Outcomes after differential use of drug-eluting stents in diabetic patients: 1-year results from the DES.DE (Drug-Eluting Stent.DEutschland) registry.

The prospective multicenter German DES.DE registry provides real world data to evaluate the therapeutic principle of two different drug-eluting stents (DES) [Sirolimus- (SES) and Paclitaxel-eluting stent (PES)] in the context of the German Health System. Differential DES have been effective in randomized trials, but their difference in safety and efficacy in diabetic patients has not been well studied. Baseline, predefined procedural as well as clinical in-hospital and follow-up events were recorded for all 1,526 diabetic patients. The composite of death, myocardial infarction (MI), and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) were defined as primary endpoints. Between October 2005 and October 2006, 1,526 diabetic patients, 34.2% of them being insulin-dependent, were enrolled (SES: n = 612; PES: n = 914) at 98 DES.DE sites. Overall, one third of patients were admitted with acute coronary syndrome (ACS) and 70% had multivessel-disease reflecting a real world scenario. With similar baseline clinical and descriptive morphology of coronary artery disease (CAD) in both DES groups, there were no statistical differences in 1-year follow-up with respect to rates of overall mortality (5.8% vs. 5.4%), TVR (12.0% vs. 11.3%), overall stent thrombosis (5.6% vs. 4.6%) and MACCE (11.4% vs. 10.3%) between both DES. The data collected in DES.DE revealed no differences in clinical outcomes within 1 year between SES and PES in diabetic patients in a "real-world" setting.

Akin I ，Bufe A ，Eckardt L ，Reinecke H ，Richardt G ，Kuck KH ，Senges J ，Schneider S ，Nienaber CA ，DES.DE Study Group ... -  《-》

Clinical outcomes after sirolimus-eluting, paclitaxel-eluting, and bare metal stents (from the first phase of the prospective multicenter German DES.DE Registry).

Nienaber CA ，Akin I ，Schneider S ，Senges J ，Fetsch T ，Tebbe U ，Willich SN ，Stumpf J ，Sabin GV ，Silber S ，Richardt G ，Kuck KH ，DES.DE Study Group ... -  《-》

Four-year clinical outcome of sirolimus- and paclitaxel-eluting stents compared to bare-metal stents for the percutaneous treatment of stable coronary artery disease.

There are limited data on the long-term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). We aimed to assess the 4-year clinical outcome in patients who received a bare-metal stent (BMS), sirolimus-eluting stent (SES), or a paclitaxel-eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000-2005. In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI-cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). At 4 years follow-up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47-0.81; HR = 0.67, 95% CI: 0.55-0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target-vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37-0.75; HR = 0.71, 95% CI: 0.62-0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow-up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI.

Simsek C ，Onuma Y ，Magro M ，de Boer S ，Battes L ，van Domburg RT ，Boersma E ，Serruys PW ，Interventional Cardiologists of the Thoraxcenter (2000-2005) ... -  《-》

Three-year outcomes following sirolimus- versus paclitaxel-eluting stent implantation in an unselected population with coronary artery disease (from the REWARDS Registry).

Hanna NN ，Gaglia MA Jr ，Torguson R ，Ben-Dor I ，Gonzalez MA ，Collins SD ，Syed AI ，Maluenda G ，Kaneshige K ，Xue Z ，Satler LF ，Kent KM ，Suddath WO ，Pichard AD ，Waksman R ... -  《-》

Comparison of outcomes in patients with insulin-dependent versus non-insulin dependent diabetes mellitus receiving drug-eluting stents (from the first phase of the prospective multicenter German DES.DE registry).

Drug-eluting stents have been effective in randomized controlled trials, but their safety and efficacy in patients with insulin-dependent diabetes has not been well studied. Baseline clinical and angiographic characteristics and in-hospital and follow-up events were recorded for enrolled patients. From October 2005 and October 2006, 581 patients with insulin-dependent diabetes and 1,078 with non-insulin-dependent diabetes treated with sirolimus- and paclitaxel-eluting stents were enrolled at 98 sites. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, as well as target vessel revascularization was used as the primary end point. Multiple logistic regression analysis was used to adjust for confounding parameters. Baseline clinical characteristics were more severe in patients with insulin-dependent diabetes, whereas descriptive characteristics were not unique. At 1-year follow-up, the comparison between the 2 groups revealed significantly higher rates of overall death (7.4% vs 4.6%, p <0.05), target vessel revascularization (15.1% vs 10.4%, p <0.05), and overall stent thrombosis (6.5% vs 4.1%, p <0.05) for insulin-dependent patients, while rates of major adverse cardiac and cerebrovascular events were not significantly different (12.8% vs 9.9%, p = 0.09). These results persisted even after risk adjustment for heterogenous baseline characteristics of the 2 groups. In conclusion, the data generated from the German Drug-Eluting Stent (DES.DE) registry revealed that even with drug-eluting stents, the annual risk for death, target vessel revascularization, and thrombotic events remains higher in patients with insulin-dependent diabetes compared to those with non-insulin-dependent diabetes.

Akin I ，Bufe A ，Eckardt L ，Reinecke H ，Senges J ，Richardt G ，Kuck KH ，Schneider S ，Nienaber CA ，DES.DE Study Group ... -  《-》