Mina Madan1, Sigrun Halvorsen2, Carlo Di Mario3, Mary Tan4, Cynthia M Westerhout5, Warren J Cantor6, Michel R Le May7, Francesco Borgia8, Federico Piscione9, Bruno Scheller10, Paul W Armstrong5, Francisco Fernandez-Aviles11, Pedro L Sanchez11, John J Graham12, Andrew T Yan12, Shaun G Goodman13. 1. Schulich Heart Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. Electronic address: mina.madan@sunnybrook.ca. 2. Department of Cardiology, Oslo University Hospital HF Ullevål, Oslo, Norway. 3. NIHR Cardiovascular BRU, Royal Brompton Hospital and NHLI Imperial College, London, United Kingdom. 4. Canadian Heart Research Centre, Toronto, Ontario, Canada. 5. Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. 6. Southlake Regional Medical Centre, Newmarket, Ontario, Canada. 7. University of Ottawa Heart Institute, Ottawa, Ontario, Canada. 8. Division of Cardiology, Federico II University, Naples, Italy. 9. Department of Medicine and Surgery, University of Salerno, Salerno, Italy. 10. University Hospital, University of Saarland, Homburg/Saar, Germany. 11. Hospital General Universitario Gregorio Marañón-Complutense University, Madrid, Spain. 12. Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 13. Canadian Heart Research Centre, Toronto, Ontario, Canada; Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Abstract
OBJECTIVES: This study investigated the relationship between time to invasive assessment and outcomes among ST-segment elevation myocardial infarction patients randomized to early angiography after fibrinolysis. BACKGROUND: The optimal timing of coronary angiography after fibrinolysis and the association with clinical outcomes is uncertain. METHODS: Patient-level data from 6 randomized trials, with a median time to angiography <12 h after fibrinolysis, were pooled. The primary endpoint was 30-day death or reinfarction. The key secondary endpoint was in-hospital major bleeding. The relationship between fibrinolysis to angiography time and symptom onset to angiography time with outcomes was studied using 2- and 4-h intervals, respectively, and in multivariable models. RESULTS: Among 1,238 patients, the median fibrinolysis to angiography time was 165 min, and the median symptom onset to angiography time was 5.33 h. The primary and key secondary endpoints occurred in 5.7% and 4.7%, respectively. These main endpoints did not vary significantly with increasing fibrinolysis to angiography time. Early angiography (<2 h) after fibrinolysis was not associated with increased bleeding. Recurrent ischemia increased with increasing fibrinolysis to angiography time (3.7% to 7.9%, p for trend = 0.02). Thirty-day and 1-year death/reinfarction and 30-day recurrent ischemia increased significantly with increasing symptom onset to angiography time. Neither fibrinolysis to angiography time nor symptom onset to angiography time was an independent predictor of the primary endpoint. Only symptom onset to angiography time was an independent predictor of 1-year death/reinfarction (hazard ratio: 1.07, 95% confidence interval: 1.02 to 1.12, p = 0.01). CONCLUSIONS:Very early angiography (<2 h) after fibrinolysis was not associated with an increased risk of 30-day death/reinfarction or in-hospital major bleeding, and angiography within 4 h after fibrinolysis was associated with reduced 30-day recurrent ischemia. A shorter symptom onset to angiography time (<4 h) was associated with reduced 30-day and 1-year death/reinfarction and 30-day recurrent ischemia. In the current environment of regional networks of 24/7 primary percutaneous coronary intervention (PCI) centers, the clinical implication of these findings is that patients initially treated with fibrinolysis should also be promptly transferred to the nearest PCI center for immediate angiography and PCI. (Early Percutaneous Coronary Intervention [PCI] After Fibrinolysis Versus Standard Therapy in ST Segment Elevation Myocardial Infarction [STEMI] Patients; NCT01014182).
RCT Entities:
OBJECTIVES: This study investigated the relationship between time to invasive assessment and outcomes among ST-segment elevation myocardial infarctionpatients randomized to early angiography after fibrinolysis. BACKGROUND: The optimal timing of coronary angiography after fibrinolysis and the association with clinical outcomes is uncertain. METHODS:Patient-level data from 6 randomized trials, with a median time to angiography <12 h after fibrinolysis, were pooled. The primary endpoint was 30-day death or reinfarction. The key secondary endpoint was in-hospital major bleeding. The relationship between fibrinolysis to angiography time and symptom onset to angiography time with outcomes was studied using 2- and 4-h intervals, respectively, and in multivariable models. RESULTS: Among 1,238 patients, the median fibrinolysis to angiography time was 165 min, and the median symptom onset to angiography time was 5.33 h. The primary and key secondary endpoints occurred in 5.7% and 4.7%, respectively. These main endpoints did not vary significantly with increasing fibrinolysis to angiography time. Early angiography (<2 h) after fibrinolysis was not associated with increased bleeding. Recurrent ischemia increased with increasing fibrinolysis to angiography time (3.7% to 7.9%, p for trend = 0.02). Thirty-day and 1-year death/reinfarction and 30-day recurrent ischemia increased significantly with increasing symptom onset to angiography time. Neither fibrinolysis to angiography time nor symptom onset to angiography time was an independent predictor of the primary endpoint. Only symptom onset to angiography time was an independent predictor of 1-year death/reinfarction (hazard ratio: 1.07, 95% confidence interval: 1.02 to 1.12, p = 0.01). CONCLUSIONS: Very early angiography (<2 h) after fibrinolysis was not associated with an increased risk of 30-day death/reinfarction or in-hospital major bleeding, and angiography within 4 h after fibrinolysis was associated with reduced 30-day recurrent ischemia. A shorter symptom onset to angiography time (<4 h) was associated with reduced 30-day and 1-year death/reinfarction and 30-day recurrent ischemia. In the current environment of regional networks of 24/7 primary percutaneous coronary intervention (PCI) centers, the clinical implication of these findings is that patients initially treated with fibrinolysis should also be promptly transferred to the nearest PCI center for immediate angiography and PCI. (Early Percutaneous Coronary Intervention [PCI] After Fibrinolysis Versus Standard Therapy in ST Segment Elevation Myocardial Infarction [STEMI] Patients; NCT01014182).
Authors: Francisco A H Fonseca; Maria Cristina Izar; Ieda M L Maugeri; Otavio Berwanger; Lucas P Damiani; Ibraim M Pinto; Gilberto Szarf; Carolina N França; Henrique T Bianco; Flavio T Moreira; Adriano Caixeta; Claudia M R Alves; Aline Soriano Lopes; Aline Klassen; Marina F M Tavares; Henrique A Fonseca; Antonio C C Carvalho Journal: Trials Date: 2017-12-19 Impact factor: 2.279
Authors: Erik Youngson; Robert C Welsh; Padma Kaul; Finlay McAlister; Hude Quan; Jeffrey Bakal Journal: Medicine (Baltimore) Date: 2016-08 Impact factor: 1.889