COlchicine in Cardiac Surgery
Condition: Colchicine Adverse Reaction; Atrial Fibrillation New Onset
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative atrial fibrillation (POAF) is a major complication of cardiac surgery, which
      could lead to high morbidity and mortality, increase duration of hospital stay and increase
      the cost of treatment. Colchicine possesses both anti-inflammatory and sympatholytic
      properties, so it has been studied to prevent POAF. The ACC/AHA guidelines for colchicine
      contain a class IIB recommendation, but the ESC guidelines do not recommend this drug. More
      researches are needed to focus on reducing of side effects by optimizing the colchicine
      regimen to reduce the incidence of gastrointestinal side effects. It is believed that further
      research is needed to investigate the efficacy and safety of colchicine in these conditions.

      This research is aimed to study the effectiveness of short-term administration of the drug.
    

Detailed description: 
      Postoperative atrial fibrillation (POAF) is a major complication of cardiac surgery, which
      could lead to high morbidity and mortality, increase duration of hospital stay and increase
      the cost of treatment. Postoperative AF is considered as a multifactorial phenomenon. Its
      pathogenesis is characterized by inflammation, oxidative stress and autonomic dysfunction.
      Several predisposing factors lead to the development of POAF, including pre -, intra-and
      postoperative factors. The main of them are age, previous history of major cardiovascular
      risk factors and ischemic reperfusion injury during surgery. Treatment of POAF involves drugs
      to control the frequency of rhythm in hemodynamically stable patients and other treatment
      regimens usually used for the treatment of AF. Intraoperative administration of beta-blockers
      and some antiarrhythmic drugs is recommended by international clinical guidelines. In
      addition, previous treatment consisting of the use of colchicine, magnesium sulfate, statins
      and antioxidants have reduced the incidence of postoperative AF. However, the results of
      large-scale randomized trials have observed the development of undesirable adverse reactions.

      Despite these recommendations, the question of the correct regimen for prevention of POAF
      remains controversial. Colchicine possesses both anti-inflammatory and sympatholytic
      properties, so it has been studied to prevent POAF. The ACC/AHA guidelines for colchicine
      contain a class IIB recommendation, but the ESC guidelines do not recommend this drug.

      Two studies sequentially COPPS-1 and COPPS-2 evaluated the effect of colchicine on the
      incidence of POAF after open heart surgery (COPPS-1) and the development of postcardiotomy
      syndrome (COPPS-2). In COPPS-1, patients (n=336) were treated with colchicine from the third
      day after surgery for a month and showed a significant decrease of POAF after heart surgery
      over the entire follow-up period. 360 patients were evaluated in the COPPS-2 study. The
      incidence of POAF between the colchicine and placebo groups was comparable, although
      colchicine significantly reduced postpericardiotomy syndrome. The main limitation of the
      COPSS-2 study was the high rate of cessation of intervention (20% of participants), which had
      a significant impact on the outcome of the trial.

      Based on the latest meta-analysis of the colchicine effect on POAF after heart surgery, it
      was found that it still reduces POAF compared with control (HR = 0.69, 95% IM 0.57-0.84, p =
      0.0002) and the duration of hospital stay was reduced by 1.2 days (95% IM -1.89 to -0.44, p =
      0.002); however, the frequency of adverse gastrointestinal events increased significantly (HR
      = 2.52, 95% IM 1.62-3.93, p < 0.0001). Despite the high level of side effects, a significant
      reduction of POAF outweighs the balance in the favor of its use. However, more researches are
      needed to focus on reducing of side effects by optimizing the colchicine regimen to reduce
      the incidence of gastrointestinal side effects. It is believed that further research is
      needed to investigate the efficacy and safety of colchicine in these conditions.

      This research is aimed to study the effectiveness of short-term administration of the drug.
    

Intervention name(s): Colchicine Pill; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Colchicine at a dose of 1 mg a day before surgery, 2, 3, 4, 5 days after surgery.; Placebo started a day before surgery, 2, 3, 4, 5 days after surgery.
Other intervention name(s): group C; group P
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized double-blind controlled trial in two groups
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Colchicine; Postoperative atrial fibrillation; Anti-inflammatory; Cardiac surgery; Sympatholytic