DANAMI3-PRIMULTI: Complete Revascularization Improves Outcomes for STEMI
SAN DIEGO, CA—Complete revascularization using FFR-guided PCI in STEMI patients reduces adverse events at 1 year compared with infarct-related artery [IRA] PCI, according to results presented March 16, 2015, at the American College of Cardiology/i2 Scientific Session. However, the difference is driven not by hard events but by a decreased need for repeat revascularization.
“Therefore, although complete revascularization should be recommended, any condition that makes complex PCI unattractive may support a more conservative strategy of IRA PCI only,” said presenter Thomas Engstrøm, MD, DMSci, PhD, of Rigshospitalet (Copenhagen, Denmark).
For the DANAMI3-PRIMULTI trial, Dr. Engstrøm and colleagues first randomized 2,239 STEMI patients presenting within 12 hours of symptom onset to conventional primary PCI, ischemic postconditioning, or deferral of stenting at 2 institutions. Of the 2,212 patients whose IRA PCI was successful, 627 had multivessel disease (average age 64 years; 81% male) and were further randomized to no additional PCI (n = 313) or FFR-guided complete revascularization before discharge (n = 314).
Within the complete revascularization arm, 294 patients (93.6%) received their assigned treatment.
As expected, procedure duration, contrast volume, and fluoroscopy dose all were greater in the complete revascularization arm (P < .0001). More than 90% of patients in each group received DES. About one-quarter were given glycoprotein IIb/IIIa inhibitors and three-quarters bivalirudin. At discharge, nearly all patients were on aspirin, two-thirds on prasugrel, and about 20% on ticagrelor.
Fewer Repeat Procedures With Complete PCI
Data were analyzed once the last patient had been followed for 1 year.
Complete revascularization resulted in a lower risk of the primary composite endpoint (all-cause death, nonfatal MI, and ischemia-driven revascularization [PCI or CABG] of non-IRA lesions) compared with IRA PCI, but this was driven by a lower rate of repeat revascularization. No differences were seen between the groups with regard to nonfatal MI or mortality.
There were no between-group differences with regard to cardiac mortality, but patients assigned to the IRA arm were more likely to undergo both urgent (P = .03) and nonurgent PCI (P = .002).
Results were consistent for most subgroups; the only interaction seen was between treatment and age (P for interaction = .02), with complete revascularization favored in patients younger than 65 years (HR 0.33; 95% CI 0.18-0.60) but not in those aged 65 and older (HR 0.89; 95% CI 0.52-1.5).
Although DANAMI3-PRIMULTI differed in many ways from the other 2 contemporary studies of complete revascularization in multivessel disease—PRAMI and CvLPRIT—Dr. Engstrøm said, all 3 collectively “showed a relative risk reduction of the primary endpoint of between 45% and 65%.”
Still Not One Size Fits All
Discussing the study, panelist Theodore A. Bass, MD, of the University of Florida College of Medicine (Jacksonville, FL), said the trial “further confirms emerging data that in the same setting or at the least same hospitalization, more aggressive treatment may be warranted in certain patients.”
But, he asked, who should be targeted for complete revascularization? And who should be performing the procedures?
“Our data support that complete revascularization can be done without harm and with a very good outcome,” Dr. Engstrøm replied. “So you might argue: Why wait for the readmission either in the case of stable… or unstable angina with a need for urgent PCI?”
However, in some cases, the lack of difference in the hard endpoints in this trial “might support a more conservative strategy,” he noted.
Given that half of the patients have known residual disease in an unblended trial, panelist Sunil V. Rao, MD, of Duke University Medical Center (Durham, NC), said this could potentially bias against the IRA-only arm.
In designing DANAMI3-PRIMULTI, Dr. Engstrøm said, “we wanted to stress quite precisely the wording of the guidelines, which state that repeat revascularization could be either due to subjective or objective ischemia and to answer this question. But of course there may be a bias when the patients leave the hospital and know that they have stenoses that are untreated.”
Being able to translate trial data into clinical practice was key, he continued. Repeat procedures are done by many centers that do not treat STEMI, Dr. Engstrøm said, “so we wanted to [leave] it up to the discretion of the physician to decide when to do the repeat revascularization” while also acknowledging the risk of selection bias.
Engstrøm T. The third DANish study of optimal Acute treatment of patients with ST-segment elevation Myocardial Infarction: PRImary PCI in MULTIvessel disease. Presented at: American College of Cardiology/i2 Scientific Session; March 16, 2015; San Diego, CA.
- Dr. Engstrøm reports no relevant conflicts of interest.
- Dr. Bass reports receiving consulting fees/honoraria from Merck.
- Dr. Rao reports receiving consulting fees/honoraria from Terumo Medical and The Medicines Company and research grants from Bellerophon.