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Current peer-reviewed PIONEER IV and PIONEER III resources supporting clinical evaluation of HT Supreme™.
PIONEER programme
The 2026 PIONEER IV interim analysis now leads this evidence summary, with PIONEER III retained for comparative and five-year context. These summaries do not replace the full publications, current instructions for use or independent clinical judgement.
Among the first 1,270 randomised all-comer participants, 12-month patient-oriented composite endpoint rates were 6.9% with QFR-guided PCI and 6.8% with usual care. The prespecified interim non-inferiority criterion was met. HT Supreme was used in both treatment strategies.
The supplied five-year PIONEER III results report similar target-lesion failure, target-vessel failure, major adverse cardiac events and stent thrombosis between groups. HT Supreme did not meet superiority.
In 1,629 patients across 74 international sites, target-lesion failure was 5.4% with HT Supreme and 5.1% with the durable-polymer everolimus-eluting stent comparator. The prespecified non-inferiority endpoint was met.
Read the peer-reviewed paperAmong 1,137 patients with complex lesions, HT Supreme appeared as safe and effective as the comparator at one year. Subgroup findings should be interpreted in the context of the full study.
Open the subgroup paperReview the registered PIONEER IV design, eligibility criteria and study outcomes under identifier NCT04923191.
View clinical trial recordClinical documentation