zotarolimus and Kidney-Failure--Chronic

Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.

Topics: Acute Coronary Syndrome; Calcinosis; Creatine Kinase; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Off-Label Use; Patient Outcome Assessment; Percutaneous Coronary Intervention; Severity of Illness Index; Sirolimus

Early cessation of dual antiplatelet therapy (DAPT) is related to stent thrombosis (ST). The use of second-generation everolimus- and zotarolimus-eluting stents is associated with low restenosis rates and short duration of clopidogrel usage. Non-cardiac surgery in recently stent-implanted patients is associated with major adverse cardiac events (MACEs). Chronic renal failure patients awaiting renal transplantation may also undergo coronary stent implantation prior to surgery. Here we aimed to investigate the safety of early (3 months) DAPT interruption in second-generation drug-eluting stent (DES)-implanted renal transplant recipients.. In total, 106 previously stent-implanted chronic renal failure patients who underwent renal transplantation were retrospectively enrolled. Three groups were formed according to stent type and the duration of DAPT: early-interruption (3 months from DES implantation), lateinterruption (3-12 months from DES implantation), and bare-metal stent (BMS; at least 1 month from BMS implantation) groups.. Comparison among BMS, DES-early and DES-late groups indicated no difference in ST, myocardial infarction, death, and MACEs. In addition, no difference was observed in ST (p=0.998), myocardial infarction (p=0.998), death (p=0.999), and MACEs (p=0.998) between DES-early and DES-late groups.. Early (3 months) interruption of antiplatelet treatment with second-generation stents before renal transplantation seems to be safe and does not lead to increase in the occurrence of ST and MACEs.

Topics: Clopidogrel; Drug Administration Schedule; Drug-Eluting Stents; Everolimus; Female; Humans; Kidney Failure, Chronic; Kidney Transplantation; Male; Middle Aged; Platelet Aggregation Inhibitors; Preoperative Period; Retrospective Studies; Sirolimus; Thrombosis

This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention.. DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated.. Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization.. Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001).. After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Kidney Failure, Chronic; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome