IMPORTANCEStrategies that enhance self-care of patients with heart failure reduce mortality and health care use. OBJECTIVE To examine whether an empowerment-based self-care education program was more effective and cost-effective to improve self-care, health status, and hospital service use than a didactic education program in patients with heart failure. DESIGN, SETTING, AND PARTICIPANTS In this double-blind randomized clinical trial, a consecutive sample of 988 patients with heart failure from the cardiac clinics of 2 regional hospitals underwent eligibility screening from February 1, 2017, to May 31, 2019, using the criteria of age of 55 years or older, heart failure diagnosed 6 months before screening, and New York Heart Association class II to IV. A total of 236 participants were randomized to the empowerment (n = 118) or education (n = 118) group. INTERVENTIONS The 12-week, group-based, empowerment-based education program included self-care assessment, goal-orientated actions in symptom recognition and response, fluid and dietary modification, and lifestyle management. Didactic education covered the same topics without empowerment strategies. MAIN OUTCOMES AND MEASURESThe primary outcome was self-care measured by the Self-care Heart Failure Index (SCHFI) maintenance, management, and symptom perception subscales at posttest and 3-month end points. Secondary outcomes included measures of knowledge, confidence, health-related quality of life, and health service use. Direct, indirect, and social costs of the 2 programs were collected for cost-effectiveness analysis. RESULTSA total of 236 Chinese patients (mean [SD] age, 70 [8.0] years; 149 [63.1%] men) were included in the study. The empowerment group reported significantly greater improvement in SCHFI management scores (mean difference, 13.76; 95% CI, 5.89-21.62; Cohen d = 0.46 at posttest and Cohen d = 0.35 at 3 months) and symptom perception scores (mean difference, 20.36; 95% CI, 13.98-26.75; Cohen d = 0.84 at posttest and Cohen d = 0.61 at 3 months). The empowerment group had lower risks of emergency department attendance (incidence rate ratio, 0.55; 95% CI, 0.31-0.95; P = .03) and hospital admission (incidence rate ratio, 0.38; 95% CI, 0.21-0.68; P = .001) and better improved self-care knowledge (change in score [empowerment minus education], 1.29; 95% CI, 0.48-2.09) and confidence (change in score [empowerment minus education], 7.98; 95% CI, 1.91-14.05). Empowerment was cost-saving and cost-effective at T2 compared with the education group for quality-adjusted life-years, with an incremental cost-effectiveness ratio of −114 485.(continued) Key Points Question What are the effectiveness and cost-effectiveness of a 12-week, empowerment-based self-care intervention on health outcomes and health care use among patients with heart failure? Findings In this randomized clinical trial of 236 patients with heart failure, when compared with didactic education, an empowerment-based self-care intervention was effective and costeffective, resulting in improvement in s...
Better antihypertensive adherence was associated with lower cardiovascular mortality. This highlights the need to promote adherence through strategies which have been proved to be effective in clinical settings.
BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )
Objectives We aimed to assess the safety and performance of the Magmaris sirolimus‐eluting bioresorbable magnesium scaffold in a large patient population. Background Magmaris has shown good outcomes in small‐sized controlled trials, but further data are needed to confirm its usability, safety, and performance. Methods BIOSOLVE‐IV is an international, single arm, multicenter registry including patients with a maximum of two single de novo lesions. Follow‐up is scheduled up to 5 years; the primary outcome is target lesion failure (TLF) at 12 months. Results A total of 1,075 patients with 1,121 lesions were enrolled. Mean patient age was 61.3 ± 10.5 years and 19.2% ( n = 206) presented with non‐ST‐elevation myocardial infarction (NSTEMI). Lesions were 3.2 ± 0.3 mm in diameter and 14.9 ± 4.2 mm long; 5.1% ( n = 57) were bifurcation lesions. Device success was 97.3% ( n = 1,129) and procedure success 98.9% ( n = 1,063). The Kaplan–Meier estimate of TLF at 12 months was 4.3% [95% confidence interval, CI: 3.2, 5.7] consisting of 3.9% target lesion revascularizations, 0.2% cardiac death, and 1.1% target‐vessel myocardial infarction. Definite/probable scaffold thrombosis occurred in five patients (0.5% [95% CI: 0.2, 1.1]), thereof four after early discontinuation of antiplatelet/anticoagulation therapy. Conclusion BIOSOLVE‐IV confirms the safety and performance of the Magmaris scaffold in a large population with excellent device and procedure success and a very good safety profile up to 12 months in a low‐risk population.
Background The use of a retrograde approach and algorithm-driven CTO (chronic total occlusion) percutaneous coronary intervention (PCI) has become widespread, and many registries have reported good results. This study established a new algorithm and applied it to current CTO practice and collected a CTO registry to document the results. It compared the outcomes of a retrograde versus antegrade approach in a contemporary multicentre CTO registry. Methods Between 1 January 2016 and 31 December 2016, consecutive patients who underwent CTO PCI performed by eight high-volume CTO operators were included in a registry. Results During this period, 485 patients with 497 CTOs were treated with technical and procedural success rates of 93.8% and 89.9%, respectively. Antegrade and retrograde technical success was 95.9% and 91.2% (p = 0.03), respectively. Procedural success for antegrade and retrograde was 94.4% and 84.6%, respectively (p < 0.001). The pure retrograde success rate was 80% and pure antegrade success rate was 75%. Technical success in different Japanese Chronic Total Occlusion (JCTO) score groups was 100% (JCTO 0), 96.2% (JCTO 1), 95.3% (JCTO 2), and 92.5% (JCTO ! 3), with no statistical difference in success rates between different JCTO scores. In-hospital major adverse cardiac event (MACE) was 3.8% and more common in the retrograde group (6.6% vs 1.5%).
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