Outcomes of the Novel Supreme Drug-Eluting Stent in Complex Coronary Lesions: A PIONEER III Substudy

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• The Supreme drug-eluting stent (DES) is engineered to enhance endothelial healing, aiming to mitigate stent-related adverse events, particularly in complex coronary lesions.
• Complex lesions present a higher risk for adverse outcomes following percutaneous coronary intervention (PCI).

Purpose of the Study:

• To compare the 1-year clinical outcomes of the Supreme DES versus contemporary durable-polymer, everolimus-eluting stents (DP-EES) in patients with complex coronary lesions.
• To evaluate the safety and efficacy of the Supreme DES in a challenging patient subset.

Main Methods:

• The PIONEER III trial was a prospective, multicenter, single-blind study randomizing 1629 patients to either Supreme DES or DP-EES.
• 1137 patients with complex lesions (ACC/AHA type B2/C) were analyzed, with specific attention to severe calcification, long length, and severe tortuosity.
• The primary endpoint was target lesion failure at 1-year post-PCI.

Main Results:

• No significant difference was observed in target lesion failure at 1 year between the Supreme DES and DP-EES groups (5.7% vs. 5.6%; HR 1.00, P=0.99).
• Secondary endpoints, including lesion success, device success, target vessel failure, major adverse cardiac events, and stent thrombosis, also showed no significant differences.
• A trend towards higher target lesion revascularization was noted with the Supreme DES (2.5% vs. 0.9%, P=0.06).

Conclusions:

• The Supreme DES exhibits comparable 1-year effectiveness and safety to DP-EES in patients with a wide range of complex coronary lesion characteristics.
• These findings suggest the Supreme DES is a viable option for percutaneous coronary intervention in complex lesion scenarios.