Abstract
Background
Novel bare metal stents with improved stent design may become a viable alternative to drug-eluting stents in certain patient groups, particularly, when long-term dual antiplatelet therapy should be avoided.
Purpose
The ENERGY registry aimed to assess the safety and benefits of a cobalt–chromium thin strut bare metal stent with a passive coating in a large series of patients under real-world conditions.
Methods and materials
This prospective registry recruited 1016 patients with 1074 lesions in 48 centers from April to November 2010. The primary endpoint was the rate of major adverse cardiac events (MACEs), a composite of cardiac death, myocardial infarction and clinically driven target lesion revascularization.
Results
More than half of the lesions (61.0%) were type A/B1 lesions, mean lesion length was 14.5 ± 6.5 mm and mean reference vessel diameter 3.2 ± 0.5 mm. MACE rates at 6, 12 and 24 months were 4.9%, 8.1% and 9.4%, target lesion revascularization rates 2.8%, 4.9% and 5.4% and definite stent thrombosis rates 0.5%, 0.6% and 0.6%. Subgroups showed significant differences in baseline and procedural characteristics which did not translate into significantly different clinical outcomes. Specifically, MACE rates at 24 months were 13.5% in diabetics, 8.6% in small stents and 9.6% in acute coronary syndrome patients.
Conclusion
The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt–chromium thin strut bare metal stent with a passive coating showed very good results up to 24 months. (ClinicalTrials.gov:NCT01056120)
Summary for annotated table of contents
The ENERGY international registry evaluated the safety and benefits of a cobalt–chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2 years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤ 2.75 mm and acute coronary syndrome.
1
Introduction
Bare Metal Stents (BMS) were designed to address the limitations of percutaneous transluminal coronary angioplasty (PTCA) , but were still associated with substantial restenosis rates . Drug-eluting stents (DES) were introduced to overcome this problem , but late and very late stent thrombosis of DES warranted further research . To address these limitations, several novel technologies have been developed, one of them being BMS with an improved stent design. Cobalt–chromium (CoCr) replaced stainless steel, allowing thinner stent struts with the associated advantages of better flexibility and reduced restenosis rates . In addition, passive stent coating may further reduce restenosis rates .
The PRO-Kinetic Energy BMS is a CoCr stent which is covered by a thin layer of amorphous silicon carbide. In animal models, silicon carbide coating has been shown to reduce direct smooth-muscle-cell stimulation and to exhibit lower adhesion and activation of blood platelets and leucocytes . It was the aim of the present registry to evaluate the clinical safety and efficacy of this latest generation BMS in a large (> 1000 patients) multi-center prospective observational trial to evaluate if the preliminary promising data obtained with a small sample size in the MULTIBENE study can be replicated in daily practice and to assess outcomes in specific pre-defined high-risk groups such as patients with diabetes, small stents, and ACS.
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