Cardiovascular morbidity is a major burden in patients with type 2 diabetes. In the Steno-2 Study, we compared the effect of a targeted, intensified, multifactorial intervention with that of ...conventional treatment on modifiable risk factors for cardiovascular disease in patients with type 2 diabetes and microalbuminuria.
The primary end point of this open, parallel trial was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, revascularization, and amputation. Eighty patients were randomly assigned to receive conventional treatment in accordance with national guidelines and 80 to receive intensive treatment, with a stepwise implementation of behavior modification and pharmacologic therapy that targeted hyperglycemia, hypertension, dyslipidemia, and microalbuminuria, along with secondary prevention of cardiovascular disease with aspirin.
The mean age of the patients was 55.1 years, and the mean follow-up was 7.8 years. The decline in glycosylated hemoglobin values, systolic and diastolic blood pressure, serum cholesterol and triglyceride levels measured after an overnight fast, and urinary albumin excretion rate were all significantly greater in the intensive-therapy group than in the conventional-therapy group. Patients receiving intensive therapy also had a significantly lower risk of cardiovascular disease (hazard ratio, 0.47; 95 percent confidence interval, 0.24 to 0.73), nephropathy (hazard ratio, 0.39; 95 percent confidence interval, 0.17 to 0.87), retinopathy (hazard ratio, 0.42; 95 percent confidence interval, 0.21 to 0.86), and autonomic neuropathy (hazard ratio, 0.37; 95 percent confidence interval, 0.18 to 0.79).
A target-driven, long-term, intensified intervention aimed at multiple risk factors in patients with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular and microvascular events by about 50 percent.
Chronic inflammatory diseases have been linked to increased risk of atherothrombotic events, but the risk associated with inflammatory bowel disease (IBD) is unclear. We therefore examined the risk ...of myocardial infarction (MI), stroke, and cardiovascular death in patients with IBD.
In a nationwide Danish population-based setting, a cohort of patients with incident IBD between 1996 and 2009 were identified in national registers. Hospitalizations with IBD as primary diagnosis, initiation of biological treatment and dispensed prescriptions of corticosteroids were all used as surrogate markers for disease activity, with flares classified as the first 120 days after diagnosis of IBD, and 120 days after a new corticosteroid prescription, biological treatment or IBD hospitalization, respectively. Continued corticosteroid prescriptions or IBD hospitalizations were defined as persistent activity, and periods free of such events were defined as remissions. Poisson regression was used to examine risk of MI, stroke, and cardiovascular death using a matched population-based comparison cohort as reference.
We identified 20,795 IBD patients with a mean age of 40.3 years that were matched according to age and sex with 199,978 controls. During the study period, there were 365 patients with MI, 454 with stroke, and 778 with cardiovascular death. Patients with IBD had an overall increased risk of MI (rate ratio RR 1.17 95% confidence interval 1.05-1.31), stroke (RR 1.15 1.04-1.27, and cardiovascular death (RR 1.35 1.25-1.45). During flares and persistent IBD activity the RRs of MI increased to 1.49 (1.16-1.93) and 2.05 (1.58-2.65), the RRs of stroke to 1.53 (1.22-1.92) and 1.55 (1.18-2.04) and for cardiovascular death 2.32 (2.01-2.68) and 2.50 (2.14-2.92). In remission periods, the risk of MI, stroke and cardiovascular death was similar to controls.
Inflammatory bowel disease is associated with increased risk of MI, stroke, and cardiovascular death during periods with active disease.
In patients with sick sinus syndrome, bradycardia can be treated with a single-lead pacemaker or a dual-chamber pacemaker. Previous trials have revealed that pacing modes preserving atrio-ventricular ...synchrony are superior to single-lead ventricular pacing, but it remains unclear if there is any difference between single-lead atrial pacing (AAIR) and dual-chamber pacing (DDDR).
We randomly assigned 1415 patients referred for first pacemaker implantation to AAIR (n = 707) or DDDR (n = 708) pacing and followed them for a mean of 5.4 ± 2.6 years. The primary outcome was death from any cause. Secondary outcomes included paroxysmal and chronic atrial fibrillation, stroke, heart failure, and need for pacemaker reoperation. In the AAIR group, 209 patients (29.6%) died during follow-up vs. 193 patients (27.3%) in the DDDR group, hazard ratio (HR) 1.06, 95% confidence interval (CI) 0.88-1.29, P = 0.53. Paroxysmal atrial fibrillation was observed in 201 patients (28.4%) in the AAIR group vs. 163 patients (23.0%) in the DDDR group, HR 1.27, 95% CI 1.03-1.56, P = 0.024. A total of 240 patients underwent one or more pacemaker reoperations during follow-up, 156 (22.1%) in the AAIR group vs. 84 (11.9%) in the DDDR group (HR 1.99, 95% CI 1.53-2.59, P < 0.001). The incidence of chronic atrial fibrillation, stroke, and heart failure did not differ between treatment groups.
