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Safety of Heparin Bridging Therapy for Transrectal Ultrasound-Guided Prostate Biopsy in Patients Requiring Temporary Discontinua

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Safety of Heparin Bridging Therapy for Transrectal Ultrasound-Guided Prostate Biopsy in Patients Requiring Temporary Discontinua View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Hamano et al. SpringerPlus (2016) 5:1917 DOI 10.1186/s40064-016-3610-6 RESEARCH Open Access Safety of heparin bridging therapy for transrectal ultrasound‑guided prostate biopsy in patients requiring temporary discontinuation of antithrombotic agents Itsuto Hamano1, Shingo Hatakeyama1* , Tohru Yoneyama2, Yuki Tobisawa1, Osamu Soma1, Teppei Matsumoto1, Hayato Yamamoto1, Atsushi Imai2, Takahiro Yoneyama2, Yasuhiro Hashimoto2, Takuya Koie1 and Chikara Ohyama1,2 Abstract Background: Safety of heparin bridging therapy for transrectal ultrasound-guided prostate (TRUS) biopsy in patients requiring temporary discontinuation of antithrombotic therapy is unknown. This study aimed to assess the relation- ship between heparin bridging therapy and the incidence of complications after TRUS biopsy. Methods: From January 2005 to November 2015, we performed 1307 consecutive TRUS biopsies on 1134 patients in our hospital. The patients were assigned to two groups: those without heparin bridging (the control group) and those with temporary discontinuation of antithrombotic agents with heparin bridging therapy (the bridging group). A 10–12-core TRUS biopsy was performed; the patients were evaluated for bleeding-related complications. Results: Of 1134 patients, 1109 (1281 biopsies) and 25 (26 biopsies) were assigned to the control and bridging group, respectively. Patient background did not significantly differ between the control and bridging groups, except for age, history of diabetes, cardiovascular diseases, and CHADS2 scores. Compared with the control group, the bridg- ing group showed a significantly higher rate of complication for any complication (35 vs. 8.3%, P < 0.001), bleeding- related complications (27 vs. 4.4%), and urinary tract infection (7.7 vs. 1.2%). No thromboembolic event was observed in the present study. Multivariate logistic analysis showed that heparin bridging therapy was a significant risk factor for the incidence of any complication and bleeding-related complications. Conclusions: Heparin bridging therapy with temporal discontinuation of antithrombotic agents may increase the risk of complications after TRUS biopsy. Further, large-scale studies are required to clarify the safety of heparin bridging therapy. Keywords: Antithrombotic agents, Discontinuation, Heparin bridging, Prostate biopsy Background and is one of the most commonly performed procedures. An estimated 106,032 transrectal ultrasound-guided The complications of TRUS biopsy have previously been prostate biopsies (TRUS biopsies) are performed annu- described (Loeb et al. 2013; Nam et al. 2013; Pinkhasov ally in Japan (Kakehi and Naito 2008). TRUS biopsy is et al. 2012; Rosario et al. 2012). The most frequent of the current gold standard for diagnosing prostate cancer these, which are usually self-limiting, is hematuria (14.7– 81.5%) (Giannarini et al. 2007; Ihezue et al. 2005; Kakehi and Naito 2008). Although the majority of patients have *Correspondence: shingoh@hirosaki‑u.ac.jp 1 Department of Urology, Hirosaki University Graduate School minor hematuria without complications, a few (0.3–6.2%) of Medicine, 5 Zaifu‑cho, Hirosaki 036‑8562, Japan can develop severe problems (Nam et al. 2013; Pinkhasov Full list of author information is available at the end of the article et al. 2012; Rosario et al. 2012). © The Author(s) 2016. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Hamano et al. SpringerPlus (2016) 5:1917 Page 2 of 8 As the world’s population ages rapidly, a relatively by reference of medical charts, according to the Common high proportion of patients are on prescribed medica- Terminology Criteria for Adverse Events (version 4.0). tion for comorbidities; these medications include long- Multivariate logistic regression analysis was performed term antithrombotic therapy using low-dose aspirin, to assess the risk factors for the incidence of complica- clopidogrel/ticlopidine, and warfarin. Several prospec- tions (of any grade), including age, heparin bridging, tive studies support the safety of continuation of low- presence of comorbidities (diabetes mellitus and hyper- dose aspirin in TRUS biopsy (Giannarini et al. 2007; tension), number of biopsy cores, and the CHADS2 score Maan et al. 2003). Conversely, no recommendation exists (congestive heart failure: 1 point; hypertension: 1 point; regarding the management of non-aspirin