Toshiki Kuno1, Hisato Takagi2, Tomo Ando3, Masaki Kodaira4, Yohei Numasawa4, John Fox5, Sripal Bangalore6. 1. Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, New York. 2. Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan. 3. Division of Cardiology, Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 4. Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Ashikaga, Japan. 5. Department of Cardiology, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, New York. 6. Division of Cardiology, University School of Medicine, New York, New York.
Abstract
BACKGROUND: Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs). METHODS: EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications. RESULTS: Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I2 = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I2 = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I2 = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I2 = 1.5%). CONCLUSIONS: Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.
BACKGROUND: Mechanical circulatory support (MCS) with Impella or intra-aortic balloon pump (IABP) is used for high-risk percutaneous coronary intervention (PCI) and/or for cardiogenic shock (CS) due to acute myocardial infarction. We aimed to investigate the efficacy and safety of Impella or IABP when compared with no MCS using a network meta-analysis of randomized controlled trials (RCTs). METHODS: EMBASE and MEDLINE were searched through February 2020 for RCT evaluating efficacy of Impella vs. IABP vs. no MCS in patients undergoing high-risk PCI or CS. The primary efficacy outcome was 30 day or in-hospital all-cause mortality whereas the primary safety outcomes were major bleeding and vascular complications. RESULTS: Our search identified nine RCTs enrolling a total of 1,996 patients with high-risk PCI and/or CS. There was no significant difference with Impella or IABP on all-cause mortality when compared with no MCS (Impella vs. no MCS; OR:0.82 [0.35-1.90], p = .65, IABP vs. no MCS; OR:0.77 [0.47-1.28], p = .31, I2 = 18.1%). Impella significantly increased major bleeding compared with no MCS (Impella vs. no MCS; OR:7.01 [1.11-44.4], p = .038, I2 = 19.2%). IABP did not increase the risk of major bleeding compared with no MCS (OR:1.27 [0.75-2.16], p = .38, I2 = 19.2%) but increased vascular complication compared with no MCS (OR:1.92 [1.01-3.64], p = .045, I2 = 1.5%). CONCLUSIONS: Neither Impella nor IABP decreased all-cause short-term mortality when compared with no MCS for high-risk PCI and/or CS. Moreover, Impella increased major bleeding compared with no MCS.
Authors: Giuseppe Panuccio; Giuseppe Neri; Lucrezia Maria Macrì; Nadia Salerno; Salvatore De Rosa; Daniele Torella Journal: Int J Cardiol Heart Vasc Date: 2022-03-25