scholarly journals Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease

Heart ◽  
2021 ◽  
pp. heartjnl-2020-318758
Author(s):  
Gilles R Dagenais ◽  
Leanne Dyal ◽  
Jacqueline J Bosch ◽  
Darryl P Leong ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Low Dose ◽  
Cardiovascular Death ◽  
Stroke Rate ◽  
Early Stopping ◽  
Peripheral Artery ◽  
Once Daily ◽  
Registration Number ◽  
Artery Disease

ObjectiveIn patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping.MethodsIncident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068).ResultsDuring randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin.ConclusionDiscontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess.Trial registration numberNCT01776424.

scholarly journals Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial

2019 ◽  
Vol 27 (3) ◽  
pp. 296-307 ◽  
Author(s):  
Thomas Vanassche ◽  
Peter Verhamme ◽  
Sonia S Anand ◽  
Olga Shestakovska ◽  
Keith AA Fox ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
Peripheral Artery Disease ◽  
Low Dose ◽  
Cardiovascular Death ◽  
Peripheral Artery ◽  
Double Blind ◽  
Artery Disease ◽  
Risk Factor Status ◽  
Ischemic Events

Aims Secondary prevention in patients with coronary artery disease and peripheral artery disease involves antithrombotic therapy and optimal control of cardiovascular risk factors. In the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) study, adding low-dose rivaroxaban on top of aspirin lowered cardiovascular events, but there is limited data about risk factor control in secondary prevention. We studied the association between risk factor status and outcomes, and the impact of risk factor status on the treatment effect of rivaroxaban, in a large contemporary population of patients with coronary artery disease or peripheral artery disease. Methods and results We reported ischemic events (cardiovascular death, stroke, or myocardial infarction) in participants from the randomized, double-blind COMPASS study by individual risk factor (blood pressure, smoking status, cholesterol level, presence of diabetes, body mass index, and level of physical activity), and by number of risk factors. We compared rates and hazard ratios of patients treated with rivaroxaban plus aspirin vs aspirin alone within each risk factor category and tested for interaction between risk factor status and antithrombotic regimen. Complete baseline risk factor status was available in 27,117 (99%) patients. Status and number of risk factors were both associated with increased risk of ischemic events. Rates of ischemic events (hazard ratio 2.2; 95% confidence interval 1.8–2.6) and cardiovascular death (hazard ratio 2.0; 1.5–2.7) were more than twofold higher in patients with 4–6 compared with 0–1 risk factors ( p < 0.0001 for both). Rivaroxaban reduced event rates independently of the number of risk factors ( p interaction 0.93), with the largest absolute benefit in patients with the highest number of risk factors. Conclusion More favorable risk factor status and low-dose rivaroxaban were independently associated with lower risk of cardiovascular events.

Abstract 24: Health Status Differences Between Early Invasive and Non Invasive Treatment Strategies in Patients With Peripheral Artery Disease: Insights From Portrait Registry

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Suveen Angraal ◽  
Vittal Hejjaji ◽  
Laith Derbas ◽  
Manesh R Patel ◽  
Jan Heyligers ◽  
...  
Keyword(s):  
Health Status ◽  
Peripheral Artery Disease ◽  
Real World ◽  
Medical Management ◽  
World Health ◽  
Peripheral Artery ◽  
Supervised Exercise ◽  
Early Revascularization ◽  
Artery Disease