antithrom- age 75 or older: 1 point; diabetes mellitus: 1 point; prior botic agents (warfarin or clopidogrel/ticlopidine) before stroke or transient ischemic attack or thromboembolism: a TRUS biopsy. Clinicians have three options for man- 2 points). The CHADS2 score is a clinical prediction rule agement, depending on the risk of thrombosis. First, for estimating the risk of stroke in patients with non- antithrombotic agents can be continued during proce- rheumatic atrial fibrillation that is a common and serious dures associated with low rates of bleeding complica- heart arrhythmia associated with thromboembolic stroke tions. Second, they can be discontinued for several days (Gage et al. 2001). To evaluate the accuracy and reliability prior to the procedure and restarted thereafter. Third, of the CHADS2 score in clinical practice, we compared they can be discontinued with bridging anticoagulation the international normalized ratio of prothrombin time using heparin (heparin bridging therapy), administered (PT-INR) and CHADS2 score between heparin bridging during the sub-therapeutic window, in patients at high and non-bridging heparin-administered patients. risk of thromboembolic events (Douketis et al. 2008; El-Hakim and Moussa 2010). However, there are few Statistical analysis prospective studies regarding the relationship between Statistical analyses of the clinical data were performed TRUS biopsy and continuation of antithrombotic agents. using SPSS version 22.0 (SPSS Inc., Chicago, IL, USA) Furthermore, the safety of short-term discontinuation of and GraphPad Prism 5.03 (GraphPad Software, San antithrombotic agents with heparin bridging therapy in Diego, CA, USA). Categorical variables were reported TRUS biopsy has not been well documented. Therefore, as percentages and compared using the Fisher’s exact we aimed to assess the safety of heparin bridging therapy test. Quantitative data were expressed as medians with for TRUS biopsy in patients requiring temporary discon- quartiles 1 and 3 (Q1 and Q3). Differences between the tinuation of antithrombotic agents in the present study. groups were statistically compared using the Student’s t test for normal distribution or the Mann–Whitney U-test Methods for non-parametric distribution. P values <0.05 were Patient selection and evaluation considered statistically significant. Risk factors for any From January 2005 to November 2015, we performed complications and bleeding-related events were identi- 1307 TRUS-biopsies on 1134 patients in our hospital. fied using univariate and logistic regression multivariate We retrospectively investigated the relationship between analyses. Odds ratios (ORs) with 95% confidence inter- heparin bridging therapy and the incidence of complica- vals were calculated after concurrently controlling for tions after TRUS biopsy and evaluated the prevalence potential confounders. Variables included in the models of these complications in patients not receiving heparin were age (>70 years), history of type 2 diabetes (positive), bridging therapy. Patients were assigned to two groups: history of hypertension (positive), prostate-specific anti- those without heparin bridging (the control group, gen (>7.8 ng/mL), prostate cancer (positive), the number n = 1109; 1281 biopsies) and those with temporary dis- of biopsy cores (>10), use of antithrombotic agents (posi- continuation of antithrombotic agents with heparin tive), the number of antithrombotic agents (2 or more), bridging therapy (the bridging group, n = 25; 26 biop- use of warfarin (positive), heparin bridging (positive), sies). The control group included patients not adminis- and the CHADS2 score (2 or higher). The median was tered any antithrombotic agents or those with temporary used as a cut-off value in quantitative data. discontinuation of antithrombotic agents. Clinical indi- cation of heparin bridging therapy was assessed by Ethics statement the physician who had medicated the patient with This study was performed in accordance with the ethical antithrombotic agents, according to the individual risks standards of the Declaration of Helsinki and approved of thromboembolism. A 10- to 12-core TRUS biopsy was by the ethics review board of Hirosaki University School performed, and patients were surveyed to evaluate any of Medicine (Authorization Number: 2013-315). For complications and bleeding-related events. The incidence this type of retrospective study, formal consent was not of complications and grades for each group was assessed required. Hamano et al. SpringerPlus (2016) 5:1917 Page 3 of 8 Results To assess the safety of heparin bridging therapy, we Of 1134 patients, 1109 (1281 biopsies) and 25 (26 biop- compared patients with temporary
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