2. Randomised A prospective, randomized clinical Patients were randomly assigned to IABP 2012, October controlled of hemodynamic support with (n = 226) or Impella®2.5 (n = 226). (RCT) Impella® 2.5 versus intra-aortic Impella®provided superior hemodynamic balloon pump in patients undergoing support in comparison with IABP (maximal high-risk percutaneous coronary decrease in CPO from baseline of intervention: the PROTECT II study W vs -0.14±0.27 W for IABP (P=0.001). The 30-day incidence of major O’Neill et al 2012 (4) AEs was not statistically different PROTECT II (P=0.277). NCT00562016 The 90-day incidence of major AEs was statistically different in Impella® supported patients compared with IABP: 40.0% vs. 51% in PP population, respectively. 3. Retrospective, Percutaneous left ventricular assist Compared outcomes from patients in 2015, November comparative, device for high-risk percutaneous multicentre registry (who would have met single-arm study coronary interventions: Real-world trial enrolment criteria for PROTECT II trial; versus clinical trial experience. n = 339) with patients in Impella® arm of PROTECT II (n = 216). et al 2015 (5) USPella registry and PROTECT II trial Registry patients had higher risk (older, data but clinical outcomes NCT00562016 appeared to be favourable and consistent with the RCT.
2. Randomised controlled (RCT) A prospective, randomized clinical of hemodynamic support with Impella® 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study O’Neill et al 2012 (4) PROTECT II NCT00562016 Patients were randomly assigned to IABP (n = 226) or Impella®2.5 (n = 226). Impella®provided superior hemodynamic support in comparison with IABP (maximal decrease in CPO from baseline of W vs -0.14±0.27 W for IABP (P=0.001). The 30-day incidence of major AEs was not statistically different (P=0.277). The 90-day incidence of major AEs was statistically different in Impella® patients compared with IABP: 40.0% vs. 51% in PP population, respectively. 2012, October 3. Retrospective, comparative, single-arm study Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. et al 2015 (5) USPella registry and PROTECT II trial data NCT00562016 Compared outcomes from patients in multicentre registry (who would have met trial enrolment criteria for PROTECT II trial; n = 339) with patients in Impella® arm of PROTECT II (n = 216). Registry patients had higher risk (older, but clinical outcomes appeared to be favourable and consistent with the RCT. 2015, November supported
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