Trial reportJournal of vascular surgery2011
Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients.
Trial report in Journal of vascular surgery, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00687076 (Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Statins for primary prevention of venous thromboembolism.The Cochrane database of systematic reviews · 2014Pooled it
- Associations Between PFA-Measured Aspirin Resistance, Platelet Count, Renal Function, and Angiotensin Receptor Blockers.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis · 2018Trial
- Aspirin and clopidogrel high on-treatment platelet reactivity and genetic predictors in peripheral arterial disease.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2018Observational
- Multi-parameter assessment of platelet inhibition and its stability during aspirin and clopidogrel therapy.Thrombosis research · 2014Article
- Association between cell-derived microparticles and adverse events in patients with nonpulsatile left ventricular assist devices.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2014Observational
- The Pre- and Postoperative Prevalence and Risk Factors of ASA Nonresponse in Vascular Surgery.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 4 countries.
Funding
Abstract
objectiveTo determine the prevalence of poor response to aspirin (ASA) therapy over 12-month follow-up in patients with lower extremity peripheral arterial disease (PAD), and to compare the classification agreement among different ASA response assays.
methodsPatients with PAD on ASA therapy at baseline were included from the ongoing Effect of Lipid Modification on Peripheral Arterial Disease after Endovascular Intervention Trial (ELIMIT), which is a randomized trial testing whether combination treatment with ezetimibe, niacin, and a statin will halt/regress atherosclerosis compared with statin monotherapy. Patients who had baseline platelet testing and repeat testing at 6-month or 12-month follow-up were included. ASA responsiveness was tested using three different assays: Optical aggregation with 0.5 mg/mL of arachidonic acid (AA), optical aggregation with 10 μM of adenosine diphosphate (ADP), and platelet function analyzer-100 (PFA-100) testing with collagen/epinephrine (Epi) loaded cartridges. ASA response was defined as AA aggregation <30%, ADP aggregation <70%, or PFA-100 Epi >164 seconds. Patients who showed response to ASA at baseline were classified as Responders. Poor response to ASA was defined as AA aggregation ≥ 30%, ADP aggregation ≥ 70%, or PFA-100 Epi ≤ 164 seconds. Patients who showed poor response (PR) to an assay at baseline, but then were responsive at follow-up visits were classified as Initial PRs. Patients who showed poor response at baseline and all follow-up visits were classified as Persistent PRs. The classification agreement between assays was tested using the kappa statistic.
resultsOf 102 patients randomized in ELIMIT, 80 patients satisfied inclusion criteria. There were no significant baseline demographic differences between Responders, Initial PRs, and Persistent PRs. The prevalence of persistent poor response varied by the assay used; 5% of subjects (4/80) were Persistent PRs by AA aggregation, compared with 27.5% (22/80) of subjects by ADP aggregation and 9.9% (7/71) of patients by PFA-100 Epi. Regarding the agreement of the assays, only AA aggregation and PFA-100 Epi agreed significantly (K = 0.3223; 95% confidence interval [CI] 0.15-0.493; P = .0001), and though statistically significant, the magnitude of this agreement is small. AA aggregation and ADP aggregation did not agree (K = 0.1161; 95% CI -0.004-0.236; P = .029), nor did ADP aggregation and PFA-100 Epi (K = 0.0044; 95% CI -0.151-0.160; P = .48).
conclusionsBetween 5% and 27.5% of PAD patients were Persistent PRs to ASA over 6- to 12-month follow-up using different platelet assays. Further, these commonly used platelet assays show weak agreement in determining poor response to aspirin.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.