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.
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.
Authors: Ahmed A Khattab; Christian W Hamm; Jochen Senges; Ralph Toelg; Volker Geist; Tassilo Bonzel; Malte Kelm; Benny Levenson; Christoph A Nienaber; Georg Sabin; Ulrich Tebbe; Steffen Schneider; Gert Richardt Journal: Clin Res Cardiol Date: 2007-02-26 Impact factor: 5.460
Authors: Ralf Zahn; C W Hamm; S Schneider; U Zeymer; G Richardt; M Kelm; B Levenson; T Bonzel; U Tebbe; G Sabin; C A Nienaber; Thomas Pfannebecker; J Senges Journal: Clin Res Cardiol Date: 2007-06-04 Impact factor: 5.460
Authors: Helge Möllmann; Albrecht Elsässer; Holger Nef; Steffen Schneider; Christoph A Nienaber; Gert Richardt; Michael Weber; Malte Kelm; Benny Levenson; Tassilo Bonzel; Ulrich Tebbe; Georg Sabin; Thomas Pfannebecker; Jochen Senges; Christian W Hamm Journal: Clin Res Cardiol Date: 2008-03-03 Impact factor: 5.460
Authors: Ralf Zahn; Franz-Josef Neumann; Heinz-Joachim Büttner; Gert Richardt; Steffen Schneider; Benny Levenson; Ulrich Tebbe; Georg Sabin; Christoph A Nienaber; Thomas Pfannebecker; Christian W Hamm Journal: Clin Res Cardiol Date: 2012-04-07 Impact factor: 5.460
Authors: A A Khattab; C W Hamm; J Senges; R Toelg; V Geist; T Bonzel; M Kelm; B Levenson; C A Nienaber; G Sabin; S Schneider; U Tebbe; G Richardt Journal: Z Kardiol Date: 2005-03
Authors: Ralf Zahn; Christian W Hamm; Uwe Zeymer; Gert Richardt; Malte Kelm; Benny Levenson; Tassilo Bonzel; Ulrich Tebbe; Georg Sabin; Christoph A Nienaber; Thomas Pfannebecker; Jochen Senges Journal: Clin Res Cardiol Date: 2009-10-31 Impact factor: 5.460
Authors: Ahmed A Khattab; Christian W Hamm; Jochen Senges; Ralph Toelg; Volker Geist; Tassilo Bonzel; Malte Kelm; Benny Levenson; Franz-Josef Neumann; Christoph A Nienaber; Thomas Pfannebecker; Georg Sabin; Steffen Schneider; Ulrich Tebbe; Gert Richardt Journal: Heart Date: 2007-10 Impact factor: 5.994