Eduardo Aguilar

Inercia terapéutica en prevención secundaria de enfermedad cardiovascular. Registro FRENA

BACKGROUND AND OBJECTIVE Although nowadays there are many cardiovascular disease (CVD) treatment protocols and evidence based guidelines, not many patients achieve the recommended levels for cardiovascular (CV) risk factor (RF) and management of disorders could be improved. Treatment inertia (TI) is the failure of health care providers to initiate or intensify therapy when indicated. The purpose of this study was to quantify TI in secondary CV prevention and identify factors influencing TI. PATIENTS AND METHOD Observational, transversal study with 1660 patients included in FRENA (The FRENA registry recruited Spanish patients in CVD secondary prevention treated by different specialists), aged 66,3 years, 74% males, 38,5% females, 38,5% coronary heart disease (CHD), 30,8% cerebrovascular disease and 32% peripheral artery disease (PAD). Final variable: TI; three types of inertia where described: treatment failure inertia, RF control inertia and the third one was at least one of the previous. Uni and multivariate analysis were done for each type of inertia. RESULTS Inertia was detected in 81,5% of the patients. RF control inertia was 85,1% and treatment failure inertia 53%. Diabetic patients are likely to be treated with TI whereas patients with renal insufficiency (RI) or arterial hypertension (AHT) are more likely to be protected against it. There is less treatment failure inertia in cerebrovascular disease or coronary heart disease Vs PAD, AHT and Dyslipemia (DL) where the rate of treatment failure inertia is higher. RF control inertia increases with the coexistence of AHT, DL and diabetes mellitus (DM) and is lower in patients with previous CVD, cerebrovascular disease, AHT and DL. CONCLUSIONS In high risk patient, TI is present in a high percentage of them. DM, PAD and the coexistence of cardiovascular risk factors are associated with a higher inertia.

Alcohol consumption and outcome in stable outpatients with peripheral artery disease

BACKGROUND The influence of alcohol consumption on outcome in patients with peripheral artery disease (PAD) has not been thoroughly studied. METHODS Factores de Riesgo y ENfermedad Arterial (FRENA) is an ongoing, multicenter, observational registry of consecutive stable outpatients with arterial disease. We compared the mortality rate and the incidence of subsequent ischemic events in patients with PAD, according to their alcohol habits. RESULTS As of August 2010, 1073 patients with PAD were recruited, of whom 863 (80%) had intermittent claudication (Fontaine stage II), 102 (9.5%) had rest pain (Fontaine stage III), and 108 (10%) had ischemic skin lesions (Fontaine stage IV). In all, 422 patients (39%) consumed alcohol during the study period. Over a mean follow-up of 13 months, 150 patients (14%) developed subsequent ischemic events (myocardial infarction 28, stroke 30, disabling claudication/critical limb ischemia 100), and 70 patients (6.5%) died. The incidence of subsequent events was the same in both subgroups: 11.8 events per 100 patient-years (rate ratio: 1.00; 95% confidence interval [CI], 0.72-1.41), but the mortality rate was significantly lower in alcohol consumers than in non-consumers: 2.78 vs 6.58 deaths per 100 patient-years (rate ratio: 0.42; 95% CI, 0.23-0.74; P = .002). This better outcome was consistently found in patients with Fontaine stages II and III or IV, and persisted after multivariate adjustment (relative risk: 0.49; 95% CI, 0.28-0.88). CONCLUSIONS In patients with PAD, moderate alcohol consumption was associated with lower cardiovascular mortality and overall mortality than abstention. These patients should be informed that low to moderate alcohol consumption may not be harmful to their health.

Anemia and Outcome in Outpatients With Peripheral Artery Disease

The influence of anemia on outcome in stable outpatients with peripheral artery disease (PAD) has not been consistently investigated. We used data from the Factores de Riesgo y ENfermedad Arterial (FRENA) Registry to compare ischemic events and mortality rates in stable outpatients with symptomatic PAD and anemia. Of 1663 patients with PAD, 208 (12.5%) had anemia. Over 18 months, patients with anemia had a higher rate of myocardial infarction (MI; rate ratio [RR]: 2.10; 95% confidence interval [CI]: 1.04-3.99), limb amputation (RR: 2.98; 95%CI: 1.70-5.05), and higher mortality (RR: 3.58; 95%CI: 2.39-5.28) than those without anemia. The rates of ischemic stroke (RR: 0.75; 95%CI: 0.23-1.93) and major bleeding (RR: 0.93; 95%CI: 0.15-3.51) were similar. On multivariable analysis, anemia was associated with an increased risk to die (hazard ratio [HR]: 2.32; 95%CI: 1.53-3.50) but not to develop MI (HR: 1.49; 95%CI: 0.73-3.05) or to have limb amputation (HR: 1.49; 95%CI: 0.86-2.59). In stable outpatients with PAD, anemia was associated with increased mortality but not with an increased rate of subsequent ischemic events or major bleeding.

