Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention (HRPCI) have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial (RCT).
Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were “PROTECT II-like” (met eligibility for PROTECT II RCT) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction (MI), and repeat revascularization, were compared at hospital discharge and 90 days.
Compared with PROTECT II (N=216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, p=0.045), with less prior CABG (13.7% vs 39.4%; p<0.001) and prior MI (40.7% vs 69.3%; p<0.001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, p<0.001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; p<0.001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; p<0.001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; p<0.001), as was procedural hypotension (2.2% vs 10.1%; p<0.001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; p<0.001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, p=0.048).
The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported HRPCI among patients with severely depressed LVEF.

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