Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.

OBJECTIVES: To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. BACKGROUND: The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. METHODS: 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. RESULTS: Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. CONCLUSIONS: This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.

Clinical Efficacy of а Medical Centre- and Home-based Cardiac Rehabilitation Program for Patients with Coronary Heart Disease After Coronary Bypass Graft Surgery.

BACKGROUND: Rehabilitation measures are crucial for maintaining clinical benefits of coronary artery bypass grafting (CABG) surgery. We evaluated the clinical efficacy of a medical centre- and home-based cardiac rehabilitation (CR) for patients after CABG in an out-patient setting. METHODS: The study included 36 male patients 3-8 weeks after CABG that were randomly assigned to either study or control group. Patients from the study group performed a 60 min excercise in controlled setting 3 times a week for 4 months followed by home-based excercise later on, while patients from the control group only received a recommendation to perform the excercise at home in an uncontrolled setting. Total duration of the follow-up was 12 months. RESULTS: Physical endurance in the study group increased by 32.6% (p <0.05) in comparison to baseline after 4 months, and was maintained at this level after 12 months, while in the control group, an improvement of 9.8% (p <0.05) was observed after 12 months. Moreover, patients from the study group demonstrated a stable level of such risk factors as blood total and low-density lipoprotein cholesterol, while in the control group, these parameters increased by 10.2% (p <0.05) and 15.6% (p <0.05) respectively by the end of follow-up. Controlled medical centre-based exercise resulted in improvement of patients' quality of life and reduction of cardiovascular complications (11.1% against 39.2% in the control group). CONCLUSION: The integral (medical centre and home-based) stage III CR program after CABG helped reducing cardiovascular risk factors, and improved clinical parameters and functional capacity of patients.