Objectives The aim of this study was to compare clinical outcomes among unselected patients stratified in categories of body mass index, who underwent percutaneous coronary intervention (PCI) with ...either sirolimus-eluting or paclitaxel-eluting stents. Background Overweight and obesity are often considered risk factors for cardiovascular events. However, recent studies have associated obesity with better outcomes after PCI with bare-metal stents. Data from routine clinical practice using drug-eluting stents (DES) focusing on this “obesity paradox” are not available. Methods We used data from DES.DE (German Drug-Eluting Stent) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing PCI with DES implantation. Primary endpoints were the rate of major adverse cardiac and cerebrovascular events (MACCE) (defined as the composite of death, myocardial infarction, and stroke) and target vessel revascularization (TVR). Results Between October 2005 and 2006, 1,436 normal weight, 2,839 overweight, and 1,531 obese patients treated with DES were enrolled at 98 sites. Baseline clinical parameters were more severe in overweight and obese patients; 1-year follow-up comparison between groups revealed similar rates of all-cause death (3.3% vs. 2.4% vs. 2.4%; p = 0.17), MACCE (7.1% vs. 5.6% vs. 5.5%; p = 0.09), and TVR in survivors (10.9% vs. 11.7% vs. 11.6%; p = 0.56) in normal weight individuals compared with overweight or obese patients. Such results persisted after risk-adjustment for heterogeneous baseline characteristics of groups and were independent of the types of DES. Conclusions DES.DE revealed no evidence of “obesity paradox” in a routine clinical practice using DES.
Repeat carotid endarterectomy (CEA) for recurrent stenosis remains a challenging treatment option associated with high morbidity and mortality. Carotid artery stenting (CAS) is an attractive ...alternative management option for these patients. However, data about the effectiveness and safety of CAS in a large number of unselected patients are less known. We evaluated 3,070 patients who underwent CAS enrolled in a German registry from 1996 to 2006 at 31 sites. We compared clinical and angiographic features and inhospital outcomes of patients with and without previous CEA who underwent CAS. Of 3,070 patients in the registry, 223 (7.3%) underwent CAS for restenosis after previous CEA. Median age was similar in patients with and without previous CEA (70 years, interquartile range 64 to 76 vs 71 years, interquartile range 65 to 76). Ipsilateral neurologic symptoms occurred in approximately 1/2 the patients in both groups. Other co-morbid conditions and angiographic or procedural factors did not differ between the 2 groups. Inhospital events including death (0% vs 0.4%), ipsilateral major stroke (1.4% vs 1.5%), death or major ipsilateral stroke (1.4% vs 1.7%), ipsilateral transient ischemic attack (1.9% vs 2.8%), myocardial infarction (0.4% vs 0.1%), and reintervention (0.7% vs 0.4%) were all low and not significantly different between those with and without previous CEA (p >0.05 for all comparisons). In conclusion, our data for a large number of patients who underwent CAS in a recent contemporary community-based practice attests to the low risk of periprocedural events in patients with recurrent stenosis after previous CEA. This low risk along with the less invasive nature of the procedure should make CAS an attractive and perhaps preferred option for the treatment of these patients.
Objectives During its German pilot phase, the EuroCMR (European Cardiovascular Magnetic Resonance) registry sought to evaluate indications, image quality, safety, and impact on patient management of ...routine CMR. Background CMR has a broad range of applications and is increasingly used in clinical practice. Methods This was a multicenter registry with consecutive enrollment of patients in 20 German centers. Results A total of 11,040 consecutive patients were enrolled. Eighty-eight percent of patients received gadolinium-based contrast agents. Twenty-one percent underwent adenosine perfusion, and 11% high-dose dobutamine-stress CMR. The most important indications were workup of myocarditis/cardiomyopathies (32%), risk stratification in suspected coronary artery disease/ischemia (31%), as well as assessment of viability (15%). Image quality was good in 90.1%, moderate in 8.1%, and inadequate in 1.8% of cases. Severe complications occurred in 0.05%, and were all associated with stress testing. No patient died during or due to CMR. In nearly two-thirds of patients, CMR findings impacted patient management. Importantly, in 16% of cases the final diagnosis based on CMR was different from the diagnosis before CMR, leading to a complete change in management. In more than 86% of cases, CMR was capable of satisfying all imaging needs so that no further imaging was required. Conclusions CMR is frequently performed in clinical practice in many participating centers. The most important indications are workup of myocarditis/cardiomyopathies, risk stratification in suspected coronary artery disease/ischemia, and assessment of viability. CMR imaging as used in the centers of the pilot registry is a safe procedure, has diagnostic image quality in 98% of cases, and its results have strong impact on patient management.
Background Patients older than 75 years undergoing percutaneous coronary interventions are at increased risk for major adverse cardiac events strongly influenced by comorbidities. In various ...randomized trials, sirolimus-eluting stent (SES) implantation has been shown to decrease the incidence of in-stent restenosis and to reduce repeat revascularization regardless of patient age. Methods The present study evaluates the outcome after SES implantation in 954 patients older than 75 years compared with 5801 patients younger than 75 years enrolled in the German Cypher Registry in a routine clinical setting. Results The elderly were at higher risk regarding renal failure, diabetes, hypertension, impaired left ventricular function, and 3-vessel disease. The SES implantation resulted in an impressive relief of angina. As expected, in-hospital and 6-month mortality rates were higher in the elderly. However, there was no difference with respect to the rate of major adverse cardiac events (death, myocardial infarction, ischemia-driven target vessel revascularization) at 6-month follow-up. Conclusions Nonfatal complications such as myocardial infarction or repeat target vessel revascularization did not increase with age, even taking patients older than 80 years into account.
The prognostic effect of β-blocker treatment on ST-elevation acute myocardial infarction (STEMI) is controversially discussed in the era of reperfusion therapy. From the German multicenter registry ...Maximal Individual Therapy of Acute Myocardial Infarction PLUS (MITRA PLUS), 17,809 consecutive patients with STEMI treated with a guideline-recommended therapy with aspirin and an angiotensin-converting enzyme inhibitor were investigated; the prognostic effect of additional acute β-blocker treatment was analyzed. Patients with cardiogenic shock were excluded. Of included patients, 77.6% received additional acute β-blocker treatment and 22.4% did not. Patients with β-blocker treatment were younger and more often received reperfusion therapy. Acute β-blocker treatment was associated with a lower hospital mortality (univariate analysis 4.9% vs 10.8%, p <0.001; multivariate analysis odds ratio OR 0.70, 95% confidence interval CI 0.61 to 0.81). Acute β blockade was significantly associated with a lower hospital mortality in patients without (OR 0.66, 95% CI 0.56 to 0.79) and with (OR 0.76, 95% CI 0.60 to 0.98) reperfusion therapy. The greatest benefit of acute β-blocker treatment, measured by the number needed to treat to save 1 life, was found in patients with anterior MI, a heart rate ≥80 beats/min, no reperfusion therapy, female gender, and age ≥65 years. In conclusion, acute β-blocker therapy in the clinical practice of treating patients with STEMI, in addition to aspirin and angiotensin-converting enzyme inhibitor therapy, was independently associated with a significant decrease in hospital mortality in patients with and without reperfusion therapy. High-risk patients with STEMI, such as elderly patients and patients without reperfusion therapy, showed a greater benefit of acute β-blocker therapy than low-risk patients with STEMI.
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