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Osteoarthritis is a major contributor to pain and disability worldwide. Inflammation plays an important role in the development of osteoarthritis, and anti-inflammatory drugs may slow disease progression. This exploratory analysis of a randomized trial examined whether colchicine reduces incident total knee and hip replacements. Visual Abstract. Association of Low-Dose Colchicine With Incidence of Knee and Hip Replacements: Osteoarthritis is a major contributor to pain and disability worldwide. Inflammation plays an important role in the development of osteoarthritis, and anti-inflammatory drugs may slow disease progression. This exploratory analysis of a randomized trial examined whether colchicine reduces incident total knee and hip replacements. Background: Osteoarthritis is a major contributor to pain and disability worldwide. Given that inflammation plays an important role in the development of osteoarthritis, anti-inflammatory drugs may slow disease progression. Objective: To examine whether colchicine, 0.5 mg daily, reduces incident total knee replacements (TKRs) and total hip replacements (THRs). Design: Exploratory analysis of the LoDoCo2 (Low-Dose Colchicine 2) randomized, controlled, double-blind trial. (Australian New Zealand Clinical Trials Registry: ACTRN12614000093684) Setting: 43 centers in Australia and the Netherlands. Patients: 5522 patients with chronic coronary artery disease. Intervention: Colchicine, 0.5 mg, or placebo once daily. Measurements: The primary outcome was time to first TKR or THR since randomization. All analyses were performed on an intention-to-treat basis. Results: A total of 2762 patients received colchicine and 2760 received placebo during a median follow-up of 28.6 months. During the trial, TKR or THR was performed in 68 patients (2.5%) in the colchicine group and 97 (3.5%) in the placebo group (incidence rate, 0.90 vs. 1.30 per 100 person-years; incidence rate difference, −0.40 [95% CI, −0.74 to −0.06] per 100 person-years; hazard ratio, 0.69 [CI, 0.51 to 0.95]). In sensitivity analyses, similar results were obtained when patients with gout at baseline were excluded and when joint replacements that occurred in the first 3 and 6 months of follow-up were omitted. Limitation: LoDoCo2 was not designed to investigate the effect of colchicine in osteoarthritis of the knee or hip and did not collect information specifically on osteoarthritis. Conclusion: In this exploratory analysis of the LoDoCo2 trial, use of colchicine, 0.5 mg daily, was associated with a lower incidence of TKR and THR. Further investigation of colchicine therapy to slow disease progression in osteoarthritis is warranted. Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

Aim: To determine whether an intensive intervention at a heart failure (HF) clinic by a combination of a clinician and a cardiovascular nurse, both trained in HF, reduces the incidence of hospitalisation for worsening HF and/or all-cause mortality (primary end point) and improves functional status (including left ventricular ejection fraction, New York Heart Association (NYHA) class and quality of life) in patients with NYHA class III or IV. Setting: Two regional teaching hospitals in The Netherlands. Methods: 240 patients were randomly allocated to the 1-year intervention (n = 118) or usual care (n = 122). The intervention consisted of 9 scheduled patient contacts-at day 3 by telephone, and at weeks 1, 3, 5, 7 and at months 3, 6, 9 and 12 by a visit-to a combined, intensive physician-and-nurse-directed HF outpatient clinic, starting within a week after hospital discharge from the hospital or referral from the outpatient clinic. Verbal and written comprehensive education, optimisation of treatment, easy access to the clinic, recommendations for exercise and rest, and advice for symptom monitoring and self-care were provided. Usual care included outpatient visits initialised by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology. Results: During the 12-month study period, the number of admissions for worsening HF and/or all-cause deaths in the intervention group was lower than in the control group (23 vs 47; relative risk (RR) 0.49; 95% confidence interval (CI) 0.30 to 0.81; p=0.001). There was an improvement in left ventricular ejection fraction (LVEF) in the intervention group (plus 2.6%) compared with the usual care group (minus 3.1%; p=0.004). Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group. Beneficial effects were also observed on NYHA classification, prescription of spironolactone, maximally reached dose of β-blockers, quality of life, self-care behaviour and healthcare costs. Conclusion: A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations far worsening HF and/or all-cause mortality and improves functional status, while decreasing healthcare costs, even in a country with a primary-care-based healthcare system. [ABSTRACT FROM AUTHOR]

