Background Because a delayed arterial healing response after drug-eluting stent implantation has raised concerns about safety in diabetic patients, long-term effects of treatment with sirolimus-eluting stent (SES), as compared with bare-metal stent (BMS), have to be established. The aim of the 5-year follow-up of the randomized, controlled, open-label multicenter SCORPIUS study was to assess long-term safety and efficacy of the CYPHER (Cordis, Johnson & Johnson, Bridgewater, NJ) SES in percutaneous coronary intervention of diabetic patients.Methods A total of 190 patients with type 2 diabetes mellitus were randomized to receive either a SES (n = 95) or a BMS (n = 95). Dual-antiplatelet therapy (aspirin plus clopidogrel) was prescribed for at least 6 months. Clinical follow-up data were scheduled at 1, 8, and 12 months and 5 years.Results Treatment with SES resulted in a 16% decrease in the rate of major adverse cardiac events (36% vs 52%; hazard ratio 0.6, 95% CI 0.4-0.9; P = .02). This reduction in major adverse cardiac events with SES at 5 years was mostly attributable to a lower number of repeat target lesion revascularization (13% vs 29%; hazard ratio 0.4, 95% CI 0.2-0.7; P = .003). No differences between groups were observed for safety end points (all-cause mortality 21% vs 21%, cardiac death 15% vs 13%, repeat myocardial infarction 8% vs 9%, and stent thrombosis 5% vs 6%) at 5 years.Conclusions The 5-year follow-up of the SCORPIUS trial demonstrates the long-term antirestenotic efficacy of SES in diabetic patients with significantly reduced target lesion revascularization and comparable rates of mortality, myocardial infarction, and stent thrombosis compared with BMS. (Am Heart J 2012;163:446-453.e1.)

Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.

—The use of quantitative coronary angiography, combined with Doppler and PET, has recently been directed at the study of α-adrenergic coronary vasomotion in humans. Confirming prior animal experiments, there is no evidence of α-adrenergic coronary constrictor tone at rest. Again confirming prior experiments, responses to α-adrenoceptor activation are augmented in the presence of coronary endothelial dysfunction and atherosclerosis, involving both α 1 - and α 2 -adrenoceptors in epicardial conduit arteries and microvessels. Such augmented α-adrenergic coronary constriction is observed during exercise and coronary interventions, and it is powerful enough to induce myocardial ischemia and limit myocardial function. Recent studies indicate a genetic determination of α 2 -adrenergic coronary constriction.

Drug Prescribing for Patients with Chronic Kidney Disease in General Practice: a Cross-Sectional Study

Anamnese und klinischer Befund: Untersuchungen: Therapie und Verlauf: Folgerung: History and clinical findings: Investigations: Treatment and course: Conclusion:

OBJECTIVES:This study sought to analyze the effectiveness of drug-eluting stents in a high-risk group of diabetic patients. Previously, this had been analyzed only in substudies of larger trials or in clinical investigations enrolling a small number of patients. BACKGROUND:Drug-eluting stents are highly effective in reducing the rate of in-stent restenosis. METHODS:Two hundred patients with diabetes and de novo coronary artery lesions were enrolled in 16 centers: 98 were randomly assigned to sirolimus-eluting stents (SES) and 102 received bare-metal stents (BMS). The primary end point was in-segment late luminal loss. Major adverse cardiac events (MACE) rate was analyzed at 30 days and 8 and 12 months. RESULTS:The extent of in-segment late luminal loss in the SES group was 0.18 mm compared with 0.74 mm in the BMS group. In-segment restenosis was identified on follow-up angiography in 8.8% of the patients in SES and in 42.1% in BMS (p < 0.0001). Target lesion revascularization was performed in 5.3% of the patients in SES and in 21.1% of the patients in BMS (p = 0.002). The SES was effective in the treatment group with oral diabetic medication as well as in the insulin-dependent treatment group (3.6% SES vs. 38.8% BMS). There was no subacute stent thrombosis in the SES group up to 1 year. The MACE rate was not significantly different at 30 days. At 12 months, MACE rate was 14.7% in SES versus 35.8% in BMS. CONCLUSIONS:The SES is safe and highly effective in patients with diabetes mellitus and coronary artery disease and associated with a significant decrease in the extent of late luminal loss.

