Smit, G.J. (Anne-Marijn) (2017) The risk of bleeding and thromboembolic complications associated with use of NOACs (dabigatran, rivaroxaban, apixabanand edoxaban) compared with VKA in ‘real world’ AF patients undergoing catheter ablation: a retrospective cohort study. thesis, Medicine.
Full text available on request.Abstract
Since non-vitamin K oral anticoagulants (NOACS) are increasingly used for stroke prevention in non-valvular atrial fibrillation (AF), many patients presenting for AF catheter ablation are currently on NOAC therapy. Available evidence on safety and efficacy of NOACs compared with traditional vitamin-K antagonists (VKAs) after catheter ablation, in daily clinical practice, is still sparse. The aim of our study was to compare bleeding and thromboembolic risks of NOACs (dabigatran, rivaroxaban, apixaban and edoxaban) and VKAs in ‘real world’ patients undergoing left atrial catheter ablation. Additionally, we aimed to identify risk factors for bleeding complications after catheter ablation in daily clinical practice. Methods This was a retrospective cohort study from a prospective AF ablation registry maintained at the Isala Heart Centre, a large, Dutch medical center. The total cohort of all 804 consecutive patients who underwent left atrial ablation between January 2014 and December 2016 was used to identify the most important risk factors for periprocedural bleeding complications. Furthermore, all patients (n=804) were grouped based on the followed periprocedural anticoagulation strategy: (1) VKA pre- and post-ablation, n=351; (2) NOAC pre- and post-ablation, n=260; (3) VKA pre- and NOAC post-ablation, n=18; (4) no OAC pre-ablation and VKA post-ablation, n=45; and (5) no OAC pre-ablation and NOAC post-ablation, n=130. Subgroups 1 and 2 were then included in a ‘medication subcohort’ (n=611). Incidence rates of bleeding and thromboembolic events occurring up to 90 days postablation were then evaluated and compared between both treatment groups: VKA (n=351) and NOAC (n=260). Results The primary composite endpoint of all major and clinically relevant bleeding complications occurred in 31 patients (8.8%) in the VKA subgroup (25 acenocoumarol [8.5%], and 6 phenprocoumon [10.5%]) and in 13 patients (5.0%) in the NOAC subgroup (0 dabigatran, 9 rivaroxaban [8.8%], 4 apixaban [3.6%], and 0 edoxaban). After adjusting for baseline and procedural discrepancies, the multivariable Cox proportional hazards model indicated that there was no significant difference in the incidence of bleeding complications between the two treatment groups, with a HR of 0.801 for NOAC versus VKA (95% CI: 0.400-1.602, p=0.530). By individual comparison of NOAC and VKA medications, no differences in bleeding risks were found. Thromboembolic events did however occur significantly more often in the NOAC subgroup (n=4 [1.5%]), compared to the VKA subgroup (n=0; p=0.032). In terms of thromboembolic events, in our study population, periprocedural apixaban (n=3 [2.7%]) was associated with a higher risk compared with acenocoumarol (n=0; P<0.020). After univariate and multivariate analysis, HASBLED scores 1, 2, ≥3 and point-by-point-ablation (PBP-ablation) were identified as independent, significant positive predictors of bleeding complications (OR: 2.564, 2.777, 4.894, and 2.067; 95% CI: 1.134-5.797, 1.089-7.085, 1.590-15.063, and 1.090-3.920; p=0.024, 0.033, 0.006, and 0.026, respectively). Conclusions NOACs are rapidly gaining terrain over VKAs, and are currently used in 66.9% of patients post-catheter ablation. They are comparable to VKA in terms of periprocedural bleeding risk in real world AF-patients undergoing left atrial catheter ablation. However, NOACs, and apixaban in particular, might be associated with a higher thromboembolic risk compared with VKAs. HASBLED score and point-by-point ablation were identified as the best independent predictors for bleeding events in real world patients undergoing a left atrial catheter ablation procedure.
| Item Type: | Thesis (Thesis) |
|---|---|
| Supervisor name: | Faculty supervisor: and Elvan, A. MD and Department of Cardiology and Isala, Zwolle |
| Supervisor name: | Methodology and statistics supervisor: and Brohet, R.M. PhD and Department of Innovation and Science and Isala, Zwolle |
| Faculty: | Medical Sciences |
| Date Deposited: | 25 Jun 2020 10:50 |
| Last Modified: | 25 Jun 2020 10:50 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/1076 |
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