Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease
(2017) In The New England journal of medicine 376. p.32-40- Abstract
BACKGROUND: Peripheral artery disease is considered to be a manifestation of systemic atherosclerosis with associated adverse cardiovascular and limb events. Data from previous trials have suggested that patients receiving clopidogrel monotherapy had a lower risk of cardiovascular events than those receiving aspirin. We wanted to compare clopidogrel with ticagrelor, a potent antiplatelet agent, in patients with peripheral artery disease.
METHODS: In this double-blind, event-driven trial, we randomly assigned 13,885 patients with symptomatic peripheral artery disease to receive monotherapy with ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily). Patients were eligible if they had an ankle-brachial index (ABI) of 0.80... (More)
BACKGROUND: Peripheral artery disease is considered to be a manifestation of systemic atherosclerosis with associated adverse cardiovascular and limb events. Data from previous trials have suggested that patients receiving clopidogrel monotherapy had a lower risk of cardiovascular events than those receiving aspirin. We wanted to compare clopidogrel with ticagrelor, a potent antiplatelet agent, in patients with peripheral artery disease.
METHODS: In this double-blind, event-driven trial, we randomly assigned 13,885 patients with symptomatic peripheral artery disease to receive monotherapy with ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily). Patients were eligible if they had an ankle-brachial index (ABI) of 0.80 or less or had undergone previous revascularization of the lower limbs. The primary efficacy end point was a composite of adjudicated cardiovascular death, myocardial infarction, or ischemic stroke. The primary safety end point was major bleeding. The median follow-up was 30 months.
RESULTS: The median age of the patients was 66 years, and 72% were men; 43% were enrolled on the basis of the ABI and 57% on the basis of previous revascularization. The mean baseline ABI in all patients was 0.71, 76.6% of the patients had claudication, and 4.6% had critical limb ischemia. The primary efficacy end point occurred in 751 of 6930 patients (10.8%) receiving ticagrelor and in 740 of 6955 (10.6%) receiving clopidogrel (hazard ratio, 1.02; 95% confidence interval [CI], 0.92 to 1.13; P=0.65). In each group, acute limb ischemia occurred in 1.7% of the patients (hazard ratio, 1.03; 95% CI, 0.79 to 1.33; P=0.85) and major bleeding in 1.6% (hazard ratio, 1.10; 95% CI, 0.84 to 1.43; P=0.49).
CONCLUSIONS: In patients with symptomatic peripheral artery disease, ticagrelor was not shown to be superior to clopidogrel for the reduction of cardiovascular events. Major bleeding occurred at similar rates among the patients in the two trial groups. (Funded by AstraZeneca; EUCLID ClinicalTrials.gov number, NCT01732822 .).
(Less)
- author
- contributor
- Gottsäter, Anders LU
- author collaboration
- organization
- publishing date
- 2017-01-05
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Adenosine/adverse effects, Aged, Cardiovascular Diseases/mortality, Clopidogrel, Double-Blind Method, Female, Hemorrhage/chemically induced, Humans, Intermittent Claudication/drug therapy, Ischemia/drug therapy, Kaplan-Meier Estimate, Leg/blood supply, Male, Middle Aged, Peripheral Arterial Disease/drug therapy, Platelet Aggregation Inhibitors/adverse effects, Purinergic P2Y Receptor Antagonists/therapeutic use, Ticagrelor, Ticlopidine/adverse effects
- in
- The New England journal of medicine
- volume
- 376
- pages
- 32 - 40
- publisher
- Massachusetts Medical Society
- external identifiers
-
- scopus:85008318890
- pmid:27959717
- ISSN
- 0028-4793
- DOI
- 10.1056/NEJMoa1611688
- language
- English
- LU publication?
- yes
- id
- 6b3b1873-d506-41ee-bb11-40100c077fff
- date added to LUP
- 2023-08-31 09:10:33
- date last changed
- 2024-04-20 03:19:20
@article{6b3b1873-d506-41ee-bb11-40100c077fff,
abstract = {{<p>BACKGROUND: Peripheral artery disease is considered to be a manifestation of systemic atherosclerosis with associated adverse cardiovascular and limb events. Data from previous trials have suggested that patients receiving clopidogrel monotherapy had a lower risk of cardiovascular events than those receiving aspirin. We wanted to compare clopidogrel with ticagrelor, a potent antiplatelet agent, in patients with peripheral artery disease.</p><p>METHODS: In this double-blind, event-driven trial, we randomly assigned 13,885 patients with symptomatic peripheral artery disease to receive monotherapy with ticagrelor (90 mg twice daily) or clopidogrel (75 mg once daily). Patients were eligible if they had an ankle-brachial index (ABI) of 0.80 or less or had undergone previous revascularization of the lower limbs. The primary efficacy end point was a composite of adjudicated cardiovascular death, myocardial infarction, or ischemic stroke. The primary safety end point was major bleeding. The median follow-up was 30 months.</p><p>RESULTS: The median age of the patients was 66 years, and 72% were men; 43% were enrolled on the basis of the ABI and 57% on the basis of previous revascularization. The mean baseline ABI in all patients was 0.71, 76.6% of the patients had claudication, and 4.6% had critical limb ischemia. The primary efficacy end point occurred in 751 of 6930 patients (10.8%) receiving ticagrelor and in 740 of 6955 (10.6%) receiving clopidogrel (hazard ratio, 1.02; 95% confidence interval [CI], 0.92 to 1.13; P=0.65). In each group, acute limb ischemia occurred in 1.7% of the patients (hazard ratio, 1.03; 95% CI, 0.79 to 1.33; P=0.85) and major bleeding in 1.6% (hazard ratio, 1.10; 95% CI, 0.84 to 1.43; P=0.49).</p><p>CONCLUSIONS: In patients with symptomatic peripheral artery disease, ticagrelor was not shown to be superior to clopidogrel for the reduction of cardiovascular events. Major bleeding occurred at similar rates among the patients in the two trial groups. (Funded by AstraZeneca; EUCLID ClinicalTrials.gov number, NCT01732822 .).</p>}},
author = {{Hiatt, William R and Fowkes, F Gerry R and Heizer, Gretchen and Berger, Jeffrey S and Baumgartner, Iris and Held, Peter and Katona, Brian G and Mahaffey, Kenneth W and Norgren, Lars and Jones, W Schuyler and Blomster, Juuso and Millegård, Marcus and Reist, Craig and Patel, Manesh R}},
issn = {{0028-4793}},
keywords = {{Adenosine/adverse effects; Aged; Cardiovascular Diseases/mortality; Clopidogrel; Double-Blind Method; Female; Hemorrhage/chemically induced; Humans; Intermittent Claudication/drug therapy; Ischemia/drug therapy; Kaplan-Meier Estimate; Leg/blood supply; Male; Middle Aged; Peripheral Arterial Disease/drug therapy; Platelet Aggregation Inhibitors/adverse effects; Purinergic P2Y Receptor Antagonists/therapeutic use; Ticagrelor; Ticlopidine/adverse effects}},
language = {{eng}},
month = {{01}},
pages = {{32--40}},
publisher = {{Massachusetts Medical Society}},
series = {{The New England journal of medicine}},
title = {{Ticagrelor versus Clopidogrel in Symptomatic Peripheral Artery Disease}},
url = {{http://dx.doi.org/10.1056/NEJMoa1611688}},
doi = {{10.1056/NEJMoa1611688}},
volume = {{376}},
year = {{2017}},
}