Five-year results of the Multicenter Randomized Controlled Open-Label Study of the CYPHER Sirolimus-Eluting Stent in the Treatment of Diabetic Patients with De Novo Native Coronary Artery Lesions (SCORPIUS) study: a German multicenter investigation on the effectiveness of sirolimus-eluting stents in diabetic patients.

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.

Federated machine learning for a facilitated implementation of Artificial Intelligence in healthcare - a proof of concept study for the prediction of coronary artery calcification scores.

The implementation of Artificial Intelligence (AI) still faces significant hurdles and one key factor is the access to data. One approach that could support that is federated machine learning (FL) since it allows for privacy preserving data access. For this proof of concept, a prediction model for coronary artery calcification scores (CACS) has been applied. The FL was trained based on the data in the different institutions, while the centralized machine learning model was trained on one allocation of data. Both algorithms predict patients with risk scores ≥5 based on age, biological sex, waist circumference, dyslipidemia and HbA1c. The centralized model yields a sensitivity of c. 66% and a specificity of c. 70%. The FL slightly outperforms that with a sensitivity of 67% while slightly underperforming it with a specificity of 69%. It could be demonstrated that CACS prediction is feasible via both, a centralized and an FL approach, and that both show very comparable accuracy. In order to increase accuracy, additional and a higher volume of patient data is required and for that FL is utterly necessary. The developed "CACulator" serves as proof of concept, is available as research tool and shall support future research to facilitate AI implementation.

Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.

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.

Endovascular stent-graft treatment of penetrating aortic ulcer: results over a median follow-up of 27 months.

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 stent-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.

Frequency and outcomes of acute renal failure following thoracic aortic stent-graft placement.

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.

Relation between progression and regression of atherosclerotic left main coronary artery disease and serum cholesterol levels as assessed with serial long-term (> or =12 months) follow-up intravascular ultrasound.

BACKGROUND: The relation between serum lipids and risk of coronary events has been established, but there are no data demonstrating directly the relation between serum low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol versus serial changes in coronary plaque dimensions. METHODS AND RESULTS: We performed standard analyses of serial intravascular ultrasound (IVUS) studies of 60 left main coronary arteries obtained 18.3+/-9.4 months apart to evaluate progression and regression of mild atherosclerotic plaques in relation to serum cholesterol levels. Overall, there was (1) a positive linear relation between LDL cholesterol and the annual changes in plaque plus media (P&M) cross-sectional area (CSA) (r=0.41, P<0.0001) with (2) an LDL value of 75 mg/dL as the cutoff when regression analysis predicted on average no annual P&M CSA increase; (3) an inverse relation between HDL cholesterol and annual changes in P&M CSA (r=-0.30, P<0.02); (4) an inverse relation between LDL cholesterol and annual changes in lumen CSA (r=-0.32, P<0.01); and (5) no relation between LDL and HDL cholesterol and the annual changes in total arterial CSA (remodeling). Despite similar baseline IVUS characteristics, patients with an LDL cholesterol level > or =120 mg/dL showed more annual P&M CSA progression and lumen reduction than patients with lower LDL cholesterol. CONCLUSIONS: There is a positive linear relation between LDL cholesterol and annual changes in plaque size, with an LDL value of 75 mg/dL predicting, on average, no plaque progression. HDL cholesterol shows an inverse relation with annual changes in plaque size.

Preprocedural statin medication reduces the extent of periprocedural non-Q-wave myocardial infarction.

BACKGROUND: Stenting-related myocardial injury has been recognized as a frequent and prognostically important event, the extent of which depends on microcirculatory impairment in association with platelet aggregation, inflammation, and increased oxidative stress. Recent studies underscored the non-lipid-lowering effects of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) with antithrombotic, antiinflammatory, and antioxidative aspects. Thus, we tested the hypothesis that preprocedural statin therapy is associated with a reduction in the extent of stenting-related myocardial injury. METHODS AND RESULTS: We stratified 296 consecutive patients who were undergoing stenting of a de novo stenosis according to the preprocedural status of statin therapy (229 statin-treated and 67 control patients). Incidence of periprocedural myocardial injury was assessed by analysis of creatine kinase (CK; upper limit of normal [ULN] 70 IU/L for women, 80 IU/L for men) and cardiac troponin T (cTnT; bedside test; threshold 0.1 ng/mL) before and 6, 12, and 24 hours after the intervention. Relative to control patients, the incidence of CK elevation >3x ULN was more than 90% lower in statin-treated patients (0.4% versus 6.0%, P=0.01). Statin therapy was the only factor independently associated with a lower risk of CK elevation >3x ULN (OR: 0.08, 95% CI: 0.01 to 0.75; P=0.03). The overall incidences of CK and cardiac troponin T elevation were slightly lower in statin-treated than in control patients (14.4% versus 20.9%, P=0.3, and 17.9% versus 22.4%, P=0.5, respectively). CONCLUSIONS: Preprocedural statin therapy is associated with a reduction in the incidence of larger-sized, stenting-related myocardial infarctions. Prospective, randomized trials are warranted to further assess this cardioprotective effect of statins in coronary intervention.

