Author + information
- Miriam Brinkert, MD,
- Lukas S. Keller, MD,
- Noriaki Moriyama, MD,
- Florim Cuculi, MD,
- Matthias Bossard, MD,
- Dirk Lehnick, PhD,
- Richard Kobza, MD,
- Mika Laine, MD,
- Fabian Nietlispach, MD, PhD and
- Stefan Toggweiler, MD∗ (, )@StToggweiler
- ↵∗Heart Center Lucerne, Cardiology, Spitalstrasse, 6000 Luzern, Switzerland
Up to one-third of patients undergoing transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis have an indication for long-term oral anticoagulation. In such patients, physicians have to balance periprocedural thromboembolic and bleeding risk. So far, data for patients undergoing transfemoral TAVR with continuation of oral anticoagulation are lacking. A recent publication showed that continuation of warfarin in patients undergoing pacemaker or defibrillator implantation was safe (1). Accordingly, we hypothesized that continuation of oral anticoagulation before and after transfemoral TAVR is equally safe and efficacious compared with interruption of anticoagulation.
Consecutive patients on oral anticoagulation therapy with either a vitamin K antagonist or a direct oral anticoagulant who underwent transfemoral TAVR at 3 European centers between 2015 and 2018 were enrolled. Anticoagulation was either stopped 2 to 4 days prior to TAVR and restarted after TAVR or was continued throughout the procedure depending on the operator’s preference. The primary clinical endpoints were life-threatening or major bleeding and major vascular complications at 30 days according to the updated definitions of the Valve Academic Research Consortium (2). Secondary endpoints included periprocedural stroke and mortality at 12 months.
Of 1,370 consecutive transfemoral TAVR patients, 186 and 185 patients underwent TAVR with continuation and interruption of anticoagulation, respectively. Indication for anticoagulation was mainly atrial fibrillation (95%). Overall, patients were at high risk for thromboembolic events, as reflected by a high CHA2DS2-VASc score in both groups (5.1 ± 1.5). Patients with continuation of anticoagulation were less often treated with direct oral anticoagulants (55 [30%] vs. 85 [46%]; p < 0.01) and had less often a history of stroke (26 [14%] vs. 45 [24%]; p = 0.01).
The rate of periprocedural major or life-threatening bleeding was almost identical in both groups (10.2% for continued anticoagulation vs. 10.8% for interrupted anticoagulation; rate difference, 0.6%; 95% confidence interval [CI]: −6.8% to 5.6%; p = 0.85) (Figure 1A).
Major vascular complications occurred in 8.6% of patients with continuation of anticoagulation compared with 10.3% of patients with interruption of anticoagulation (rate difference: 1.7%; 95% CI: −7.6% to 4.3%; p = 0.58). Strokes occurred in 1 (0.6%) and 6 (3.2%) patients with continuation and interruption of anticoagulation, respectively (rate difference: 2.7%; 95% CI: −5.5% to 0.1%; p = 0.06). Annual mortality rates were similar in both groups (9.38% vs. 9.83%; log rank p = 0.897) (Figure 1B).
To date, 180,000 patients/year could be considered as potential TAVR candidates in Europe and in Northern America (3). In the present study, 27% of consecutive patients undergoing TAVR were on oral anticoagulants. Patients with continuation of anticoagulation did not have a higher rate of bleeding than those with interruption of anticoagulation, showing that with current puncture and closure techniques, very high rates of mechanical hemostasis can be achieved. In addition, there was a signal toward a lower stroke rate in patients with continuation of anticoagulation. Cerebral embolism of aortic valve debris or atherosclerotic debris from the aorta seems to be the major underlying mechanism for stroke with TAVR. However, fracturing valvular tissue and triggering coagulation cascades and platelet activation during valve implantation may also increases the risk for thrombogenic complications, and therefore, continuation of anticoagulation might be beneficial in preventing strokes during TAVR (4).
We are well aware of certain limitations that apply to our study. We did include consecutive real-world patients, but it was not a randomized study and not powered to detect differences in mortality and stroke rates.
In summary, patients with continuation of oral anticoagulation throughout TAVR did not have more bleeding or vascular complications. There was a signal toward lower stroke rates in patients with continuation of anticoagulation. According to our results, simplifying TAVR procedure protocols with continuation of oral anticoagulation throughout TAVR appears to be safe and may help preventing periprocedural stroke during TAVR.
Please note: Dr. Kobza has received institutional grants from Boston Scientific, Biosense Webster, Biotronik, Medtronic, Abbott, and SIS-Medical. Dr. Nietlispach has served as a consultant for Edwards Lifesciences, Medtronic, and Abbott Vascular. Dr. Toggweiler has served as a consultant for, served as a proctor, and received honoraria from Boston Scientific and New Valve Technology; and has received an institutional research grant from Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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