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Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease
William R Hiatt1, F Gerry R Fowkes1, Gretchen Heizer1
1From the University of Colorado School of Medicine and CPC Clinical Research, Aurora (W.R.H.); Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh (F.G.R.F.); Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (G.H., W.S.J., C.R., M.R.P.); the Departments of Medicine and Surgery, New York University School of Medicine, New York (J.S.B.); Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (I.B.); AstraZeneca Gothenburg, Mölndal (P.H., J.B., M.M.), and Faculty of Medicine and Health, Örebro University, Örebro (L.N.) - both in Sweden; AstraZeneca Gaithersburg, Gaithersburg, MD (B.G.K.); and Stanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA (K.W.M.).
Ticagrelor did not prove superior to clopidogrel in reducing cardiovascular events for peripheral artery disease patients. Both treatments showed similar rates of major bleeding, indicating comparable safety profiles for this patient group.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Peripheral artery disease (PAD) is a manifestation of systemic atherosclerosis, linked to adverse cardiovascular and limb events.
- Prior research suggested clopidogrel monotherapy may lower cardiovascular event risk compared to aspirin.
- A need exists to compare the efficacy and safety of ticagrelor versus clopidogrel in PAD patients.
Purpose of the Study:
- To compare the efficacy of ticagrelor monotherapy against clopidogrel monotherapy in patients with symptomatic peripheral artery disease.
- To evaluate the safety profiles, specifically major bleeding events, of ticagrelor and clopidogrel in this patient population.
Main Methods:
- A double-blind, event-driven trial randomized 13,885 patients with symptomatic PAD to ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily).
- Eligibility criteria included an ankle-brachial index (ABI) ≤ 0.80 or prior lower limb revascularization.
- The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or ischemic stroke; the primary safety endpoint was major bleeding, with a median follow-up of 30 months.
Main Results:
- The primary efficacy endpoint occurred in 10.8% of patients on ticagrelor versus 10.6% on clopidogrel (hazard ratio, 1.02; P=0.65), showing no significant difference.
- Rates of acute limb ischemia were similar between groups (1.7% in both; hazard ratio, 1.03; P=0.85).
- Major bleeding events occurred in 1.6% of patients in both the ticagrelor and clopidogrel groups (hazard ratio, 1.10; P=0.49).
Conclusions:
- Ticagrelor monotherapy was not superior to clopidogrel monotherapy in reducing cardiovascular events in patients with symptomatic peripheral artery disease.
- Major bleeding rates were comparable between the ticagrelor and clopidogrel treatment groups.
- The study provides evidence that ticagrelor does not offer additional cardiovascular benefit over clopidogrel in PAD patients, with similar safety profiles.
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