title: Study Design of PROCEDURE Study. A Randomized Comparison of the Dose-Dependent Effects of Pitavastatin in Patients with Abdominal Aortic Aneurysm with Massive Aortic Atheroma: Prevention of Cholesterol Embolization during Endovascular and Open Aneurysm Repair with Pitavastatin (PROCEDURE) Study.
abstract: Outcomes of abdominal aortic aneurysm (AAA) repair have improved in the 2 decades since the emergence of endovascular aneurysm repair (EVAR). However, EVAR is considered a contraindication for shaggy aorta because of the high risk of shower embolization. Recently, statins have been implicated in preventing embolization in patients with shaggy aorta via its pleiotropic effects, including atheroma reduction and coronary artery stabilization. We selected pitavastatin, a statin with potent effects, discovered and developed by a Japanese company because it has shown excellent pleiotropic effects on atheromatous arteries in the Japanese population. A randomized comparison study of dose-dependent effects of pitavastatin in patients with AAA with massive atheromatous aortic thrombus (PROCEDURE study) has begun. PROCEDURE has an enrollment goal of up to 80 patients with AAA with massive aortic atheroma (excluding intrasac atheroma), randomly allocated into 2 groups receiving pitavastatin at a dose of 1 or 4 mg/day. The endpoints of the PROCEDURE study include change in atheroma volume, major adverse events related to shower embolization after aneurysm repair, and lipid-lowering effects. When complete, results of the PROCEDURE study should provide objective evidence to use statins preoperatively for AAA with massive aortic atheroma.
authors: Division of Vascular Surgery, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
authors: Katsuyuki
authors: K
authors: Hoshina
authors: Masaru
authors: M
authors: Nemoto
authors: Takuya
authors: T
authors: Hashimoto
authors: Sumio
authors: S
authors: Miura
authors: Go
authors: G
authors: Urabe
authors: Tatsu
authors: T
authors: Nakazawa
authors: Akihiro
authors: A
authors: Hosaka
authors: Masaaki
authors: M
authors: Kato
authors: Nobukazu
authors: N
authors: Ohkubo
authors: Takeshi
authors: T
authors: Miyairi
authors: Hiroyuki
authors: H
authors: Okamoto
authors: Kunihiro
authors: K
authors: Shigematsu
authors: Tetsuro
authors: T
authors: Miyata
keywords: abdominal aortic aneurysms; massive atheroma; shaggy aorta; statin
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