tolerated. Reduced infarct size in the apheresis group compared to the control group (primary endpoint) was not achieved according to the original statistical analysis plan. Taking into account the individual CRP levels, however, revealed significant results. Modifications of the analysis plan were introduced in order to recruit a sufficient number of patients.Conclusions: This pilot study in humans reveals a correlation between CRP concentration and myocardial infarct size. CRP concentrations in STEMI can effectively be reduced by CRP apheresis without relevant side effects. CRP apheresis has the potential to interfere with deleterious aspects of STEMI. By lowering CRP levels, it resulted in the loss of correlation of CRP concentrations with myocardial infarct sizes as well as LV function. These results encourage a larger, randomized clinical trial.Clinical Trial Registration:https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008988, DRKS00008988. |
| first_indexed | 2024-12-17T08:42:05Z |
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| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-12-17T08:42:05Z |
| publishDate | 2021-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-605584fcc8614f0a9dd8a1bad51f48342022-12-21T21:56:19ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2021-03-01810.3389/fcvm.2021.591714591714C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 StudyWolfgang Ries0Jan Torzewski1Franz Heigl2Christian Pfluecke3Sebastian Kelle4Sebastian Kelle5Sebastian Kelle6Harald Darius7Hueseyin Ince8Steffen Mitzner9Peter Nordbeck10Christian Butter11Horst Skarabis12Ahmed Sheriff13Christoph D. Garlichs14Medical Clinic, Diakonissenhospital Flensburg, Flensburg, GermanyCardiovascular Center Oberallgäu-Kempten, Kempten, GermanyMedical Care Center Kempten-Allgäu, Kempten, GermanyDepartment for Internal Medicine/Cardiology, Heart Center Dresden, Dresden, GermanyDepartment of Internal Medicine/Cardiology, German Heart Center Berlin, Berlin, GermanyDepartment of Internal Medicine/Cardiology, Charité University Medicine Berlin, Campus Virchow, Berlin, GermanyDeutsches Zentrum für Herz-Kreislauf-Forschung (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, GermanyClinic for Cardiology, Angiology, Nephrology, Intensive Care Medicine, Vivantes Clinic Neukölln, Berlin, GermanyDivisions of Cardiology and Nephrology, Department of Internal Medicine, University Medicine Rostock, Rostock, GermanyDivisions of Cardiology and Nephrology, Department of Internal Medicine, University Medicine Rostock, Rostock, Germany0Medical Clinic (Cardiology), University Clinic Würzburg, Würzburg, Germany1Immanuel Clinic Bernau, Heart Center Brandenburg, Bernau, Germany2Statistical Consultant, Groß-Oesingen, Germany3Department of Gastroenterology/Infectiology/Rheumatology, Charité University Medicine Berlin, Berlin, GermanyMedical Clinic, Diakonissenhospital Flensburg, Flensburg, GermanyBackground: C-reactive protein (CRP) is a well-known marker of inflammation. It is less known that CRP mediates tissue damage in acute myocardial infarction (AMI) thus potentially worsening prognosis. A newly developed specific CRP adsorber allows efficient lowering of CRP levels and may improve survival.Objectives: Aim of this multi-center, controlled, non-randomized first-in-man CRP apheresis in Acute Myocardial Infarction study (CAMI-1) was to investigate the relationship between CRP levels (CRP gradient), myocardial infarct size and function as well as safety and efficacy of CRP apheresis in the setting of acute ST-segment Elevation Myocardial Infarction (STEMI) in humans.Methods: Eighty-three patients (45 apheresis, 38 controls) were recruited. CRP apheresis was performed 24 ± 12, 48 ± 12, and optionally 72 ± 12 h after onset of symptoms. First aphereses were performed at a median CRP concentration of 23.0 mg/L (range 9–279). In each apheresis session, 5,900 ± 400 mL plasma was processed via peripheral venous access. Primary study endpoint was a reduction in myocardial infarct size after STEMI as determined by cardiovascular magnetic resonance (CMR).Results: In controls, the CRP concentration significantly correlated with infarct size (p = 0.002) and decreased myocardial function (p ≤ 0.001). The CRP concentration in apheresis patients did not correlate with infarct size (p = 0.66) or left ventricular (LV) function (p = 0.79) and global strains and therefore significantly differed from controls (p = 0.03 and p = 0.002). Three major adverse cardiac events occurred in the control group after 12 months, none occurred in the apheresis group. Mean CRP depletion achieved over all apheresis procedures was 53.0 ± 15.1%. Apheresis sessions were well-tolerated. Reduced infarct size in the apheresis group compared to the control group (primary endpoint) was not achieved according to the original statistical analysis plan. Taking into account the individual CRP levels, however, revealed significant results. Modifications of the analysis plan were introduced in order to recruit a sufficient number of patients.Conclusions: This pilot study in humans reveals a correlation between CRP concentration and myocardial infarct size. CRP concentrations in STEMI can effectively be reduced by CRP apheresis without relevant side effects. CRP apheresis has the potential to interfere with deleterious aspects of STEMI. By lowering CRP levels, it resulted in the loss of correlation of CRP concentrations with myocardial infarct sizes as well as LV function. These results encourage a larger, randomized clinical trial.Clinical Trial Registration:https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008988, DRKS00008988.https://www.frontiersin.org/articles/10.3389/fcvm.2021.591714/fullapheresismyocardial infarctionCRPimmunoadsorptioninflammation |
| spellingShingle | Wolfgang Ries Jan Torzewski Franz Heigl Christian Pfluecke Sebastian Kelle Sebastian Kelle Sebastian Kelle Harald Darius Hueseyin Ince Steffen Mitzner Peter Nordbeck Christian Butter Horst Skarabis Ahmed Sheriff Christoph D. Garlichs C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study Frontiers in Cardiovascular Medicine apheresis myocardial infarction CRP immunoadsorption inflammation |
| title | C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study |
| title_full | C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study |
| title_fullStr | C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study |
| title_full_unstemmed | C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study |
| title_short | C-Reactive Protein Apheresis as Anti-inflammatory Therapy in Acute Myocardial Infarction: Results of the CAMI-1 Study |
| title_sort | c reactive protein apheresis as anti inflammatory therapy in acute myocardial infarction results of the cami 1 study |
| topic | apheresis myocardial infarction CRP immunoadsorption inflammation |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2021.591714/full |
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