Incidence of Bleeding in ‘Real-Life’ Acute Coronary Syndrome Patients Treated with Antithrombotic Therapy

Abstract

Objective: Randomized clinical trials have reported low risks of bleeding in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients receiving triple antithrombotic treatment (aspirin, clopidogrel and heparin). As trial patients often differ substantially from unselected patients treated in routine clinical settings, we compared the incidence of bleeding in ‘real-life patients’ with the incidence in the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) trial. Methods: We conducted a historical follow-up study based on 195 nonselected patients diagnosed with NSTE-ACS admitted to a Danish hospital. Data were obtained through systematic review of medical records. Bleeding complications were registered for 6 months after the event. Results: One hundred and nineteen (61.0%) patients fulfilled the inclusion and exclusion criteria of the CURE trial and were treated with triple antithrombotic therapy. Eleven (9.2%) of the 119 patients suffered a life-threatening bleeding. Their relative risk of life-threatening bleeding was 4.3 (95% CI 2.4–7.7) compared with the CURE study population. There was no difference in minor bleeding. Among patients not eligible according to the CURE criteria, but receiving intensive antithrombotic treatment, the relative risk of life-threatening bleeding was 6.4 (95% CI 3.1–12.9). Conclusions: When triple antithrombotic therapy is used in clinical practice in NSTE-ACS patients, the risk of bleeding may exceed that reported in trials. Assessment of the bleeding risk in the individual patient is warranted.

Ethnic differences in the occurrence of acute coronary syndrome: results of the Malaysian National Cardiovascular Disease (NCVD) Database Registry (March 2006 - February 2010)

“…Registry data [92], prospective study [93] and randomized controlled trials (RCT) [94] of developed countries in ACS patients reported that the major bleeding risk was between 4.6–10.9%. Compared to developed countries, major bleeding in NCVD was generally low among all ethnic groups (0.2–0.7%) and this finding was similar to those in the ACS Registry in India (0.2–0.3%) (CREATE) and Middle Eastern countries (0.83%) [95].…”

Predictors of Bleeding and Time Dependence of Association of Bleeding With Mortality

“…2,16 However, this approach is also associated with a higher incidence of bleeding. [17][18][19] Therefore, it is not surprising that treatment with prasugrel and other novel and potent P2Y 12 antagonists was associated with a higher incidence of several types of bleeding events. 20 The large sample size, long-term follow-up, well characterized population, adjudication of bleeding events, and opportunity to study patients with 2 drugs of differing potency are strengths of the analyzed cohort.…”

“…2,16 Ez a megközelítés azonban magasabb vérzési incidenciával is társul. [17][18][19] Így nem meglepő, hogy a prasugrellel, illetve más új és hatékony P2Y 12 -antagonistával történő kezelés bizonyos vérzéstípusok magasabb incidenciájával járt együtt. 20 A nagy mintaméret, a hosszú távú utánkövetés, az alaposan elemzett populáció, a vérzési események megítélése és a betegek két különböző erősségű gyógyszerrel történő tanulmányozásának lehetősége képezik az elemzett kohorsz erős-ségeit.…”

External Validity of the ARISTOTLE Trial in Real‐Life Atrial Fibrillation Patients

“…Consequently, patient selection in any RCT depends on the inclusion and exclusion criteria, and the study population always differs from the general population with the index disease. When applying the tested intervention to patients not fulfilling enrollment criteria the observed effect and safety may differ from what was seen in the clinical trial .…”