In patients with sick sinus syndrome, there is no statistically significant difference in death from any cause between AAIR pacing and DDDR pacing. AAIR pacing is associated with a higher incidence of paroxysmal atrial fibrillation and a two-fold increased risk of pacemaker reoperation. These findings support the routine use of DDDR pacing in these patients.
URL http://www.clinicaltrials.gov. Unique identifier: NCT00236158.
The Stenting Coronary Arteries in Non-Stress/Benestent Disease (SCANDSTENT) Trial
Henning Kelbæk, Leif Thuesen, Steffen Helqvist, Lene Kløvgaard, Erik Jørgensen, Samir Aljabbari, Kari Saunamäki, Lars ...R. Krusell, Gunnar V. H. Jensen, Hans E. Bøtker, Jens F. Lassen, Henning R. Andersen, Per Thayssen, Anders Galløe, Anton van Weert, for the SCANDSTENT Investigators
We randomly assigned 322 patients with complex coronary lesions to receive sirolimus-eluting or bare metal stents in occluded, bifurcational, ostial, or angulated lesions. At follow-up, patients with sirolimus stents had a larger minimal lumen diameter (2.48 mm vs. 1.65 mm, p < 0.001) and 2.0% versus 32% developed restenosis (p < 0.001). Major adverse cardiac events occurred in 3.1% (stent thrombosis in 0.6%) with sirolimus-eluting stents versus 30.2% (stent thrombosis 3.1%) with bare metal stents (p < 0.001). Sirolimus-eluting stents reduce restenosis and major cardiac events in patients with complex coronary artery lesions without increasing the risk of stent thrombosis.
The purpose of the SCANDSTENT study was to evaluate the use of sirolimus-eluting stents (SES) in complex coronary lesions.
The use of SES improves angiographic and clinical outcomes compared with bare-metal stents (BMS) in simple coronary artery lesions, but there is limited evidence of their safety and efficacy when implanted in complex lesions.
We randomly assigned 322 patients with symptomatic complex coronary artery disease to receive either SES or BMS. The lesions were occluded (36%), bifurcational (34%), ostial (22%), or angulated (8%) in morphology. The primary end point was the difference in minimal lumen diameter six months after stent implantation.
The patients were well matched in terms of demographic and angiographic baseline characteristics; 18% had diabetes. The reference vessel diameter was 2.86 mm in mean, and the lesion length 18.0 mm. At follow-up, patients who received SES had a minimal lumen diameter of 2.48 mm compared with 1.65 mm in those who received BMS (p < 0.001), a diameter stenosis of 19.3% versus 43.8% (p < 0.001), and 2.0% versus 31.9% developed restenosis (p < 0.001). The rate of major adverse cardiac events was 4.3% with SES versus 29.3% with BMS (p < 0.001), and stent thrombosis was observed in 0.6% in the SES group versus 3.1% in the BMS group (p = 0.15).
The use of SES markedly reduced restenosis and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of stent thrombosis.
Abstract The approach to managing asymptomatic or questionably symptomatic patients for aortic stenosis is difficult. We aimed to determine whether cardiopulmonary exercise testing (CPET) is ...prognostically useful in such patients. Patients judged asymptomatic or questionably symptomatic for aortic stenosis with aortic valve area index <0.6 cm2 /m2 and left ventricular ejection fraction ≥0.50 were managed conservatively provided they either had: (Group 1) normal peak oxygen consumption and peak oxygen pulse (>83% and >95% of the predicted values, respectively) or (Group2) subnormal peak oxygen consumption or peak oxygen pulse but with CPET data pointing to pathologies other than hemodynamic compromise from aortic stenosis. Increase in systolic blood pressure < 20 mm Hg, ST-depression ≥ 2mm or symptoms during the exercise test were allowed. Unexpected events included cardiac death or hospitalization with heart failure in patients that had not been recommended valve replacement. The median age of the study population (n = 101) was 75 years (interquartile range 65-79 years), and 67% were judged questionably symptomatic. During a follow-up at 24 ± 6 months, the rate of unexpected cardiac death and unexpected hospitalization with heart failure was 0% and 6.0%, respectively. All-cause mortality was 4.0% compared to 8.0% in the age- and sex-matched population. For Group 1 26/70 (37.1%) suffered from cardiac death, hospitalization with heart failure, or valve replacement, and for Group 2 this was 12/31 (38.7%). In conclusion, if CPET does not indicate a significant hemodynamic compromise because of aortic stenosis, an initially conservative strategy results in a good prognosis and an acceptable event rate.
