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

• Published in: Circulation. Cardiovascular interventions Vol. 13; no. 4; p. e008717
• Main Authors: Shah, Binita, Pillinger, Michael, Zhong, Hua, Cronstein, Bruce, Xia, Yuhe, Lorin, Jeffrey D., Smilowitz, Nathaniel R., Feit, Frederick, Ratnapala, Nicole, Keller, Norma M., Katz, Stuart D.
• Format: Journal Article
• Language: English
• Published: United States American Heart Association, Inc 01.04.2020
• Subjects: 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; New York City; colchicine; percutaneous coronary intervention; biomarker; inflammation; myocardial infarction
• ISSN: 1941-7632; 1941-7640; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.119.008717

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. 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. 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%, =0.19). The composite outcome of death, nonfatal myocardial infarction, and target vessel revascularization at 30 days (11.7% versus 12.9%, =0.82), and the outcome of PCI-related myocardial infarction defined by the Society for Cardiovascular Angiography and Interventions (2.9% versus 4.7%, =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], =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], =0.001). 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.