OBJECTIVES: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS). BACKGROUND: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding. RESULTS: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups. CONCLUSIONS: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.
Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
OBJECTIVES: The effectiveness and safety of aminoglycoside (AG)/beta-lactam combination therapy has been questioned in several meta-analyses. We examined the association between AG combination therapy and mortality and increase in serum creatinine in adult patients with bacteraemia given appropriate empirical antibiotic therapy. METHODS: Historical cohort study based on prospective registration of bacteraemias in a Danish hospital 1996-2002. AG + beta-lactam was the recommended empirical therapy for severe sepsis. We identified 1,257 patients, of whom 969 received gentamicin or tobramycin (AG cohort); 288 patients not given AGs formed the non-AG cohort. We used Cox regression analysis to compare adjusted mortality rates; the association between AG therapy and increase in serum creatinine was analysed by logistic regression. RESULTS: The cumulative 30 day mortality in the AG cohort was 17.3% versus 18.1% in the non-AG cohort [adjusted mortality rate ratio (MRR) 1.02; 95% CI 0.74-1.39]. The adjusted 31-180 day MRR in the AG cohort was 1.72 (95% CI 1.15-2.55). AG therapy was associated with lower 30 day mortality in patients with an abdominal focus (adjusted 30 day MRR 0.52; 95% CI 0.24-1.10) or a urinary tract focus (adjusted 30 day MRR 0.48; 95% CI 0.22-1.08), but with a worse prognosis in patients with a respiratory tract focus (adjusted 30 day MRR 2.06; 95% CI 0.93-4.53). An increase in serum creatinine of >or=45 micromol/L was observed similarly often in AG- and non-AG-treated patients [14.1% versus 12.4%, adjusted odds ratio 1.06; 95% CI 0.63-1.79]. CONCLUSIONS: Among patients with bacteraemia receiving appropriate empirical coverage, AG combination therapy was not associated with increased 30 day mortality and only a modest risk of raised serum creatinine. The longer-term prognosis should, however, be explored further.
Tiotropium (Spiriva is an inhaled, once-daily anticholinergic medication for chronic obstructive pulmonary disease (COPD). We conducted a population-based cohort study to examine the risk of cardiovascular and respiratory hospitalizations and mortality with tiotropium. Using the Danish healthcare registries, we identified persons >/=40 years old in three counties who were hospitalized for COPD from 1/1/1977 to 12/31/2003. Respiratory and cardiovascular medications were assessed from dispensing records. Cox regression was used to compute incidence rate ratios (RR) and 95% confidence intervals (CI) for hospitalization and death between 1/1/2002 and 12/31/2003, associated with periods of tiotropium use compared to non-use, controlling for age, gender, time since COPD, concomitant respiratory and cardiovascular medications, prior hospitalizations and Charlson comorbidity index. Among persons with COPD (10,603), 75% were >/=60 years old. Follow-up was >/=18 months for 64%. Among those exposed to tiotropium compared to periods of non-use, the RR for total and cause-specific hospitalization endpoints were not elevated except for COPD hospitalization (RR = 1.52, 95% CI: 1.29, 1.79). Mortality endpoints included total mortality (RR = 0.77, 95% CI: 0.65, 0.91), respiratory mortality (RR = 0.79, 95% CI: 0.60, 1.04), sudden death (RR = 0.71, 95% CI: 0.21, 2.34), cardiac arrest (RR = 0.74, 95% CI: 0.42, 1.32), heart failure (RR = 0.84, 95% CI: 0.41, 1.75), and myocardial infarction (RR = 1.25, 95% CI: 0.49, 3.17). Compared to periods of non-use, tiotropium was associated with reduced respiratory and overall mortality and was not associated with increased cardiac mortality. An increase in COPD hospitalization is inconsistent with clinical trial data and suggests preferential prescribing due to disease severity.
