Aperture Science Medical Devices Evidence overview
Clinical Evidence

PIONEER III · Complex-lesion substudy

Outcomes in complex coronary lesions

JSCAI · Volume 1, 2022

This prespecified PIONEER III substudy compared one-year outcomes between Supreme DES and durable-polymer everolimus-eluting stents in patients with complex coronary lesions.

1,137patients with complex lesions
70%of the trial population
5.7%Supreme DES TLF
5.6%comparator TLF
Evidence summary

Population

Complex lesions were defined as American College of Cardiology/American Heart Association type B2 or C. The analysis included long lesions, severe calcification and severe tortuosity assessed by an independent angiographic core laboratory.

One-year outcome

Target-lesion failure was 5.7% with Supreme DES and 5.6% with the comparator (hazard ratio 1.00; 95% CI, 0.59-1.68; P=0.99).

Secondary outcomes

The investigators reported no significant differences in lesion success, device success, target-vessel failure, major adverse cardiac events or stent thrombosis. A numerical trend toward higher target-lesion revascularisation was reported with Supreme DES (2.5% versus 0.9%; P=0.06).

Interpretation

The publication concluded that the findings suggest comparable safety and effectiveness at one year across a broad spectrum of lesion complexity. As a subgroup analysis, the results should be interpreted alongside the full PIONEER III trial and the paper's stated limitations.

Clinical documentation

Request current product information.

cardio@apsci.co.za