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

Abstract

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 12 h prior to surgery and continuing for 7 days every 24 h after surgery) and a statin plus LMWH group (20 mg 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.