The use of percutaneous ventricular support during high-risk complex PCI has been proposed as a strategy to prevent hemodynamic deterioration in patients with severe left ventricular dysfunction and complex coronary anatomy. In this context, the CHIP-BCIS3 trial was designed, focusing on a population at particularly high risk of post-procedural morbidity and mortality.
The aim of the CHIP-BCIS3 trial was to compare a PCI strategy using a micro-axial support device (Impella) versus standard treatment (ST) in patients with left ventricular ejection fraction ≤35%, extensive coronary artery disease defined by a BCIS Jeopardy Score ≥8/12, and planned complex PCI (including left main lesions, extensive calcium modification, or retrograde CTO).
A randomized study was conducted across 21 centers in the United Kingdom. A total of 300 patients were enrolled: 148 assigned to Impella and 152 to standard treatment, with a mean follow-up of 22 months. The study population was at very high risk: mean age 73 years, 83% male, median LVEF 27% (IQR 20–32), BCIS-JS 12 (IQR 10–12), and SYNTAX score 38 (IQR 30–47), with 76% presenting with acute coronary syndromes. The primary endpoint was a hierarchical composite based on pairwise comparison, including all-cause death, stroke, spontaneous MI, cardiovascular hospitalization, and periprocedural myocardial injury.
Planned PCI was performed in 100% of the support group and 99% of the standard treatment group, with a higher proportion of single-stage procedures in the Impella arm (93% vs 82%). In terms of safety, more access-site and bleeding-related events were observed in the support group, with major bleeding rates of 10.8% vs 7.3% and vascular complications of 16.9% vs 10.6%.
In the primary endpoint analysis, the overall result numerically favored standard treatment. Cumulative wins were 36.6% for the micro-axial system and 43.0% for standard treatment, with a win ratio of 0.85 (95% CI 0.63 to 1.15).
In the component analysis, all-cause death showed 16.4% wins for the support arm and 23.4% for standard treatment, while spontaneous MI favored the support group (4.6% vs 1.9% wins).
Notably, all-cause mortality was 32.6% in the Impella group versus 23.4% in the standard treatment group (HR 1.54; 95% CI 0.99 to 2.41; p=0.054), a trend that persisted for cardiovascular mortality (26.7% vs 14.5%; HR 1.91; 95% CI 1.11 to 3.30; p=0.018).
Conclusions: Impella use does not reduce major adverse events in high-risk complex PCI
In a very high-risk population undergoing complex PCI, the use of micro-axial support (Impella) did not reduce major adverse clinical events compared with standard treatment and was associated with increased cardiovascular mortality.
Presented by Divaka Perera at Late-Breaking Clinical Trials, ACC.26, March 28–30, New Orleans, USA.
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