Rationale and design of STOP DVT study: rosuvastatin for the prevention of deep vein thrombosis in patients undergoing total knee replacement arthroplasty--a prospective randomized open-label controlled trial.
Author(s): Park WJ, Jo SH, Kim SA, Kim HS, Han SJ, Choi YJ, Rhim CY
Affiliation(s): Division of Cardiology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggi-do, Republic of Korea.
Publication date & source: 2011-09, Contemp Clin Trials., 32(5):779-82. Epub 2011 Jun 12.
BACKGROUND: Deep vein thrombosis (DVT) frequently occurs in high-risk cardiovascular patients receiving orthopedic surgery, despite prophylactic measures for its prevention. Statins, a class of drugs used to lower cholesterol levels, have been reported to help prevent the development of DVT. METHODS: We will conduct a prospective randomized clinical trial to compare the effects of high-dose rosuvastatin plus a low-molecular-weight heparin (LMWH), enoxaparin, with conventional LMWH therapy in the prevention of DVT. Patients will be naive to both statins and anti-coagulants and then underwent total knee replacement arthroplasty (TKRA). In total, 180 patients will be randomized into two groups of 90, consisting of a LMWH group (40 mg enoxaparin subcutaneously beginning at 12h prior to surgery and continuing for 7 days every 24h after surgery) and a statin plus LMWH group (20mg rosuvastatin orally for 14 days, 7 days before and after surgery in combination with LMWH). All patients will undergo computed tomography angiography of both extremities 7 days after index surgery to assess the development of DVT. DISCUSSION: DVT remains prevalent despite the use of conventional prophylactic measures, in part because certain patients (particularly the elderly) are unable to receive preventive treatment because of a high risk of bleeding complications and co-morbidity. Statins have been shown to have beneficial effects in arterial atherothrombosis and are frequently administered to elderly patients to treat coronary artery. We hypothesize that peri-operative statin treatment may be beneficial in those patients restricted from the conventional prophylaxis for DVT. Copyright (c) 2011 Elsevier Inc. All rights reserved.