Effect of Remote Ischemic Preconditioning on Myocardial Injury in Noncardiac Surgery: The PRINCE Randomized Clinical Trial.
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Greco Massimiliano, Lombardi Gaetano, Brusasco Claudia, Pieri Marina, Roasio Agostino, Monaco Fabrizio, Berikashvili Levan, Belletti Alessandro, Meroi Francesco, Fresilli Stefano, Kabibulatov Aituar, Giardina Giuseppe, Russo Andrea, Oliva Federico Mattia, Efremov Sergey, Lembo Rosalba, Wang Lini, Vietri Simone, Momesso Elena, D'Amico Filippo, Kadantseva Kristina, Labanca Rosa, Ryzhkov Pavel, Marmiere Marilena, Subbotin Valerii, Pruna Alessandro, Rana Nerlep, Livi Francesca, Mantilla-Gutierrez Hugo, Guarracino Fabio, Schiavoni Lorenzo, Šitum Ivan, Micali Marco, Bosso Stefano, Smirnova Anastasia, Fresta Giuseppe, Cherednichenko Andrey, Beretta Luigi, Monti Giacomo, Ti Lian Kah, Sansone Pasquale, Corradi Francesco, Cecconi Maurizio, Yavorovskiy Andrey, Lei Chong, Konkayev Aidos, Bove Tiziana, Likhvantsev Valery, Zangrillo Alberto, Landoni Giovanni, Bellomo Rinaldo, Covello Remo Daniel, Turi Stefano, PRINCE Study Group
Аннотация
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.