Background: Recent studies demonstrated that rate control is an acceptable alternative for rhythm control in patients with persistent atrial fibrillation (AF). However, optimal heart rate during AF is still unknown. Objective: To show that in patients with permanent AF, lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, New York Heart Association class for heart failure, left ventricular function, left atrial size, quality of life, and costs. Methods: The RACE II study is a prospective multicenter trial in The Netherlands that will randomize 500 patients with permanent AF (≤12 months) to strict or lenient rate control. Strict rate control is defined as a mean resting heart rate <80 beats per minute (bpm) and heart rate during minor exercise <110 bpm. After reaching the target, a 24-hour Holter monitoring will be performed. If necessary, drug dose reduction and/or pacemaker implantation will be performed. Lenient rate control is defined as a resting heart rate <110 bpm. Patients will be seen after 1, 2, and 3 months (for titration of rate control drugs) and yearly thereafter. We anticipate a 25% 2.5-year cardiovascular morbidity and mortality in both groups. Results: Enrollment started in January 2005 in 29 centers in The Netherlands and is expected to be concluded in June 2006. Follow-up will be at least 2 years with a maximum of 3 years. Conclusion: This study should provide data how to treat patients with permanent AF. [Copyright &y& Elsevier]

Coronary computed tomography angiography (CCTA) is widely used to exclude coronary artery disease (CAD) in patients with low-to-intermediate pretest probability (PTP) of obstructive CAD. The aim of our study was to investigate the reclassification by CCTA and the implications of CCTA results on management because limited studies exist on these subjects; 1,560 patients with chest pain without a history of CAD and with low or intermediate PTP of CAD referred for CCTA from the out-patient clinic were prospectively included. PTP was defined by the Duke Clinical Score as either low (<15%), low-intermediate (15% to 50%), or high-intermediate (50% to 85%). Distribution of CCTA results among the categories of PTP of CAD and the influence of CCTA results on management were analyzed. CCTA revealed obstructive CAD in 7%, 15%, and 23% of cases, in patients with low, low-intermediate, and high-intermediate PTP, respectively; 855 of 1,031 patients (83%) with intermediate PTP of CAD showed no obstructive CAD on CCTA and were consequently reclassified. Management changes after CCTA occurred in 689 patients (44%). In 633 patients (41%), medication was altered and 135 (9%) were referred for invasive coronary angiography. Treatment with statin was initiated in 442 (28%) and stopped in 71 patients (5%). Aspirin was initiated in 192 (12%) and stopped in 139 patients (9%). In conclusion, in a routine clinical cohort, CCTA resulted in reclassification in most patients. Furthermore, our study suggests that the Duke Clinical Score overestimates the probability of obstructive CAD compared with CCTA findings. Finally, CCTA results have implications on patient management, with medication changes in 41% of patients. [ABSTRACT FROM AUTHOR]

Familial hypercholesterolemia (FH) is an inherited disorder associated with increased risk of coronary heart disease as a result of high LDL-cholesterol (LDL-C). The clinical diagnosis can be made with the Dutch Lipid Clinic Network criteria (DLCN criteria). FH is an underdiagnosed disorder, possibly due to false negative LDL-C interpretation during lipid lowering therapy (LLT). We hypothesized that automated health record-based integration of data can provide a signal to facilitate identification of FH patients. We included patients with LDL-C ≥6.5 mmol/l after correction for LLT in all patients testing LDL-C in Northwest Clinics, The Netherlands. Patients previously diagnosed with FH were excluded. The primary endpoint was the additional number of patients with DLCN criteria ≥6 points after correction for LLT. Secondary endpoints were the additional number of patients with DLCN criteria ≥6 points after also adding data on patient- and family history, and LDL-C before and after correction for LLT. Analysis was performed in a daily automated routine (HiX ChipSoft). In a total of 41,937 individual LDL-C measurements during 26 weeks, we found 351 patients with LDL-C ≥6.5 mmol/l after automated correction for LLT. FH had previously been diagnosed in 42 patients. In the remaining 309 patients (58.3% female; age: 66 ± 11 yrs (mean ± SD); 85.8% on LLT), the number of patients with DLCN criteria ≥6 points increased from 9 to 95 after correction for LLT, and to 127 after also adding patient and family history. The mean LDL-C before and after correction for LLT was 4.69 ± 1.42 mmol/l and 8.16 ± 1.68 mmol/l, respectively (mean ± SD; p < 0.001). We conclude that automated medical record-based integration of LDL-C, LLT and patient- and family history can provide a crucial signal to facilitate identification of FH. Whether this signal results in subsequent genetic identification of FH patients and their relatives requires further study. Image 1 • Familial hypercholesterolemia (FH) results in high risk of coronary heart disease. • FH is underdiagnosed, possibly due to lack of recognition by physicians. • An automated algorithm in electronic health records (EHR) may facilitate detection of FH. • Correction for lipid lowering therapy and patient characteristics are taken into account. • This continuous EHR-based algorithm can facilitate FH detection. [ABSTRACT FROM AUTHOR]

