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Published on: May 14, 2013
Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk
Ran Kornowski1,2, Maayan Konigstein3,2, Michael Jonas4
1Rabin MC Tel-Aviv Israel.
Insights
Shortened dual antiplatelet therapy (DAPT) following ridaforolimus-eluting stent implantation is safe and effective for high bleeding risk patients. This approach resulted in low ischemic and bleeding event rates at one year.
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.
Background:
Patients treated with percutaneous coronary intervention are often considered to be at a high bleeding risk (HBR). Drug-eluting stents have been shown to be superior to bare-metal stents in patients with HBR, even when patients were given abbreviated periods of dual antiplatelet therapy (DAPT). Short DAPT has not been evaluated with the EluNIR ridaforolimus-eluting stent. The aim of this study was to evaluate the safety and efficacy of a shortened period of DAPT following implantation of the ridaforolimus-eluting stent in patients with HBR.
Methods And Results:
This was a prospective, multicenter, binational, single-arm, open-label trial. Patients were defined as HBR according to the LEADERS-FREE (Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug-Coated Stent versus the Gazelle Bare-Metal Stent in Patients at High Bleeding Risk) trial criteria. After percutaneous coronary intervention, DAPT was given for 1 month to patients presenting with stable angina. In patients presenting with an acute coronary syndrome, DAPT was given for 1 to 3 months, at the investigator's discretion. The primary end point was a composite of cardiac death, myocardial infarction, or stent thrombosis up to 1 year (Academic Research Consortium definite and probable). Three hundred fifteen patients undergoing percutaneous coronary intervention were enrolled, and 56.4% presented with acute coronary syndrome; 33.7% were receiving oral anticoagulation. At 1 year, the primary end point occurred in 15 patients (4.9%), meeting the prespecified performance goal of 14.1% (P<0.0001). Stent thrombosis (Academic Research Consortium definite and probable) occurred in 2 patients (0.6%). Bleeding Academic Research Consortium type 3 and 5 bleeding occurred in 6 patients (1.9%).
Conclusions:
We observed favorable results in patients with HBR who underwent percutaneous coronary intervention with a ridaforolimus-eluting stent and received shortened DAPT, including a low rate of ischemic events and low rate of stent thrombosis.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03877848.
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