Noninvasive assessment of microvascular function in arterial hypertension by transthoracic Doppler harmonic echocardiography.

OBJECTIVES: The present study sought to investigate the use of transthoracic Doppler harmonic echocardiography (TTDHE) to evaluate changes in coronary flow dynamics due to microvascular dysfunction. BACKGROUND: Coronary flow velocity reserve (CFVR) measurements by TTDHE are useful for assessing epicardial coronary artery stenoses. It remains unclear, however, if microvascular disease can be detected. METHODS: In 54 patients with chest pain, intracoronary Doppler (ICD) and TTDHE were used to measure average peak velocity at baseline and hyperemia. Significant coronary lesions had been ruled out by both angiography and intravascular ultrasound. Comparative measurements were performed in the distal left anterior descending coronary artery after intracoronary and intravenous administration of adenosine, and CFVR was calculated. Hypertensive patients (n = 25) were studied and compared to a control group (26 normotensive individuals). RESULTS: Three patients (5%) had to be excluded because of insufficient image quality or side effects. In both groups, TTDHE-derived CFVR data correlated closely with ICD measurements (group 1: y = 0.67x + 0.076, standard error of estimate [SEE] = 0.25, r = 0.87, p < 0.001; group 2: y = 0.64x + 1.11, SEE = 0.26, r = 0.87, p < 0.001). CFVR was lower in hypertensives than in normotensive controls (2.44 +/- 0.49 vs. 3.33 +/- 0.40, p < 0.001, cut point = 2.84). CONCLUSIONS: The newly described echocardiographic method is suitable for assessing microvascular dysfunction noninvasively and corresponds well to invasive measurements.

Treatment of orthostatic hypotension.

Orthostatic hypotension (OH) is a fall in blood pressure after assuming an upright position. Whereas asymptomatic patients usually need no treatment, the majority of symptomatic patients can be cured by avoidance of trigger mechanisms and the use of physical countermaneuvers and non-pharmacological interventions. Several pharmacological therapies are available and generally fludrocortisone and midodrine are the drugs of first choice. Recently, highly individualized therapy with ambulatory norepinephrine therapy was able to mobilize otherwise immobile patients.

Role of the eNOS Glu298Asp variant on the GNB3825T allele dependent determination of alpha-adrenergic coronary constriction.

The 825T allele of a polymorphism at GNB3, encoding the G protein beta(3) subunit, is associated with an enhanced coronary blood flow (CBF) reduction in response to alpha(2)-, but not to alpha(1)-adrenoceptor activation. Because the regulation of vascular tone by alpha(2)-adrenoceptors includes direct vasoconstriction as well as vasodilatation by endothelial release of nitric oxide, the eNOS Glu298Asp variant might further contribute to explain the variability of CBF reduction in response to alpha-adrenoceptor activation. Genotyping at the GNB3 and the eNOS gene was performed on 48 individuals receiving either the alpha(1)-adrenoceptor agonist methoxamine (5 mg i.c.) and/or the alpha(2)-adrenoceptor agonist BHT 933 (5 mg i.c.). CBF was calculated from quantitative coronary angiography and intracoronary Doppler flow velocity measurement. To analyse the impact of genotypes and coronary artery disease, a linear regression model was used, including cholesterol levels, heart rate, smoking and mean aortic blood pressure. An initial, univariate analysis suggested an impact of the eNOS Glu298Asp variant on alpha(2)-adrenoceptor-induced coronary constriction (CBF reduction 53.4 ch006.1 TT/TG versus 30.7 ch006.9% GG; P = 0.003). However, multifactorial analysis showed that the GNB3825T allele was associated exclusively with the CBF reduction on alpha(2)-adrenoceptor activation (58.2 +/- 4.4% TT/TC versus 27.9 +/- 4.3% CC; P < 0.0001). Contrary to the initial analysis, the Glu298Asp variant of the eNOS gene provides no additional information on the genetic basis of alpha(2)-adrenoceptor-induced coronary vasoconstriction, which appears exclusively associated to the 825T allele at GNB3. Analysis of modifying genes appears crucial for the understanding of genetic associations.

