Abiomed has announced the results of PROTECT III, an ongoing, prospective, single-arm US Food and Drug Administration (FDA) post-market approval (PMA) study for Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI). PROTECT III follows the PROTECT II randomised controlled trial.
A press release from the company highlights that PROTECT III demonstrated a reduction in the primary endpoint of death, stroke, myocardial infarction and repeat procedures at 90 days with Impella-supported protected PCI, compared to PROTECT II.
The findings of the interim analysis on 898 patients were announced at the Transcatheter Cardiovascular Therapeutics conference (TCT 2019; 24–29 September, San Francisco, USA) by Jeffrey J Popma (Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA).
According to Abiomed, the PROTECT series of FDA clinical studies—PROTECT I, PROTECT II, and PROTECT III—is the largest-ever FDA study of haemodynamically supported high-risk PCI patients, and Impella is the most studied mechanical circulatory support device in the history of the FDA. The series has enrolled 1,366 patients as of July 2019, and includes the only FDA randomised controlled trial ever conducted for haemodynamically supported high-risk PCI. PROTECT III includes 898 patients enrolled at 45 sites in the USA between March 2017 and July 2019.
The press release states that patients in PROTECT III are statistically older (71 years), include more women (26%) and non-Caucasians (33%), received longer support and had more complex procedures with more vessels treated than patients in PROTECT II. Despite this, the 90-day major adverse cardiac and cerebrovascular events (MACCE) rate in PROTECT III is lower than the intra-aortic balloon pump (IABP) control arm from PROTECT II. The composite MACCE rate in the IABP arm was 31%, compared to the Impella 2.5 and Impella CP arm at 16.8% (p<0.0001).
In the press release, Popma comments: “Based on the learnings from the PROTECT studies, decisions to provide haemodynamic support during PCI should be made in the context of providing complete revascularisation, and patient outcomes should include in-hospital and out-of-hospital improvements, Prior studies have demonstrated it is important to achieve complete revascularisation because it can result in a 30–50% reduction in MACCE, compared to incomplete revascularisation.”