BACKGROUND:The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established.METHODS:We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean follow-up interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention.RESULTS:The overall risk of death (hazard ratio, 1.03; 95% confidence interval [CI], 0.80 to 1.30) and the combined risk of death or myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantly different for patients receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.CONCLUSIONS:The use of sirolimus-eluting stents does not have a significant effect on overall long-term survival and survival free of myocardial infarction, as compared with bare-metal stents. There is a sustained reduction in the need for reintervention after the use of sirolimus-eluting stents. The risk of stent thrombosis is at least as great as that seen with bare-metal stents.

Sowohl aus prognostischen Gründenals auch unter Kostenaspekten soll der Fokus des Gesundheitssystemsin Zukunft vermehrt auf der Präventionvon Erkrankungen statt auf der Behandlungbzw. Palliation liegen. Der Wert solcher Untersuchungenist umstritten, und es liegen nur wenige Beobachtungenzu diesem Thema vor.

Ziele: Die retrospektive Auswertung der Untersuchungsergebnisse von 1007 Patienten, die im Rahmen von Vorsorgeuntersuchungen klinisch und MR-tomographisch untersucht wurden. Methode: 720Männer und 287 Frauen wurden klinisch (körperl. Untersuchung, Sonographie der Schilddrüse und Carotiden, Labor, EKG, Bel.-EKG, Lungenfunktion) und MR-tomographisch untersucht. Das MR-Untersuchungsprotokoll beinhaltete bei allen Patienten eine Standard-Untersuchung des Gehirns, eine kontrastunterstützte MRA der großen Arterien und eine Standarduntersuchung des Herzens. 855 der Patienten (855/1007) unterzogen sich zusätzlich einer MR-Kolonographie, 152 der Patienten (152/1007) anstatt der MR-Kolonographie einer MR-Abdomenübersichtsdarstellung (T1 Vibe). Patienten mit MR-Kolonographie erhielten gewichtsadaptiert triple-dose Gd-BOPTA, Patienten ohne Kolondarstellung double-dose Gd-BOPTA. Patienten mit akuten Erkrankungen wurden von der Auswertung ausgeschlossen. Ergebnis: Alle MR-tomographischen Untersuchungen waren diagnostisch. Die MR-tomographischen Untersuchungsergebnisse wurden durch klinische oder technische Zusatzuntersuchungen kontrolliert. Insgesamt wurden bei diesen 1007 Patienten 891 relevante Diagnosen gefunden, hiervon 24% dieser Diagnosen (216/891) ausschließlich MR-tomographisch. Den größten Anteil MR-basierter Diagnosen machten mit 8,2% (73/891) kardio-vaskuläre Erkrankungen aus, darunter 34 (3,8%, 34/891) stumme kardiale Infarkte). 27 (3%, 27/891) Aortenaneurysmen wurden neu diagnostiziert, davon 2 größer als 5cm. 11 (1,2%, 11/891) intracranielle extraaxiale Tumore wurden nachgewiesen, 75 (8,4% 75/891) Kolonpolypen, 4 (0,44%, 4/891) Neoplasien, 2 (0,22%, 2/891) zerebrale Aneurysmen. Falsch positive Ergebnisse traten beim Nachweis von 2 Kolonpolypen auf. Schlussfolgerung: MR basierte Screening Untersuchungen sind eingebettet in ein klinisches Gesamtkonzept sinnvoll. Der prozentual größte Anteil neuer MR-tomographisch nachweisbarer und therapierelevanter Diagnosen sind kardiovasculäre Erkrankungen. Die Detektionsrate von 4 Malignomen korreliert mit der natürlichen Prävalenz dieser Erkrankungen.

