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Background: Drugeluting stents (DES) are currently judged to be a "break-through" technology for the prevention of restenosis after percutaneous coronary interventions (PCI). However, experience is limited to randomised controlled clinical trials (RCT) in selected lesions and the currently available DES are more expensive compared to conventional "bare" stents. Therefore, actual clinical practice may be very different to RCT., Methods: We analysed the data of the German Cypher trade mark Registry, a nationwide registry which was initiated in parallel to the launch of the first DES, the Cypher trade mark sirolimus-eluting coronary stent, in April 2002., Results: From April 2002 until March 2003, 1638 procedures at 88 hospitals were included in the German Cypher trade mark Registry. The mean inclusion rate per centre and month remained low (<3 procedures/month and participating hospital) during the whole inclusion period. Most patients presented with stable angina pectoris (45.8%); however, 6.4% of patients were treated for a non-ST elevation myocardial infarction, 10.3% of patients for ST elevation myocardial infarction and 1.7% in cardiogenic shock. In patients without ST elevation myocardial infarction, a de novo stenosis was treated in 68.4% of cases, a restenosis in 4.1%, and an in-stent restenosis in 25.5% of cases. Chronic total occlusions were treated in 6.1% of patients. Predilatation was performed in 68.3% of patients and 1.05 +/- 0.35 Cypher trade mark stents were implanted per patient with a median (quartiles) stent length of 18 (13-21) mm. PCI-related death occurred in 0.1% of patients and a Q-wave myocardial infarction in 1.1%. Urgent re-PCI before hospital discharge was performed in 1.3% and urgent bypass surgery in 0.1% of cases., Conclusions: The use of the sirolimus-eluting coronary stents in this "real life" registry was found to be safe concerning acute complications. In about one half of the registry patients, the DES was implanted in lesions that were excluded from RCTs.

In patients with aortic valve stenosis, the determination of the transstenotic pressure gradient is usually performed by cardiac catheterization with retrograde passage of the aortic valve. The aim of this study was to determine retrospectively the risk of the invasive examination with retrograde catheterization of the left ventricle and predictors for an increased risk. From 1984 to 1995, 457 patients (63 +/- 11 years) with aortic stenosis were investigated in the Medizinische Klinik Tübingen. In 435 patients (95.2%), the retrograde catheterization of the left ventricle was successful; in 19 cases a transseptal left heart catheterization was performed, and in 3 patients an invasive determination of the pressure gradient was not assessed. Complications occurred in 39 patients (8.5%). 5 patients died due to the catherization procedure (mortality rate 1.1%), 2 of them as a consequence of perforation of the left ventricle, one patient of heart failure, one of myocardial infarction, and another of fulminant pulmonary embolism. Four procedures (0.9%) were complicated by cerebral embolism, in 3 patients a pericard tamponade occurred, and in one case caused by transseptal punction of the interatrial septum. The most complications were peripheral vascular problems in 19 patients (4.2%). Predictors for increased risk dur to retrograde catheterization were age > 70 years (p = 0.008) and aortic valve area < or = 0.7 cm2 (p = 0.02). patients with a doppler echocardiographic instantaneous pressure gradient > or = 70 mm Hg were more likely to sustain a complication (p = 0.04). The retrograde catheterization of a stenotic aortic valve was successful in most cases. In approximately 2% of patients, complications occurred which can be attributed directly to retrograde catheterization and with significant higher frequency in patients over 70 years and with severe stenosis. Especially in these cases, invasive determination of the gradient should not be performed if reliable doppler echocardiographic information is available.