Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease.

Background: Colchicine has shown potential cardioprotective effects owing to its broad anti-inflammatory properties. We performed a meta-analysis to assess its safety and efficacy in secondary prevention in patients with established coronary artery disease (CAD). Methods: We searched Ovid Healthstar, MEDLINE, and Embase (inception to May 2022) for randomized controlled trials (RCTs) evaluating the cardiovascular effects of colchicine compared with placebo or usual care in patients with CAD. Study-level data on efficacy and safety outcomes were pooled using the Peto method. The primary outcome was the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke. Results: A total of 8 RCTs were included with a follow-up duration of ≥1 month, comprising a total of 12,151 patients. Compared with placebo or usual care, colchicine was associated with a significant risk reduction in the primary outcome (odds ratio (OR) 0.70, 95% CI 0.60 to 0.83, P < 0.0001; I2 = 52%). Risks of MI (OR 0.75, 95% CI 0.62 to 0.91, P = 0.003; I2 = 33%), stroke (OR 0.47, 95% CI 0.30 to 0.74, P = 0.001; I2 = 0%), and unplanned coronary revascularization (OR 0.67, 95% CI 0.55 to 0.82, P = 0.0001; I2 = 58%) were all reduced in the colchicine group. Rates of CV and all-cause mortality did not differ between the two groups, but there was an increase in noncardiac deaths with colchicine (OR 1.54, 95% CI 1.10 to 2.15, P = 0.01; I2 = 51%). The occurrence of all other adverse events was similar between the two groups, including GI reactions (OR 1.06, 95% CI 0.94 to 1.20, P = 0.35; I2 = 42%) and infections (OR 1.04, 95% CI 0.84 to 1.28, P = 0.74; I2 = 53%). Conclusions: Colchicine therapy may reduce the risk of future cardiovascular events in patients with established CAD; however, there remains a concern about non-CV mortality. Further trials are underway that will shed light on non-CV mortality and colchicine NCT03048825, and NCT02898610.

Safety and efficacy of low-dose intracoronary thrombolysis during primary percutaneous coronary intervention in patients with ST elevation myocardial infarction: A meta-analysis of randomized trials.

BACKGROUND: In patients with ST elevation myocardial infarction (STEMI), intracoronary thrombolysis (ICT) may reduce thrombotic burden and microvascular obstruction in the infarct-related artery. We performed a meta-analysis to evaluate the role of adjunctive low-dose ICT during primary percutaneous coronary intervention (PPCI) in improving clinical outcomes and indices of microvascular function. METHODS: We searched electronic databases (Cochrane, EMBASE, Medline; inception to October 2023) for randomized controlled trials (RCTs) evaluating the effects of adjunctive ICT in STEMI patients undergoing PPCI, compared with placebo or usual care. Study-level data on efficacy and safety outcomes were pooled using a fixed-effect model. The primary outcome was major adverse cardiovascular events (MACE). RESULTS: A total of 8 RCTs were included, comprising a total of 1,208 patients. Compared with placebo or usual care, ICT was associated with a trend towards lower MACE (11.3% vs. 15.1%; odds ratio [OR] 0.73, 95% confidence interval [CI] 0.51 to 1.04). Infarct size (mean difference [MD] -1.98, 95% CI -3.68 to -0.27; p=0.02), ST-segment resolution (MD: 6.06, 95% CI: 0.69 to 11.43; p=0.03) and corrected TIMI frame count (MD: -2.26, 95% CI: -4.03 to -0.48; p=0.01; I2=78%). The odds for major (0.7% vs. 0.7%; OR 0.94, 95% CI 0.24 to 3.7; p=0.93) and minor bleeding (7.7% vs. 4.3%; OR 1.81, 95% CI 0.87 to 3.76; p=0.11) were similar between the two groups. CONCLUSION: Adjunctive low-dose ICT during PPCI is safe, associated with a trend towards lower MACE, and may improve surrogate markers of microvascular function. These hypothesis-generating findings warrant validation in larger, adequately powered randomized trials.

Ultrasound Guidance in Femoral Artery Catheterization: A Systematic Review and a Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: During percutaneous cardiac procedures, the use of radial access is growing, but femoral access remains needed for large-bore, high-risk procedures. Methods are needed to make femoral access safer. In this systematic review and meta-analysis of randomized-controlled trials (RCTs), we assess whether ultrasound guidance is associated with a decreased risk of vascular complications during femoral artery catheterization. METHODS: Medline, Embase, and Cochrane Central were searched from inception to April 2018. RCTs assessing the use of ultrasound among adult patients undergoing a femoral artery catheterization were included. The primary outcome was vascular-access related complications. Secondary outcomes included major and minor vascular access bleeding, success rate, venipuncture, number of attempts, and successful placement into the common femoral artery. RESULTS: Five RCTs (n = 1553) met the inclusion criteria, with two trials using blinded outcome assessment. Ultrasound use was associated with a reduction in the rate of vascular-access related complications (1.9% vs 4.3%; odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81; P<.01). This was primarily driven by a reduction in local hematomas; once hematomas were excluded, the association was no longer significant (0.6% vs 1.7%; OR, 0.39; 95% CI, 0.15-1.07; P=.07). There was no significant reduction in major bleeding (0.3% vs 1.3%; OR, 0.28; 95% CI, 0.07-0.1.16; P=.08) or minor bleeding (1.4% vs 2.8%; OR, 0.50; 95% CI, 0.24-1.05; P=.07). CONCLUSIONS: Ultrasound guidance during femoral artery catheterization is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas. Larger trials are needed to determine the effect of ultrasound on major bleeding and vascular complications (excluding hematomas).