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PostSubject: I think we all knew this, why don't they know this?   Thu Dec 10, 2009 9:36 pm

Risk of venous thromboembolism greater, lasts longer, than thought

December 3, 2009
Lisa Nainggolan

Oxford, UK - New research in middle-aged women suggests that the risk of venous thromboembolism (VTE) after many different types of surgery is greater and lasts for longer than has previously been appreciated [1].

The findings are crucial because they show that the risk is greatest in the first six weeks following surgery, peaking around three weeks afterward. But most patients receive prophylaxis only for the duration of their hospital stay, which averages around six days, say Dr Sîan Sweetland (University of Oxford, UK) and colleagues in a report published online December 3, 2009 in BMJ. The risk of VTE also remains high for 12 months postoperatively, they found.

In an accompanying editorial [2], vascular surgeon Dr Alexander T Cohen (King's College Hospital, London, UK) says the study by Sweetland et al "confirms and broadens the findings of existing studies on the ongoing risk of VTE after surgery" and "is a wake-up call to all surgeons."

Second author of the BMJ paper, Dr Jane Green (University of Oxford, UK), told heartwire that the strengths of the study are its large size and breadth. A key finding relates to the duration of risk of VTE, she says: "We haven't had reliable figures before, particularly on the timing and the long time for which these risks are quite high." She believes these new data are "reliable enough to consider seriously as part of any review of prophylaxis for VTE."

Risk highest for knee and hip replacements, cancer surgery

Sweetland et al conducted their analysis to discover more about the exact pattern and scale of the increased risk of VTE following various types of surgery. Using data from the prospective Million Women Study in the UK, they examined questionnaires linked with National Health Service (NHS) hospital admission and death records for 947 454 middle-aged women recruited from 1996 to 2001. They excluded 207 302 women who had had surgery in the previous year or who had had a hospital admission for VTE before recruitment, history of a blood clot, or a previous cancer.

During follow-up (average 6.2 years), there were 239 614 hospital admissions for surgery and 5419 admissions for VTE, and a further 270 women died from VTE.

Compared with the risk without surgery, women were almost 70 times more likely (relative risk 69.1) to be admitted with VTE during the first six weeks after an inpatient operation—with the peak incidence being three weeks afterward—and almost 10 times more likely after a day case operation (RR 9.6).

The fact that day surgery was associated with an increased and prolonged risk of VTE—albeit a lesser one than that for inpatient surgery—is important because preventive treatment for thrombosis is not normally used in day surgery patients, the researchers say.

The risks were lower but still elevated seven to 12 weeks after surgery, with those women almost 20 times more likely to suffer VTE compared with those undergoing no surgery (RR 19.6). And in most cases, an increased risk remained for at least one year, the researchers note.

Risk also varied considerably by type of surgery, being highest after inpatient surgery for hip or knee replacement (relative risk 220.6) and cancer (RR 91.6) within the first six weeks postoperatively. This confirms in clinical practice previous findings from clinical trials about the highest-risk surgical groups for VTE, says Cohen.

Sweetland and colleagues say this means, in real terms, that one in 140 middle-aged women in the UK will be admitted to the hospital with VTE during the 12 weeks after any inpatient surgery, one in 45 after hip- or knee-replacement surgery, and one in 85 after surgery for cancer. This compares with one in 815 after a day case procedure and only one in 6200 women during a 12-week period without surgery.

New data lower threshold for prolonged prophylaxis

In his editorial, Cohen says that worldwide, the use of recommended VTE prophylaxis is "suboptimal—only 59% of surgical patients receive recommended treatment," and use varies among different countries.

Current evidence suggests it is needed for inpatients undergoing many orthopedic-, general-, and cancer-surgery procedures and should be given for at least seven to 10 days. In addition, prolonged prophylaxis for four to five weeks also shows a net clinical benefit in high-risk patients and procedures, but "we have no studies that have examined whether treatment should be extended for more than five weeks in any group of patients," he observes.

But this research by Sweetland et al "should lower the threshold for using prolonged prophylaxis in lots of patients with respect to thrombosis," he told heartwire.

One reason for the poor uptake of VTE prophylaxis is the "relative inconvenience of parenteral anticoagulants," such as low-molecular weight heparin (LMWH), the current recommended treatment, he says, adding that previously the only oral option, warfarin, was "not effective enough" for VTE prevention.

The availability of newer oral anticoagulants "will be important if prolonged treatment is needed," he concludes. Examples of such products recently approved in Europe for use in VTE prophylaxis following orthopedic surgeries include dabigatran (Boehringer Ingelheim) and rivaroxaban (Johnson & Johnson), he noted.

Results on the RE-COVER trial, comparing dabigatran with warfarin in the treatment of acute venous thromboembolism, are slated for presentation during a plenary session December 6, 2009, at the American Society of Hematology meeting.
Sweetland et al report no conflicts of interest. Cohen has received consultancy and clinical-trial funding from a number of pharmaceutical companies, including, most relevant to this editorial, Boehringer Ingelheim, Bayer, Bristol-Myers Squibb, Daiichi-Sankyo, Johnson & Johnson, Pfizer, and Sanofi-Aventis.
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