Background Penetrating aortic ulcer (PAU) is increasingly acknowledged as a, pathological variant of classic false-lumen aortic dissection with a high incidence of bleeding complications and rupture in up to 40% of patients. The objective of this study was to investigate the results of endovascular stent-graft placement for the treatment of patients with PAUs.Methods Between July 1999 and December 2004, endovascular scent-graft repair of PAU was performed in 22 patients (69.1 +/- 7.8 years, 16 men), 3 (14%) of whom had contained aortic rupture. Stent-graft placement was performed in the cardiac catheterization laboratory with the patient under general anesthesia, using a surgical access.Results Procedural success was achieved in all but 1 patient (technical success rate 96%). Postoperatively, 1 (5%) patient had minor stroke with transient amentia. There were no other inhospital complications or deaths. During a median follow-up of 27 (range 1-62) months, 1 patient underwent adjunctive stent-graft placement for type I endoleak. Three patients died unrelated to the aortic disease late during, follow-up. Overall survival rates were 100% at 30 days, 100% at 1 year, 82.5% 11.3% at 2 years, and 61.9% +/- 20.0% at 5 years.Conclusions Endovascular stent-graft treatment is an effective treatment for patients with PAU and is associated with low procedural morbidity. Both acute and midterm mortality of this novel treatment concept appear to be favorable compared with the natural course of the disease.

Despite advances in medical and surgical treatment, acute as well as chronic diseases of the thoracic aorta are still associated with a high mortality. For the descending thoracic aorta, endovascular stent-graft placement competes with surgical therapy for clinical outcome. From July 1999 till December 2004, a total of 84 patients (64 +/- 14 years) with aortic disease of the descending thoracic aorta were treated. Nine patients had acute (AAD) and 35 chronic aortic dissection (AD), 16 had thoracic aortic aneurysms (TAA), 21 had penetrating aortic ulcer (PAU), and 3 patients had traumatic dissection (trans). Initial clinical status was assessed using the American Society of Anesthesiologists (ASA) classification. Fifty-three patients were in class 2, 16 in class 3, 8 in class 4, and 7 in class 5. Stent-graft placement was performed in the cardiac catheterization laboratory with the patient under general anesthesia. Technical success was obtained in 81/84 patients (96%). Within 30 days, seven patients (8%) died, four of them due to aortic rupture. In 14 patients, additional stent-grafts had to be implanted due to type I endovascular leakage (n = 5) or additional entry site adding up to a total of 107 implanted stent-grafts. During a follow-up period of 21 +/- 18 months, 17 additional patients died (22%). In 10 patients, death was disease- or procedure-related (13%). This long-term mortality depended on the underlying disease and was highest in the group with TAA (45%) followed by AAD (38%) and AD (18%). Patients in ASA class 4 and 5 had a significantly worse outcome. No aortic-related death occurred among patients with PAU or traumatic transsections. Overall, there was only one transient neurological deficit. Endovascular stent-graft placement has acceptable results in the treatment of patients with disease of the descending thoracic aorta. The outcome strongly depends on the underlying aortic pathology and the clinical health status of the patients. Randomized trials are necessary in order to establish the exact value of this new therapeutic option.

We assessed the incidence, correlates, and outcomes of acute renal failure (ARF) after thoracic aortic stent-graft placement. Postprocedural ARF is an inherent complication of catheter-based interventional procedures that use intra-arterial contrast agents and has adverse effects on short- and long-term outcomes. However, few data exist on the incidence, predictors, and outcomes of ARF after thoracic aortic stent-graft placement. We analyzed data of 97 patients (64.4 +/- 11.6 years of age; 73% men) who underwent thoracic aortic stent-graft placement from July 1999 to October 2005. Postprocedural ARF was defined as an increase > or = 25% and/or > or = 0.5 mg/dl in preprocedural serum creatinine at 48 hours after the procedure. Baseline estimated glomerular filtration rate was 65 +/- 24 ml/min/1.73 m2. Chronic kidney disease (glomerular filtration rate < or = 60 ml/min/1.73 m2) at baseline was present in 45% of patients. During the stent-graft procedure, patients received 307 +/- 188 ml of nonionic contrast medium. Postprocedural ARF occurred in 33 patients (34%), and 3 required dialysis. Multivariable analysis identified American Society of Anesthesiologists class > 3 (odds ratio 5.53, 95% confidence interval 1.71 to 17.85, p = 0.004) and duration of the stent-graft procedure (odds ratio 1.01, 95% confidence interval 1.001 to 1.014, p = 0.022) as independent predictors of postprocedural ARF. Compared with patients without ARF, those with ARF had markedly higher 30-day (18.2 +/- 6.7% vs 1.6 +/- 1.6%, p = 0.0022) and 1-year (35.2 +/- 8.6% vs 10.1 +/- 3.9%, p = 0.001) mortality. In conclusion, postprocedural ARF is a frequent complication of thoracic aortic stent-graft placement and has a significant adverse effect on 30-day and 1-year survival. Baseline factors identified in our study as associated with increased risk of ARF may facilitate a comprehensive informed consent process by way of patient education. In addition, identification of an at-risk subset may allow modification of reversible periprocedural factors that may help decrease postprocedural ARF.

