CAPTIM / CAPTIM-WEST
The Comparison of primary Angioplasty and Pre-hospital fibrinolysis In acute Myocardial Infarction (CAPTIM) study was a randomised, clinical, multi-centre trial comparing pre-hospital thrombolysis with transfer to an interventional facility (and, if necessary, percutaneous coronary intervention [PCI]) with primary PCI in patients with ST-segment-elevation myocardial infarction (STEMI).
Through the collaboration between the CAPTIM and the WEST trialists more than 300 similarly randomised STEMI patients were added to the initial CAPTIM enrolment. The CAPTIM-WEST study examined the relationship between reperfusion strategy and time from symptom onset on 1-year mortality.
In CAPTIM 840 patients who presented within 6 h of onset of symptoms of acute myocardial infarction (characteristic pain lasting for at least 30 min, not responsive to nitrates, with ECG ST-segment elevation of ≥0.2 mV in two or more contiguous leads, or left bundle-branch block) were randomly assigned to either pre-hospital fibrinolysis with accelerated alteplase (n=419) or primary angioplasty (n=421). All patients were then transferred to a centre with access to emergency angioplasty. The trial took part in 27 tertiary hospitals and their affiliated mobile emergency care.
The primary endpoint was a composite of death, non-fatal re-infarction or non-fatal disabling stroke at 30 days.
Secondary endpoints included cardiovascular mortality, refractory recurrent ischaemia, cardiogenic shock, severe bleeding, or emergent revascularisation (angioplasty or CABG).
In CAPTIM-WEST 221 patients from the WEST trial were added to the fibrinolysis arm of CAPTIM and 107 patients were added to the primary PCI arm of CAPTIM. A total of 1168 STEMI patients were examined in the combined analysis.
The primary endpoint was all-cause mortality within 1 year.
CAPTIM/ CAPTIM-WEST: study design
There was no significant difference in the composite primary endpoint between the pre-hospital fibrinolysis group and the primary PCI group at 30 days (8.2% versus 6.2%; risk difference 1.96; 95% confidence interval [CI] -1.53 to 5.46; p=0.29).
There were some differences in benefit between the two groups when the time elapsed from treatment onset was considered.
- Randomisation within 2 h (n=460) or beyond 2 h (n=374) of symptom onset had no impact on the effect of treatment on the 30-day composite primary endpoint. However, patients randomised within 2 h had a strong trend toward lower 30-day mortality with pre-hospital fibrinolysis compared to those randomised to primary PCI (2.2% versus 5.7%, p=0.058) whereas patients randomised after 2 h had similar mortality (5.9% versus 3.7%, p=0.47).
- Patients randomised 2 h to receive pre-hospital fibrinolysis had a lower incidence of cardiogenic shock than patients receiving primary PCI (1.3% versus 5.3%, p=0.032) whereas incidences were similar for patients randomised >2 h.
- The differences in cardiogenic shock were mainly driven by lower incidences of shock developing in <2 h pre-hospital fibrinolysis patients during transport to the hospital.
CAPTIM: 30-day survival, patients treated within and after 2 hours of symptom onset
Overall 1-year mortality in CAPTIM-WEST was not significantly different between thrombolysis and primary PCI (4.6% vs. 6.5%, p=0.263).
CAPTIM-WEST: Kaplan-Meier curve of 1-year survival according to treatment
The interaction between treatment and time from symptom onset to randomisation was statistically significant (p = 0.043).
- Patients randomised < 2 hours of symptom onset benefited from treatment with thrombolysis compared to those receiving primary PCI (2.8% vs 6.9%, p = 0.021, HR 0.43, 95% CI 0.20- 0.91).
- Beyond 2 hours, no treatment difference in 1-year mortality was observed (6.9% vs 6.0%, p = 0.529, HR 1.23, 95% CI 0.61-2.46).
CAPTIM-WEST: 1-year mortality, patients treated within and after 2 hours of symptom onset
Data from the CAPTIM 5-year follow-up largely support the findings from the 30-day clinical outcome data.
- Mortality at 5 years was similar for the pre-hospital fibrinolysis group and the primary PCI group (9.7% versus 12.6%; HR 0.75; 95% CI 0.50 to 1.14; p=0.18).
- However, for patients randomised within 2 h of symptom onset, mortality was lower in the pre-hospital fibrinolysis group than the primary PCI group (5.8% versus 11.1%; HR 0.50; 95% CI 0.25 to 0.97; p=0.04).
- For patients randomised after 2 h, mortality was similar.
CAPTIM: 5-year follow-up patient treated within 2 hours
- Both, the 1- year follow-up of CAPTIM-WEST and the long-term follow-up of the CAPTIM study confirm that in reference to mortality, a strategy of pre-hospital fibrinolysis with immediate transfer and rescue angioplasty if needed appears to yield similar long-term survival benefits to primary PCI in STEMI patients managed within 6 h of symptom onset.
- In patients managed within 2 hours, the pre-hospital fibrinolysis strategy reduced long-term mortality
- The data underline that different reperfusion strategies might bring similar results at the acute phase of a myocardial infarction when an appropriate pre-hospital organisation is operative.
- Bonnefoy, E, Lapostolle, F, Leizorovicz, A, et al. Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study. The Lancet 2002;360:825-829.
- Bonnefoy, E, Steg, PG, Boutitie, F, et al. Comparison of primary angioplasty and pre-hospital fibrinolysis in acute myocardial infarction (CAPTIM) trial: a 5-year follow-up. Eur Heart J 2009;30:1598-1606.
- Steg, PG, Bonnefoy, E, Chabaud, S, et al. Impact of Time to Treatment on Mortality After Prehospital Fibrinolysis or Primary Angioplasty. Circulation 2003;108:2851-2856.
- Westerhout, CM, Bonnefoy, E, Welsh, RC, et al. The influence of time from symptom onset and reperfusion strategy on 1-year survival in ST-elevation myocardial infarction: A pooled analysis of an early fibrinolytic strategy versus primary percutaneous coronary intervention from CAPTIM and WEST. Am Heart J 2011;161(2):283-290.