Thank you very much and I’m going to be talking about our project in which we specifically tried to answer the question that I pose: which is worse, bleeding or clotting after having a patient developing a thrombosis in patients with cancer? The background is basically derived because of the fact that we know, and we have known for a very long time, that cancer patients have a higher risk for thrombosis, clots in the lungs or the veins of the legs. But they also have a higher risk of bleeding and we know that all of these patients need to be treated with blood thinners, with anticoagulants which will lower the risk of having a second clot but will also further increase the risk of bleeding that has already increased in this population.
So there’s a previous study that looked at what are the risks of dying from a thrombosis recurrence or a bleeding event in overall patients and this came from a meta-analysis from [?? 1:07] in Ottawa published a few years ago. They found that the risk of thrombosis and bleeding are similar but patients with cancer could not be individually assessed in that particular study. So our objective was to determine what is the risk of dying from a thrombosis recurrence or a bleeding event in elderly patients with cancer and thrombosis.
We conducted a cohort study, a retrospective cohort study, population based in Ontario, Canada. We included patients 65 years or older with cancer, either a solid or a haematological malignancy, as well as deep vein thrombosis or a pulmonary embolism diagnosed within six months of the initial cancer diagnosis. We estimated the recurrence of VTE and major bleeding events which we defined as the occurrence of either an intracranial bleeding or a gastrointestinal bleeding event. Then we estimated a seven day mortality after the recurrence of the venous thrombosis or the major bleeding event as well as the ratio of the mortality for major bleeding compared to VTE together with the 95 confidence intervals.
For the period comprehended between 2004 and 2014 we included short of 7,000 events in cancer patients with a mean age of about 75 years and roughly 50% of them were male. The vast majority of them were treated with low molecular weight heparin alone, although there were a number of them that were treated with low molecular weight heparin and warfarin or warfarin alone, depending on what their registries had information about. A small amount of them were treated with rivaroxaban but because of the very small numbers those were eliminated from the analysis.
What we found is that at six months of the index VT, so the first deep vein thrombosis or pulmonary embolism, there were about 3% major bleeding events, 235, and about 17% recurrences of the thrombosis and this is fairly in line with previous information. What was more interesting is that the seven day mortality rate was about 0.5% for patients who had a thrombotic recurrence compared to about 11% for those who had a major bleeding event. If you estimate the mortality rate ratio for major bleeding to VT it was 22 times higher. So with the confidence interval that’s a little bit wide but in the best case scenario it would be estimated to be at least 9 times higher than the mortality for a thrombotic recurrence.
So we concluded that when we use anticoagulants in cancer patients that are 65 or older and they develop a thrombosis if they bleed this results in at least a nine times higher mortality rate than if they have a thrombotic recurrence. We do believe that this information should be taken into account when designing further studies and this certainly needs to be confirmed in other cohorts because this would actually change what we would do in terms of long-term treatment of thrombosis.
Thank you very much and I am happy to take any questions.