Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies

Abstract

AimsTo compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce.Methods and resultsPatients ≥75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enroling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9%) and 34 (25.4%) in the fibrinolysis arm [odds ratio (OR), 0.69; 95% confidence interval (CI) 0.38–1.23; P = 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2%, P = 0.43), re-infarction (5.3 vs. 8.2%, P = 0.35), or disabling stroke (0.8 vs. 3.0%, P = 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7%, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95% CI 0.45–0.91).ConclusionPrimary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available.Clinicaltrials.gov # NCT00257309.

Clinical outcome, and survival between primary percutaneous coronary intervention versus fibrinolysis in patients older than 60 years with acute myocardial infarction

“…Use of stents in this trial was higher (100%) than in previous studies (51% in the Zwolle series[4]) but TIMI flow was similar. There was no difference in the mean ejection fraction measured with echocardiography between the two groups.…”

Percutaneous coronary intervention in the elderly with ST-segment elevation myocardial infarction

“…The larger as yet unpublished Senior PAMI (Primary Angioplasty in Myocardial Infarction) trial (ClinicalTrials.gov identifier NCT00136929),14,15 which included 481 patients older than 70 years, failed to document a difference between primary PCI and fibrinolysis with regard to primary outcome (30-day mortality or stroke) or mortality. TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos [Treatment of acute myocardial infarction in the elderly]) was a randomized multicenter, open-label, clinical trial that included patients aged ≥75 years who presented with STEMI within the first 6 hours after symptom onset 16. The primary endpoint was reached in 25 (18.9%) patients in the primary PCI group and 34 (25.4%) in the fibrinolysis group (odds ratio [OR] 0.69; 95% confidence interval [CI] 0.38–1.23; P =0.21).…”

Study to Improve Cardiovascular Outcomes in high-risk older patieNts (ICON1) with acute coronary syndrome: study design and protocol of a prospective observational study

“…6 Notable studies, recruiting patients >75 years of age, have been reported in recent years, in the context of invasive and non-invasive management of ST-elevation MI and non-ST-elevation ACS. [7][8][9][10] Evidence-based recommendations from trials do not account for age-related differences in physiology, disease and comorbidities, which may alter the risk-benefit profile of cardiovascular treatments and interventions. The age mismatch between trial and community populations begins at 75 years and widens with age.…”