FFR Disappoints as Files for PCI on Non-Culprit Lesions in STEMI

Hemodynamic review did no longer give a enhance to guidance for total revascularization in multivessel stenting for sufferers with ST-phase elevation MI (STEMI), based mostly solely on the FLOWER-MI trial.

Fractional movement reserve (FFR) used to be no higher than angiography at guiding percutaneous coronary intervention (PCI) on nonculprit lesions by manner of 1-year scientific outcomes among extra than 1,000 scrutinize participants, reported Etienne Puymirat, of the European Health heart of Georges Pompidou in Paris.

By then, the blended rate of all-motive mortality, MI, or unplanned hospitalization main to pressing revascularization used to be identical between sufferers randomized to FFR or angiographic guidance (5.5% vs 4.2%, HR 1.32, 95% CI 0.78-2.23). There were no variations particularly person endpoint parts either, Puymirat talked about on the American College of Cardiology (ACC) digital assembly. FLOWER-MI outcomes were concurrently revealed in the Modern England Journal of Medication.

“On the opposite hand, given the wide confidence intervals for the estimate of arrangement, the findings mark no longer enable for a conclusive interpretation,” Puymirat’s community warned. A necessary limitation of the trial used to be the low selection of scientific occasions ensuing in the necessary evaluation being underpowered.

Essentially based mostly totally on William Fearon, MD, of Stanford College in California, it will most likely perchance be expected that the 2 groups would don’t absorb any incompatibility in outcomes on condition that every affected person acquired main PCI and nearly all of each and each community underwent subsequent PCI for a nonculprit vessel. He used to be no longer interesting with FLOWER-MI.

Yet the numerically higher event rate after FFR guidance used to be a surprise, based mostly solely on Roxana Mehran, MD, of Mount Sinai Health heart in Modern York Metropolis, who used to be also no longer fascinated by the scrutinize.

In the end, the shortcoming of statistical incompatibility in outcomes between groups “begs the request of whether or no longer physiology-guided PCI is ample in combating subsequent occasions, especially in borderline lesions in the environment of MI, when we know that these sufferers produce other inclined plaques that can perchance no longer be most efficient detected by physiologic overview,” Mehran talked about.

“Given the inconclusive FLOWER-MI trial outcomes, clinicians need to peaceable continue performing non-wrongdoer PCI in sufferers with STEMI and multivessel illness, but need to peaceable mark so the employ of an angio-[guided] quite than an FFR-guided, approach,” commented Herbert Aronow, MD, MPH, of Lifespan Cardiovascular Institute and Alpert Medical College of Brown College in Providence, Rhode Island.

FLOWER-MI used to be a multicenter trial that enrolled STEMI sufferers with multivessel illness after they’d gone by successful PCI of the infarct-connected artery. Contributors were randomized to FFR guidance (n=586) or angiographic guidance (n=577).

The 2 groups shared identical baseline traits. Mean age used to be 62.2, and males accounted for over 80% of the general cohort.

Entire revascularization happened over staged intervention around 3 days apart in over 95% of other folks in every scrutinize arm, suggesting that “FFR dimension that is performed on the a comparable time as PCI of the infarct-connected artery shall be unrealistic under routine scientific conditions,” based mostly solely on the FLOWER-MI community.

“Our outcomes need to peaceable therefore be interpreted as relating sufferers who’re undergoing staged multivessel procedures. Staged procedures say the affected person to a second design with its connected dangers, and in some instances the second design proves pointless since no intervention shall be performed,” the authors talked about.

Average selection of stents positioned per affected person in nonculprit lesions used to be 1.01 and 1.50 among FFR and angiography groups, respectively.

This used to be a ravishing incompatibility “suggesting that most nonculprit lesions were severe and no longer intermediate, where dimension of FFR can also merely need extra of a earnings,” Fearon talked about.

FFR guidance had been beforehand proven to minimize necessary destructive cardiovascular occasions over angiography in PCI on other folks with stable multivessel illness in the FAME trial, scrutinize authors smartly-known.

It’s a long way unclear why the findings of FAME differ from FLOWER-MI.

Notably, PCI used to be performed in 66.2% of FFR community and 97.1% of the angiography community in FLOWER-MI, reflecting stricter requirements for performing PCI with FFR. Operators had been told to measure FFR in all lesions judged to absorb stenosis on the very least 50% on visible estimation; FFR 0.80 or less used to be regarded as clinically necessary.

“In our trial, the event-rate curves for the necessary diverged after 6 months. Despite the truth that this divergence can also merely constitute an artifact in gape of the puny selection of occasions, moreover it is a long way most likely that some lesions that had been left untreated in the FFR-guided community worsened throughout observe-up, which ended in the occurrence of scientific occasions,” Puymirat’s community urged.

Aronow cited DANAMI-3 and Evaluate-Acute as trials that had supported FFR guidance in total revascularization.

Future comparisons of FFR and angiography in total revascularization for STEMI are no longer doubtless to occur, Puymirat and colleagues urged.

“Given the low incidence of occasions noticed, extra than 8,000 sufferers would be wished to expose a 15% decrease relative disaster of the composite ; this reduction would correspond to a decrease absolute disaster of 0.6 share aspects for the FFR-guided approach, a incompatibility of uncertain scientific significance,” they wrote.