umirolimus and Cardiovascular-Diseases

Patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and have a worse prognosis after percutaneous coronary interventions (PCI). The BioFreedom polymer-free biolimus-A9-eluting stent (PF-BES) has shown promising results in patients at high bleeding risk; however, its performance in CKD patients has yet to be analyzed.. The all-comers RUDI-FREE registry documented patients undergoing PCI with PF-BES in routine clinical practice. Patients were stratified into three groups according to their estimated glomerular filtration rate (eGFR): preserved renal function, mild renal insufficiency (RI), and with moderate to severe RI (eGFR ≥ 90, between 90 and 45, and <45 ml/min/1.73 m2, respectively). The primary safety end point was a patient-oriented composite end point of cardiovascular death, myocardial infarction (MI), and definite or probable stent thrombosis (ST). The primary efficacy end point was target lesion revascularization (TLR).. The registry documented 1,104 consecutive patients treated with PF-BES: 258 (23.4%) with preserved renal function, whereas 712 (64.7%) and 131 (11.9%) had mild and moderate to severe RI, respectively. At 1 year, the primary safety end point was significantly higher in patients with moderate to severe RI (3.5% vs. 2.8% vs. 11.5%; P < 0.001). Conversely, TLR proved similar among groups (0.4% vs. 1.8% vs. 0.8%; P = 0.235).. Patients with worse renal function had increased risk of the composite of cardiovascular deaths, MI, and definite or probable ST. However, the PF-BES showed similar efficacy despite differences in renal function. These findings need to be confirmed in large-scale randomized trials.

Topics: Aged; Cardiovascular Diseases; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Renal Insufficiency, Chronic; Sirolimus; Thrombosis

Biodegradable polymer drug-eluting stents may improve biocompatibility and reduce the risk of very late stent thrombosis (ST) but outcomes are nevertheless unknown in diabetic patients. The purpose of this study was to assess the long-term efficacy and safety of the biodegradable polymer biolimus A9-eluting stent (BP-BES) in comparison with the current reference durable polymer everolimus-eluting stent (DP-EES) in diabetic patients.. 119 BP-BES and 178 DP-EES were implanted respectively in 105 and 146 diabetic patients presenting similar clinical and peri-procedural characteristics. The median follow-up time was 20.8 months. No statistically significant difference was observed between the BP-BES and DP-EES groups in terms of occurrence of the composite primary end point of cardiac death, spontaneous myocardial infarction and clinically indicated target lesion revascularization (8 patients [8%] in the BP-BES group versus 24 patients [17%] in the DP-EES group; HR 1.36, 95% CI 0.59-3.15, P = 0.47) and of the rate of ST (5 patients [5%] in the BP-BES group versus 11 patients [8%] in the DP-EES group; HR 0.73, 95% CI 0.22-2.37, P = 0.60).. In spite of a trend in favour of the BP-BES, long-term efficacy and safety were similar for both the BP-BES and the DP-EES in this specific population of diabetic patients. Considering the low incidence of the studied clinical events, other studies with larger population sizes are needed to confirm this observation.

Topics: Aged; Cardiovascular Diseases; Coated Materials, Biocompatible; Diabetes Complications; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Patient Safety; Polymers; Prospective Studies; Registries; Sirolimus