• Complex PCI Leads to Worse 1-Year Outcomes than Non-Complex PCI, Registry Analysis Shows

    Rates of TLF, CV death below 5% for all study patients at 1 year

    Patients who undergo percutaneous coronary intervention (PCI) for complex lesions have a higher risk of cardiac death at 1 year than patients who undergo PCI for non-complex lesions, according to a post hoc subgroup analysis of a real-world registry cohort.

    This is true even when the PCI involves a latest-generation drug-eluting stent (DES).

    Marco Roffi, MD, of Geneva University Hospitals, presented these results Thursday at the PCR e-Course. Mohamed O. Mohamed, MRCP, of Keele University, U.K., and colleagues wrote a manuscript reporting these findings that was simultaneously published online in EuroIntervention.

    The investigators performed a post hoc subgroup analysis of 35,839 patients on the e-Ultimaster multicenter registry. The analysis was stratified by procedure complexity and then by number and type of complex features.

    The registry’s primary objective is to evaluate the safety and performance of the Ultimaster DES system (Terumo Corp.) in an all-comer patient population. The Ultimaster is a new-generation, open-cell, cobalt-chromium, thin-strut (80 μm) sirolimus-eluting stent with an abluminal biodegradable-polymer coating (poly-D, L-lactic acid polycaprolactone).

    The primary outcome was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR) at 1 year.

    The analysis found that complex PCI patients (n=9,793, 27.3% of the registry cohort) were older (complex mean age 64.9 years vs. non-complex mean age 63.9 years; p<0.0001), more likely to be men (complex male 78.4% vs. non-complex male 75.1%; p<0.0001), and had more comorbidities. In the complex PCI group, 7,174 (73.3%) had one or two complex features, and the remainder had three to six complex features.

    The TLF rate was low in both complex and non-complex patients, but it was significantly higher in the complex group at 1 year (4.2% vs. 2.8%; p<0.0001). Complex PCI patients showed an increased risk of TLF (adjusted hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.25-1.59; p<0.0001), as well as its individual components: cardiac death (adjusted HR, 1.28; 95% CI, 1.05-1.55; p=0.01), target vessel myocardial infarction (adjusted HR, 1.48; 95% CI, 1.18-1.86; p=0.001), and clinically driven target lesion revascularization (adjusted HR, 1.42; 95% CI, 1.20-1.68; p<0.0001).

    Furthermore, the risk of each component of TLF increased as the number of complex features in patients rose, the study found.

    “The findings provide operators with novel insights regarding clinical outcomes of individual complex features and emphasize that the number and types of complex features both have an impact on procedural outcomes,” Mohamed and colleagues write in the manuscript.

    The e-Ultimaster registry is funded by Terumo Europe, Middle East & Africa (Leuven, Belgium).

    PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.


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