Effect of Remote Ischemic Preconditioning on Myocardial Injury in Noncardiac Surgery: The PRINCE Randomized Clinical Trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Major noncardiac surgery is associated with high rates of postoperative myocardial injury and other complications. Remote ischemic preconditioning (RIPC) was reported to decrease these complication rates. However, such supportive evidence lacks robustness. METHODS: In a multinational, double-blind trial, we randomly assigned adult high-risk patients undergoing noncardiac surgical procedures to receive RIPC or sham RIPC after the induction of general anesthesia and before surgery. RIPC involved three 5-minute ischemic cycles, each followed by 5 minutes of reperfusion, using a blood pressure cuff inflated to 200 mm Hg. The primary end point was the rate of myocardial injury, defined by an increase in postoperative troponin levels above the highest 99th percentile of reference values. Secondary outcomes included myocardial infarction, stroke, acute kidney injury, need for intensive care unit, length of hospital stay, and 30-day all-cause mortality. RESULTS: We recruited 1213 patients in 25 hospitals and 8 countries. We randomly assigned 599 patients to RIPC and 614 to sham RIPC. The most frequent surgical procedures were abdominal or intrathoracic surgeries (406 patients [33.6%]). RIPC was applied to the upper limb in 1014 patients (84.8%) and to the lower limb in 182 patients (15.2%). Postoperative myocardial injury occurred in 215 of 566 patients (38.0%) in the RIPC group and in 223 of 596 patients (37.4%) in the sham RIPC group (relative risk, 1.02 [95% CI, 0.88–1.18; P =0.84). There were no significant differences in the rate of any secondary outcomes. We observed 11 episodes of limb petechiae (10 [1.7%] in the RIPC group versus one [0.2%] in the sham RIPC group) and 34 (6.0%) hospital readmissions in the RIPC group versus 20 (3.5%) in the sham RIPC group. CONCLUSIONS: Among adult patients undergoing noncardiac surgery, RIPC did not reduce myocardial injury or other postoperative complications. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02427867.
Source: Circulation
Authors: Massimiliano Greco, Gaetano Lombardi, Claudia Brusasco, Marina Pieri, Agostino Roasio, Fabrizio Monaco, Levan Berikashvili, Alessandro Belletti, Francesco Meroi, Stefano Fresilli, Aituar Kabibulatov, Giuseppe Giardina, Andrea Russo, Federico Mattia Oliva, Sergey Efremov, Rosalba Lembo, Lini Wang, Simone Vietri, Elena Momesso, Filippo D’Amico, Kristina Kadantseva, Rosa Labanca, Pavel Ryzhkov, Marilena Marmiere, Valerii Subbotin, Alessandro Pruna, Nerlep Rana, Francesca Livi, Hugo Mantilla-Gutierrez, Fabio Guarracino, Lorenzo Schiavoni, Ivan Šitum, Marco Micali, Stefano Bosso, Anastasia Smirnova, Giuseppe Fresta, Andrey Cherednichenko, Luigi Beretta, Giacomo Monti, Lian Kah Ti, Pasquale Sansone, Francesco Corradi, Maurizio Cecconi, Andrey Yavorovskiy, Chong Lei, Aidos Konkayev, Tiziana Bove, Valery Likhvantsev, Alberto Zangrillo, Giovanni Landoni, Rinaldo Bellomo, Remo Daniel Covello, Stefano Turi, Matteo Aldo Bonizzoni, Tiziana Cabrini, Francesca Cavenago, Benedetta Chiodi, Edoardo Cristallo, Jacopo D’Andria Ursoleo, Noemi De Piccoli, Francesco Deni, Sara Fiorito, Rosario Losiggio, Renato Meani, Elena Moizo, Cristina Nakhnoukh, Francesco Giuseppe Nisi, Lisa Notarianni, Anita Nutta, Domenico Pontillo, Erica Ronca, Tommaso Scquizzato, Luisa Zaraca, Özgün Ömer Asiller, Marta Veneziano, Federico Ghignone, Vincenzo Bosco, Giuseppe Neri, Assyia Kadralinova, Nazerke Zhanarystan, Augusta Danella, Lorenzo Foti, Alessandra Besozzi, Laura Pasin, Jelena Lesanovis, Milica Stojicic, Michela Gandini, Marco Gemma, Michele Introna, Carolina Sassorossi, Yamume Tshomba, Renato Ricciardi, Felix Ramon Montes, Pavel Bagdasarov, Daria Yavorovskaya, Federico Piccioni, Andrea Pradella, Roman Mikhey, Yuki Kotani, Sergey Ushakov, Ekaterina Svetalkina, Massimo Zambon, Paolo Maino, Valeria Govorushkina, Maxim Monastyrnyy, Nicoletta Boffa, Maria Carmen Guarino, Ante Erceg, Federico Faitini, Daniele Orso, Cono Alberto Lanza, Martina Baiardo Redaelli, Desjan Filolli, Katia Donadello, Ekaterina Chernevskaya, Mikhail Yadgarov, Baobao Gao, Xue Yang, Antonio Pisano, Alessandro Putzu, Carolina Soledad Romero Garcia, Massimiliano Greco, Gaetano Lombardi, Marina Pieri, Rosalba Lembo, Lian Kah Ti, Chong Lei, Aidos Konkayev, Tiziana Bove, Alberto Zangrillo, Giovanni Landoni, Rinaldo Bellomo, Remo Daniel Covello, Stefano Turi, Claudia Brusasco, Agostino Roasio, Fabrizio Monaco, Giuseppe Giardina, Federico Mattia Oliva, Fabio Guarracino, Lorenzo Schiavoni, Pasquale Sansone, Valery Likhvantsev, Antonio Pisano, Alessandro Putzu, Carolina Soledad Romero Garcia
Institutions: Humanitas University, IRCCS Ospedale San Raffaele, IRCCS Humanitas Research Hospital, IRCCS San Raffaele Roma, Ente Ospedaliero Ospedali Galliera, Vita-Salute San Raffaele University, Azienda Sanitaria Locale di Asti, V.A. Negovsky Scientific Research Institute of General Reanimatology, Ospedale Santa Maria della Misericordia di Udine, Azienda sanitaria universitaria Friuli Centrale, Astana Medical University, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, St Petersburg University, Xijing Hospital, Ospedale di San Donà di Piave, Moscow Clinical Scientific Center, Ospedale regionale di Lugano, Azienda Ospedaliero-Universitaria Careggi, Institute of Cardiology, Azienda Ospedaliera Universitaria Pisana, Campus Bio Medico University Hospital, University Hospital Centre Zagreb, National University Hospital, National University Health System, University of Campania "Luigi Vanvitelli", University of Pisa, Sechenov University, University of Udine, Ministry of Health of the Russian Federation, The University of Melbourne, Monash University, Ospedale di Circolo di Busto Arsizio, Azienda Socio Sanitaria Territoriale della Valle Olona
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Ministero della Salute
Award: G378179233
OpenAlex ID: W4411283383