Real-World Data Mirror Clinical Trial Results for Impella Use in High-Risk PCI

October 13, 2015

Today at TCT, an abstract by Dr. Mauricio Cohen of University of Miami Medical Center was discussed during a poster session. The data, which was published online in a paper in the American Heart Journal on August 15, 2015, included the largest cohort of complex high-risk PCI patients supported by the Impella 2.5 in real-world practice and in clinical trials. The data demonstrated that clinical trial results mirror real world experience in the use of high risk PCI with pVADs.

A new development discussed was the transition of the USpella registry to the now global, cVAD registry. The cVAD registry will include patients treated with all of the devices within the Impella platform and currently includes 2,655 patients enrolled from 47 sites.

The objectives of the study, noted Dr. Cohen, were to describe the type of patients, procedural characteristics and outcomes of high-risk PCI supported with Impella 2.5 in the U.S. and to compare these patients and procedures with the lmpella arm of the PROTECT II trial. The researchers looked at retrospective data from the USpella registry, analyzing 637 patients that met the criteria for the PROTECT II trial (LVEF ≤ 35% and intervention to the last patent conduit or UPLM, or LVEF ≤ 30% and 3VD) who were treated at 47 U.S. and two Canadian sites between June 2007 and September 2013. All patients underwent PCI.


Among registry patients, 53.2% would have met the enrollment criteria for PROTECT II. Most had 2-vessel disease, including 16% with left main disease. In routine practice, interventional cardiologists identified high-risk patients, with similar characteristics to PROTECT II trial

Results demonstrated that left ventricular function increased substantially from baseline to discharge in the registry group (21.4% to 28.4%; P < .0001). And, assessment of NYHA class showed a 42.2% reduction from baseline to discharge in class III-IV symptoms in registry patients with available data (P < .0001) and a 27.8% reduction in PROTECT II trial participants (P = .008).


This session was an interesting perspective on how closely real world experience has mirrored the PROTECT II data in safety and improved clinical status and LVEF. According to Dr. Cohen, the data concluded that in this high risk population the use of Protected PCI with Impella 2.5 is associated with favorable outcomes with relatively low incidence of adverse events.

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