Year : 2021 | Volume
: 37 | Issue : 1 | Page : 99--100
Pharmacological prophylaxis for venous thromboembolism: Is it time to change the gold standard?
Department of Urology, AIIMS, Bhubaneshwar, Odisha, India
Department of Urology, AIIMS, Bhubaneshwar, Odisha
|How to cite this article:|
Kumaraswamy S. Pharmacological prophylaxis for venous thromboembolism: Is it time to change the gold standard?.Indian J Urol 2021;37:99-100
|How to cite this URL:|
Kumaraswamy S. Pharmacological prophylaxis for venous thromboembolism: Is it time to change the gold standard?. Indian J Urol [serial online] 2021 [cited 2023 Feb 5 ];37:99-100
Available from: https://www.indianjurol.com/text.asp?2021/37/1/99/306046
The PREVENTER trial evaluated the benefits of the addition of pharmacological prophylaxis (PP) to pneumatic compression (PC) in preventing venous thrombo-embolization (VTE) after radical prostatectomy (RP). This prospective phase 4 randomized study from the Johns Hopkins University, USA, was aimed at obtaining the current data on the incidence of symptomatic VTE with and without PP, the overall incidence of VTE following RP, and estimation of the adverse effects of PP. The study recruited patients undergoing RP, either by minimally invasive or open technique. Patients in the control arm received intermittent PC while those in the treatment arm received 5000 units of heparin subcutaneously eight hourly until discharge along with PC with an emphasis on early mobilization. The two cohorts were stratified based on an optional USG doppler screening on the 30th postoperative day to look for asymptomatic VTE. The study was terminated early after the second interim analysis of 445 patients as it met the endpoint for futility.
Baseline characteristics were balanced for age, race, body mass index, Caprini score, biopsy Gleason score, NCCN clinical risk group, and the surgical approach. Most of the surgeries were for NCCN intermediate-risk prostate cancers (56%) and were done by the robotic approach (73%). Seven patients experienced symptomatic VTE (treatment arm-2 vs. control arm-5) with a relative risk in the treatment arm of 0.4% (95% confidence interval [CI] 0.08–2.03, P = 0.3). VTE event rate was more in the pT3 stage, but after adjustment for confounding factors, the pathological stage had minimal impact on VTE events (pT3 vs. pT2: RR 0.42 [95% CI 0.08–2.12], P = 0.3). Gleason score, pathological stage, operative time, pelvic lymph node dissection, number of lymph nodes dissected, and lymph node metastasis did not significantly affect VTE. None of the safety outcomes, i.e., symptomatic lymphocele formation, symptomatic hematoma formation, intraoperative blood loss, drain output, and complications in the postoperative period, demonstrated a significant difference. On USG Doppler screening, VTE's overall incidence (symptomatic + asymptomatic) was low (treatment vs. control: 2.4 vs. 3.3%, P = 0.7). The authors concluded that PP does not significantly reduce symptomatic VTE or overall VTE after RPLND and also does not increase the incidence of symptomatic lymphoceles, hematoma, and bleeding.
The decision of adding PP to PC depends on balancing the risks of VTE with that of bleeding. Level 1 evidence in urological practice is limited. Almost all the patients receive PP in the UK, compared to only 18% in the USA, due to its doubtful advantage and an increased risk of bleeding. The only available study from 1989 showed a significant decrease in VTE incidence (from 11% to 0%, P = 0.05) and an increase in lymphocele formation (from 11% to 38%, P = 0.01). Since then, surgical techniques have advanced, causing less tissue trauma, with the majority being done by minimally invasive techniques that allow early ambulation. The well-designed phase 4 PREVENTER trial provides recent data with most surgeries done by a minimally invasive approach. USG screening for overall VTE, the strong point of the study, shows a very low event rate. A subgroup analysis also failed to show any effect based on Gleason score, pathological stage, operative time, pelvic lymph-node dissection, the number of lymph nodes dissected, and lymph node metastasis. A limitation of the generalizability of these results is that the study was done at a high-volume center. Another limitation is the low event rate of VTE in the recruited patients, because of which the results become underpowered. The EAU guidelines employ a risk-stratified approach and recommend against PP after robotic RP without PLND or for low-risk patients with standard PLND. The open technique, however, requires PP irrespective of PLND. These guidelines should be adapted cautiously in the Indian population, who have a low incidence of VTE compared to patients in developed nations. Low event rates of VTE in Indians and no advantage of PP over PC, suggest abandoning the prolonged and costly LMWH injections in prostate cancer surgery done using minimally-invasive approaches.
Financial support and sponsorship: Nil.
Conflicts of interest: There are no conflicts of interest.
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