1. Twelve-Month Results of a Randomized Trial Comparing Mono With Dual Antiplatelet Therapy in Endovascularly Treated Patients With Peripheral Artery Disease
- Author
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Claus D. Claussen, Maximilian F. Reiser, Klaus Brechtel, Joerg Schmehl, Gunnar Tepe, Frederik F. Strobl, and Thomas Zeller
- Subjects
Male ,medicine.medical_specialty ,Ticlopidine ,Time Factors ,medicine.medical_treatment ,Placebo-controlled study ,Balloon ,law.invention ,Peripheral Arterial Disease ,Double-Blind Method ,Restenosis ,Randomized controlled trial ,Recurrence ,law ,Germany ,Angioplasty ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,cardiovascular diseases ,Aged ,Aged, 80 and over ,Aspirin ,business.industry ,Stent ,Middle Aged ,Clopidogrel ,medicine.disease ,Surgery ,Treatment Outcome ,Drug Therapy, Combination ,Female ,Stents ,Cardiology and Cardiovascular Medicine ,business ,Angioplasty, Balloon ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
To present the 12-month results of a trial investigating the effects of dual antiplatelet therapy on target lesion revascularization (TLR) after balloon angioplasty ± stenting in the femoropopliteal segment.A prospective, randomized, single-center, double-blinded and placebo-controlled clinical trial randomly assigned 40 patients to receive pre- and postinterventional therapy with aspirin and clopidogrel. Another 40 patients received the same doses of aspirin and placebo instead of clopidogrel. Clopidogrel and placebo were stopped after 6 months, and patients remained on aspirin only. At 12 months after the intervention, 36 clopidogrel patients and 37 placebo patients were reevaluated.At 6 months, clopidogrel patients had significantly lower rates of TLR compared to placebo patients [2 (5%) vs. 8 (20%), p=0.04]. After stopping clopidogrel/placebo after 6 months, there was no significant difference in TLR at 12 months after treatment [9 (25%) clopidogrel vs. 12 (32.4%) placebo, p=0.35]. Mortality was 0 vs. 1 in the placebo group at 6 months (p=0.32) and 0 vs. 3 at 12 months (p=0.08).In contrast to the first report of a reduction in the TLR at 6 months, this advantage of dual antiplatelet therapy does not persist after stopping clopidogrel. Prolonged dual therapy (6 months) should be considered in patients who are at high risk for restenosis.
- Published
- 2013
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