DANAMI 3-DEFER: No benefit from delayed stenting for patients with STEMI

CHICAGO — Deferred stent implantation does not reduce all-cause mortality or hospitalization for HF, recurring MI or repeat revascularization in patients with STEMI, researchers reported at the American College of Cardiology Scientific Session.

Perspective from Khaldoon Alaswad, MD

“The take-home message from this study is that deferred stent implantation cannot be recommended as a routine procedure for STEMI patients treated with primary [PCI],” Henning Kelbӕk, MD, from Zealand University Hospital in Roskilde, Køge, Denmark, said in a press release.

Henning Kelbӕk

Patient criteria included acute onset of symptoms of 12 hours’ duration or less and ST-segment elevation ≥ 0.1 mV in at least two contiguous ECG leads or newly developed left bundle branch block.

The 1,207 patients in the DANAMI 3-DEFER study were randomly assigned to either standard primary PCI with stent implantation or delayed stenting for 48 hours. The primary endpoint was a composite of all-cause mortality, hospitalization for HF, reinfarction and repeat target lesion revascularization. The secondary endpoint was left ventricular ejection fraction at 18 months. Follow-up lasted for more than 3 years.

The results were published simultaneously in the Lancet.

Seventeen percent in the DEFER group and 18% in the standard treatment group met the primary endpoint (HR = 0.99; 95% CI, 0.75-1.29; P = .92). LVEF at 18 months was 57% for traditional PCI and 60% for delayed stenting (P = .04).

In other results, the rate of procedure-related MI, stroke, bleeding requiring transfusion or surgery and contrast-induced nephropathy was 5% in the standard treatment group vs. 4% in the delayed stenting group; this finding was not significant (P = .94).

Kelbӕk acknowledged certain limitations to the study, including that it was a relatively small sample and that very high-risk patients were mostly not included.

Kelbӕk and colleagues plan on conducting subgroup analyses on patients who might have benefited from deferred stenting in addition to patients in whom the treatment might have worsened their condition.

“Don’t consider this trial as negative even though the results were neutral,” he said during a press conference. “We will be looking closer at subgroups to see if there are some patients who would benefit from deferred stenting.”

He pointed out that they found a small improvement in heart-muscle function 18 months after treatment in the deferred stenting group. – by Tracey Romero

Reference:

Kelbӕk H, et al. Joint ACC/TCT Late-Breaking Clinical Trials III. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Kelbӕk H, et al. Lancet. 2016; doi:10.1016/S0140-6736 (16) 30072.

Disclosure: The study was funded by the Danish Agency for Science, Technology and Innovation and Danish Council for Strategic Research. Kelbӕk reports no relevant financial disclosures.

Perspective

Khaldoon Alaswad, MD

There are a couple of important messages from this trial. First, for the current generation of cardiologists who have always stented immediately, it is important for them to see that there is not much penalty for delaying it when required. Second, while we always thought that we tended to oversize the stent, these findings show that the average diameter of the stents in both groups was 3.5 mm. Overall, the findings don’t give us a final answer. We still have work to do.

Khaldoon Alaswad, MD

Director, Catheterization Laboratory

Edith and Benson Ford Heart & Vascular Institute, Henry Ford Hospital, Detroit

Governor, Michigan Chapter, ACC

Disclosures: Alaswad reports no relevant financial disclosures.