Background: Octogenarian patients represent an increasingly growing population. In addition, this age group has a higher proportion of co-morbidities with more extensive and complex coronary disease. However, they have often been excluded from major studies, whose average age is usually 60 years. Despite having a more complex coronary anatomy, the role of pharmacological stent (DES) in this age group is unknown due to the high risk of bleeding in the event of receiving prolonged dual antiplatelet therapy.
Methods and Results: The study was conducted in centers in Spain and the UK with patients aged 80 years or over who had stable angina or acute coronary syndrome requiring angioplasty with stent placement in one of the following situations: trunk injuries of left coronary lesions ≥ 15 mm in length with a vessel diameter of ≤ 3mm or lesions with increased risk of restenosis, (total occlusions, bifurcations, severe calcification). We excluded patients with ST-segment elevation AMI, cardiogenic shock, a life expectancy of less than 1 year, recent gastrointestinal bleeding, a prior hemorrhagic cerebrovascular event or a known allergy to clopidogrel/ASA/heparin /contrast. The primary endpoint was the occurrence of death, MI, stroke, reoperation or hemorrhage, (stratified by TIMI study), after 1 year of follow up. Patients were randomized to the implantation of DES, (N = 399), or bare metal stent, (BMS, N = 401). The BMS group of patients received dual antiplatelet therapy for 1 month, while the DES group of patients received 12 months. After 12 months of follow up, the DES group presented a lower incidence of myocardial infarction, (4.3 versus 8.7%, P = 0.01), and reoperation, (2 versus 7%, p = 0.0009), with similar mortality stroke and bleeding. With regard to bleeding, when we separated the group in relation to the period in which the bleeding occurred, we noted a trend showing a higher number bleeding after 6 months follow-up, (0.2 versus 1%, p = 0.22) , but with no differences in other intervals, (after 0.7 months versus 0.5, and 0.7 versus 1-6 months. 0.8).
Conclusions: Octogenarian patients produced good results both with the use of DES and with BMS, presenting similar survival or bleeding rates between the groups. Patients receiving the DES implantation had lower rates of MI and repeat procedures.
3_adam_belder
Adam J. de Belder
2012-10-26
Original title: XIMA: A prospective Randomized Trial of Everolimus-Eluting Stents vs Bare-Metal Stents in Octogenarians