BACKGROUND Contrast media-induced nephropathy (CIN) is an increasing cause of hospital-acquired acute kidney injury and leads to a significant increase in mortality. There is uncertainty whether the use of iso-osmolar contrast media as opposed to the use of low-osmolar contrast media would be associated with a lower incidence of CIN. Therefore, we compared the nephrotoxicity of isoosmotic contrast media iodixanol with the low-osmotic contrast media iopromid in patients receiving contrast media during coronary angiography. METHODS In this prospective double-blind study we examined 221 patients with normal renal function who received up to 1,000 ml of contrast media during coronary angiography, and compared the effect of iodixanol and iopromid on inducing contrast media nephropathy. Patients received 800 ml fluid orally before contrast media administration and 1,000 ml saline i.v. thereafter. Creatinine clearance, serum creatinine and urine-N-acetyl-beta-D-glucosaminidase (NAG) concentration was obtained 24 h before and 48 h after contrast media administration. Decrease of 20% of the creatinine clearance, increase of 25% of serum creatinine and increase of 20% of the urine concentration of NAG was defined as CIN. RESULTS Incidence of CIN assessed by decreased creatinine clearance was 22.2% in the iopromid group and 19.7% in the iodixanol group. CIN defined by increased serum creatinine was 6.9% in the iopromid group and 8.6% in the iodixanol group. The difference between these two groups was not significant. Subgroup analysis of the diabetic patients or the patients that received high dose of contrast media revealed no significant difference in the incidence of CIN between the two contrast media. CONCLUSION The iso-osmolar and the low-osmolar contrast media exhibited the same incidence of CIN in our study population. If fluid administration is sufficient, the selection of either iopromid or iodixanol has no impact on the risk of developing CIN in patients with normal renal function, even when they are diabetic or receive a high dose of more than 500 ml contrast media.

Objective We investigated the impact of the -786C allele at the promoter and the 894T allele in exon 7 of the gene encoding the endothelial nitric oxide synthase (NOS3) on coronary vasomotor responses to exogenous and endogenous stimuli. Methods In 47 individuals undergoing coronary angiography for chest pain, but without significant stenosis in the left anterior descending artery (LAD), nitroglycerine and acetylcholine were infused intracoronarily, and a cold pressor test (CPT) was performed. Coronary blood flow (CBF) in the LAD was calculated from quantitative coronary angiography and intracoronary Doppler measurements. Aortic and coronary sinus lactate levels were determined in 18 individuals. To analyze the impact of NOS3 genotypes, a logistic regression model was used. Results In response to acetylcholine (p = 0.002) and CPT (p = 0.015) CBF reduction was associated with homocygosity for the -786C allele. Myocardial lactate uptake was reversed into net lactate production in CC homocygotes. No independent effects of the G894T polymorphism were observed in the present study. Haplotype analysis revealed a significant linkage disequilibrium between both polymorphisms (p < 0.001). Conclusions Our findings suggest a pathophysiologically relevant role for the T-786C polymorphism in human coronary vasomotion. The observed linkage disequilibrium between both NOS3 genotypes deserves further research in future studies.