INTRODUCTION: Mortality rates after hip fracture have not declined in 20 years. We assessed the impact of chronic obstructive pulmonary disease (COPD) on mortality after hip fracture, and compared mortality in this cohort to persons without hip fracture in a population-based prospective cohort study. METHODS: Using Danish health care registries, we identified persons >or=40 years old with first-time hospitalization for hip fracture between 1/1/1998 and 1/31/2003. Hospitalization for COPD was assessed from hospital discharge registries. Using Cox regression, we computed relative risks (RR) and 95% confidence intervals (CI) for mortality endpoints among persons with COPD compared to persons without COPD. Mortality following hip fracture was also compared to age and gender matched controls without hip fracture. RESULTS: We identified 11, 985 persons with first-time hospitalization for hip fracture; 771 (6.4%) had a diagnosis of COPD. Average follow up was 22 months. Compared to persons without COPD, mortality following hip fracture in persons with COPD was RR=1.58 (95% CI 1.30-1.90) at 30 days, RR=1.52 (95% CI 1.30-1.77) at 90-days, RR=1.58 (95% CI 1.40-1.78) at 1 year, and RR=1.71 (95% CI 1.55-1.88) overall. The 1-year mortality in persons with hip fracture and COPD was approximately 3-5 times greater than in controls without hip fracture. CONCLUSIONS: In this cohort, persons with COPD have a 60-70% higher risk of death following hip fracture than those without COPD. In addition, hip fracture and COPD increased 1-year mortality 3-5 times that of persons without hip fracture.
OBJECTIVE: While maternal diabetes is a known risk factor for perinatal complications, there is little data on long-term intellectual outcome in offspring. We compare the rejection rate and cognitive functioning of military conscripts according to maternal diabetes status during pregnancy. RESEARCH DESIGN AND METHODS: We identified a cohort of Danish male offspring of diabetic mothers born between 1976 and 1984 and followed this cohort together with population-based control subjects to military conscription. The main outcome was army rejection rate and cognitive function measured with a validated intelligence test. RESULTS: The army rejection rate was 52.5% among 282 men whose mothers had diabetes during pregnancy and 45.4% among 870 control subjects (risk difference 7.3 [95% CI 0.6-14.0]). Mean cognitive scores were 41.4 units (95% CI 40.2-42.6) in diabetes-exposed conscripts and 42.7 units (42.0-43.4) in control subjects. Stratification by gestational age, Apgar score, and White's class (A-F) did not change the associations. In a subgroup analysis using available data on A1C levels during pregnancy, this variable was inversely associated with cognitive functioning. In men with maternal A1C
OBJECTIVE: The aim of this study was to assess cognitive function, quality of life, and psychological distress after surgery for early breast cancer but before initiation of adjuvant treatment. MATERIAL AND METHODS: We performed a population-based study in the county of North Jutland, Denmark, including 124 women aged less than 60 years who had surgery for early breast cancer from 2004 - 2006. They were compared with an aged-matched group of 224 women without previous cancer selected randomly from the same population. The cognitive function of patients and controls was tested using a revised battery from the ISPOCD study. Data were collected on quality of life (EORTC QLQ-C30) and psychological distress (POMS). RESULT: The neuropsychological tests did not reveal significant differences between patients and controls. Compared to the control group, breast cancer patients had a significantly 3 - 4 fold increased risk of experiencing cognitive impairment. Quality of life and psychological distress were also significantly poorer among patients. CONCLUSION: This study demonstrated that women diagnosed with breast cancer experience a significant deterioration of their perceived cognitive functioning, quality of life and of psychological well being.
BACKGROUND: It has been suggested that specific antihypertensive medications (AHT) may either increase or decrease breast cancer risk. METHODS: We studied breast cancer incidence among 49,950 women in North Jutland, Denmark in order to determine if breast cancer risk is associated with specific classes of AHT use. Poisson regression analyses were used to calculate rate ratios for ever or exclusive use of each class of AHT, number of prescriptions for AHT, and years of follow-up. RESULTS: There was no statistically significant association between ever use of any AHT overall (RR = 0.95; 95% CI = 0.81-1.10) or any specific class of AHT (diuretics, beta blockers, calcium channel blockers (CCBs), angiotensin converting enzyme (ACE) inhibitors, and angiotensin II antagonists) and breast cancer. CONCLUSIONS: This study should offer further reassurance to women currently using AHT that their medication use is unlikely related to breast cancer risk.
