薬剤によりいくつかの術後合併症が減少する（Presentation #891）
心臓手術の術前および術後の経口コルヒチン（通常、痛風に用いられる植物ベースの薬物）投与による合併症軽減に対する効果は様々であるが、消化器系 有害事象のリスクは上昇させる。COPPS-2（COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation）トライアルの結果が、2014年European Society of Cardiology Congressホットラインセッションで発表され、同時にJAMAオンライン版に掲載された。このランダム化トライアルは、イタリアの11施設の心臓手術患者360人を組み入れ、プラセボ（180人）またはコルヒチン（180人）を術前48～72時間に開始し、術後1か月間継続する群に割り付けた。スタディの一次計測アウトカムである3か月以内の心膜切開後症候群は、コルヒチン群の35人（19.4%）およびプラセボ群の53人（29.4%）に発現した。術後AF（コルヒチン33.9%；プラセボ41.7%）および術後心嚢液/胸水（コルヒチン57.2%；プラセボ58.9%） に関しては、コルヒチン群とプラセボ群とで有意差はなかった。コルヒチン群患者の約20%が、主に消化器系の忍容性が原因でコルヒチン内服を中断した。コ ルヒチンはよく吟味された患者において検討すべきである、と筆者らは提言している。
Administration of colchicine, a plant-based medication commonly used to treat gout, before and after cardiac surgery showed mixed results in reducing potential complications from this type of surgery, but it did increase the risk of gastrointestinal adverse effects. Results of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2) were presented during a Hot Line session at the European Society of Cardiology Congress and simultaneously published online in JAMA.
Common complications after cardiac surgery include postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative pericardial/pleural effusions, affecting more than one-third of patients. These complications may lead to prolonged hospital stay, readmissions, and need for invasive interventions. Postoperative use of colchicine helped prevent these complications in a single trial, according to background information in the article.
Massimo Imazio, M.D., of Maria Vittoria Hospital, Torino, Italy, and colleagues randomly assigned 360 cardiac surgery patients from 11 centers in Italy to receive placebo (n=180) or colchicine (n=l80) starting between 48 and 72 hours before surgery and continued for 1 month after surgery.
The primary measured outcome for the study, postpericardiotomy syndrome within 3 months, occurred in 35 patients (19.4 percent) assigned to colchicine and in 53 (29.4 percent) assigned to placebo. There were no significant differences between the colchicine and placebo groups for postoperative AF (colchicine, 33.9 percent; placebo, 41.7 percent) or postoperative pericardial/pleural effusion (colchicine, 57.2 percent; placebo, 58.9 percent).
Adverse event rates occurred in 21 patients (11.7 percent) in the placebo group and 36 (20.0 percent) in the colchicine group, primarily because of an increased incidence of gastrointestinal intolerance (6.7 percent in the placebo group; 14.4 percent in the colchicine group). Discontinuation rates were similar in both groups.
"In this multicenter trial, perioperative administration of colchicine significantly reduced the incidence of postpericardiotomy syndrome after cardiac surgery but did not reduce the risk of postoperative AF and postoperative pericardial/pleural effusions by intention-to-treat analysis," the authors write. "About 20 percent of all patients enrolled in the trial discontinued study drug; this relatively high rate may have affected the overall efficacy of the drug, especially for postoperative AF prevention."
"The high rate of adverse effects is a reason for concern and suggests that colchicine should be considered only in well-selected patients."
The COPPS-2 trial was supported by Azienda Sanitaria 3 of Torino (now ASLTO2) within the Italian National Health Service. Acarpia (Madeira, Portugal) provided the study drug and placebo as an unrestricted institutional grant. FARGIM (Catania, Italy) provided funding to support insurance costs for the trial.
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