Cilostazol and outcome in outpatients with peripheral artery disease.

BACKGROUND Cilostazol increases the walking distance in patients with intermittent claudication, but there is scarce evidence of any effect on the risk for subsequent ischemic events, bleeding or death. PATIENTS AND METHODS We used data from the FRENA Registry to compare the clinical outcome in stable outpatients with intermittent claudication, according to the use of cilostazol. RESULTS As of January 2013, 1,317 patients with intermittent claudication were recruited in FRENA, of whom 191 (14.5%) received cilostazol. Over a mean follow-up of 18months, 39 patients developed myocardial infarction, 23 ischemic stroke, 20 underwent limb amputation, 15 had major bleeding and 70 died. There were no significant differences in the rate of subsequent ischemic events, major bleeding or death between patients receiving or not receiving cilostazol. On multivariate analysis, the use of cilostazol had no influence on the risk for subsequent myocardial infarction (hazard ratio [HR]: 0.97; 95% CI: 0.33-20.8), ischemic stroke (HR: 1.46; 95% CI: 0.48-4.43), limb amputation (HR: 0.34; 95% CI: 0.04-20.6), major bleeding (HR: 1.52; 95% CI: 0.33-7.09) or death (HR: 0.90; 95% CI: 0.40-20.0). CONCLUSIONS In stable outpatients with intermittent claudication, the use of cilostazol was not associated with increased rates of subsequent ischemic events, major bleeding or death.

Cardiac Rehabilitation and Outcome in Stable Outpatients With Recent Myocardial Infarction

OBJECTIVE To compare the mortality rate and the rate of subsequent ischemic events (myocardial infarction [MI], ischemic stroke, or limb amputation) in patients with recent MI according to the use of cardiac rehabilitation or no rehabilitation. DESIGN Longitudinal observational study. SETTING Ongoing registry of outpatients. PARTICIPANTS Patients (N=1043) with recent acute MI were recruited; of these, 521 (50%) participated in cardiac rehabilitation. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Subsequent ischemic events and mortality rates were registered. RESULTS Over a mean follow-up of 18 months, 50 patients (4.8%) died and 49 (4.7%) developed 52 subsequent ischemic events (MI: n=43, ischemic stroke: n=6, limb amputation: n=3). Both the mortality rate (.16 vs 5.57 deaths per 100 patient-years; rate ratio=.03; 95% confidence interval [CI], 0.0-0.1]) and the rate of subsequent ischemic events (1.65 vs 4.54 events per 100 patient-years; rate ratio=0.4; 95% CI, 0.2-0.7) were significantly lower in cardiac rehabilitation participants than in nonparticipants. Multivariate analysis confirmed that patients in cardiac rehabilitation had a significantly lower risk of death (hazard ratio=.08; 95% CI, .01-.63; P=.016) and a nonsignificant lower risk of subsequent ischemic events (hazard ratio=.65; 95% CI, .30-1.42). CONCLUSIONS The use of cardiac rehabilitation in patients with recent MI was independently associated with a significant decrease in the mortality rate and a nonsignificant decrease in the rate of subsequent ischemic events.