Successful reduction of in-stent restenosis in long lesions using beta-radiation--subanalysis from the RENO registry.

PURPOSE: Long lesions remain a challenging task in interventional cardiology, with a high propensity of restenosis, especially within the stented segment. Although intracoronary gamma-radiation has been proved to reduce diffuse in-stent restenosis in long lesions, such an effect remains to be determined using beta-radiation. METHODS AND MATERIALS: Of 1098 consecutive patients at 46 European centers treated with localized beta-radiation ((90)Sr, Novoste Beta-Cath System), 139 patients (mean age 61.5 +/- 10.7 years, 84% male, 22% with diabetes mellitus) with lesions treated using a >40-mm source length underwent radiation using a single 60-mm source train (34%) or a stepping/pullback procedure with a 30-mm (12%) or 40-mm (87%) source length after conventional interventional procedures. The mean lesion length was 35.3 +/- 17.9 mm. RESULTS: Technical success was achieved in 96% of cases. Geographic miss was noted in 9 patients (6.5%). The reference (placebo) group was obtained from the Washington Hospital Center for In-Stent Restenosis Trial (WRIST) and the WRIST Trial for long lesions (LONG WRIST) studies by selecting the cases (94 patients) that required a dummy source length >/=13 seeds (or >51 mm in length). Statistically significant improvement was noted in late angiographic restenosis (34.7% vs. 76.5%, p <0.0001), target vessel revascularization (14.9% vs. 60.6), and major adverse cardiac events (i.e., death, myocardial infarction, or total vessel revascularization) (17.9% vs. 64.9%, p <0.0001) at 6 months in reference to the nonradiation group. CONCLUSION: This subanalysis from the Radiation in Europe with Novoste study confirms the safety and efficacy of beta-radiation combined with conventional interventional procedures in patients with diffuse, long, in-stent restenosis

Impact of moderate lesion calcium on mechanisms of coronary stenting as assessed with three-dimensional intravascular ultrasound in vivo.

Axial plaque redistribution is an important mechanism of lumen enlargement after stenting of noncalcified lesions. To assess effects of lesion calcification on mechanisms of coronary stenting, we analyzed 55 lesions with noncircumferential calcification with 3-dimensional intravascular ultrasound (IVUS) (standard qualitative and quantitative analyses) before and after implantation of balloon-expandable stents. Thirty-two plaques (58%) showed arcs of calcium <120 degrees of vessel circumference (group A), whereas 23 lesions (42%) contained arcs of calcium > or =120 degrees of vessel circumference (group B). In the entire cohort of 55 lesions, as well as groups A and B, which were studied separately, both single-slice IVUS analysis (performed at minimum lumen site before intervention) and mean stented segment IVUS analysis showed an increase in lumen and vessel area and a decrease in plaque area (p <0.001). The magnitude of lumen and vessel increase and of plaque decrease was similar in both groups. Group A lesions showed significant plaque extrusion into the distal reference segment that was not observed in group B (increase in plaque area of 1.3 +/- 1.9 vs 0.1 +/- 2.0 mm(2), p <0.04). Stenting did not alter plaque area of the proximal reference segment in either group. In addition, there was an increase in vessel area of the distal reference of both groups, indicating that stent-induced vessel expansion observed within the lesion also affected the distal reference. Thus, longitudinal plaque redistribution and vessel expansion contribute to increased lumen dimensions during stenting of lesions with varying amounts of calcium; however, marked plaque extrusion was found only in lesions with a calcium arc of <120 degrees.

Spectrum of remodeling behavior observed with serial long-term (>/=12 months) follow-up intravascular ultrasound studies in left main coronary arteries.

