FAST-MI Registry: Fibrinolysis, Primary PCI Yield Similar 5-Year Survival in STEMI Patients

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Patients with ST-segment elevation myocardial infarction (STEMI) who receive thrombolytic therapy with or without rescue PCI have long-term survival comparable to those who undergo primary percutaneous coronary intervention (PCI), according to data from a ‘real-world’ registry published online March 21, 2014, ahead of print in Circulation.

Nicolas Danchin, MD, PhD, of Hôpital Européen Georges Pompidou (Paris, France), and colleagues examined 5-year all-cause mortality rates for 1,492 STEMI patients enrolled in the 2005 cohort of the FAST-MI (French registry of Acute ST-elevation or non-ST elevation Myocardial Infarction) registry at 223 centers. All patients sought medical attention within 12 hours of symptom onset, with patients receiving:

  • Fibrinolysis (n = 447; 30%)
  • Primary PCI (n = 583; 39%)
  • No reperfusion (n = 462; 31%)

Within the fibrinolysis group, 66% of patients were treated before hospital arrival and 84% subsequently required rescue PCI.

Trends Favor Fibrinolytic Therapy

At 5 years, crude survival rates were 65% in patients without reperfusion, 88% for the fibrinolysis group, and 84% for the primary PCI group. Compared with no reperfusion, adjusted hazard ratios for 5-year death were similar for primary PCI (HR 0.57; 95% CI 0.43-0.74) and the pharmaco-invasive strategy (HR 0.48; 95% CI 0.35-0.68). However, direct comparison of the 2 reperfusion techniques showed a trend favoring fibrinolysis (HR 0.73; 95% CI 0.50-1.06; P = 0.10).

Analysis of the timing of fibrinolytic therapy indicated that prehospital administration was associated with lower 5-year mortality compared with primary PCI (HR 0.57; 95% CI 0.36-0.88), while in-hospital administration was associated with a trend toward higher 5-year mortality (HR 1.19; 95% CI 0.72-1.96).

Fibrinolysis patients who underwent rescue PCI saw a trend toward increased 5-year mortality compared with routine PCI following fibrinolysis (adjusted HR 1.68; 95% CI 0.85-3.33). Subgroup analyses showed no interaction between type of reperfusion therapy and age, sex, time from symptom onset to call seeking treatment, or diabetes.

The study included a subset of patients who had a time from symptom onset to call within 180 minutes and were treated with either fibrinolysis or primary PCI beyond 90 minutes of that first call. In this group, 5-year survival was 88% with fibrinolysis and 81% with intended primary PCI (P = 0.009) with an adjusted HR of 0.63 (95% CI 0.41-0.98; P = 0.039).

In propensity-matched analysis of 348 pairs, 5-year survival was similar for primary PCI and fibrinolysis (85.3% vs 87.9%; P = 0.30). Adjustment for admission to site with catheterization laboratory, use of GPIs within 24 hours of admission, and performance of angiography in the fibrinolysis group did not change the results.

EMS System May Play Role in Advantage

In an editorial accompanying the study, Frans Van de Werf, MD, PhD, and Peter R. Sinnaeve, MD, PhD, both of KU Leuven (Leuven, Belgium), say there is likely to be “at least some bias” in the treatment strategy selected for individual patients.

They point out that those in the fibrinolysis group were more likely to be transported by an ambulance with a physician on board, which probably expedited initiation of treatment and also diagnosis in case of atypical presentation. It is unclear whether the high 5-year survival rates seen in FAST-MI can be obtained in other healthcare systems, especially those made up exclusively of paramedics, they note.

Additionally, Drs. Van de Werf and Sinnaeve surmise that prehospital fibrinolysis was likely given to early presenters with a clear diagnosis and no obvious comorbidity, features associated with better long-term survival.

“Taken together, and awaiting long-term follow-up from STREAM [Strategic Reperfusion Early After Myocardial Infarction trial], a contemporary pharmaco-invasive management appears to be at least as good as primary PCI in STEMI patients presenting early after symptom onset when a timely PCI is not an option,” they observe.

Not So FAST

“Frankly, to get thrombolytics, you have to be intrinsically healthier,” said Jeffrey W. Moses, MD, of NewYork-Presbyterian Hospital/Columbia University Medical Center (New York, NY), in a telephone interview with TCTMD. “My problem with looking at survival curves in this type of environment is: are you just looking at confounding [due to] the triage of the individual?”

He agreed that in certain situations, particularly when PCI access is limited, “thrombolysis perhaps isn’t as unsafe as we thought based on the ASSENT trials if you time the intervention carefully and use the right doses. But there are still trade-offs of bleeding. [Thrombolysis has] never been demonstrated in a convincing fashion to be better than PCI. But in my mind [this study] does leave the door open in remote geographies [where] it seems to be an acceptable therapy.”

However, Dr. Moses expressed reservations about thrombolytic therapy for STEMI. “I’m not sure we have convincing evidence that it’s the best way to go,” he added. “This study does give us some useful information, but more is obviously needed.”

Study Details

Patients who did not receive reperfusion therapy were older, with more frequent history of cardiovascular disease and comorbidity, and an overall higher-risk profile.

Patients treated with either fibrinolysis or intended primary PCI had similar GRACE scores. However, the fibrinolysis patients sought medical attention earlier after symptom onset than those who received primary PCI (352 min vs 384 min; P < 0.001). They also more often had initial TIMI 3 flow and were less likely to receive low molecular weight heparin, clopidogrel, or GPI therapy. Final TIMI 3 flow was more commonly achieved after primary PCI (90%) than in the totality of patients undergoing angiography after fibrinolysis (83%).

 


Sources:

1. Danchin N, Puymirat E, Steg PG, et al. Five-year survival in patients with ST-segment elevation myocardial infarction according to modalities of reperfusion therapy: the French registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 cohort. Circulation. 2014;Epub ahead of print.

2. Sinnaeve PR, Van de Werf F. Primary PCI not always the best reperfusion strategy? Circulation. 2014;Epub ahead of print.

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Disclosures
  • The FAST-MI registry is supported by unrestricted grants from Pfizer and Servier.
  • Dr. Danchin reports receiving research grants from AstraZeneca, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, MSD, Novartis, Pfizer, Sanofi, Servier, and The Medicines Company and consulting or lecture fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Menarini, Merck-Serono, Novo Nordisk, Roche, Servier, and Sanofi.
  • Dr. Sinnaeve reports receiving speaker and consulting fees from Boehringer Ingelheim.
  • Dr. Van de Werf reports receiving a research grant for the STREAM trial and speaker and consulting fees from Boehringer Ingelheim.
  • Dr. Moses reports serving as a consultant to Boston Scientific.

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