Sirolimus-eluting stent implantation improves the outcome in simple coronary artery lesions compared with bare metal stents, but there is limited evidence of their safety and efficacy when implanted ...in complex lesions like coronary bifurcations.
SCANDSTENT was a randomized controlled study comparing implantation of sirolimus-eluting stents with bare-metal stents in patients with complex coronary artery disease. This substudy evaluates the angiographic and clinical outcome of 126 patients with lesions located in a coronary bifurcation.
The baseline characteristics of the patients were comparable: 15% had diabetes, and 1.7 stents were implanted per lesion. At follow-up, the minimum lumen diameter of the main branch was 2.35 mm in patients who received sirolimus-eluting stents compared with 1.68 mm in those who received bare-metal stents, and that of the side branch was 1.70 versus 1.19 mm (both
P < .001). The late lumen loss in the main branch was 0.12 mm in the sirolimus-eluting stent group versus 0.99 mm in the bare-metal stent group and 0.03 versus 0.56 mm in the side branch (both
P < .001). Thus, sirolimus-eluting stents reduced the restenosis rate from 28.3% to 4.9% in the main branch and from 43.4% to 14.8% in the side branches (both
P < .001). Major adverse cardiac events occurred in 9% with sirolimus-eluting stents versus 28% with bare-metal stents (
P = .01), and stent thrombosis was observed in 0% versus 9% (
P = .02).
Sirolimus-eluting stent implantation improves both the angiographic and clinical outcomes considerably compared with that of bare-metal stents in patients with stenoses located in coronary bifurcations.
Our purpose was to evaluate the long-term use of sirolimus-eluting stents (SES) and bare-metal stents (BMS) in patients with complex coronary artery lesions.
Although the use of SES has proved to be ...effective in patients with simple coronary artery lesions, there are limited data of the long-term outcome of patients with complex coronary artery lesions.
We randomly assigned 322 patients with total coronary occlusions or lesions located in bifurcations, ostial, or angulated segments of the coronary arteries to have SES or BMS implanted.
At 3 years, major adverse cardiac events had occurred in 20 patients (12%) in the SES group and in 59 patients (38%) in the BMS group (p < 0.001). Four versus 2 patients suffered a cardiac death (p = NS), and 5 versus 1 died of a noncardiac disease (p = NS) in the SES versus the BMS group. Six patients in the SES group versus 15 patients in the BMS group suffered a myocardial infarction (p < 0.05) during the 3-year observation period, and target lesion revascularization was performed in 8 patients (4.9%) versus 53 patients (33.8%), respectively (p < 0.001); of these, 4 in the SES versus 7 in the BMS group were performed between 1 and 3 years after the index treatment (p = NS). According to revised definitions, stent thrombosis occurred in 5 patients (3.1%) in the SES group and in 7 patients (4.4%) in the BMS group (p = NS); very late stent thrombosis was observed in 4 versus 1 patient.
