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WASHINGTON — When treating ST-segment elevation MI (STEMI) patients with multivessel disease, a fraction flow reserve (FFR)-guided strategy of complete revascularization produced better outcomes than stenting the culprit artery alone, according to a late-breaking trial presented here.

Twelve months after the percutaneous coronary intervention (PCI), incomplete revascularization was associated with a nearly tripled rate of adverse events (combined all-cause death, nonfatal MI, revascularization, and cerebrovascular events): 20.5% compared with 7.8% for complete revascularization (HR 0.35 with complete versus incomplete revascularization, 95% CI 0.22-0.55, P<0.001), reported Pieter C. Smits, MD, PhD, of Maasstad Hospital in the Netherlands, at the annual American College of Cardiology meeting.

The study’s findings were also published online in the .

According to Smits and collaborators of the Compare-Acute trial, there was no difference between groups for death (1.4% for complete revascularization versus 1.7% for infarct artery-only stenting, HR 0.80, 95% CI 0.25-2.56) and MI (2.4% versus 4.7%, HR 0.50, 95% CI 0.22-1.13).

Incomplete revascularization was namely disadvantaged by repeat revascularizations (6.1% versus 17.5%, 95% CI 0.32, 95% CI 0.20-0.54) and cerebrovascular events (0% versus 0.7%). There were also two FFR-related serious adverse events in this cohort: a dissection leading to occlusion and and fatal MI; and an occlusion followed by STEMI and recurrent chest pain.

According to , of The University of Texas Health Science Center at Houston, “the weakness of the trial was the inclusion of revascularization in the primary endpoint. After FAME 2, there was the question of should we focus more on hard outcomes?”

“Is this something patients will want? And that health care systems will want to pay for? A move to a FFR strategy means having to pay for extra wires. That will be useful to do if you can show a reduction in death and MI,” the panelist continued.

“There was a 40% relative reduction, but that didn’t reach statistical significance because of the modest trial size,” he said. “We need to wait for further outcomes trials.”

“In contrast with the DANAMI-3-PRIMULTI trial, in our trial the FFR-guided revascularizations were performed during primary PCI. This strategy limits the need for sequential catheterizations and has the potential to limit costs, given the significantly lower frequency of predischarge stress tests and recurrent hospital admissions for chest pain and heart failure in the group receiving FFR-guided revascularization,” Smits’ group commented in the NEJM paper.

Complete revascularization added just 6 minutes on average and used 22 mL more contrast.

Panelist , of VA Long Beach Health Care System School of Medicine, Calif., said he was a “fan” of routine FFR assessment in the cath lab. “Now you could defer the intervention to another day as in staged procedure, but at least you’ll know whether or not to do that instead of blindly bringing them back and then do FFR.”

In the multicenter trial, 885 STEMI patients in Europe and Asia with multivessel disease (at least 50% stenosis in a nonculprit lesion) were enrolled. All had already undergone primary PCI of the culprit artery when they were randomized to FFR-guided stenting of non-infarct-related coronary arteries during the index hospitalization (n=295) or FFR evaluation without further revascularization (n=590).

Stenting of nonculprit vessels was done, preferably with everolimus-eluting stents, if FFR was at or below 0.80.

Clinically indicated elective revascularizations within 45 days of incomplete PCI were not counted in the primary endpoint. Excluded from the study were individuals with left main disease, chronic total occlusion, severe stenosis, suboptimal primary PCI, severe valve dysfunction, and Killip class III and IV heart failure.

Approximately half of non-infarct-related arteries deemed significant on coronary angiography turned out to have FFR values above 0.80 and were therefore not physiologically significant.

“Should the Compare-Acute trial, in combination with previous randomized trials, result in a change in guidelines to support the use of complete revascularization in all patients with STEMI and multivessel disease? This strategy appears to be safe, but it may not be necessary in all patients,” according to , of Denmark’s Rigshospitalet, in an editorial accompanying the NEJM study.

“Only one third of repeat revascularizations were performed as a result of acute coronary syndromes, a finding that is consistent with … another trial involving FFR-guided intervention. The results of the Compare-Acute trial represent a select population in which fewer than one patient per month per center underwent randomization, on average. Unfortunately, the investigators were not able to provide information on patients who were eligible for the study but were not enrolled.”

“In addition, treatment allocation and angiographic results were known by treating physicians,” Køber commented.

“The observation that patients with FFR-negative nonculprit stenoses in the complete-revascularization group had fewer events than patients with FFR-negative nonculprit stenoses in the infarct-artery-only group suggests that knowledge that the patient had not undergone complete revascularization may have triggered earlier repeat revascularization in the infarct-artery-only group.”

“It remains uncertain whether the strategy will translate into a reduction in the rate of hard end points,” the editorialist concluded. “Larger trials powered for hard end points (recurrent MI or cardiovascular mortality) are needed to determine the effects of an FFR-guided complete-revascularization strategy on those outcomes and to identify the subgroups of patients most likely to benefit.”

Køber noted that one such trial, , is in the recruiting phase.

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