INFORMATION FOR PATIENTS
A study of the effect of platelet inhibitors on the prevention of new stenosis after angioplasty in the arteries of the legs
Patients with pain when walking, at rest, or with wounds due to arterial stenosis might undergo an angioplasty. An angioplasty reopens narrowed arteries by using a balloon, to which, more blood flows to the legs. After this treatment, patients always receive, as a follow-up treatment, a platelet inhibitor. It is still unclear which platelet inhibitor or combination of platelet inhibitors works best. This leads to variation in daily practice. The CLEAR-PATH study, led by Gert Jan de Borst and Çağdaş Ünlü, aims to clarify this.
Platelet inhibitors may reduce the risk of new artery stenosis in the treated leg or elsewhere in the body. But an additional platelet inhibitor might give, as a disadvantage, a higher risk of bleeding. Therefore, it is necessary to carefully consider the pros and cons of the existing platelet inhibitor treatments. In the CLEAR-PATH study, the platelet inhibitors clopidogrel and aspirin are being investigated. These antiplatelet drugs have been prescribed for decades after angioplasty. Thus, this study does not test new treatments but aims to test the effectiveness of already existing platelet inhibitor treatments.
Right platelet inhibitor combination
During this study, patients are randomly divided into two groups; clopidogrel with a so-called placebo pill (a pill without an active substance) or clopidogrel and aspirin for one year. During this period, it will be investigated if there is a difference between these two groups. Ultimately, this research will be incorporated into national and international guidelines but above all, it will lead to the proper use of platelet inhibitors in this patient group. Objective: The right platelet inhibitor (combination) for the right patient.
The study started in Augustus 2022 and will end after approximately 30 months. A total of 12 hospitals are involved in this study.
INFORMATION FOR PHYSICIANS
Rationale
Long-term antiplatelet therapy is the standard of care in patients with peripheral arterial disease (PAD) because it reduces atherothrombotic events. Despite this supportive treatment, atherothrombotic events remain high in PAD patients. In both coronary and cerebrovascular disease dual antiplatelet therapy has proven to reduce atherothrombotic events. However, as we have experienced with previous trials, interventions successful in CHD and stroke, cannot be simply extrapolated to PAD patients, and thus there is an evidence gap in antiplatelet therapy in PAD patients. The most recent guidelines on PAD show discrepancies in the choice for dual or monotherapy after endovascular therapy. Related to this, different surveys among vascular surgeons show different use in antiplatelet prescription patterns. Current practice is based on the expert opinion of the physician treating the patient which induces the risk of incoherent choices.
Objective
Our main goal is to assess whether and to what extent dual therapy clopidogrel 75mg/acetylsalicylic acid 80 mg daily is superior to clopidogrel 75mg daily alone.
Study design
Multicenter double-blind placebo-controlled randomized trial.
Study population
All patients suffering from chronic lower extremity artery disease are eligible for inclusion if there is a need for therapy including percutaneous endovascular intervention.
Inclusion criteria
(1) Lesions of the iliac, femoropopliteal, and below-the-knee (BTK) arteries;
(2) At least one TASC lesion;
(3) Rutherford (1-6) classes with an indication for an endovascular intervention;
(4) Proficient understanding of the consequences of enrolment by the patient;
(5) Written informed consent by the patient;
(6) Age ≥ 45 years
(7a) Percutaneous transluminal angioplasty (PTA) or recanalization with or without additional stenting based on prevailing guidelines, or;
(7b) Hybrid procedure with an endarterectomy of the common femoral artery and additional iliac, femoral or tibial PTA, or;
(7c) A reintervention within 2 months due to a phased treatment.
Intervention
The intervention is comparing two groups: clopidogrel(75 mg)/placebo versus dual therapy clopidogrel (75 mg)/acetylsalicylic acid (80 mg).