BACKGROUND: Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabetic patients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. METHODS AND RESULTS: 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabetic patients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). CONCLUSION: The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.
BACKGROUND:Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) are at increased risk for adverse outcomes. The use of sirolimus eluting stents (SES) has been shown to improve outcomes in diabeticpatients. Since results from randomized trials were derived from selected patients scientific scrutiny under real world conditions is necessary. METHODS AND RESULTS: 1,948 patients with DM and 4,707 patients without DM were included in the German Cypher Registry, a post-marketing survey of use of SES in Germany. In >99% of entry cases a structured clinical follow-up was completed. By angiographic criteria severity of coronary artery disease was higher in diabeticpatients compared to non-diabetics. However, procedural success and in-hospital complication rates were comparable between DM- and non-DM-patients. 6 months MACE rate in the DM group was significantly higher than in the non-DM group (16.4% vs. 13.0%) but lower than expected from historical data with the use of bare metal stents (BMS). CONCLUSION: The results with SES in diabetics are encouraging but DM remains a risk factor for poor outcome of PCI. No statement is justified whether the treatment of diabetics with SES is at least as safe as bypass surgery. This intriguing question has to be answered in a direct randomized head-to-head comparison with state of the art surgery.
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Authors: Giuseppe Biondi-Zoccai; Imad Sheiban; Claudio Moretti; Tullio Palmerini; Antonio Marzocchi; Davide Capodanno; Corrado Tamburino; Massimo Margheri; Giuseppe Vecchi; Giuseppe Sangiorgi; Andrea Santarelli; Antonio L Bartorelli; Carlo Briguori; Luigi Vignali; Francesco di Pede; Angelo Ramondo; Massimo Medda; Marco de Carlo; Giovanni Falsini; Alberto Benassi; Cataldo Palmieri; Vincenzo Filippone; Diego Sangiorgi; Fabio Barlocco; Stefano de Servi Journal: Clin Res Cardiol Date: 2010-12-03 Impact factor: 5.460
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Authors: Ibrahim Akin; Alexander Bufe; Steffen Schneider; Holger Reinecke; Lars Eckardt; Gert Richardt; Detlev Burska; Jochen Senges; Karl-Heinz Kuck; Christoph A Nienaber Journal: Clin Res Cardiol Date: 2010-03-11 Impact factor: 5.460
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