DANVERS -
PROTECT III is an ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. The PROTECT III interim analysis findings are being presented by
PROTECT III builds on the PROTECT II Randomized Controlled Trial (RCT) which found, when compared to intra-aortic balloon pump (IABP), Impella use led to a 29% reduction in MACCE at 90 days. The study authors analyzed patients in PROTECT III who would have qualified for PROTECT II, known as 'PII-like' patients, and compared them to PROTECT II patients. PII-like patients in PROTECT III had improved 90-day MACCE rates, compared to PROTECT II patients (15% vs. 21.9%, p=0.035).
The study also found PII-like patients in PROTECT III were older, sicker and more complex, with more comorbidities, more vessels treated and more rotational atherectomy, yet they had improved in-hospital safety with: Significantly fewer bleeding complications (1.8% vs. 12.5%, p
(C) 2020 Electronic News Publishing, source