A study among patients with diabetes, drawn from seven randomised trials, has shown that bleeding within 30 days of percutaneous coronary intervention is associated with an increased risk of one-year mortality, non-fatal myocardial infarction or stent thrombosis.
Bleeding within 30 days of percutaneous coronary intervention (PCI) in patients with diabetes is associated with a significant increase in the risk of one-year mortality and morbidity, according to a study, recently published in EuroIntervention, conducted by Gjin Ndrepepa (Deutches Herzzentrum, Munich, Germany) and others.
The study identified patients with type 2 diabetes who had taken part in seven randomised trials involving intracoronary stenting conducted between 2000 and 2011. Of 4,329 patients with type 2 diabetes who underwent PCI via the femoral artery route, bleeding events occurred within 30 days in 474 patients (access-site bleeding occurred in 274 patients and non-access-site bleeding occurred in 200). Within the first year, there were 198 deaths, occurring in 45 patients (9.6%) with bleeding, and 153 patients (4%) without bleeding. Of the 45 patients with bleeding who died, 25 (12.7%) had non-access site bleeding and 20 (7.4%) had access-site bleeding. Non-fatal myocardial infarction within the first year occurred in 70 patients who bled (14.8%) and 206 who did not (5.4%). There was no significant difference in the frequency of myocardial infarction between non-access site bleeding and access-site bleeding. Definite stent thrombosis occurred in 46 patients, nine among patients who bled and 37 among those who did not.
The authors comment: “Peri-PCI bleeding in patients with diabetes is associated with an increased risk of one-year mortality, non-fatal myocardial infarction or stent thrombosis. The occurrence of bleeding doubled the risk of mortality and stent thrombosis and almost tripled the risk of non-fatal myocardial infarction. These data suggest that bleeding avoidance strategies should preferentially be used in diabetic patients to reduce the occurrence of bleeding and its deleterious impact on mortality and morbidity.”
They add that a small body mass index, reduced renal function, elevated troponin and type of antithrombotic therapy were associated with an increased risk of bleeding. The use of bivalirudin therapy significantly reduced the risk of bleeding compared with abciximab or unfractionated heparin. The frequency of serious bleeding (Bleeding Academic Research Consortium class ≥2) was 6.8% among the patients with diabetes in the study, and this was higher than a frequency of 5.4% found in a mixed group of patients with and without diabetes treated with PCI.
Ndrepepa et al conclude that peri-PCI bleeding provides prognostic information that is independent of and beyond that provided by cardiovascular risk factors and relevant clinical variables. They say the deleterious effect of bleeding may be the same in patients with diabetes as those without, but diabetes and bleeding complications may act synergistically to promote an increased risk of death or acute thrombotic events. The combination of bleeding and diabetes – each known to be associated with various comorbidities – may lead to a markedly worse cardiovascular risk profile, while both diabetic status and bleeding may accentuate a prothrombotic state leading to an increased frequency of ischaemic/thrombotic events.
Ndrepepa told Cardiovascular News: “We do believe that the results of present study may have clinical relevance since they increase the awareness about the increased frequency and the poor outcome of peri-procedural bleeding complications in diabetic patients undergoing percutaneous coronary interventions. This issue is particularly relevant since one fourth to one third of all percutaneous coronary interventions are performed in diabetic patients. As a consequence, bleeding-avoidance strategies may be preferentially used in diabetic patients undergoing percutaneous coronary interventions to reduce the frequency of bleeding and minimise its deleterious impact on mortality and morbidity.”