Most intravascular ultrasound (IVUS) studies of arterial remodeling in native coronary arteries reported a remodeling index obtained at a single time point. We analyzed serial IVUS examinations, including the vessel cross-sectional area changes (remodeling behavior), of 60 hemodynamically nonstenotic left main lesions (baseline vs 18.4 +/- 9.4 months follow-up). Lumen reduction resulted from vessel reduction (sometimes despite plaque + media decrease), plaque + media increase (with or without vessel increase), or both. The percent annual changes in lumen area correlated strongly with changes in vessel (r = 0.84), but not with changes in plaque + media area. Plaques were classified as group A lesions, reflecting positive remodeling behavior (vessel changes >0), or group B lesions, reflecting negative (or intermediate) remodeling behavior (vessel changes <==0). Both groups did not differ significantly in demographics, laboratory data, and medications. Group A lesions (n = 40) more often showed plaque + media increase than group B lesions (32 of 40 [80%] vs 9 of 20 [45%]; p = 0.02). Group A lesions had, on average, mild annual lumen increase despite mild plaque + media increase, i.e, overcompensation of remodeling for plaque + media increase (vessel increase greater than plaque + media area increase, 19 of 40 [47%]). Conversely, group B lesions (n = 20) showed a significant lumen area reduction (-2.8 +/- 2.6 mm(2)/year) as a result of a decrease in vessel area only. Thus, serial long-term reduction of lumen size may result from vessel shrinkage (sometimes despite plaque decrease), plaque increase (with or without vessel increase), or both; overall, only the remodeling behavior has a significant relation to lumen changes. More than 30% of lesions show a negative remodeling behavior, which shows no relation to patient characteristics or initial plaque burden.

Preintervention arterial remodeling affects vessel stretch and plaque extrusion during coronary stent deployment as demonstrated by three-dimensional intravascular ultrasound.

The mechanisms of lumen enlargement during stent implantation may be significantly affected by arterial remodeling. To assess effects of lesion remodeling, we performed 3-dimensional intravascular ultrasound (IVUS) analyses in 55 coronary lesions before and after deployment of balloon-expandable stents. Standard quantitative analysis was performed, and arterial remodeling was assessed by the remodeling index (target site divided by mean of proximal and distal reference segment vessel areas), which classified lesions into group A (remodeling index < or =1, negative or intermediate remodeling, n = 40) or group B (remodeling index >1, positive remodeling, n = 15) lesions. Characteristics of the 55 patients and the interventional procedures were similar in the 2 groups. IVUS demonstrated that stenting resulted in increased lumen and vessel dimensions and in a reduced plaque size (p < or =0.001 each) in both group A and group B lesions. The extent of lumen increase inside the stents was almost identical, but resulted from different mechanisms: (1) vessel stretch was greater in group A (p <0.002 at minimum lumen site); (2) plaque compression (or embolization) tended to be greater in group B (p = 0.05, along entire stented segment); (3) plaque redistribution within the stent was observed in both groups (p <0.005 both); and (4) significant (p <0.01) plaque extrusion into the distal reference segment was found in group B only. Thus, the remodeling pattern of coronary lesions has a significant impact on the mechanisms of lumen enlargement during stent deployment. Lesions with positive remodeling show more plaque extrusion into the distal reference and less stent-induced vessel stretch than those with negative remodeling.

Endoluminal stent graft repair for acute and chronic type B aortic dissection and atherosclerotic aneurysm of the thoracic aorta: an interdisciplinary task.

OBJECTIVE: Endoluminal thoracic aortic stenting is a new therapeutic tool in reducing the operative trauma of the patient. However, the inherent risks of aortic stent grafting are perivascular leakage, stent dislocation, blunt rupture of the aorta, side branch occlusion and neurological sequelae. To reduce these risks, in our institution all stent implantations were performed in close collaboration with our fellow cardiologists under biplane X-ray control supported by simultaneous intravascular and transoesophageal ultrasound imaging. METHODS: Between August 1999 and August 2001, endovascular stent graft repair was performed in 34 patients (27 male, seven female) with a mean age of 68.6+/-7 years (range 58-84). Indication for treatment was an acute Type B aortic dissection in six patients (18%), a symptomatic chronic Type B dissection in 12 patients (35%), a true aneurysm of the descending aorta in seven patients (21%) and an atherosclerotic contained rupture of the descending aorta in nine (26%) patients. Out of six acute type B dissections three patients (8.8%) and one patient (2.9%) out of the chronic dissection group were in severe haemorrhagic shock, ventilated and required high-dose adrenergic support. The others (30 patients, 88.3%) remained symptomatic despite maximum medical treatment. In a special case a combined surgical and endoluminal stent graft repair was performed. Individually manufactured Talent, Medtronic AVE (33), and Gore (1) stents were used. Follow-up examination was performed 1 week after implantation and repeated every 3 months (mean follow-up 8 months, range 1-24). RESULTS: In all patients the aneurysm or the entry of the dissection could be excluded. The observed hospital mortality was 2.9% (one patient). No perivascular leakage, no stent dislocation, no neurological deficit or perfusion impairment was observed. All patients except four were extubated immediately after the procedure and discharged from hospital on postoperative day 2-3. The late procedure-related mortality was 5.8% (two patients) resulting in an overall mortality of 8.8% (three patients). CONCLUSION: Stent graft repair is a safe and feasible treatment option for selected patients, especially in emergency situations, if the aortic lesions can be clearly identified and localized. The use of biplane X-ray control combined with simultaneous intravascular and transoesophageal ultrasound imaging in an interdisciplinary approach enables a more precise targeting of the stent landing zone, resulting in low morbidity and mortality rates.