A continued benefit was observed up to 3 years after implantation of SES in patients with complex coronary artery lesions. The rate of late adverse events was similar in the 2 groups, and stent thromboses occurred rarely after 1 year. (Sirolimus Eluting Stents in Complex Coronary Lesions SCANDSTENT; NCT00151658)
Purpose The purpose of this study was to determine the outcomes of arthroscopy after proximal humeral plating and the occurrence of concomitant pathology and avascular necrosis. Methods Forty-five ...patients (28 women; median age, 58.5 years range, 30 to 82 years) underwent arthroscopies of 46 shoulders because of unsatisfactory results after locked plating of proximal humeral fractures. They were prospectively followed up for 3, 12, and 24 months postoperatively. Relevant intra-articular lesions were documented. The patients were assigned to 1 of the following groups: (1) articular screw perforation, (2) subacromial plate impingement, or (3) post-traumatic/postoperative shoulder stiffness. Shoulder range of motion and function as measured with the age- and gender-adjusted Constant-Murley score, as well as the Simple Shoulder Test, were compared among the groups. Results Concomitant lesions of the articular cartilage, long head of the biceps tendon, tuberosities, and rotator cuff were found in 34 patients (75%). Two-thirds of patients (n = 31) had a partial or complete 270° capsular release. Of the patients, 84% (n = 38) underwent 3 and 12 months' follow-up and 82% (n = 37) underwent 24 months' follow-up. The active range of abduction ( P = .029), flexion ( P = .048), and internal rotation ( P = .0005) had improved significantly at 24 months' follow-up compared with the preoperative status. The mean adjusted Constant-Murley score of patients with post-traumatic shoulder stiffness (n = 15, 64.2% ± 7.9%) and articular screw perforation (n = 19, 73.3% ± 8.4%) was significantly lower ( P = .0089 and P = .042, respectively) than that of patients with subacromial plate impingement (n = 12, 93.4% ± 4.3%). Conclusions High rates of relevant articular pathologies and the necessity of capsular release in a majority of patients with unsatisfactory results after locked plating of proximal humeral fractures make arthroscopy a valuable revision tool with promising results in cases of high plate positioning, screw perforation, and postoperative/post-traumatic shoulder stiffness. Level of Evidence Level IV, therapeutic case series.
In the recently published DANPACE trial, incidence of atrial fibrillation (AF) was significantly higher with single-lead atrial (AAIR) pacing than with dual-chamber (DDDR) pacing. The present ...analysis aimed to evaluate the importance of baseline PQ-interval and percentage of ventricular pacing (VP) on AF.
We analysed data on AF during follow-up in 1415 patients included in the DANPACE trial. In a subgroup of 650 patients with DDDR pacemaker, we studied whether %VP, baseline PQ-interval, and programmed atrio-ventricular interval (AVI) was associated with AF burden measured as time in mode-switch (MS) detected by the pacemaker. In the entire DANPACE study population, the incidence of AF was significantly higher in patients with baseline PQ-interval >180 ms (P< 0.001). Among 650 patients with DDDR pacemaker, telemetry data were available for 1.337 ± 786 days, %VP was 66 ± 33%, AF was detected at planned follow-up in 160 patients (24.6%), MS occurred in 422 patients (64.9%), and AF burden was marginally higher with baseline PQ-interval >180 ms (P= 0.028). No significant association was detected between %VP and %MS (Spearman's ρ 0.056, P= 0.154). %MS was not different between minimal-paced programmed AVI ≤ 100 and >100 ms (median value), respectively (P= 0.60).
The present study indicates that a longer baseline PQ-interval is associated with an increased risk of AF in patients with sick sinus syndrome. Atrial fibrillation burden is not associated with the percentage of VP or the length of the programmed AVI.
Background
The aims of this study were to evaluate treatment failure and revision rates of proximal humeral fracture (PHF) treatment with a standardized treatment algorithm within the reality of a ...level-1 trauma center and to identify predictors of subsequent surgery.
Materials and methods
The medical database of a level-1 trauma center was screened for all primary treatments of PHFs between January 2009 and June 2012. Medical records and imaging were analyzed to identify the fracture morphology, pre-existing diseases, revision surgeries and treatment failures (conversion to another treatment). The patients were asked about subsequent surgeries by phone. A functional outcome questionnaire was mailed to participating patients.
Results
Follow-up data were available for 423 of 521 patients (312 females, 111 males). The mean age at the time of primary treatment was 68.3 years; mean follow-up was 24.6 ± 12.3 months. The overall rate of mandatory re-operations was 15.6%, including a failure rate of 8.3%; another 7.6% of patients had additional arthroscopic surgeries. Treatment with anatomic hemi-prostheses was associated with the highest re-operation rates, and lowest outcomes. Involvement of the medial calcar region, complex fracture morphologies, cigarette smoking and alcohol-abuse were predictors for subsequent surgery. Patients without subsequent surgery had significantly higher functional outcome scores than patients with additional surgery.
Conclusions
With the use of a standardized treatment algorithm no treatment modality was at significantly higher risk for having additional surgery. Complex fracture types, involvement of the medial calcar, cigarette-smoking and alcohol-abuse were associated with subsequent surgeries.
Level of evidence
Level IV case series.
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