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Transfer for primary PCI remains superior to fibrinolysis at 16 years in DANAMI-2

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PARIS — The benefit of interhospital transfer for primary PCI over fibrinolysis at the local hospital was maintained at 16-year follow-up in the DANAMI-2 trial, according to data presented at the European Society of Cardiology Congress.

In DANAMI-2, 1,572 patients with STEMI were randomly assigned to primary PCI or fibrinolysis at 24 referral hospitals and five invasive centers in Denmark. Patients randomly assigned to primary PCI at referral hospitals were immediately transported to the nearest invasive center.

At 16 years, the primary composite endpoint of death or rehospitalization for MI was lower among patients assigned to primary PCI compared with those treated with fibrinolysis in the overall cohort (58.7% vs. 62.3%; HR = 0.86; 95% CI, 0.76-0.98), and among those transported for primary PCI (58.7% vs. 64.1%; HR = 0.82; 95% CI, 0.71-0.96). According to the researchers, the reduction in the composite endpoint was primary caused by lower rehospitalization for MI in the primary PCI group (19% vs. 24.5%; HR = 0.75; 95% CI, 0.6-0.93), Michael Maeng, MD, of Aarhus University Hospital and Aarhus University, said during a press conference.

Also at 16 years, results showed an absolute reduction of 4.4 percentage points in cardiac death (18.3% vs. 22.7%; HR = 0.78; 95% CI, 0.63-0.98) and an absolute reduction of 5.5 percentage points in reinfarction rates (19% vs. 24.5%; HR = 0.75; 95% CI, 0.6-0.93), both in favor of primary PCI.

“[T]he study is the first to document a significant reduction of cardiac mortality compared to fibrinolysis,” the researchers wrote in European Heart Journal.

Additionally, primary PCI postponed time to reinfarction or death by 12.3 months compared with fibrinolysis (95% CI, 5-19.5).

Results were similar in subgroup analyses of referral hospitals and invasive hospitals, Maeng said.

“Physicians should feel confident that primary PCI is the best way to treat STEMI patients — even after 16 years — if transport can be achieved within 2 hours,” Maeng said here.

Previously reported results from DANAMI-2 showed that the reperfusion strategy with primary PCI improved the composite outcome of death, reinfarction or disabling stroke at 30 days, when transport was achieved within 2 hours. Follow-up studies found sustained benefit at 3 and 8 years. This finding was later confirmed in other studies, including PRAGUE-2.

DANAMI-2 enrolled patients with STEMI from December 1997 to October 2011. The median age at baseline was 63 years.

At 16 years, vital status was available for 99.7% of the overall population.

These findings support “the current international guidelines, which state that primary PCI should be offered if time of STEMI diagnosis or first medical contact to reperfusion (wire crossing) is within 120 minutes, and reinforce that a primary PCI strategy with fast access to primary PCI-capable hospitals should be implemented in countries or regions where this strategy is possible,” the researchers wrote in European Heart Journal. – by Katie Kalvaitis

References:

Maeng M. Hot Line Session 4. Presented at: European Society of Cardiology Congress; Aug. 31-Sept. 4, 2019; Paris.

Thrane PG, et al. Eur Heart J. 2019;doi:10.1093/eurheartj/ehz595.

Disclosure: Maeng reports no relevant financial disclosures.