Background: In patients with symptomatic peripheral artery disease (PAD), a key treatment goal is to improve their health status; their symptoms, function, and quality of life (QoL). While medical therapy with lifestyle changes is recommended in all, revascularization can be a consideration to alleviate PAD symptoms. We sought to compare the real-world impact of either treatment strategy on patients’ health status improvement. Methods: Patients with new or worsening PAD symptoms (Rutherford category 1-3), from 10 U.S. specialty vascular clinics between 2011-2015, who either underwent early revascularization (using stent, angioplasty or surgery within 3 months of enrolment) or medical management alone (statin, aspirin, cilostazol, supervised exercise therapy, risk factor (diabetes, hypertension) management) were identified from the Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry. The Peripheral Artery Questionnaire (PAQ) was used to assess patients’ disease-specific health status at enrollment and at 3, 6 and 12 months of follow up. The differences in PAQ overall summary scores, and each subdomain, were compared using an adjusted generalized linear model for repeated measures (Figure 1). Results: Among 797 patients (mean age of 68.6 years, 58.1% male), 226 underwent early revascularization and 571 were managed medically. At baseline, patients in the revascularization vs. medical management cohort had lower PAQ summary scores (mean ± SD; 42.6 ± 20.7 vs. 48.5 ± 22.3, P<0.001) and QoL scores (43.4 ± 23.9 vs. 50.4 ± 26.4, P<0.001). Over 1 year of follow-up, patients who underwent revascularization reported significantly higher health status over time than patients managed medically without revascularization (P <0.001 for all PAQ sub-domains; Figure 1). Conclusion: Patients with PAD who received early revascularization had worse health status at baseline, but they reported a greater degree of improvement over 1 year of follow-up when compared to patients managed medically without revascularization. Summarizing real-world health status benefits following a PAD diagnosis is critical to help guide preference-sensitive decisions on PAD management.

461Modulation of ischemic and bleeding risk by peripheral artery disease after an acute coronary syndrome

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Cespon Fernandez ◽  
S Raposeiras Roubin ◽  
E Abu-Assi ◽  
S Manzano-Fernandez ◽  
F Dascenzo ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Peripheral Artery Disease ◽  
Cumulative Incidence ◽  
Bleeding Risk ◽  
Peripheral Artery ◽  
Data Set ◽  
Coronary Syndrome ◽  
Artery Disease ◽  
The Impact

Abstract Introduction Peripheral artery disease (PAD) is associated with heightened ischemic and bleeding risk in patients with acute coronary syndrome (ACS). With this study from real-life patients, we try to analyze the balance between ischemic and bleeding risk during treatment with dual antiplatelet therapy (DAPT) after an ACS according to the presence or not of PAD. Methods The data analyzed in this study were obtained from the fusion of 3 clinical registries of ACS patients: BleeMACS (2004–2013), CardioCHUVI/ARRITXACA (2010–2016) and RENAMI (2013–2016). All 3 registries include consecutive patients discharged after an ACS with DAPT and undergoing PCI. The merged data set contain 26,076 patients. A propensity-matched analysis was performed to match the baseline characteristics of patients with and without PAD. The impact of prior PAD in the ischemic and bleeding risk was assessed by a competitive risk analysis, using a Fine and Gray regression model, with death being the competitive event. For ischemic risk we have considered a new acute myocardial infarction (AMI), whereas for bleeding risk we have considered major bleeding (MB) defined as bleeding requiring hospital admission. Follow-up time was censored by DAPT suspension/withdrawal. Results From the 26,076 ACS patients, 1,600 have PAD (6.1%). Patients with PAD were older, and with more cardiovascular risk factors. DAPT with prasugrel/ticagrelor was less frequently prescribed in patients with PAD in comparison with the rest of the population (8.2% vs 22.8%, p<0.001). During a mean follow-up of 12.2±4.8 months, 964 patients died (3.7%), and 640 AMI (2.5%) and 685 MB (2.6%) were reported. After propensity-score matching, we obtained two matched groups of 1,591 patients. Patients with PAD showed a significant higher risk of both AMI (sHR 2.17, 95% CI 1.51–3.10, p<0.001) and MB (sHR 1.51, 95% CI 1.07–2.12, p=0.018), in comparison with those without PAD. The cumulative incidence of AMI was 63.9 and 29.8 per 1,000 patients/year in patients with and without PAD, respectively. The cumulative incidence of MB was 55.9 and 37.6 per 1,000 patients/year in patients with and without PAD, respectively. The rate difference per 1,000 patient-years for AMI between patients with and without PAD was +34.1 (95% CI 30.1–38.1), and for MB +18.3 (16.1–20.4). The net balance between ischemic and bleeding events comparing patients with and without PAD was positive (+15.8 per 1,000 patients/year, 95% CI 9.7–22.0). Conclusions PAD was associated with higher ischemic and bleeding risk after hospital discharge for ACS treated with DAPT. However, the balance between ischemic and bleeding risk was positive for patients with PAD in comparison with patients without PAD. As summary, ACS patients with PAD had an ischemic risk greater than the bleeding risk.

