Alfonso Ielasi1, Salvatore Brugaletta2, Antonio Silvestro1, Angel Cequier3, Andrés Iñiguez4, Antonio Serra5, Rosana Hernandez-Antolin6, Vicente Mainar7, Marco Valgimigli8, Pieter den Heijer9, Armando Bethencourt10, Nicolás Vazquez11, Patrick Serruys12, Manel Sabate2, Maurizio Tespili13. 1. Hospital "Bolognini" Seriate, Bergamo, Italy. 2. University Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 3. Heart Institute, University Hospital of Bellvitge, Barcelona, Spain; University Hospital of Bellvitge (IDIBELL), Barcelona, Spain. 4. Hospital do Meixoeiro, Vigo, Spain. 5. University Hospital of Sant Pau, Barcelona, Spain. 6. University Hospital San Carlos, Madrid, Spain. 7. Hospital General of Alicante, Alicante, Spain. 8. University Hospital Ferrara, Ferrara, Italy. 9. Amphia Ziekenhuis, Breda, The Netherlands. 10. Hospital Son Dureta, Palma de Mallorca, Spain. 11. Hospital Juan Canalejo, A Coruña, Spain. 12. Erasmus Medical Center, Rotterdam, The Netherlands. 13. Hospital "Bolognini" Seriate, Bergamo, Italy. Electronic address: tespili@katamail.com.
Abstract
BACKGROUND: The elderly (≥75years) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly (<75years). Whether the effects of everolimus-eluting stent (EES) in ST-segment elevation myocardial infarction (STEMI) are independent of age has not been reported. We investigated the outcomes following primary PCI (PPCI) with bare-metal stent (BMS) or EES in elderly vs. non-elderly STEMI patients. METHODS: The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES. The primary patient-oriented endpoint (POCE) was the combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization at 1-year. The secondary endpoint included the device-oriented combined (DOCE) of cardiac death, target-vessel MI and target-lesion revascularization. These endpoints and their components were compared between elderly and non-elderly. RESULTS: Among patients enrolled in the trial, 245 (16.3%) were elderly, allocated to BMS (n=132) or EES (n=113), while the remaining 1253 (83.7%) were non-elderly, allocated to BMS (n=615) or EES (n=638). At 1-year, both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group (24.5% vs. 10.5%, p<0.001 and 15.9% vs. 5.1%, p<0.001). Whereas in non-elderly, both POCE and DOCE were lower in EES vs. BMS (12.4% vs. 8.8%, p=0.03 and 6.7% vs. 3.6%, p=0.01), no differences were found in elderly, with a tendency for interaction between age and stent type for POCE (p=0.05). On multivariate analysis age ≥75 years was an independent predictor of POCE (HR 2.19 [95%CI 1.59-3.01], p<0.0001) and DOCE (HR 2.42 [95%CI 1.60-3.7], p<0.001) at 1-year. CONCLUSIONS:In STEMI patients undergoing PPCI, advanced age (≥75 years) is associated with worse outcomes. The beneficial effects of EES over BMS tended to be age-dependent.
RCT Entities:
BACKGROUND: The elderly (≥75years) constitute a high-risk subset of patients who continue to have a poorer prognosis than non-elderly (<75years). Whether the effects of everolimus-eluting stent (EES) in ST-segment elevation myocardial infarction (STEMI) are independent of age has not been reported. We investigated the outcomes following primary PCI (PPCI) with bare-metal stent (BMS) or EES in elderly vs. non-elderly STEMI patients. METHODS: The EXAMINATION trial randomized 1498 STEMI patients to BMS or EES. The primary patient-oriented endpoint (POCE) was the combined of all-cause death, any-recurrent myocardial infarction (MI) and any-revascularization at 1-year. The secondary endpoint included the device-oriented combined (DOCE) of cardiac death, target-vessel MI and target-lesion revascularization. These endpoints and their components were compared between elderly and non-elderly. RESULTS: Among patients enrolled in the trial, 245 (16.3%) were elderly, allocated to BMS (n=132) or EES (n=113), while the remaining 1253 (83.7%) were non-elderly, allocated to BMS (n=615) or EES (n=638). At 1-year, both the POCE and DOCE were observed more frequently in elderly vs. non-elderly group (24.5% vs. 10.5%, p<0.001 and 15.9% vs. 5.1%, p<0.001). Whereas in non-elderly, both POCE and DOCE were lower in EES vs. BMS (12.4% vs. 8.8%, p=0.03 and 6.7% vs. 3.6%, p=0.01), no differences were found in elderly, with a tendency for interaction between age and stent type for POCE (p=0.05). On multivariate analysis age ≥75 years was an independent predictor of POCE (HR 2.19 [95%CI 1.59-3.01], p<0.0001) and DOCE (HR 2.42 [95%CI 1.60-3.7], p<0.001) at 1-year. CONCLUSIONS: In STEMI patients undergoing PPCI, advanced age (≥75 years) is associated with worse outcomes. The beneficial effects of EES over BMS tended to be age-dependent.