title: The efficacy and safety of mechanical hemodynamic support in patients undergoing high-risk percutaneous coronary intervention with or without cardiogenic shock: Bayesian approach network meta-analysis of 13 randomized controlled trials.
abstract: BACKGROUND
  Studies have reported conflicting results regarding efficacy of mechanical hemodynamic support using intra-aortic balloon pump (IABP) or percutaneous ventricular assisted device (pVAD) in patients undergoing high-risk PCI. We performed a Bayesian network meta-analysis comparing the safety and efficacy of mechanical hemodynamic support devices and medical therapy (MT).
  
  
  RESULTS
  RCTs comparing overall mortality of IABP versus MT or IABP versus pVAD in high-risk PCI populations were included. The primary endpoint was overall mortality, using the longest available follow-up in each study. This analysis included 2843 patients from 13 trials. In network meta-analysis, overall survival benefit was not significant with IABP (RR 0.84, 95% CrI 0.56-1.24) or pVAD (RR 0.95, 95% CrI 0.42-2.06), compared with MT. IABP or pVAD also did not show early survival benefit compared with MT. In terms of bleeding, pVAD was the worst (versus IABP: RR 29.4, 95% CrI 5.99-221.0; versus MT: RR 41.7, 95% CrI 8.19-330.0), which was mainly driven by the higher incidence of bleeding in the ECMO and TandemHeart, while IABP was worse than MT (RR 1.41, 95% CrI 1.01-2.08). The incidence of acute limb ischemia or vascular complication was not different between treatment groups.
  
  
  CONCLUSIONS
  In this meta-analysis, routine elective use of IABP or pVAD did not reduce mortality, while it increased bleeding, compared with MT in high-risk PCI population or even in the patients with cardiogenic shock. Thoughtful selection of appropriate patients and balancing the risk and benefit should be the prerequisites to the use of mechanical hemodynamic support devices.
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Joo Myung
authors.initials: JM
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Jonghanne
authors.initials: J
authors.lastname: Park
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Jeehoon
authors.initials: J
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Ki-Hyun
authors.initials: KH
authors.lastname: Jeon
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Ji-Hyun
authors.initials: JH
authors.lastname: Jung
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Sang Eun
authors.initials: SE
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Jung-Kyu
authors.initials: JK
authors.lastname: Han
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Boramae Medical Center, Seoul National University, Seoul, Republic of Korea.
authors.forename: Hack-Lyoung
authors.initials: HL
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Han-Mo
authors.initials: HM
authors.lastname: Yang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Kyung Woo
authors.initials: KW
authors.lastname: Park
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Bon-Kwon
authors.initials: BK
authors.lastname: Koo
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Boramae Medical Center, Seoul National University, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea; Molecular Medicine & Biopharmaceutical Science, Graduate School of Convergence Science & Technology, Seoul National University, Seoul, Republic of Korea. Electronic address: usahyosoo@gmail.com.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D001499:Bayes Theorem; D006439:Hemodynamics; D006801:Humans; D007423:Intra-Aortic Balloon Pumping / Q000009:adverse effects / Q000401:mortality*; D061214:Patient Safety; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012307:Risk Factors; D012770:Shock, Cardiogenic / Q000175:diagnosis / Q000401:mortality* / Q000601:surgery; D016896:Treatment Outcome
keywords: Aortic balloon pump; Coronary intervention; Left ventricular assist device; Primary PCI