Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease

2020 ◽  
Author(s):  
Yan Liang ◽  
Jun Zhu ◽  
Lisheng Liu ◽  
Sonia S Anand ◽  
Stuart J Connolly ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Peripheral Artery Disease ◽  
Major Bleeding ◽  
Stable Coronary Artery Disease ◽  
Major Adverse Cardiovascular Events ◽  
Peripheral Artery ◽  
Chronic Coronary Artery Disease ◽  
Once Daily ◽  
Artery Disease

Abstract Aims The COMPASS trial demonstrated that the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease or peripheral artery disease by 24% during a mean follow-up of 23 months. We explored whether this effect varies by sex. Methods and results The effects were examined in women and men using log-rank tests and Kaplan–Meier curve. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were obtained from stratified Cox proportional hazards models to explore subgroup effects including subgroup of women and men according to baseline modified REACH risk score. Of 27 395 patients randomized, 18 278 were allocated to receive rivaroxaban plus aspirin (n = 9152) or aspirin alone (n = 9126), and of these, 22.1% were women. Women compared with men had similar incidence rates for MACE and major bleeding but borderline lower rates for myocardial infarction (1.7% vs. 2.2%, P = 0.05). The effect of combination therapy compared with aspirin in women and men was consistent for MACE (women: 3.8% vs. 5.2%, HR 0.72, 95% CI 0.54–0.97; men: 4.2% vs. 5.5%, HR 0.76, 95% CI 0.66–0.89; P interaction 0.75) and major bleeding (women: 3.1% vs. 1.4%, HR 2.22, 95% CI 1.42–3.46; men: 3.2% vs. 2.0%, HR 1.60, 95% CI 1.29–1.97; P interaction 0.19). There was no significant interaction between randomized treatment and baseline modified REACH score above or below the median for MACE or major bleeding. Conclusion In patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban (2.5 mg twice daily) and aspirin compared with aspirin alone appears to produce consistent benefits in women and men, independent of baseline cardiovascular risk.

Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial

2020 ◽  
Vol 25 (2) ◽  
pp. 124-132 ◽  
Author(s):  
Arman Qamar ◽  
David A Morrow ◽  
Mark A Creager ◽  
Benjamin M Scirica ◽  
Jeffrey W Olin ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Absolute Risk ◽  
Major Adverse Cardiovascular Events ◽  
Number Needed To Treat ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Intensive antithrombotic therapy reduces major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Recent studies have suggested heterogeneity in risk and benefit in those with and without concomitant coronary artery disease (CAD) and peripheral revascularization. We evaluated the risk of MACE and MALE in patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization and whether the efficacy and safety of vorapaxar were similar in these subgroups. The TRA 2°P-TIMI 50 trial randomized 26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or placebo. This analysis examined the effect of vorapaxar in a broad population of 6136 patients with PAD. Overall, vorapaxar significantly reduced MACE (HR 0.85, 95% CI 0.73, 0.99; p = 0.034) and MALE (HR 0.70, 95% CI 0.53, 0.92; p = 0.011) in patients with PAD. The absolute risk reduction (ARR) for MACE was greater in patients with PAD and CAD versus those with PAD alone (–2.2% vs 0.1%: number needed to treat (NNT) 45 vs 1000). Conversely, the ARR for MALE was higher in those with prior lower extremity revascularization (2.5% vs 0.2%: NNT 40 vs 500). Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003). The net clinical outcome in all patients with PAD was reduced with vorapaxar (HR 0.82, 95% CI 0.72, 0.94; p = 0.004), with benefits driven by reductions in MACE for those with CAD and by reductions in MALE for those with prior peripheral revascularization. Among patients with PAD, vorapaxar resulted in a net clinical benefit; however, the drivers of benefit were heterogeneous, with greater reductions in MACE in those with concomitant CAD and greater reductions in MALE in those with prior lower extremity revascularization, and unclear benefit in patients with neither. These clinical characteristics may be useful in identifying the subgroups of patients with PAD most likely to benefit from potent antithrombotic therapies. ClinicalTrials.gov Identifier: NCT00526474

scholarly journals Antithrombotic Treatments in Patients with Chronic Coronary Artery Disease or Peripheral Artery Disease: A Systematic Review of Randomised Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
Rupert Bauersachs ◽  
Olivia Wu ◽  
Jean-Baptiste Briere ◽  
Kevin Bowrin ◽  
Katarzyna Borkowska ◽  
...  
Keyword(s):  
Systematic Review ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Peripheral Artery Disease ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Peripheral Artery ◽  
Chronic Coronary Artery Disease ◽  
Artery Disease ◽  
Randomised Controlled