Objectives: To identify determinants of postinterventional death after endovascular stent-graft placement for acute rupture of the descending thoracic aorta, an emerging therapeutic modality for this highly life-threatening condition. Methods: Between July 1999 and November 2004, 17 patients (14 males; mean age, 65 +/- 16 (25-83) years) underwent stent-graft repair of the descending thoracic aorta for acute rupture from a thoracic aneurysm (TAA, n = 6), acute aortic dissection (AAD, n = 6), penetrating aortic ulcer (PAU, n = 3), or blunt chest trauma (n = 2). Immediate, 30-day, 1-year, and 3-year mortality was assessed. Twenty-one clinical and procedural variables were evaluated in a post-hoc analysis regarding their influence on mortality. Of these, four preprocedural factors with the greatest impact were used to construct a rupture score with a scale from 0 (no adverse prognostic factors present) to 4 (all four adverse factors present). Results: Stent-graft placement was technically feasible in all patients. Complete exclusion of the ruptured aortic pathology could be achieved in only 11 (65%) patients, despite implantation of 1.6 +/- 0.9 stent-grafts per patient, with a median length of 130 mm. There was one procedure-related early complication (bleeding at the access site). One patient died immediately following the procedure because of progressive mediastinal hematoma, although the rupture site was effectively sealed. Overall survival rates were (76.5 +/- 10.3)% at 30 days and (52.9 +/- 12.1)% at 1 year and remained at (52.9 +/- 12.1)% at 3 years. The four most important preprocedural denominators of death were (1) TAA or AAD as the underlying etiology of aortic rupture (P = 0.024), (2) maximum aortic diameter >5 cm (P = 0.024), (3) presence of mediastinal hematoma [P = 0.056), and (4) an estimated lesion length requiring >1 stent-graft to be covered (P = 0.009). Furthermore, residual leakage at the conclusion of the procedure (P = 0.009), post-procedural need for dialysis (P = 0.004), and prolonged ventilation (P = 0.043) were significantly associated with postprocedural death. Using a threshold of >3, the rupture score constructed on the basis of the four preprocedural denominators of death was found to be well suited to discriminate postprocedural death (1-year survival: (20.0 +/- 12.7)% in patients with a rupture score >3 vs. 100% in patients with a rupture score <3, P = 0.001). Conclusion: Endovascular stent-graft placement in patients with acute aortic rupture was technically feasible, albeit still associated with high mortality. A simple risk score constructed in retrospect, on the basis of preprocedural prognostic factors, appeared to provide a useful separation of candidates who are likely to benefit from a straightforward endovascular procedure and should be tested prospectively in future studies. (c) 2005 Wiley-Liss, Inc.

Our patients exhibited a relative percentage of in-stent restenosis of 33.6% defined by a stenosis of at least 50% of the vessel diameter in any of the coronary arteries. There was no significant correlation between the rate of restenosis and homocysteine plasma levels. In contrast, the luminal diameter, the length of the stent and the percentage of stenosis correlated with the appearance of restenosis. Thus, as to our results, homocysteine may not be used as a safe and independent biomarker of in-stent restenosis after a six months period following percutaneous coronary stenting.

Alms To investigate the results of endovascular stent-graft placement for the treatment of patients with type B aortic dissection (B-AD).Methods and results A total of 38 patients (62 +/- 10 years, 32 mate) with acute (n = 10) and chronic (n = 28) type B-AD were treated with endovascular stent-grafts. The implantation procedure was successful in all patients. Peri-procedural non-fatal complications occurred in four (11%) patients. Overall, 4/38 (11%) patients died during the in-hospital period. Patients undergoing stent-graft placement for acute AD had a significantly higher in-hospital mortality than patients with chronic AD (40 vs. 0%, P = 0.001). During a median follow-up of 18 (1-57) months, there were six additional deaths. Overall survival rates were 97.4 +/- 2.6% at 30 days, 80.4 +/- 6.7% at 1 year, 73.2 +/- 7.8% at 2 years, and 54.9 +/- 16.9% at 4 years. Patients with a poor clinical health status (ASA class > 3) had a significantly reduced life expectancy compared with patients with only moderate co-morbidities (ASA class <= 3) (1-year survival rate 28.6 +/- 17.1 vs. 92.6 +/- 6.7%, P = 0.0001). Multivariable analysis revealed that a poor clinical health status (ASA > 3) pre-operatively (HR = 29.5, 95% Cl 1.5-581.9, P = 0.026) and increased age (HR = 1.1, 95% CI 0.9-1.2, P = 0.084) were independent determinants of post-interventional mortality.Conclusion Endovascular stent-graft treatment is a safe alternative for patients with AD. The pre-operative clinical health status of the patient is the most important determinant of post-interventional outcome. Careful patient selection is thus of particular importance.