Claudio Moretti1, Enrico Cerrato2, Erika Cavallero3, Song Lin4, Marco Luciano Rossi5, Andrea Picchi6, Francesca Sanguineti7, Fabrizio Ugo8, Alberto Palazzuoli9, Maurizio Bertaina1, Patrizia Presbitero5, Chen Shao-Liang4, Roberto Pozzi10, Massimo Giammaria11, Ugo Limbruno6, Thierry Lefèvre7, Valeria Gasparetto12, Roberto Garbo8, Pierluigi Omedè1, Imad Sheiban12, Javier Escaned13, Giuseppe Biondi-Zoccai14, Fiorenzo Gaita1, Leor Perl15, Fabrizio D'Ascenzo1. 1. Division of Cardiology, Città Della Salute e Della Scienza, Turin, Italy. 2. Interventional Unit, University Hospital San Luigi Gonzaga, Orbassano and Rivoli Infermi Hospital, Rivoli (Turin), Italy. Electronic address: enrico.cerrato@gmail.com. 3. Division of Cardiology, Ospedale Civile SS. Annunziata, Savigliano (Cuneo), Italy. 4. Department of Cardiology, Njang, China. 5. Division of Cardiology, Istituto Clinico Humanitas, Rozzano, Milan, Italy. 6. Division of Cardiology, Grosseto, Italy. 7. Division of Cardiology, Massy, Paris, France. 8. Division of Cardiology, Hospital Giovanni Bosco, Turin, Italy. 9. Cardiovascular Diseases Unit Department of Internal Medicine, Le Scotte Hospital, University of Siena, Italy. 10. Interventional Unit, University Hospital San Luigi Gonzaga, Orbassano and Rivoli Infermi Hospital, Rivoli (Turin), Italy. 11. Division of Cardiology, Hospital Maria Vittoria, Turin, Italy. 12. Division of Cardiology, Pederzoli Hospital - Peschiera del Garda, Verona, Italy. 13. Hospital Clinico San Carlos, Madrid, Spain. 14. Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli. 15. Department of Cardiology, Rabin Medical Center, Petach-Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
BACKGROUND: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 receivedPCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabetic patients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabetic patients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS:Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabetic patients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.
RCT Entities:
BACKGROUND: The potential protective effects of remote ischemic preconditioning (RIPC) on contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) remain to be defined. METHODS AND RESULTS: A double blind, randomized, placebo controlled multicenter study was performed. Patients younger than 85years old, with a renal clearance of 30-60ml/min/1.73m2, who were candidates for PCI for all clinical indications except for primary PCI, were allocated 1:1 to RIPC or to standard therapy. The primary endpoint was incidence of CIN. The secondary endpoint was incidence of peri-procedural myocardial infarction (PMI). From February 2013 to April 2014, 3108 patients who were scheduled for coronary angiography were screened for the study. 442 fulfilled the inclusion criteria and 223 received PCI. These patients were randomized to sham RIPC (n=107) or treatment group (n=116). The only pre-specified subgroup of diabeticpatients included 85 (38%) cases. RIPC significantly reduced CIN incidence in the overall population (12.1% vs. 26.1%, p=0.01, with a NNT=9) and in non-diabeticpatients (9.2% vs. 25.0%, p=0.02), but showed no benefit in diabetics (16.7% vs. 28.2%, p=0.21). A trend for lower PMI was seen in the intervention arm (creatine kinase - muscle brain >5 URL; 8.4% vs. 16.4%, p=0.07; troponin T >5 URL; 27% vs. 38%, p=0.21). CONCLUSIONS: Remote ischemic preconditioning significantly reduces the incidence of acute kidney injury in non-diabeticpatients undergoing PCI. Larger sample size is presumably needed to assess the effect of RIPC for patients with diabetes mellitus. Clinical Trial number:NCT02195726https://www.clinicaltrial.gov/.
Authors: Ovidio De Filippo; Fabrizio D'Ascenzo; Francesco Piroli; Carlo Budano; Gaetano Maria De Ferrari Journal: J Thorac Dis Date: 2019-07 Impact factor: 2.895