umirolimus and Angina-Pectoris

The Nobori stent is a new drug-eluting stent (DES) with biodegradable polymer coating limited to the abluminal side of stents. Biolimus A9 is a novel sirolimus derivative specifically developed for DES, and polymer load 15.6 μg of biolimus A9 per 1 mm of stent. A non-randomized multicenter trial was conducted in Japan. Twenty-two de novo lesions were treated by Nobori stents and biolimus A9 concentration in whole blood was serially measured at 14 predetermined time points using a validated chromatography-tandem mass spectrometry (LC-MS/MS) assay. The C max was 85.3 ± 37.9 pg/mL (min-max 46.7-169 pg/mL) in the 18 mm cohort and 198 ± 81 pg/mL (min-max 82.5-365 pg/mL) in the ≥ 28 mm cohort and no early or late bursts of biolimus A9 release were documented. After 4 weeks, no measurable concentration of biolimus A9 was observed in any patient. Estimated AUC0-t was 1.12 ± 1.16 ng/mL h in the 18 mm group, and 5.93 ± 4.41 ng/mL h for the ≥ 28 mm group. A significant association between loaded biolimus A9 dose adjusted by patient weight and pharmacokinetic parameters was observed. The systemic exposure of biolimus A9 eluting from the Nobori stent was low and proportional to the loaded amount of biolimus A9, and clearance from the blood was rapid. These findings suggest that the Nobori stent is feasible and safe. Systemic lower exposure of biolimus A9 after Nobori stent implantation may have beneficial effects on stent endothelialization.

Topics: Aged; Angina Pectoris; Angina, Unstable; Angioplasty, Balloon, Coronary; Area Under Curve; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Angina Pectoris; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Coronary Aneurysm; Coronary Angiography; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Echocardiography, Stress; Humans; Male; Middle Aged; Monitoring, Physiologic; Platelet Aggregation Inhibitors; Sirolimus; Treatment Outcome

The development of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. Stent fracture (SF) of DESs, however, has recently emerged as a rare but serious complication, which may lead to acute coronary syndrome or sudden cardiac death. DES fracture results from metal fatigue and vessel hemodynamic stress on the stent strut, due to markedly reduced neointimal formation. Although actual incidence of SF is not known, previous reports have demonstrated that SF rates are specific to each DES type. In this report, 2 cases of fracture of a Nobori stent are described, with insights into the mechanisms of SF and strategies for its successful management.

Topics: Aged, 80 and over; Angina Pectoris; Angioplasty, Balloon, Coronary; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Prosthesis Failure; Sirolimus