-
Frontiers in Pharmacology 2024Rapamycin, an established mTOR inhibitor in clinical practice, is widely recognized for its therapeutic efficacy. Ridaforolimus, a non-prodrug rapalog, offers improved... (Review)
Review
Rapamycin, an established mTOR inhibitor in clinical practice, is widely recognized for its therapeutic efficacy. Ridaforolimus, a non-prodrug rapalog, offers improved aqueous solubility, stability, and affinity compared to rapamycin. In recent years, there has been a surge in clinical trials involving ridaforolimus. We searched PubMed for ridaforolimus over the past decade and selected clinical trials of ridaforolimus to make a summary of the research progress of ridaforolimus in clinical trials. The majority of these trials explored the application of ridaforolimus in treating various tumors, including endometrial cancer, ovarian cancer, prostate cancer, breast cancer, renal cell carcinoma, and other solid tumors. These trials employed diverse drug combinations, incorporating agents such as ponatinib, bicalutamide, dalotuzumab, MK-2206, MK-0752, and taxanes. The outcomes of these trials unveiled the diverse potential applications of ridaforolimus in disease treatment. Our review encompassed analyses of signaling pathways, ridaforolimus as a single therapeutic agent, its compatibility in combination with other drugs, and an assessment of adverse events (AEs). We conclude by recommending further research to advance our understanding of ridaforolimus's clinical applications.
PubMed: 38584599
DOI: 10.3389/fphar.2024.1173240 -
Journal of the American Heart... Jan 2024Patients 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... (Randomized Controlled Trial)
Randomized Controlled Trial
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% (<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.
Topics: Humans; Drug-Eluting Stents; Platelet Aggregation Inhibitors; Acute Coronary Syndrome; Prospective Studies; Treatment Outcome; Hemorrhage; Stents; Percutaneous Coronary Intervention; Thrombosis; Drug Therapy, Combination; Coronary Artery Disease; Sirolimus
PubMed: 38214256
DOI: 10.1161/JAHA.122.029051 -
Coronary Artery Disease Sep 2023The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial...
BACKGROUND
The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions.
METHODS
A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization.
RESULTS
A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ± 8.3, reference vessel diameter 2.88 mm ± 0.45, minimal lumen diameter 0.80 mm ± 0.41, and percent diameter stenosis 72.6% ± 13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%).
CONCLUSION
Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions. (ClinicalTrials.gov NCT03702608).
Topics: Humans; Coronary Artery Disease; Percutaneous Coronary Intervention; Drug-Eluting Stents; Constriction, Pathologic; Prospective Studies; Bionics; Stents; Treatment Outcome
PubMed: 37471280
DOI: 10.1097/MCA.0000000000001264 -
Catheterization and Cardiovascular... Jan 2024The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. (Clinical Trial)
Clinical Trial
INTRODUCTION
The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus.
AIM OF STUDY
To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease.
METHODS
A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE).
RESULTS
A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively.
CONCLUSION
The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.
Topics: Humans; Constriction, Pathologic; Coronary Artery Disease; Drug-Eluting Stents; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Treatment Outcome
PubMed: 38098249
DOI: 10.1002/ccd.30924