Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk.

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Patients undergoing percutaneous coronary intervention (PCI) often have high bleeding risk (HBR).
• Drug-eluting stents (DES) are superior to bare-metal stents in HBR patients, even with abbreviated dual antiplatelet therapy (DAPT).
• The EluNIR ridaforolimus-eluting stent's performance with short DAPT in HBR patients has not been previously evaluated.

Purpose of the Study:

• To assess the safety and efficacy of a shortened DAPT duration after ridaforolimus-eluting stent implantation in HBR patients.
• Evaluate the composite endpoint of cardiac death, myocardial infarction, or stent thrombosis.
• Determine the rates of stent thrombosis and major bleeding events.

Main Methods:

• Prospective, multicenter, single-arm, open-label trial.
• Patients defined as HBR based on LEADERS-FREE criteria.
• DAPT duration: 1 month for stable angina, 1-3 months for acute coronary syndrome.
• Primary endpoint: composite of cardiac death, MI, or ARC definite/probable stent thrombosis at 1 year.

Main Results:

• 315 HBR patients enrolled; 56.4% presented with acute coronary syndrome; 33.7% on oral anticoagulation.
• The primary endpoint occurred in 4.9% of patients, significantly below the 14.1% performance goal (P<0.0001).
• Stent thrombosis (ARC definite/probable) occurred in 0.6% of patients; BARC types 3/5 bleeding in 1.9%.

Conclusions:

• Shortened DAPT with the ridaforolimus-eluting stent demonstrated favorable safety and efficacy in HBR patients.
• Low rates of ischemic events and stent thrombosis were observed.
• This strategy supports the use of ridaforolimus-eluting stents with abbreviated DAPT in high-risk populations.