Adherence to statin therapy favours survival of patients with symptomatic peripheral artery disease

2019 ◽  
Author(s):  
Jörn F Dopheide ◽  
Jonas Veit ◽  
Hana Ramadani ◽  
Luise Adam ◽  
Lucija Papac ◽  
...  
Keyword(s):  
Statin Therapy ◽  
Peripheral Artery Disease ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Peripheral Artery ◽  
All Cause Mortality ◽  
Statin Medication ◽  
Artery Disease ◽  
Statin Adherence

Abstract Aims  We hypothesized that adherence to statin therapy determines survival in patients with peripheral artery disease (PAD). Methods and results  Single-centre longitudinal observational study with 691 symptomatic PAD patients. Mortality was evaluated over a mean follow-up of 50 ± 26 months. We related statin adherence and low-density lipoprotein cholesterol (LDL-C) target attainment to all-cause mortality. Initially, 73% of our PAD patients were on statins. At follow-up, we observed an increase to 81% (P &lt; 0.0001). Statin dosage, normalized to simvastatin 40 mg, increased from 50 to 58 mg/day (P &lt; 0.0001), and was paralleled by a mean decrease of LDL-C from 97 to 82 mg/dL (P &lt; 0.0001). The proportion of patients receiving a high-intensity statin increased over time from 38% to 62% (P &lt; 0.0001). Patients never receiving statins had a significant higher mortality rate (31%) than patients continuously on statins (13%) or having newly received a statin (8%; P &lt; 0.0001). Moreover, patients on intensified statin medication had a low mortality of 9%. Those who terminated statin medication or reduced statin dosage had a higher mortality (34% and 20%, respectively; P &lt; 0.0001). Multivariate analysis showed that adherence to or an increase of the statin dosage (both P = 0.001), as well as a newly prescribed statin therapy (P = 0.004) independently predicted reduced mortality. Conclusion  Our data suggest that adherence to statin therapy is associated with reduced mortality in symptomatic PAD patients. A strategy of intensive and sustained statin therapy is recommended.

scholarly journals Burden of hospitalization in clinically diagnosed peripheral artery disease: A community-based study

2017 ◽  
Vol 23 (1) ◽  
pp. 23-31 ◽  
Author(s):  
Adelaide M Arruda-Olson ◽  
Homam Moussa Pacha ◽  
Naveed Afzal ◽  
Sara Abram ◽  
Bradley R Lewis ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Ankle Brachial Index ◽  
Inception Cohort ◽  
Peripheral Artery ◽  
Community Based ◽  
Increased Risk ◽  
Artery Disease ◽  
Recurrent Hospitalization ◽  
Over Time

The burden and predictors of hospitalization over time in community-based patients with peripheral artery disease (PAD) have not been established. This study evaluates the frequency, reasons and predictors of hospitalization over time in community-based patients with PAD. We assembled an inception cohort of 1798 PAD cases from Olmsted County, MN, USA (mean age 71.2 years, 44% female) from 1 January 1998 through 31 December 2011 who were followed until 2014. Two age- and sex-matched controls ( n = 3596) were identified for each case. ICD-9 codes were used to ascertain the primary reasons for hospitalization. Patients were censored at death or last follow-up. The most frequent reasons for hospitalization were non-cardiovascular: 68% of 8706 hospitalizations in cases and 78% of 8005 hospitalizations in controls. A total of 1533 (85%) cases and 2286 (64%) controls ( p < 0.001) were hospitalized at least once; 1262 (70%) cases and 1588 (44%) controls ( p < 0.001) ≥ two times. In adjusted models, age, prior hospitalization and comorbid conditions were independently associated with increased risk of recurrent hospitalizations in both groups. In cases, severe PAD (ankle–brachial index < 0.5) (HR: 1.25; 95% CI: 1.15, 1.36) and poorly compressible arteries (HR: 1.26; 95% CI: 1.16, 1.38) were each associated with increased risk for recurrent hospitalization. We demonstrate an increased rate of hospitalization in community-based patients with PAD and identify predictors of recurrent hospitalizations. These observations may inform strategies to reduce the burden of hospitalization of PAD patients.

scholarly journals Sortilin levels correlate with major cardiovascular events of diabetic patients with peripheral artery disease following revascularization: a prospective study