Because patients with stable coronary artery disease are at continued risk of major atherosclerotic events despite effective secondary prevention strategies, there is a need to continue to develop additional safe, effective and well-tolerated therapies for secondary prevention of cardiovascular disease. RATIONALE AND DESIGN: The LoDoCo (Low Dose Colchicine) pilot trial showed that the anti-inflammatory drug colchicine 0.5 mg once daily appears safe and effective for secondary prevention of cardiovascular disease. Colchicine's low cost and long-term safety suggest that if its efficacy can be confirmed in a rigorous trial, repurposing it for secondary prevention of cardiovascular disease would have the potential to impact the global burden of cardiovascular disease. LoDoCo2 is an investigator-initiated, international, multicentre, double-blind, event driven trial in which 5522 patients with stable coronary artery disease tolerant to colchicine during a 30-day run-in phase have been randomized to colchicine 0.5 mg daily or matching placebo on a background of optimal medical therapy. The study will have 90% power to detect a 30% reduction in the composite primary endpoint: cardiovascular death, myocardial infarction, ischemic stroke and ischemia-driven coronary revascularization. Adverse events potentially related to the use of colchicine will also be collected, including late gastrointestinal intolerance, neuropathy, myopathy, myositis, and neutropenia. CONCLUSION: The LoDoCo2 Trial will provide information on the efficacy and safety of low-dose colchicine for secondary prevention in patients with stable coronary artery disease., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aim: To determine whether an intensive intervention at a heart failure (HF) clinic by a combination of a clinician and a cardiovascular nurse, both trained in HF, reduces the incidence of hospitalisation for worsening HF and/or all-cause mortality (primary end point) and improves functional status (including left ventricular ejection fraction, New York Heart Association (NYHA) class and quality of life) in patients with NYHA class III or IV., Setting: Two regional teaching hospitals in The Netherlands., Methods: 240 patients were randomly allocated to the 1-year intervention (n = 118) or usual care (n = 122). The intervention consisted of 9 scheduled patient contacts-at day 3 by telephone, and at weeks 1, 3, 5, 7 and at months 3, 6, 9 and 12 by a visit-to a combined, intensive physician-and-nurse-directed HF outpatient clinic, starting within a week after hospital discharge from the hospital or referral from the outpatient clinic. Verbal and written comprehensive education, optimisation of treatment, easy access to the clinic, recommendations for exercise and rest, and advice for symptom monitoring and self-care were provided. Usual care included outpatient visits initialized by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology., Results: During the 12-month study period, the number of admissions for worsening HF and/or all-cause deaths in the intervention group was lower than in the control group (23 vs 47; relative risk (RR) 0.49; 95% confidence interval (CI) 0.30 to 0.81; p = 0.001). There was an improvement in left ventricular ejection fraction (LVEF) in the intervention group (plus 2.6%) compared with the usual care group (minus 3.1%; p = 0.004). Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group. Beneficial effects were also observed on NYHA classification, prescription of spironolactone, maximally reached dose of beta-blockers, quality of life, self-care behaviour and healthcare costs., Conclusion: A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations for worsening HF and/or all-cause mortality and improves functional status, while decreasing healthcare costs, even in a country with a primary-care-based healthcare system.

Background: Several randomised studies of heart failure (HF) management programmes in the United States, Australia and Europe have shown a considerable reduction in hospitalisation rates for HF. In this article, a comprehensive review of these studies will be provided and their applicability to countries, with a primary care-based healthcare system, will be discussed. In addition, the design of the Deventer-Alkmaar HF Project (DEAL-HF), a randomised study of the effect of a nurse and physician-directed intervention over 1 year in The Netherlands, will also be presented., Aim: To discuss the applicability of the results of available studies on heart failure management programmes to countries with well-structured primary care facilities and to determine whether additional trials should be conducted in these countries., Methods: We performed a literature search in PubMed. In a review of the available studies, essential methodological aspects, in particular, the population involved, the sample size, follow-up period, setting, type of intervention, and the outcome parameters, are discussed critically. Also, the applicability of these studies to countries with a primary care-based healthcare system and easy access to medical care is evaluated., Conclusion: Applicability of the results of the available studies on the efficacy of heart failure management programmes to countries with a primary care-based health care system is doubtful. An efficacy trial in a country with a well-established primary care-based healthcare system, such as The Netherlands, is due to report soon (DEAL-HF).