Clinical outcome following combination of cutting balloon angioplasty and coronary beta-radiation for in-stent restenosis: a report from the RENO registry.

At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary beta-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary beta-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary beta-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27 0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.

Impact of gender on femoral access complications secondary to application of a collagen-based vascular closure device.

BACKGROUND: Vascular complications at the femoral access site continue to be a significant problem after cardiac catheterization procedures. It was the aim of the present study to assess the impact of gender on the incidence of severe femoral access complications following the application of a collagen-based vascular closure device after transfemoral catheterization procedures. METHODS: A total of 1,294 consecutive patients (977 male, 317 female) underwent closure of femoral access sites with 8F collagen-based vascular closure devices (Angioseal) immediately after diagnostic or interventional coronary catheterization procedures, independently of the coagulation status. All patients were closely monitored for the occurrence of complications during the following 24 hours. RESULTS: Between male and female patients, there was no difference in the technical performance of the device with successful deployment being achieved in 96.7% and 95.9%, respectively (p=0.60). Severe access complications were found to be significantly higher in female versus male patients (1.6% vs. 0.2%; Odds ratio 7.7, 95% confidence interval 1.5-40.1; p=0.015), although similar accomplishment of an immediate hemostasis was seen in 92.8% and 92.4% of male and female patients (p=0.98). CONCLUSION: Women show a significantly increased risk of developing severe femoral access complications secondary to the application of a collagen-based vascular closure device, although the overall incidence of these complications is relatively low. We speculate that the increased risk in women may be related to smaller arterial dimensions, which could be evaluated by femoral angiography prior to deployment of a closure device.

Identification of syndrome X using intravascular ultrasound imaging and Doppler flow mapping.

BACKGROUND: The purpose of this study was to assess the morphological changes and physiological function of coronary arteries in patients presenting with chest pain but having normal coronary angiograms, using intravascular ultrasound imaging (IVUS) and intracoronary Doppler (ICD) flow measurements, in order to elucidate the mechanism of syndrome X. METHODS: A total of 126 patients [67 males, 59 females, mean age (53.1 +/- 13.0) years] who experienced chest pain but had normal coronary angiograms were included in this study. ICD flow measurements of the left anterior descending coronary artery (LAD) were performed using a Cardiometrics FloMap II system. Coronary flow velocity reserve (CFVR) was defined as the ratio of the average peak velocity during hyperemia to that at baseline, induced by an intracoronary bolus injection of 18 microg adenosine. A 3.2F or 2.9 F 30 MHz mechanical rotating ultrasound catheter (CVIS, Boston Scientific) or a 3.0 F 20 MHz electronic ultrasound catheter (Endosonics) was used for IVUS. RESULTS: The mean CFVR value of the LAD was 2.71 +/- 0.74. Reduction of CFVR (< 3.0) was found in 82 of 126 (65.1%) patients. IVUS images of the LAD were available for 109 patients. Plaque formation was detected in 76/109 (69.7%) patients. Based on the presence or absence of plaque formation as well as the reduction or non-reduction of CFVR, patients were divided into four groups: Group I (n = 10), normal IVUS findings and normal CFVR; Group II (n = 23), normal IVUS findings with reduction in CFVR; Group III (n = 29), IVUS evidence of plaque formation but normal CFVR; and Group IV (n = 47), IVUS evidence of plaque formation with reduction in CFVR. CONCLUSION: This study shows the important clinical value of a combination of IVUS and ICD in diagnosing patients with angiographically normal coronary arteries. Only 10% of patients studied (Group I) were found to be truly free of coronary disease, while 20% of patients (Group II) would be diagnosed as suffering from syndrome X.

Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with diabetes mellitus: a patient-level meta-analysis of randomized trials.

BACKGROUND: 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. METHODS: We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2 years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated. RESULTS: There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36-0.63, P < 0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18-0.41, P < 0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59-1.41, P = 0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54-1.09, P = 0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15-1.69, P = 0.26). CONCLUSIONS: Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.