BACKGROUND: Periprocedural management of oral anticoagulation (OAC) in patients undergoing cardiac rhythm management (CRM) device implantation is controversial. Prior studies demonstrate that uninterrupted OAC may be safe, but limited data from randomized trials exist. METHODS: We conducted a multicenter, randomized trial to evaluate the safety of uninterrupted OAC during CRM device implantation. Patients on long-term warfarin (N=213) treatment with contemporary indication for CRM device implantation were randomized to uninterrupted versus interrupted (2 days) OAC therapy. The primary outcome included major bleeding events necessitating additional intervention and thromboembolic events during 4 weeks follow-up. RESULTS: The randomized groups were well matched in terms of bleeding and thromboembolic risk. Only one (1%) patient in the uninterrupted OAC group (N=106) needed blood transfusion due to rupture of proximal cephalic vein. Large hematomas were detected in 6% of patients in both groups, but there was no need for pocket revision in either group. Any pocket hematoma was observed in 35 patients (33%) in the uninterrupted OAC group and in 43 patients (40%) with interrupted OAC and uninterrupted OAC strategy was non-inferior to interrupted OAC (HR 0.86, 95%, p=0.001 for non-inferiority). One patient with interrupted OAC had stroke 3 days after the procedure. Hospital stay was comparable in all patient groups. CONCLUSION: Our randomized study demonstrates that CRM devices can be safely implanted without discontinuation of warfarin treatment.
RCT Entities:
BACKGROUND: Periprocedural management of oral anticoagulation (OAC) in patients undergoing cardiac rhythm management (CRM) device implantation is controversial. Prior studies demonstrate that uninterrupted OAC may be safe, but limited data from randomized trials exist. METHODS: We conducted a multicenter, randomized trial to evaluate the safety of uninterrupted OAC during CRM device implantation. Patients on long-term warfarin (N=213) treatment with contemporary indication for CRM device implantation were randomized to uninterrupted versus interrupted (2 days) OAC therapy. The primary outcome included major bleeding events necessitating additional intervention and thromboembolic events during 4 weeks follow-up. RESULTS: The randomized groups were well matched in terms of bleeding and thromboembolic risk. Only one (1%) patient in the uninterrupted OAC group (N=106) needed blood transfusion due to rupture of proximal cephalic vein. Large hematomas were detected in 6% of patients in both groups, but there was no need for pocket revision in either group. Any pocket hematoma was observed in 35 patients (33%) in the uninterrupted OAC group and in 43 patients (40%) with interrupted OAC and uninterrupted OAC strategy was non-inferior to interrupted OAC (HR 0.86, 95%, p=0.001 for non-inferiority). One patient with interrupted OAC had stroke 3 days after the procedure. Hospital stay was comparable in all patient groups. CONCLUSION: Our randomized study demonstrates that CRM devices can be safely implanted without discontinuation of warfarin treatment.
Authors: Antti Palomäki; Tuomas Kiviniemi; Juha E K Hartikainen; Pirjo Mustonen; Antti Ylitalo; Ilpo Nuotio; Päivi Hartikainen; Jussi Jaakkola; Riho Luite; K E Juhani Airaksinen Journal: Clin Cardiol Date: 2016-05-30 Impact factor: 2.882
Authors: Simon Pecha; Ayhan Ayikli; Iris Wilke; Samer Hakmi; Yalin Yildirim; Nils Gosau; Hermann Reichenspurner; Stephan Willems; Muhammet Ali Aydin Journal: Heart Vessels Date: 2017-10-13 Impact factor: 2.037
Authors: Pauliina Nordling; Tuomas Kiviniemi; Marjatta Strandberg; Niko Strandberg; Juhani Airaksinen Journal: BMJ Open Date: 2016-02-24 Impact factor: 2.692