Aims. Acetylsalicylic acid (ASA) is widely used for the prevention of atherothrombotic events in patients with chronic coronary artery disease (CAD) and peripheral artery disease (PAD), but the risk of vascular events remains high. We aimed at identifying randomised controlled trials (RCTs) on antithrombotic treatments in patients with chronic CAD or PAD. Methods. Searches were conducted on MEDLINE, EMBASE, and CENTRAL on March 1st, 2018. This systematic review (SR) uses a narrative synthesis to summarize the evidence for the efficacy and safety of antiplatelet and anticoagulant therapies in the population of both chronic CAD or PAD patients. Results. Four RCTs from 27 publications were included. Study groups included 15,603 to 27,395 patients. ASA alone was the most extensively studied (n=3); other studies included rivaroxaban with or without ASA (n=1), vorapaxar alone (n=1), and clopidogrel with (n=1) or without ASA (n=1). Clopidogrel alone and clopidogrel plus ASA compared to ASA presented similar efficacy with comparable safety profile. Rivaroxaban plus ASA significantly reduced the risk of the composite of cardiovascular death, myocardial infarction, and stroke compared to ASA alone, although major bleeding with rivaroxaban plus ASA increased. Conclusion. There is limited and heterogeneous evidence on the prevention of atherothrombotic events in patients with chronic CAD or PAD. Clopidogrel alone and clopidogrel plus ASA did not demonstrate superiority over ASA alone. A combination of rivaroxaban plus ASA may offer significant additional benefit in reducing cardiovascular outcomes, yet it may increase the risk of bleeding, compared to ASA alone.

scholarly journals Association of Heart Failure With Outcomes Among Patients With Peripheral Artery Disease: Insights From EUCLID

2021 ◽  
Author(s):  
Marc D. Samsky ◽  
Anne Hellkamp ◽  
William R. Hiatt ◽  
F. Gerry R. Fowkes ◽  
Iris Baumgartner ◽  
...  
Keyword(s):  
Risk Factors ◽  
Heart Failure ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Peripheral Artery Disease ◽  
Cardiovascular Events ◽  
Major Adverse Cardiovascular Events ◽  
Peripheral Artery ◽  
Factors Associated ◽  
Artery Disease

Background Peripheral artery disease (PAD) and heart failure (HF) are each independently associated with poor outcomes. Risk factors associated with new‐onset HF in patients with primary PAD are unknown. Furthermore, how the presence of HF is associated with outcomes in patients with PAD is unknown. Methods and Results This analysis examined risk relationships of HF on outcomes in patients with symptomatic PAD randomized to ticagrelor or clopidogrel as part of the EUCLID (Examining Use of Ticagrelor in Peripheral Arterial Disease) trial. Patients were stratified based on presence of HF at enrollment. Cox models were used to determine the association of HF with outcomes. A separate Cox model was used to identify risk factors associated with development of HF during follow‐up. Patients with PAD and HF had over twice the rate of concomitant coronary artery disease as those without HF. Patients with PAD and HF had significantly increased risk of major adverse cardiovascular events (hazard ratio [HR], 1.31; 95% CI, 1.13–1.51) and all‐cause mortality (HR, 1.39; 95% CI, 1.19–1.63). In patients with PAD, the presence of HF was associated with significantly less bleeding (HR, 0.65; 95% CI, 0.45–0.96). Characteristics associated with HF development included age ≥66 (HR, 1.29; 95% CI, 1.18–1.40 per 5 years), diabetes mellitus (HR, 1.85; 95% CI, 1.41–2.43), and weight (bidirectionally associated, ≥76 kg, HR, 0.77; 95% CI, 0.64–0.93; <76 kg, HR, 1.12; 95% CI, 1.07–1.16). Conclusions Patients with PAD and HF have a high rate of coronary artery disease with a high risk for major adverse cardiovascular events and death. These data support the possible need for aggressive treatment of (recurrent) atherosclerotic disease in PAD, especially patients with HF.

Systemic inflammation is higher in peripheral artery disease than in stable coronary artery disease

2015 ◽  
Vol 239 (2) ◽  
pp. 299-303 ◽  
Author(s):  
Philipp Rein ◽  
Christoph H. Saely ◽  
Günther Silbernagel ◽  
Alexander Vonbank ◽  
Rainer Mathies ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Peripheral Artery Disease ◽  
Systemic Inflammation ◽  
Stable Coronary Artery Disease ◽  
Peripheral Artery ◽  
Artery Disease
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