Effects of Acute Colchicine Administration Prior to Percutaneous Coronary Intervention: COLCHICINE-PCI Randomized Trial

Circ Cardiovasc Interv. 2020 Apr;13(4):e008717. doi: 10.1161/CIRCINTERVENTIONS.119.008717. Epub 2020 Apr 16.

Abstract

Background: Vascular injury and inflammation during percutaneous coronary intervention (PCI) are associated with increased risk of post-PCI adverse outcomes. Colchicine decreases neutrophil recruitment to sites of vascular injury. The anti-inflammatory effects of acute colchicine administration before PCI on subsequent myocardial injury are unknown.

Methods: In a prospective, single-site trial, subjects referred for possible PCI (n=714) were randomized to acute preprocedural oral administration of colchicine 1.8 mg or placebo.

Results: Among the 400 subjects who underwent PCI, the primary outcome of PCI-related myocardial injury did not differ between colchicine (n=206) and placebo (n=194) groups (57.3% versus 64.2%, P=0.19). The composite outcome of death, nonfatal myocardial infarction, and target vessel revascularization at 30 days (11.7% versus 12.9%, P=0.82), and the outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions (2.9% versus 4.7%, P=0.49) did not differ between colchicine and placebo groups. Among 280 PCI subjects in a nested inflammatory biomarker substudy, the primary biomarker end point, change in interleukin-6 concentrations did not differ between groups 1-hour post-PCI but increased less 24 hours post-PCI in the colchicine (n=141) versus placebo group (n=139; 76% [-6 to 898] versus 338% [27 to 1264], P=0.02). High-sensitivity C-reactive protein concentration also increased less after 24 hours in the colchicine versus placebo groups (11% [-14 to 80] versus 66% [1 to 172], P=0.001).

Conclusions: Acute preprocedural administration of colchicine attenuated the increase in interleukin-6 and high-sensitivity C-reactive protein concentrations after PCI when compared with placebo but did not lower the risk of PCI-related myocardial injury. Registration: URL: https://www.clinicaltrials.gov; Unique Identifiers: NCT02594111, NCT01709981.

Keywords: biomarker; colchicine; inflammation; myocardial infarction; percutaneous coronary intervention.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / mortality
  • Acute Coronary Syndrome / therapy*
  • Administration, Oral
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Biomarkers / blood
  • C-Reactive Protein / metabolism
  • Colchicine / administration & dosage*
  • Colchicine / adverse effects
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Inflammation / blood
  • Inflammation / etiology
  • Inflammation / mortality
  • Inflammation / prevention & control*
  • Inflammation Mediators / blood
  • Interleukin-6 / blood
  • Male
  • Middle Aged
  • New York City
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / instrumentation
  • Percutaneous Coronary Intervention / mortality
  • Prospective Studies
  • Risk Factors
  • Stents
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Biomarkers
  • IL6 protein, human
  • Inflammation Mediators
  • Interleukin-6
  • C-Reactive Protein
  • Colchicine

Associated data

  • ClinicalTrials.gov/NCT02594111
  • ClinicalTrials.gov/NCT01709981