2020 ◽  
Author(s):  
Federico Biscetti ◽  
Elisabetta Nardella ◽  
Maria Margherita Rando ◽  
Andrea Leonardo Cecchini ◽  
Nicola Bonadia ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Cardiovascular Events ◽  
Vascular Complications ◽  
Diabetic Patients ◽  
Operating Characteristics ◽  
Peripheral Artery ◽  
Baseline Serum ◽  
Increased Risk ◽  
Artery Disease

Abstract Background: Peripheral artery disease (PAD) represents one of the most relevant vascular complications of type 2 diabetes mellitus (T2DM). Moreover, T2DM patients suffering from PAD have an increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Sortilin, a protein involved in apolipoproteins trafficking, is associated with lower limb PAD in T2DM patients.Objective: To evaluate the relationship between baseline serum levels of sortilin, MACE and MALE occurrence after revascularization of T2DM patients with PAD and chronic limb-threatening ischemia (CLTI).Research Design and Methods: We performed a prospective non-randomized study including 230 statin-free T2DM patients with PAD and CLTI. Sortilin levels were measured before the endovascular intervention and incident outcomes were assessed during a 12-month follow-up.Results: Sortilin levels were significantly increased in individuals with more aggressive PAD (2.25 ± 0.51 ng/mL vs 1.44 ± 0.47 ng/mL, p < 0.001). During follow-up, 83 MACE and 116 MALE occurred. In patients, who then developed MACE and MALE, sortilin was higher. In particular, 2.46 ± 0.53 ng/mL vs 1.55 ± 0.42 ng/mL, p < 0.001 for MACE and 2.10 ± 0.54 ng/mL vs 1.65 ± 0.65 ng/mL, p < 0.001 for MALE. After adjusting for traditional atherosclerosis risk factors, the association between sortilin and vascular outcomes remained significant in a multivariate analysis. In our receiver operating characteristics (ROC) curve analysis using sortilin levels the prediction of MACE incidence improved (area under the curve [AUC] = 0.94) and MALE (AUC = 0.72).Conclusions: This study demonstrates that sortilin correlates with incidence of MACE and MALE after endovascular revascularization in a diabetic population with PAD and CLTI.

scholarly journals Sortilin levels correlate with major cardiovascular events of diabetic patients with peripheral artery disease following revascularization: a prospective study

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Federico Biscetti ◽  
Elisabetta Nardella ◽  
Maria Margherita Rando ◽  
Andrea Leonardo Cecchini ◽  
Nicola Bonadia ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Cardiovascular Events ◽  
Vascular Complications ◽  
Diabetic Patients ◽  
Operating Characteristics ◽  
Peripheral Artery ◽  
Baseline Serum ◽  
Increased Risk ◽  
Artery Disease

Abstract Background Peripheral artery disease (PAD) represents one of the most relevant vascular complications of type 2 diabetes mellitus (T2DM). Moreover, T2DM patients suffering from PAD have an increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Sortilin, a protein involved in apolipoproteins trafficking, is associated with lower limb PAD in T2DM patients. Objective To evaluate the relationship between baseline serum levels of sortilin, MACE and MALE occurrence after revascularization of T2DM patients with PAD and chronic limb-threatening ischemia (CLTI). Research design and methods We performed a prospective non-randomized study including 230 statin-free T2DM patients with PAD and CLTI. Sortilin levels were measured before the endovascular intervention and incident outcomes were assessed during a 12 month follow-up. Results Sortilin levels were significantly increased in individuals with more aggressive PAD (2.25 ± 0.51 ng/mL vs 1.44 ± 0.47 ng/mL, p < 0.001). During follow-up, 83 MACE and 116 MALE occurred. In patients, who then developed MACE and MALE, sortilin was higher. In particular, 2.46 ± 0.53 ng/mL vs 1.55 ± 0.42 ng/mL, p < 0.001 for MACE and 2.10 ± 0.54 ng/mL vs 1.65 ± 0.65 ng/mL, p < 0.001 for MALE. After adjusting for traditional atherosclerosis risk factors, the association between sortilin and vascular outcomes remained significant in a multivariate analysis. In our receiver operating characteristics (ROC) curve analysis using sortilin levels the prediction of MACE incidence improved (area under the curve [AUC] = 0.94) and MALE (AUC = 0.72). Conclusions This study demonstrates that sortilin correlates with incidence of MACE and MALE after endovascular revascularization in a diabetic population with PAD and CLTI.

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