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 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.

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.

scholarly journals Prediction of Coronary Artery Disease in Patients With Lower Extremity Peripheral Artery Disease

2015 ◽  
Vol 56 (2) ◽  
pp. 209-212 ◽  
Author(s):  
Sung Woo Cho ◽  
Byung Gyu Kim ◽  
Deok Hee Kim ◽  
Byung Ok Kim ◽  
Young Sup Byun ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Peripheral Artery ◽  
Artery Disease

scholarly journals Association of Health Status Scores With Cardiovascular and Limb Outcomes in Patients With Symptomatic Peripheral Artery Disease: Insights From the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) Trial

2020 ◽  
Vol 9 (19) ◽  
Author(s):  
Jennifer A. Rymer ◽  
Hillary Mulder ◽  
Kim G. Smolderen ◽  
William R. Hiatt ◽  
Michael S. Conte ◽  
...  
Keyword(s):  
Health Status ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Cardiovascular Events ◽  
Major Adverse Cardiovascular Events ◽  
Peripheral Artery ◽  
Vas Scores ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Background There are limited data on health status instruments in patients with peripheral artery disease and cardiovascular and limb events. We evaluated the relationship between health status changes and cardiovascular and limb events. Methods and Results In an analysis of the EUCLID (Examining Use of Ticagrelor in Symptomatic Peripheral Artery Disease) trial, we examined the characteristics of 13 801 patients by tertile of health status instrument scores collected in the trial (EuroQol 5‐Dimensions [EQ‐5D], EQ visual analog scale [VAS], and peripheral artery questionnaire). We assessed the association between the baseline health status measurements and major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization procedures during trial follow‐up and the association between 12‐month health status change scores and subsequent end points during follow‐up. There were 13 217 (95%) patients with EQ‐5D scores, 13 533 (98%) with VAS scores, and 4431 (32%) with peripheral artery questionnaire scores. Patients in the lowest baseline EQ‐5D tertile (0 to <0.69) were more likely to be female with severe claudication compared with the highest tertile (0.79–1.0; P <0.01). Patients in the lowest VAS (0–60) and peripheral artery questionnaire (0–49) tertiles had lower ankle–brachial indices compared with the highest tertiles (80–100 and 76–108, respectively; P <0.01). There was a significant association between baseline EQ‐5D, VAS, and peripheral artery questionnaire scores and adjusted major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization ( P <0.05). Improved EQ‐5D and VAS scores over 12 months were associated with reduced risk of subsequent major adverse cardiovascular events or lower‐extremity revascularization (all P <0.01). Conclusions Although health status instruments are rarely used in clinical practice, these measures are associated with outcomes, including major adverse cardiovascular events, major adverse limb events, and lower‐extremity revascularization. Further research is needed to determine the relationship between changes in these instruments, revascularization, and outcomes.

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