Cost-effectiveness analysis of statins in primary care: results from the Arteris cohort study.

BACKGROUND: The Swiss Federal Office of Public Health performed a health technology assessment regarding statins in primary care. The chosen models may lead to a situation where a clinically indicated statin therapy is estimated not to be cost effective. METHODS: We performed a cohort study regarding cardiovascular events, comparing SCORE and AGLA risk categories with tertiles of carotid plaque burden and used two models for cost-effectiveness analysis of high-potency statins. RESULTS: Subjects (n = 2842) were followed up for 5.9 ± 2.9 years with the occurrence of 154 cardiovascular events (extrapolated 10-year risk was 9.2%). Carotid plaque imaging (total plaque area, TPA) significantly improved cardiovascular risk prediction compared with AGLA and SCORE for event-free survival prediction, test accuracy (discrimination) and calibration. Discrimination was significantly improved by about 4% with the inclusion of TPA. Cost-effectiveness analysis using quality-adjusted life years (QALYs) and sensitivity analyses (based on 16 models) ranged between CHF 144,496 and −128,328 per QALY. Cost-effectiveness analysis using direct and indirect costs showed that a treat-them-all strategy in the Swiss population would be cost effective with a return-on-investment per patient in 10 years of between CHF 4442 and 19,059, and the use of carotid imaging was also cost effective (incremental cost-efficiency ratio −2.97 to −7.86). CONCLUSIONS: Carotid ultrasound significantly improved cardiovascular risk stratification and is cost effective. The Swiss Medical Board QALY model presents several drawbacks, which are shown in our sensitivity analysis, where results vary considerably and are not useful for clinical decision making. A “treat them all” strategy with statins in the Swiss population aged 30–65 years may be cost effective, when indirect costs of avoidable cardiovascular events are included, even at an unacceptably low value of a statistical life year.

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.

OBJECTIVES: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies. BACKGROUND: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes. METHODS: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization. RESULTS: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919). CONCLUSIONS: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).

Clinical Events After Deferral of LAD Revascularization Following Physiological Coronary Assessment.

BACKGROUND: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

[Health promotion and inpatient rehabilitation. Long-term effects of education in patients with coronary heart disease]. / Gesundheitsförderung durch eine stationäre Rehabilitation. Langzeiteffekte von Schulungsmassnahmen bei Patienten mit koronarer Herzkrankheit.

BACKGROUND AND PURPOSE: The most important goals in the rehabilitation of patients with a coronary heart disease (CHD) include the diagnosis and treatment of risk factors, health promotion, and education. The knowledge on and awareness of cardiovascular risk factors is an important precondition for a high patient compliance. Former studies on patients in cardiologic departments of hospitals showed no effect of health promotion and education on patients' knowledge on risk factors, presumably because of the setting in acute therapy. Therefore, the possible effects of health promotion and education on the knowledge of patients were studied in the setting of an inpatient rehabilitation. METHODS: Over 1 year, 426 patients, admitted to an inhospital rehabilitation, were questioned on the first and last day of their stay using a validated instrument ("Bochumer Bewertungsbogen-Kardiovaskuläre Risikofaktoren" [BBKR], Table 1). 1 year after discharge, the same questionnaire was sent to the surviving 423 patients. Of these, 267 patients (63.1%) answered. The average age was 64.3 years (standard deviation [SD] 11.3). Demographic data and clinical history are summarized in Table 2. RESULTS: For most of the known risk factors of CHD, the number of patients mentioning them significantly increased during the observation period. On the day of admittance, only 59.2% mentioned diabetes mellitus as a risk factor compared to 74.6% 1 year after discharge. Especially patients with a CHD improved their knowledge on their disease (Figure 1). Education and number of rehabilitations in the past had an influence on the knowledge of interviewed patients on the day of admittance. Especially elderly patients had an increase in knowledge, indicated by a higher score in the questionnaire (Table 3). Participation in patients' self-help meetings within the observation time had no influence on the knowledge. Patients with known hypertension or hyperlipoproteinemia and overweight patients could increase knowledge on the cardiovascular risk of their disease (Figure 2). CONCLUSION: The results of this query document the lack of knowledge on cardiovascular risk factors of patients before rehabilitation. Especially the results of patients with a diagnosed (and treated) CHD after an inpatient stay in an acute hospital in the past were surprising. The stationary rehabilitation is an appropriate measure to improve this knowledge. It can be used for secondary prevention. The raise in knowledge was evident 1 year after discharge; a long-term effect of health education during stationary rehabilitation is likely.