PRAGUE, Czech Republic — Two new meta-analyses of previous studies have added further encouragement on the issue of resuming oral anticoagulant therapy in patients with atrial fibrillation (AF) who have sustained an intracerebral hemorrhage (ICH).
The two new analyses, both reported at the recent 3rd European Stroke Organisation Conference (ESOC) 2017, show lower rates of mortality and recurrent stroke without significant increases in recurrent ICH.
“These are reassuring data,” Bart van der Worp, University Medical Center, Utrecht, the Netherlands, co-chair of the session at which both new studies were presented and president-elect of the European Stroke Organisation, commented to Medscape Medical News.
“Both presentations suggest that giving oral anticoagulation is at least not extremely dangerous, but as all these data are observational we do need confirmation from randomized trials, which are now being planned.”
Introducing the first presentation on this issue, Joji Kuramatsu, MD, Friedrich-Alexander-University of Erlangen-Nürnberg, Germany, referred to a quote from a 2014 editorial in Neurology that described restarting anticoagulation after an ICH as “a risky decision with no recipe.”
Dr Kuramatsu and his colleagues conducted a meta-analysis of three ICH studies (RETRACE, MGH, and ERICH) in a total of 1027 patients who had been diagnosed with acute ICH and had been taking oral anticoagulation for prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.
They investigated the outcomes for resumption of oral anticoagulation at 1 year from the index ICH, including mortality, favorable functional outcome, recurrent ICH, and ischemic stroke.
The study focused particularly on the location of the ICH (lobar vs nonlobar). Dr Kuramatsu explained that the ICH location provides information on underlying cause and can be associated with different ICH recurrence rates. The association of ICH location on the resumption of oral anticoagulation therapy after ICH has not previously been investigated.
Results showed that resumption of oral anticoagulation was associated with reduced mortality risk, improved functional outcomes, and decreased ischemic stroke risk at 1 year in patients with lobar and those with nonlobar ICH, without a significant increase in recurrent ICH.
Table 1. Outcomes at 1 Year: Resuming vs Not Resuming Anticoagulation
| Endpoint | Nonlobar ICH: HR (95% CI) | Nonlobar ICH: P Value | Lobar ICH: HR (95% CI) | Lobar ICH: P Value |
|---|---|---|---|---|
| Mortality | 0.26 (0.17 – 0.39) | <.0001 | 0.29 (0.20 – 0.42) | <.0001 |
| Favorable outcome (mRS score, 0 – 3) | 4.41 (2.92 – 6.67) | <.0001 | 4.15 (2.81 – 6.13) | <.0001 |
| Recurrent ICH | 1.12 (0.94 – 1.34) | .22 | 1.26 (0.99 – 1.60) | .059 |
| Recurrent ischemic stroke | 0.42 (0.22 – 0.81) | .011 | 0.48 (0.27 – 0.85) | .013 |
| Results adjusted for confounding factors by propensity score. CI = confidence interval; HR = hazard ratio; mRS = modified Rankin Scale. | ||||
Dr Kuramatsu pointed out that this study had several limitations, including its observational framework, follow-up limited to 1 year and few patients taking the new novel oral anticoagulant drugs. “So we cannot recommend patients resume anticoagulants just based on this study.”
But he added that the results were encouraging and “strongly support the conduct of a randomized trial evaluating the resumption of oral anticoagulants after primary ICH.”
In the second presentation, Eleni Korompoki, MD, Imperial College London, United Kingdom, noted that at least 20% of patients with ICH have AF and 80% to 90% of the patients have an HADSVASC score of 2 or greater and are therefore at a high risk for an ischemic stroke.
She reported another meta-analysis of seven observational studies looking at oral anticoagulant (vitamin K antagonists) or antiplatelet resumption in a total of 2452 patients with ICH and AF.
Results showed that anticoagulants were associated with a lower risk for ischemic stroke, but antiplatelets were not.
Table 2. Risk for Ischemic Stroke With Oral Anticoagulants or Antiplatelets vs No Treatment
| Treatment | HR (95% CI) |
|---|---|
| Anticoagulants | 0.46 (0.29 – 0.72) |
| Antiplatelets | 1.06 (0.72 – 1.54) |
Another analysis of the data looked at pooled annual event rates, which again suggested a lower rate of ischemic stroke with oral anticoagulants but no significant difference in recurrent ICH rates.
Table 3. Pooled Annual Events Rates (95% CI)
| Treatment | Ischemic Stroke | ICH Recurrence |
|---|---|---|
| Oral anticoagulants | 3.3 (2.0 – 4.9) | 4.6 (3.1 – 6.6) |
| Antiplatelets | 9.5 (7.3 – 12.0) | 3.7 (2.5 – 5.4) |
| No antithrombotics | 6.1 (4.9 – 7.6) | 4.2 (3.2 – 5.5) |
As in the first study, Dr Korompoki pointed out limitations of the analysis, including observational data, confounding by indication, and unmeasured selection bias.
And she reached the same conclusion as the previous presentation — that a randomized controlled trial of antithrombotic therapy, preferably using the new direct oral anticoagulant drugs, is needed to guide decision-making in patients who have sustained an ICH.
Randomized trials investigating use of oral anticoagulants in patients with a previous ICH are now planned. One small trial is already ongoing in the Netherlands (APACHE-AF), and other such trials are being planned in the United Kingdom and France.
Dr Kuramatsu and Dr Korompoki have disclosed no relevant financial relationships.
3rd European Stroke Organisation Conference (ESOC) 2017. Session P24. Presented May 18, 2017.
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