Supervised versus non-supervised exercise in patients with recent myocardial infarction: A propensity analysis

Background The influence of supervised versus non-supervised exercise training on outcome in patients with a recent myocardial infarction (MI) is controversial. Design Longitudinal observational study. Methods FRENA is an ongoing registry of stable outpatients with symptomatic coronary, cerebrovascular or peripheral artery disease. We compared the rate of subsequent ischaemic events (MI, ischaemic stroke or lower limb amputation) and the mortality rate in patients with recent MI, according to the use of supervised versus non-supervised exercise training. The influence of physical activity on outcomes was estimated by using propensity score method in multivariate analysis. Results As of February 2014, 1124 outpatients with recent MI were recruited, of whom 593 (53%) participated in a supervised exercise training programme. Over a mean follow-up of 15 months, 25 patients (3.3%) developed 26 subsequent ischaemic events – 24 MI, one stroke, one lower-limb amputation – and 12 (1.6%) died. The mortality rate (0.15 vs. 2.89 deaths per 100 patient-years; rate ratio = 0.05; 95% confidence interval, 0.01–0.39) was significantly lower in supervised exercise than in non-supervised exercise patients. On propensity score analysis, the rate of the composite outcome was significantly lower in supervised exercise patients (1.80 vs. 6.51 events per 100 patient-years; rate ratio = 0.28; 95% confidence interval, 0.12–0.64). Conclusions The use of supervised exercise training in patients with recent MI was associated with a significant decrease in the composite outcome of subsequent ischaemic events and death.

Raised Fibrinogen Levels and Outcome in Outpatients With Peripheral Artery Disease

The influence of raised fibrinogen levels on outcome in stable outpatients with peripheral arterial disease (PAD) has not been consistently investigated. We used data from the Factores de Riesgo y ENfermedad Arterial (FRENA) registry to compare ischemic events, major bleeding, and mortality in stable outpatients with PAD, according to their baseline plasma fibrinogen levels. Of 1363 outpatients with PAD recruited in FRENA, 558 (41%) had fibrinogen levels >450 mg/100 mL. Over 18 months, 43 patients presented with acute myocardial infarction, 37 had an ischemic stroke, 51 underwent limb amputation, 19 had major bleeding, and 90 died. Compared to patients with normal levels, those with raised fibrinogen levels had an over 2-fold higher rate of ischemic stroke (rate ratio [RR]: 2.30; 95% confidence interval [CI]: 1.19-4.59), limb amputation (RR: 2.58; 95% CI: 1.46-4.67), or death (RR: 2.27; 95% CI: 1.49-3.51) and an over 3-fold higher rate of major bleeding (RR: 3.90; 95% CI: 1.45-12.1). On multivariate analysis, patients with raised fibrinogen levels had an increased risk of developing subsequent ischemic events (hazard ratio [HR]: 1.61; 95% CI: 1.11-2.32) and major bleeding (HR: 3.42; 95% CI: 1.22-9.61). Stable outpatients with PAD and raised plasma fibrinogen levels had increased rates of subsequent ischemic events and major bleeding.

Lipoprotein (a) levels and outcomes in stable outpatients with symptomatic artery disease

BACKGROUND AND AIMS Although genetic and epidemiological studies support that people with high lipoprotein (a) [Lp(a)] levels are at an increased risk for arterial disease, its prognostic value in patients with established artery disease has not been consistently evaluated. METHODS FRENA is a prospective registry of consecutive outpatients with coronary, cerebrovascular or peripheral artery disease. We assessed the risk for subsequent myocardial infarction, ischemic stroke or limb amputation according to Lp(a) levels at baseline. RESULTS As of December 2016, 1503 stable outpatients were recruited. Of these, 814 (54%) had levels <30 mg/dL, 319 (21%) had 30-50 mg/dL and 370 (25%) had ≥50 mg/dL. Over a mean follow-up of 36 months, 294 patients developed subsequent events (myocardial infarction 122, ischemic stroke 114, limb amputation 58) and 85 died. On multivariable analysis, patients with Lp(a) levels of 30-50 mg/dL were at a higher risk for myocardial infarction (hazard ratio [HR]: 4.67; 95%CI: 2.77-7.85), ischemic stroke (HR: 8.27; 95%CI: 4.14-16.5) or limb amputation (HR: 3.18; 95%CI: 1.36-7.44) than those with normal levels. Moreover, patients with levels ≥50 mg/dL were at increased risk for myocardial infarction (HR: 19.5; 95%CI: 10.5-36.1), ischemic stroke (HR: 54.5; 95%CI: 25.4-116.7) or limb amputation (HR: 22.7; 95%CI: 9.38-54.9). CONCLUSIONS Stable outpatients with symptomatic artery disease and Lp(a) levels >30 mg/dL were at a 5-fold higher risk for subsequent myocardial infarction, stroke or limb amputation. Those with levels >50 mg/dL were at an over 10-fold higher risk.