Getinge (PINK:GETI B) late last week released results from a pilot study of its intra-aortic balloon pump exploring its use with patients with extensive myocardial infarction complicated by persistent ischemia following primary percutaneous coronary interventions.
Results from the pilot study were presented by co-principal investigator Dr. Lokien van Nunen of Eindoven, The Netherlands’ Catharina Hospital at the EuroPCR 2018 annual meeting in Paris last week, the company said.
The prospective, randomized, comparative single-center Semper Fi pilot study aimed to evaluate the use of IABP in patients with extensive MI complicated by persistent ischemia after a PCI procedure, and included 100 patients with acute STEMI and insufficient ST-segment resolution as determined by an ECG 10 to 30 minutes after PCI in a cath lab.
Patients in the study were randomized to IABP for 12 to 24 hours or no IABP, and were followed up with at six months, Getinge said.
Results from the study indicated that those who presented with large acute MI trended towards decreased mortality, LVAD use and hospital readmission for heart failure within six months after IABP use. A total of 2% of patietns in the IABP arm experienced the primary endpoint versus 8% in the non-IABP group.
“Determining which STEMI patients will benefit from IABP has been difficult because of varying results from retrospective and prospective studies. We are encouraged by the results of the Semper Fi pilot study, which showed a strong signal that IABP may be beneficial in patients with extensive acute MI who continue to experience ischemia even after stenting. We expect that these results will bear out in a trial adequately powered to demonstrate a statistically significant reduction in the composite endpoint if this trend were to continue,” Dr. van Nunen said in a prepared statement.
“The trend toward a mortality benefit with the use of IABP observed in the Semper Fi pilot study is encouraging because the study was well controlled and did not allow crossover from the conventionally-treated group to IABP, which could have confounded the results. This pilot study is a testament to Getinge’s commitment to support clinical research to increase the body of knowledge for our life-saving therapies,” acute care therapies chief medical officer Dr. Claudius Diez said in a press release.
Earlier this year, Getinge said it won FDA 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module.
