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Enoxaparin Cost-Effective for Post-Cystectomy VTE Prevention

Clicks:Updated:2016-05-11 09:05:51

SAN DIEGO -- Thirty days of enoxaparin was a cost-effective measure to prevent venous thromboembolism (VTE) after radical cystectomy, researchers reported here.

Within 30 days of radical cystectomy, only one of 52 patients who were discharged with extended-duration enoxaparin prophylaxis as part of a pilot study was diagnosed with VTE, said Harras Zaid, MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

Although VTE events are rare following radical cystectomy, they are expensive when they do occur, with an approximate net cost of VTE-related treatment of $53,000. In contrast, the cost of the medication to treat the 52 patients in the pilot study was $5,284, they explained in a presentation at the American Urological Association meeting.

Because most VTE events in patients who have undergone radical cystectomy occur within 30 days, Zaid's group evaluated the effect of prophylactic enoxaparin (40 mg/day subcutaneously for 30 days) in preventing VTE events, defined as symptomatic pulmonary embolus (PE) or deep venous thrombosis (DVT).

The rate of VTE events was compared between the pilot period and the 1 year prior, when 82 patients who underwent radical cystectomy did not receive prophylaxis.

About 80% of patients during each period had open radical cystectomy while approximately 20% had robotic surgery. Mean operative time was comparable between the two periods; the median hospital stay was identical before and after the pilot period at 5 days.

Compared with the one VTE event recorded during the pilot, there were six such events (two DVT alone, two DVT and PE, two PE alone) in the year prior (1.9% vs 6.1%).

Three patients developed a symptomatic lymphocele within 30 days -- one who received extended prophylaxis and two that did not (1.9% vs 2.4%). No patient during either period was rehospitalized for a bleeding complication.

The median hemoglobin level was not significantly different between patients who received extended-duration enoxaparin and those who did not when measured within 45 days of discharge (10.7 vs 10.3 g/dL, P=0.25) and beyond 45 days post discharge (12.0 versus 12.3 g/dL, P=0.41).

"Based on these data, Mayo Clinic is sending all radical cystectomy patients home with 30 days of prophylaxis to prevent blood clot events," provided patients have no history of allergy to enoxaparin or a bleeding disorder, Zaid told MedPage Today.

"At discharge, usually 5 to 7 days after cystectomy, patients are instructed by a nurse pharmacist on to how to administer this medication," he said. "We don't routinely surveil these patients for VTE; for example, we don't routinely do a Doppler ultrasound or chest CT. All the diagnosed clot events were symptomatic, meaning they had to have swelling of the leg or pulmonary symptoms to suggest PE."

A second study -- a retrospective chart review -- showed that VTE was common in radical cystectomy patients undergoing preoperative chemotherapy for invasive bladder cancer. Outcomes were examined for 357 patients treated with preoperative chemotherapy plus radical cystectomy/pelvic lymph node dissection from June 2000 to January 2013.

The rate of preoperative VTE events was 16% (57 of 357), reported Aditya Bagrodia, MD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City. A VTE event was significantly more likely in patients with advanced pathology (P=0.016) and in those who underwent invasive procedures (P=0.03).

A preoperative VTE did not adversely affect perioperative outcomes, and the total rate of perioperative complications was not significantly different between patients with and without a preoperative VTE (40% vs 46%, P=0.50).

Recurrence-free survival was not significantly different between patients who experienced a VTE and those who did not (HR 0.99, 95% CI 0.61-1.59, P=1.00). There was also no significant difference in overall survival patients with a VTE and those without VTE (HR 1.44, 95% CI 0.98-2.10, P=0.061).

Bagrodia's group concluded that VTE during chemotherapy does not preclude completion of chemotherapy or have a negative impact on oncologic outcomes.

Co-author Eric Levy, MD, also of MSKCC, said that some studies suggest that cisplatin itself is a thrombogenic agent, but the cancer and the radical cystectomy procedure are major contributors to VTE risk.

In the Mayo Clinic study, the percentage of patients receiving neoadjuvant chemotherapy was approximately 70% in both the group that received prophylaxis and the group that did not, Zaid explained, adding that the number of VTE events was too few to assess whether or not neoadjuvant chemotherapy was a significant predictor of VTE events.

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