Complete Revascularization, Clinical Research & Data, Protected PCI

EuroPCR 2023: Complete Revascularization with pVAD vs IABP


In this EuroPCR 2023 presentation, Vasileios Panoulas, MD, discusses data regarding completeness of revascularization in high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS). “It is an interesting topic,” he states, “because there’s not much data out there.” Dr. Panoulas is an interventional cardiologist in London, United Kingdom.

Dr. Panoulas explains that the COMPLETE trial in the STEMI population and a pooled analysis of the SYNTAX, PRECOMBAT & BEST trials in stable ischemic heart disease, highlight that more complete revascularization is associated with a lower incidence of clinical events. He then describes a pooled analysis of individual patient data (IPD) from contemporary prospective studies—PROTECT II, PROTECT III, and RESTORE EF—in which he and collegues evaluated the potential mechanisms of the observed efficacy and safety of Protected PCI (PCI with pVAD hemodynamic support) compared to other MCS, namely intra-aortic balloon pump (IABP). In this trial they tested the hypothesis that Protected PCI may be associated with a greater revascularization extent and, thus, may contribute to superior clinical outcomes compared to PCI of equivalent complexity utilizing IABP.

Dr. Panoulas describes the statistical methods, baseline characteristics, and results from this analysis. Pooling data from PROTECT II, PROTECT III, and RESTORE EF, results showed a 40% relative reduction in residual SYNTAX score (rSS) with Impella® heart pump versus IABP and twice as many patients in the group supported by Impella devices achieved complete revascularization. He explains that this is a hypothesis-generating study with several limitations, which he discusses.

“In essence we have seen that if you combine all these datasets, approximately twice as many patients achieved complete revasc with percutaneous VADs, such as Impella, compared to the balloon pump. And you achieve about 40% higher revascularzation levels with Impella compared to balloon pump,” Dr. Panoulas concludes. “ And this is something that we are hoping to be able to show in a randomized fashion in the ongoing PROTECT IV trial.”

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