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Because of data from cardiological studies, combination therapies consisting of ASA and clopidogrel are often used in routine clinical practice after stent implantation in the coronary arteries. Robust evidence for their use in the peripheral arterial flow path is lacking.
The authors rightly mention the MIRROR Study (1), to date the only randomized study investigating this research question.
The primary endpoints in this study of 80 patients were, however, local concentrations of platelet-activating beta-thromboglobulin, CD40L, and the rate of clopidogrel resistance. The clinical endpoints reintervention and hemorrhage were defined as secondary endpoints. After dual platelet inhibition, reintervention in the target lesion was significantly rarer, but the absolute number of reinterventions (two versus eight in patients receiving ASA) was also very low. The limitations of this first randomized study in two centers were a small number of patients, the study design (clinically defined events as secondary endpoints), and the small absolute number of reinterventions. We still agree with Strobl and Tepe that the study is the first to show well-founded indications of dual platelet inhibition for six months after endovascular therapy in the femoropopliteal region. A larger multicenter randomized controlled study is required to confirm the results of the MIRROR Study. Until then, our recommendation—which is consistent with international guidelines (2)—holds: after infrainguinal endovascular therapy, a temporary combination of aspirin and clopidogrel can be recommended (consensus recommendation) (3).
Meyer critically questions the value of aspirin and statins in medication therapy of patients with peripheral arterial vascular disease. In actual fact, the event rate (primary endpoint: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in the cited study reported by Berger et al (4) is 8.9% under ASA (alone or combined with dipyramidole); in the control group it is 11% (relative risk 0.88; 95% confidence interval [0.76; 1.04].The rate of major hemorrhage was not raised under ASA. Peripheral arterial events were not considered in this study.
We just do not understand the conclusion—that patients with symptomatic peripheral arterial vascular disease receiving ASA prophylaxis do not benefit—especially as in the cited study the number of strokes was reduced significantly in the group of patients with peripheral arterial vascular disease who were treated with ASA.
We presented a critical overview of the discussion around statin therapy and lipid measurements in patients with peripheral arterial vascular disease. Independently of indications of improved patency and survival rates in revascularized patients (5), administration of a statin is indicated in such patients at high cardiovascular risk, so as to reduce the rate of cardiovascular events (2).
Dr. med. Holger Lawall
Praxis für Herzkreislauferkrankungen Ettlingen
Max Grundig Klinik Bühlerhöhe
Prof Dr. med. Peter Huppert
Prof. Dr. med. Christine Espinola-Klein
Prof. Dr. med. Gerhard Rümenapf
Conflict of interest statement
Dr. Lawall is a member of the UCB advisory board. He has received third-party funding for carrying out clinical trials on behalf of Astra Zeneca, Novartis, and UCB. He has been paid for preparing scientific lectures by UCB, BARO, Bayer Vital GmbH, medac GmbH, and Amgen.
Prof. Espinola-Klein is a member of the advisory boards of Merck, Sharp & Dohme GmbH, Amgen, Boehringer Ingelheim, and Daiichi Sankyo. She has received funding from Berlin Chemie for a research project that she initiated, and for carrying out clinical trials. She has received third-party funding for carrying out clinical trials on behalf of Merck, Sharp & Dohme GmbH, Astra Zeneca, Bayer Vital GmbH, and Sanofi Aventis. She has been paid for preparing scientific lectures by Bayer Vital GmbH, Pfizer Pharma GmbH, Amgen, Boehringer Ingelheim, Daiichi Sankyo, and Bristol-Myers Squibb.
Prof. Rümenapf has received reimbursement of meeting participation fees and travel and accommodation expenses from Jotec.
Prof. Huppert states that he has no conflict of interest.
|1.||Tepe G, Bantleon R, Brechtel K, et al.: Management of peripheral arterial interventions with mono or dual antiplatelet therapy-the MIRROR study: a randomised and double-blinded clinical trial. Eur Radiol 2012; 22: 1998–2006 CrossRef MEDLINE|
|2.||Gerhard-Herman MD, Gornik HL, Barrett C, et al.: AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: medical therapy in PAD. J Am Coll Cardiol 2016; 735–1097|
|3.||Lawall H, Huppert P, Espinola-Klein C, Rümenapf G: Clinical practice guideline: The diagnosis and treatment of peripheral arterial vascular disease. Dtsch Arztebl Int 2016; 113: 729–36 VOLLTEXT|
|4.||Berger JS, Krantz MJ, Kittelson JM, Hiatt WR: Aspirin for the prevention of cardiovascular events in patients with peripheral artery dis-ease: a meta-analysis of randomized trials. JAMA 2009; 301: 1909–19 CrossRef MEDLINE|
|5.||De Martino RR, Eldrup-Jorgensen J, Nolan BW, et al.: Perioperative managment with antiplatelet and statin medication is associated with reduced mortality following vascular surgery. J Vasc Surg 2014; 59: 1615–21 CrossRef MEDLINE PubMed Central|