Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)

Dr Vincent Misrai

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia; Anticoagulant Adverse Reaction

Treatments: Other: Maintenance of OAC in surgery of BPH by PVP.; Other: Discontinuation of OAC in surgery of BPH by PVP.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03297281

2017-A01236-47

Details and patient eligibility

About

Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

Full description

SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study.

The expected benefits are to foster and make the perioperative management of OAC safer in patients undergoing BPH surgery with PVP.

Enrollment: 389 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate volume < or = 30 gr
• Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...)
• Patient candidate for photovaporization of the prostate
• Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months
• Unprotected major
• Patient affiliated to a social security scheme or equivalent
• Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form.

Exclusion criteria

• History of prostate cancer
• Previous pelvic radiotherapy
• History of stenosis of the urethra
• Patient with one or more bladder polyps
• Patient under antiplatelet agent other than aspirin
• Allergy to heparin or history of heparin-induced thrombocytopenia
• Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux)
• Any mechanical prosthetic heart valve
• Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks
• Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
• Major bleeding within past 6 weeks
• Severe renal insufficiency (calculated creatinine clearance < 30 mL / min)
• Thrombocytopenia (platelet count < 100 x 10^9 / L)
• Life expectancy < 1 month
• Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)
• Contra-indication to PVP surgery or contra-indication to general anesthesia
• Protected patients : majors under some form of guardianship
• Patient participating in another clinical study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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389 participants in 2 patient groups

S1: maintenance

Experimental group

Description:

Maintenance of OAC in surgery of BPH by PVP.

Treatment:

Other: Maintenance of OAC in surgery of BPH by PVP.

S2 : discontinuation

Active Comparator group

Description:

Discontinuation of OAC in surgery of BPH by PVP.

Treatment:

Other: Discontinuation of OAC in surgery of BPH by PVP.