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Prof. Philippe Gabriel Steg,
Presenter report: Nielsen, Torsten Toftegaard (Denmark)
Long-term randomized results on transfer for primary angioplasty (pPCI) versus on-site fibrinolysis for treatment of STEMI patients are sparse.The DANAMI-2 trial randomized 1572 STEMI patients to primary angioplasty (pPCI) or fibrinolysis (alteplase); 1129 of the patients were enrolled at 24 local hospitals without PCI facilities. Ninety-six percent of inter-hospital transfers for pPCI were completed within two hours. At 30 days, inter-hospital transfer for pPCI compared with fibrinolysis halved the primary composite endpoint of death, clinical reinfarction, or disabling stroke. The present study reports the long term (3 year) outcome. No patients were lost to follow-up. The initial benefit of transfer for primary angioplasty based on the composite endpoint was sustained after three years (20.1 vs 26.7%, p=0.0007). Death occurred in 13.6 vs 16.4% (p=0.18), clinical reinfarction in 8.9% vs 12.3% (p=0.05), and disabling stroke in 3.2 vs 4.7% (p=0.23). Independent predictors of death were: clinical reinfarction, HR: 5.23 (3.63-7.54), anterior STEMI, HR.1.68 (1.26-2.23) and age, HR 1.08 (1.07-1.10). We conclude that when inter-hospital transfer can be completed within two hours, primary angioplasty should be preferred over on-site fibrinolysis.
Discussant report: Steg, Philippe Gabriel (France) The DANAMI 2 trial investigators presented 3 year follow up of their landmark randomized clinical trial which compared fibrinolysis to transfer for primary PCI in STEMI patients.
The follow up rate was 100 % testifying to the excellent quality of the conduct of the trial. The main result is that the 30 day benefit which was seen in the composite endpoint of death, reinfarction or stroke is essentially maintained at 3 years.
That benefit, which was driven by the reduction in reinfarction, should however be analyzed in the light of points which have emerged since DANAMI 2 was designed and performed
1. The rate uf use of rescue PCI was very low 1.9%, despite the fact that 40 to 50% are known to fail thrombolysis (but the result s of the REACT trial which have established the benefits of rescue PCI were not known at the time). 2. The use of clopidogrel was restricted to the group of patients randomized to PCI. Yet we have learned since CLARITY that clopidogrel in conjunction with aspirin is extremely effective at preventing reinfarction. 3. Finally, the rate of use of early PCI in the 30 days following randomization was low. Yet, 3 randomized trials (GRACIA 1, CAPITAL MI and SIAM III have suggested benefit of early PCI following lysis (in contrast to systematic immediate PCI, ineffective in ASSENT 4 PCI). The results of the upcoming CARESS in AMI trial, which has compared early PCI following lysis to a strategy of medical therapy (but allowing rescue PCI in case of lysis failure) will help to clarify the interpretation of DANAMI-2.
Finally, a more speculative point is that the outcomes in lysis patients treated in PCI centers were markedly superior to those of lysis patients treated in referral centers, a finding which may reflect superior quality of care in large PCI centres, or a greater use of PCI following lysis.
In conclusion, DANAMI 2 changed practice (and rightfully so) and, 3 years down the line, the results are still valid and consistent with the early outcomes. Congratulations to our Danish colleagues!
Clinical Trial Update I