Vergleich von Drug-Eluting Stents und konventionellen Bare-Metal Stents im Langzeitverlauf bei Patienten mit koronarer Herzerkrankung

In randomized studies drug-eluting stents (DES) show an advantage over bare-metal stents (BMS) concerning the risk of restenosis. These studies mostly include certain patient groups observed over a short period of time. The analysis of this registry is supposed to provide an overall picture in the long-term for patients with coronary heart disease, without excluding certain groups of patients. Furthermore, this work aims at comparing both BMS and DES implantations in one patient, at the same time because in this case the entry requirements are identical concerning the anamnesis. Particularly target lesion revascularisation (TLR) is considered in more detail when it comes to target lesion. The Marburg Stent Registry contains data of 869 patients who received a total number of 1.691 stents in the period from January 1st 2004 to December 31st 2006. Following BMS stents were included: Coroflex®, Coroflex®Blue and following DES stents were included: Coroflex®Please, Taxus®Liberté® and Taxus®Express®. The patients were divided into three groups: Firstly, patients, who received only BMS, secondly, patients, who received only DES, and thirdly, patients, who received both BMS and DES. A subgroup analysis of diabetic patients was also conducted. Ultimate objective of the study was the occurrence of MACE (death, CABG surgery, myocardial infarction, TVR, TLR) after 48 months as well as the survival time analysis using the Kaplan Meier method. The results of DES vs. BMS in different patients showed significant differences in baseline characteristics. DES patients showed more risk factors in their anamneses. After 4 years there was no significant difference between the patient groups (DES or BMS) in terms of MACE rate. Moreover, after 4 years freedom from TLR and TVR were not significantly different. Freedom from myocardial infarction, CABG surgery and death were similar in both groups and amounted to about 80%. The results of DES vs. BMS in one patient showed a significant difference after 3 years with an advantage in the DES with regards to the TLR rate and TVR rate. After 24 months, freedom from MACE resulted in 23.7% for the patients. Freedom from myocardial infarction, CABG surgery and death resulted in more than 88%. In contrast to BMS, DES showed a reduced TLR rate in diabetic patients. Concerning the lesion, the evaluation showed an increased rate of TLR of BMS in bifurcations in lesions of type B2 and C and in the LAD. Leaving aside the stent type a similar freedom from TLR occurred after 2 years in the LAD, the RCX and RCA Moreover, an increased number of events in the vein graft and in smaller vessels could be observed. In contrast to A, B1 and B2 lesions, type C lesions had the lowest freedom from TLR after 3 years. In contrast to randomized studies, the Marburg Stent Registry shows increased MACE and TLR rates. This is due to worse conditions concerning the input history of the anamnesis and the cardiac data. Furthermore, care must be taken because our definition of MACE included more event types than in comparable studies. A non-integration of revascularization (TLR or TVR) in the MACE definition leads to a significant reduction in MACE rates. Concerning the implantation of BMS and DES in one patient there were, significant differences favouring DES, as also described in literature. In contrast, there were no significant differences in the implantation of stents in different patients. Compared to the results of our registry, the randomized studies SIRIUS, RAVEL, TAXUS II and TAXUS IV demonstrated a similar number of BMS events and a reduced number of events in the DES group. The TAXUS V and TAXUS VI studies, which examined more complex lesions, presented almost identical event rates regarding MACE and TLR in the DES. Our results showed no significant differences between DES and BMS groups, regarding the events of death, myocardial infarction and CABG surgery, which also corresponds to current literature. In diabetic patients as well as in bifurcations and in lesions of type B2 and C DES demonstrate an advantage over BMS regarding a new TLR after stent implantation. A new prospective randomized study should take a closer look at potential differences within the DES (Taxus®Liberte®/ Express® and Coroflex ®Please) and BMS (Coroflex® and Coroflex®Blue) group. This requires a sufficient and equal number of stents in each group.