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Abstract

Aim

To study in patients performing international normalized ratio (INR) self-control the efficacy and safety of an INR target range of 1.6–2.1 for aortic valve replacement (AVR) and 2.0–2.5 for mitral valve replacement (MVR) or double valve replacement (DVR).

Methods and results

In total, 1304 patients undergoing AVR, 189 undergoing MVR and 78 undergoing DVR were randomly assigned to low-dose INR self-control (LOW group) (INR target range, AVR: 1.8–2.8; MVR/DVR: 2.5–3.5) or very low-dose INR self-control once a week (VLO group) and twice a week (VLT group) (INR target range, AVR: 1.6–2.1; MVR/DVR: 2.0–2.5), with electronically guided transfer of INR values. We compared grade III complications (major bleeding and thrombotic events; primary end-points) and overall mortality (secondary end-point) across the three treatment groups.

Findings

Two-year freedom from bleedings in the LOW, VLO, and VLT groups was 96.3, 98.6, and 99.1%, respectively (P = 0.008). The corresponding values for thrombotic events were 99.0, 99.8, and 98.9%, respectively (P = 0.258). The risk-adjusted composite of grade III complications was in the per-protocol population (reference: LOW-dose group) as follows: hazard ratio = 0.307 (95% CI: 0.102–0.926; P = 0.036) for the VLO group and = 0.241 (95% CI: 0.070–0.836; P = 0.025) for the VLT group. The corresponding values of 2-year mortality were = 1.685 (95% CI: 0.473–5.996; P = 0.421) for the VLO group and = 4.70 (95% CI: 1.62–13.60; P = 0.004) for the VLT group.

Conclusion

Telemedicine-guided very low-dose INR self-control is comparable with low-dose INR in thrombotic risk, and is superior in bleeding risk. Weekly testing is sufficient. Given the small number of MVR and DVR patients, results are only valid for AVR patients.

Mechanical heart valve replacement, Oral anticoagulation, Vitamin K antagonists, International normalized ratio, Bleeding event, Thrombotic event
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: [email protected].
Topic:
Issue Section:
Clinical Research > Thrombosis and antithrombotic therapy
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Comments (1)
Re:"Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants"Koertke, et al., 36 (21): 1297-1305 doi:10.1093/eurheartj/ehu330
14 July 2015
Mustafa Ozan Gürsoy, Cardiologist, Macit Kalçık, Cardiologist, Mahmut Yesin, Cardiologist, Süleyman Karakoyun, Cardiologist, Mehmet Özkan, Cardiologist
Gaziemir State Hosp., İzmir, Turkey, İskilip Atıf Hoca State Hosp., Çorum, Turkey, Kars State Hosp., Turkey, Kars Kafkas Univ, Turkey, Koşuyolu Kartal Heart Training & Research Hosp., Istanbul, Turkey
Dear Editor, We have recently read with great interest the article reported by Koertke et al. which was recently published in the European Heart Journal. The authors aimed to evaluate the efficacy and safety of a lower international normalized ratio (INR) target in patients who have mechanical heart valves and perform INR self-control. Thanks to the authors for their contribution of such a report which is based on a large number of patients and INR values. On the other hand, we want to make several criticisms, mostly about the methodology of the study. The primary end-points of the study included freedom from major bleeding complications and major thrombotic events. They stated that there were no cases of prosthetic valve thrombosis (PVT). Although it is not directly within the scope of the study, there is limited data about the imaging modalities which were used during the current study to exclude PVT. Two dimensional (2D) transesophageal echocardiography (TEE) has been the gold standard method for evaluation of PVT, but the detection of nonobstructive PVT can be challenging, especially when Doppler parameters are within normal limits and clinical findings are subtle. On the other hand, nonobstructive PVT may carry potential risk for thromboembolism such as coronary, visceral, and cerebral emboli (2, 3). A high level of experience is required for the accurate acquisition and interpretation of 2D images. The diagnostic accuracy for detecting prosthetic valve thrombosis has been improved after introduction of real-time three dimensional (RT-3D) TEE (2, 3). It can disclose the concealed base of the thrombotic mass, which poses risk for thromboembolism (2, 3). In current study we do not have much idea about the imaging tools used. For mitral prosthesis, it is not easy to say that the prosthesis is completely free of thrombosis without performing RT-3D TEE. Our recent experiences showed that the nonobstructive ring thrombosis, especially those on mitral position, may be a nidus for further thromboembolic events, especially in case of inadequate anticoagulation (2, 3) and RT-3D TEE is an indispensible guide for detecting these thrombi. Another noteworthy issue is that the current study included small number of patients with mitral prosthesis (< 20%) and the findings of the study are only valid for patients with aortic prosthesis, as the authors stated. Recently our group have published two trials, (TROIA, which included the largest cohort of PVT patients published to date, and PROMETEE trial) (4,5) which included a total number of 340 episodes with PVT, located mostly on mitral position (~ 80% ). In these studies the reported rate of sub-therapeutic anticoagulation was approximately 80 %. Therefore, keeping INR in lower levels may pose high risk for patients with mitral prosthesis, including those with new generation valves. REFERENCES 1- Koertke H, Zittermann A, Wagner O, Secer S; Christ of Huth, Sciangula A, Saggau W, Sack FU, Ennker J, Cremer J, Musumeci F, Gummert JF. Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants. Eur Heart J 2015 Jun 1;36(21):1297-305. doi: 10.1093/ eurheartj/ehu330. 2- Ozkan M, Gursoy OM, Astarcioglu MA, Gündüz S, Cakal B, Karakoyun S, Kalçık M, Kahveci G, Duran NE, Yıldız M, Cevik C. Real-time three-dimensional transesophageal echocardiography in the assessment of mechanical prosthetic mitral valve ring thrombosis. Am J Cardiol 2013;112:977–983. 3- Gürsoy OM, Ozkan M. The role of real-time 3-dimensional transesophageal echocardiography in depiction of the concealed base of the iceberg. Anadolu Kardiyol Derg 2012;12(5):E22-23. 4- Özkan M, Gündüz S, Biteker M Astarcioglu MA, Çevik C, Kaynak E, Yıldız M, Oğuz E, Aykan AÇ, Ertürk E, Karavelioğlu Y, Gökdeniz T, Kaya H, Gürsoy OM, Çakal B, Karakoyun S, Duran N, Özdemir N. Comparison of different TEE-guided thrombolytic regimens for prosthetic valve thrombosis: the TROIA trial. JACC Cardiovasc Imaging 2013;6:206-216. 5- Ozkan M, Gündüz S, Gürsoy OM, Karakoyun S, Astarcıoğlu MA, Kalçık M, Aykan AÇ, Çakal B, Bayram Z, Oğuz AE, Ertürk E, Yesin M, Gökdeniz T, Ekşi NE, Yıldız M, Esen AM. Ultra-slow thrombolytic therapy: A novel strategy in the management of PROsthetic MEchanical valve Thrombosis and the prEdictors of outcomE: The Ultra-slow PROMETEE trial." Am Heart J doi: 10.1016 /j.ahj. 2015.04.025 (in press).
Submitted on 14/07/2015 12:00 AM GMT