BACKGROUND AND AIMS: Identifying predictors for mortality following hip fracture is essential in order to improve survival, especially among the elderly. We compared mortality after hip fracture to controls without hip fracture, and assessed the impact of comorbidity on mortality following hip fracture in a population-based cohort study. METHODS: The health care databases in Western Denmark (1.4 million inhabitants) were used to identify all persons > or = 40 years of age with first-time hospitalization for hip fracture between 1/1/1998 and 1/31/2003. Five population controls without hip fracture were matched to hip fracture patients on age and gender. Prior hospitalization for selected comorbidities among hip fracture subjects was assessed from hospital discharge registries. Cox regression analysis was used to compute crude and adjusted relative risks and 95% confidence intervals for 30-day, 90-day, and 1-year mortality associated with hip fracture, and with prior hospital history of selected comorbidities. RESULTS: The cohort was followed for an average of 22 months. Females comprised 71% of the cohort and 90% was aged 65 years or older. Compared to persons without hip fracture, persons with hip fracture had from 2 to >3-fold higher risk of death at 1 year. History of congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), dementia, tumor, and malignancy increased adjusted 1-year mortality from 50% to 3-fold among persons with hip fracture. CONCLUSIONS: Hip fracture increased 1-year mortality more than 3-fold compared with mortality without hip fracture. Among hip fracture subjects, the presence of selected comorbidities further increased the risk of mortality after hip fracture.
The aim of this study was to examine outcomes subsequent to implantation of drug-eluting stents (DESs) and bare-metal stents (BMSs) in patients with diabetes. From January 2002 to June 2005, data from all percutaneous coronary interventions performed in Western Denmark were prospectively recorded. A total of 1,423 consecutive diabetic patients treated with stent implantation (2,094 lesions) were followed up for 15 months. Of these, 871 patients (1,180 lesions) were treated with a BMS, and 552 patients (914 lesions) were treated with a DES. Dual antiplatelet therapy was recommended for 12 months in both treatment groups. Data for death and myocardial infarction (MI) were ascertained from national health care databases. Use of DESs was not associated with increased risk of definite stent thrombosis (adjusted relative risk [RR] 0.76, 95% confidence interval [CI] 0.10 to 3.26) or MI (adjusted RR 0.90, 95% CI 0.53 to 1.52). In the DES group compared with the BMS group, adjusted RRs of target-lesion revascularization (adjusted RR 0.48, 95% CI 0.33 to 0.71), total mortality (adjusted RR 0.66, 95% CI 0.44 to 0.99), and cardiac mortality (adjusted RR 0.53, 95% CI 0.31 to 0.90) decreased by 52%, 34%, and 47%, respectively. In conclusion, use of DESs reduced target-lesion revascularization in diabetic patients receiving routine clinical care. This result was obtained without increased risk of death, stent thrombosis, or MI.
BACKGROUND: Recently, the authors have shown a doubled risk of having an advanced rectal cancer (RC) (Dukes' stage C or D) at the time of treatment, if the interval between onset of symptoms and start of treatment (treatment delay) was >60 days [Korsgaard M, Pedersen L, Sorensen HT, Laurberg S. Treatment delay is associated with advanced stage of rectal cancer but not of colon cancer. Cancer Detect Prev 2006;30(4):341-6]. The authors examined the treatment delay for colorectal cancer (CRC), as influenced by the patients, the general practitioners (G.P.), and the hospitals. METHOD: Population-based prospective observational study based on 743 Danish CRC-patients. Treatment delay was determined through questionnaire interviews. We examined the patient delay, the G.P. delay, and the hospital delay, and thereby the frequency of patients for whom the Danish fast-track recommendations of a maximum of 14 days to diagnose CRC, and 14 days from the diagnosis to start the of treatment, were met. Colon cancer (CC) and RC-patients were analyzed separately. RESULTS: Patient delay, in particular, was long, and longest for RC-patients (median 44 days vs.18 days). Median G.P. delay was short, but 25% of the CC-patients had a G.P. delay of 59 days or more, and 25% of the RC-patients had a G.P. delay of 53 days or more. The fast-track recommendations were poorly met; 53% of the CC-patients and 39% of the RC-patients waited >14 days after referral for the diagnosis. 29% of the CC-patients, and 53% of the RC-patients waited >14 days before the start of treatment. CONCLUSION: The total delay was too long, and can be shortened by optimizing all delay intervals.