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.

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.

Renal function and short-term outcome in stable outpatients with coronary, cerebrovascular or peripheral artery disease.

BACKGROUND: The influence of renal function on outcome in stable outpatients with atherosclerotic disease has not been thoroughly studied. METHODS: We used the FRENA Registry data to compare the incidence of subsequent ischemic events (myocardial infarction [MI], ischemic stroke or limb amputation) in patients with coronary (CAD), cerebrovascular (CVD) or peripheral artery disease (PAD), according to their estimated glomerular filtration rate (eGFR) at baseline. RESULTS: As of April 2012, 3860 patients were recruited in FRENA: 1439 with CAD, 1118 with CVD and 1303 with PAD. Over a mean follow-up of 14 ± 12 months, 97 patients suffered subsequent MI, 93 had ischemic stroke and 46 underwent limb amputation. In all, 2699 patients (70%) had eGFR > 60 mL/min/1.73 m(2), 1022 (26%) had 30-60 mL/min/1.73 m(2), and 139 (3.6%) had <30 mL/min/1.73 m(2). Among patients with CAD, the rate of subsequent MI was: 1.38 (95% CI: 0.85-2.11), 5.79 (95% CI: 3.90-8.31) and 18.8 (95% CI: 9.14-34.4) events per 100 patient-years, respectively. On multivariable analysis, the hazard ratio for MI (compared with patients with eGFR > 60 mL/min/1.73 m(2)) was of 1.77 (95% CI: 1.15-2.73) for patients with eGFR of 30-60 mL/min/1.73 m(2), and 3.15 (95% CI: 1.61-6.14) for those with eGFR < 30 mL/min/1.73 m(2). Among patients with CVD or PAD, there was no increasing rate of subsequent ischemic events with decreasing renal function. CONCLUSIONS: Among stable outpatients with CAD, there is an increasing rate of subsequent MI with decreasing renal function, independently of potentially confounding variables. These findings were not observed in patients with CVD or PAD.

Clinical outcome of stable outpatients with coronary, cerebrovascular or peripheral artery disease, and atrial fibrillation.

BACKGROUND: The influence of atrial fibrillation (AF) on outcome in patients with symptomatic atherosclerotic disease has not been thoroughly studied. METHODS: FRENA is an ongoing registry of stable outpatients with coronary (CAD), cerebrovascular (CVD), or peripheral (PAD) artery disease. With the aim to guide therapy, we assessed the incidence of subsequent myocardial infarction (MI), ischemic stroke or major bleeding in patients with AF, according to initial presentation. RESULTS: As of June 2011, 3848 patients were recruited: 1436 had CAD, 1104 CVD, and 1308 had PAD. Of these, 470 (12%) had AF: 151 patients with CAD, 157 with CVD, and 162 with PAD. Over a mean follow-up of 16 ± 13 months, 19 patients with AF developed acute MI, 22 ischemic stroke and 7 bled. Among AF patients with CAD, the incidence of subsequent MI (5.00 events per 100 patient-years; 95% CI: 2.54-8.91) was non-significantly higher than that of stroke (1.48; 95% CI: 0.38-4.04) or major bleeding (1.47; 95% CI: 0.37-4.01). Among those with CVD, the incidence of stroke (5.61; 95% CI: 2.95-9.75) exceeded that of MI (no events) or major bleeding (0.51; 95% CI: 1.24-6.36). Among those with PAD, the incidence of MI (4.41; 95% CI: 2.15-8.10) and stroke (3.93; 95% CI: 1.82-7.46) were similar. CONCLUSIONS: CAD patients with AF are at a higher risk of subsequent MI than of stroke. Among those with CVD, the risk of stroke far exceeds that of MI. Those with PAD have a high and similar risk for both events.

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.