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DANAMI-2

Primary percutaneous coronary intervention (PCI) has been shown to be superior to fibrinolysis in the treatment of ST-segment elevation myocardial infarction (STEMI) patients when it can be delivered in a timely manner by an experienced team. However, the advantages of primary PCI are less certain when there are delays associated with its administration. The DANish Acute Myocardial Infarction 2 (DANAMI-2) study compared fibrinolysis within hospitals with transfer to invasive-treatment centres for PCI. The average distance between referring hospitals and invasive-treatment centres was 50 km and up to 150 km.

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The DANAMI-2 study randomly assigned 1,572 patients with acute ST-elevation myocardial infarction (symptoms present for ≥30 min but <12 h) to treatment with primary PCI or fibrinolysis (accelerated treatment with intravenous alteplase). Patients were enrolled at either 1 of 24 referral hospitals (n=1,129) or 1 of 5 invasive-treatment centres (n=443).

The primary endpoint was a composite of death from any cause, clinical evidence of re-infarction, or disabling stroke within 30 days of follow-up.

Recruitment of patients to the DANAMI-2 trial was stopped ahead of schedule when the third interim analysis showed a significant benefit of PCI in the subpopulation of patients from referring hospitals.

The 30-day clinical outcomes support primary PCI over fibrinolysis for STEMI patients, even when the patients have to be transported from a local hospital to an invasive-treatment centre. The superiority of PCI over thrombolysis was driven by a 75% reduction in re-infarction, whereas the reductions in death and stroke did not reach statistical significance.

DANAMI-2: Clinical outcome at 30 days (n=1572)

DANAMI-2 Clinical outcome at 30 days

At long-term follow-up (median time 7.8 years), the benefit of primary PCI over fibrinolysis was maintained. There was a statistically significant reduction in re-infarction, whereas the reduction in death did not reach statistical significance.

(N.B. Stroke was not considered in the long-term follow-up as a clinical diagnosis could not be extracted from the registries.)

DANAMI-2: Clinical outcome at long-term follow-up (median time 7.8 years)

Figure showing the clinical outcome at long term follow up for the DANAMI-2 study: The benefits of primary PCI over fibrinolysis was maintained in the long term follow up.

 

  • The clinical benefit of primary PCI over fibrinolysis was seen at both 30 days and at long-term follow-up, largely due to a reduction in the risk of re-infarction.
  • If the transfer of a patient to an invasive-treatment centre can be completed within 2h, primary PCI is superior to on-site fibrinolysis.
References:

  1. Nielsen, PH, Maeng, M, Busk, M, et al. Primary Angioplasty Versus Fibrinolysis in Acute Myocardial Infarction. Circulation 2010;121:1484-1491.

  2. Andersen, HR, Nielsen, TT, Rasmussen, K, et al. A Comparison of Coronary Angioplasty with Fibrinolytic Therapy in Acute Myocardial Infarction. N Engl J Med 2003;349:733-742.