A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery
Patrick Meybohm, Berthold Bein, Oana Brosteanu, Jochen Cremer, Matthias Gruenewald, Christian Stoppe, Mark Coburn, Gereon Schaelte, Andreas Böning, Bernd Niemann, Jan Roesner, Frank Kletzin, Ulrich Strouhal, Christian Reyher, Rita Laufenberg-Feldmann, Marion Ferner, Ivo F Brandes, Martin Bauer, Sebastian N Stehr, Andreas Kortgen, Maria Wittmann, Georg Baumgarten, Tanja Meyer-Treschan, Peter Kienbaum, Matthias Heringlake, Julika Schön, Michael Sander, Sascha Treskatsch, Thorsten Smul, Ewa Wolwender, Thomas Schilling, Georg Fuernau, Dirk Hasenclever, Kai Zacharowski, RIPHeart Study Collaborators, Ana Stevanovic, Rolf Rossaint, Marc Felzen, Andreas Goetzenich, Tobias Moormann, Katharina Chalk, Pascal Knuefermann, Olaf Boehm, Andreas Hoeft, Michael Winterhalter, Sonja Iken, Christian Weber, Carolin Wiedenbeck, Gerhard Schwarzmann, Karin Pense, Andreas Zierer, Stephan Fichtlscherer, Gerold Goerlach, Matthias Wollbrueck, Ursula Boening, Markus Weigand, Julia Strauchmann, Konrad August, Kai U Morsbach, Markus Paxian, Konrad Reinhard, Jens Scholz, Jochen Renner, Ole Broch, Helga Francksen, Martin Albrecht, Bernd Kuhr, Hermann Heinze, Hauke Paarmann, Hans-Hinrich Sievers, Stefan Klotz, Thomas Hachenberg, Christian Werner, Susanne Mauff, Angela Alms, Stefan Bergt, Norbert Roewer, Patrick Meybohm, Berthold Bein, Oana Brosteanu, Jochen Cremer, Matthias Gruenewald, Christian Stoppe, Mark Coburn, Gereon Schaelte, Andreas Böning, Bernd Niemann, Jan Roesner, Frank Kletzin, Ulrich Strouhal, Christian Reyher, Rita Laufenberg-Feldmann, Marion Ferner, Ivo F Brandes, Martin Bauer, Sebastian N Stehr, Andreas Kortgen, Maria Wittmann, Georg Baumgarten, Tanja Meyer-Treschan, Peter Kienbaum, Matthias Heringlake, Julika Schön, Michael Sander, Sascha Treskatsch, Thorsten Smul, Ewa Wolwender, Thomas Schilling, Georg Fuernau, Dirk Hasenclever, Kai Zacharowski, RIPHeart Study Collaborators, Ana Stevanovic, Rolf Rossaint, Marc Felzen, Andreas Goetzenich, Tobias Moormann, Katharina Chalk, Pascal Knuefermann, Olaf Boehm, Andreas Hoeft, Michael Winterhalter, Sonja Iken, Christian Weber, Carolin Wiedenbeck, Gerhard Schwarzmann, Karin Pense, Andreas Zierer, Stephan Fichtlscherer, Gerold Goerlach, Matthias Wollbrueck, Ursula Boening, Markus Weigand, Julia Strauchmann, Konrad August, Kai U Morsbach, Markus Paxian, Konrad Reinhard, Jens Scholz, Jochen Renner, Ole Broch, Helga Francksen, Martin Albrecht, Bernd Kuhr, Hermann Heinze, Hauke Paarmann, Hans-Hinrich Sievers, Stefan Klotz, Thomas Hachenberg, Christian Werner, Susanne Mauff, Angela Alms, Stefan Bergt, Norbert Roewer
Abstract
Background: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains.
Methods: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90.
Results: A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed.
Conclusions: Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).
Source: PubMed