Dabigatran safety confirmed in real-world study
Real-world studies on patients with atrial fibrillation (AF) show that dabigatran is safe with low bleeding and stroke rates when used for long term (over 2 years) or used continuously in patients undergoing cardiovascular (CV) interventions, according to phase II results of the prospective, observational, global registry programme GLORIA-AF* presented at the EHRA 2018 Annual Congress.
In the first analysis involving 4,873 patients (mean age 70.2 years, 55.6 percent male) with new-onset AF, patients were prescribed dabigatran 150 mg (55 percent), 110 mg (43 percent), or 75 mg (2 percent) for a mean duration of 18.3 months. [EHRA 2018, abstract 1055]
Over 2 years of follow-up, event rates for stroke and major bleeding were low with dabigatran, at 0.65 percent and 0.97 percent, respectively. The findings are consistent with data from other real-world studies, as well as randomized clinical trials such as the RE-LY** EU label analysis which showed a 1.10-percent stroke rate and 3.02-percent major bleeding rate with dabigatran. [Circulation 2015;131:157-164; Thromb Haemost 2014;111:933-942]
Rates of other clinical outcomes such as vascular death (0.85 percent) and life-threatening bleeds (0.46 percent) were also low.
“These prospective data from routine clinical care confirm the sustained safety and effectiveness of dabigatran over 2 years of follow-up … which is reassuring for physicians treating patients with AF,” according to study principal investigator Dr Gregory Lip from University of Birmingham, UK.
According to Lip, the GLORIA-AF study is currently ongoing and the phase III analysis of the programme will provide comparative data on the safety and efficacy of NOACs vs vitamin-K antagonists in the real world.
“Long-term, ‘real-world’ data are important to cardiologists as they help build a bigger picture of how an antithrombotic medication works in daily clinical practice,” he added.
Another analysis of the GLORIA-AF phase II programme included 4,859 patients (mean age 67.2 years, 64.5 percent male) who had been prescribed dabigatran for a mean duration of 18.3 months, of which 332 patients underwent 412 CV interventions with uninterrupted dabigatran. CV interventions included cardioversions (n=299), catheter ablations (n=38), pacemaker implantations (n=25), angiographic procedures (n=26), and angioplasty with or without stenting or catheter-based interventions (n=24). [EHRA 2018, abstract 200]
A mean follow-up of 7.52 weeks showed low rates of stroke/systemic embolism and major bleeds, occurring once each out of 412 interventions (risk, 0.25, 95 percent confidence interval, 0.01–1.36 for both events).
“The prospective analysis supports the favourable safety and effectiveness of dabigatran in clinical practice, complementing randomized trial data,” said Lip, citing the RE-CIRCUIT*** randomized controlled study which showed a 1.6 percent incidence rate of major bleeds during the 8 weeks after ablation. [N Engl J Med 2017;376:1627-1636]