麻豆传媒

ATLANTA -- Fractional flow reserve (FFR)-guided complete revascularization in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease did not result in better outcomes compared with primary percutaneous coronary intervention (PCI) of the culprit lesion, the randomized FULL REVASC trial showed.

At a median follow-up of 4.8 years, a primary outcome event -- death from any cause, myocardial infarction (MI), or unplanned revascularization -- had occurred in 19% of patients in the complete-revascularization group versus 20.4% of those in the culprit-lesion-only group (HR 0.93, 95% CI 0.74-1.17, P=0.53), reported Felix Böhm, MD, PhD, of the Karolinska Institutet and Danderyd Hospital in Sweden, during the American College of Cardiology annual meeting.

There were also no differences in the composite of death from any cause or MI between the complete-revascularization group and the culprit-lesion-only group (16.5% vs 15.3%; HR 1.12, 95% CI 0.87-1.44) or unplanned revascularization (9.2% vs 11.7%; HR 0.76, 95% CI 0.56-1.04), as noted in the .

There was a benefit with full revascularization in reducing the need for planned or unplanned subsequent revascularization (HR 0.59, 95% CI 0.45-0.78), but Böhm said that came with an increased incidence of stent thrombosis.

The study did not show any differences between the two groups in the incidence of stroke, major bleeding, or rehospitalization for heart failure.

"Although the use of fractional flow reserve led to fewer stents placed in patients assigned to the complete-revascularization group, it did not affect clinical outcomes," Böhm said. "In fact, we observed a higher incidence of re-stenosis, stent thrombosis, and target-vessel revascularization in the fractional flow reserve-guided complete-revascularization group than in the culprit-lesion-only group. Moreover, the inability of fractional flow reserve to detect possible vulnerable plaques in non-culprit vessels may contribute to the absence of significant between-group differences in hard clinical outcomes."

In a , Vijay Kunadian, MBBS, MD, of Newcastle University and Cardiothoracic Centre in England, wrote, "On the basis of the results from the current trial, is it now time to give up on physiological guidance in patients with acute coronary syndromes? The answer is no!"

"In the context of acute coronary syndromes, the combination of physiological guidance and other strategies, such as intracoronary imaging, is essential to optimize the procedure and tailor the treatment approach to the clinical needs of patients," she wrote. "For more definitive evidence on the roles of physiological guidance and imaging in the management of non-culprit lesions in patients with acute coronary syndromes, we await the results of the ongoing , which will recruit more than 5,000 patients with STEMI and non-STEMI."

Commenting on the study, Jennifer Rymer, MD, of Duke University Medical Center in Durham, North Carolina, told 麻豆传媒, that "these results should be taken with caution. This trial recruited less than half the number of people they originally intended -- 1,542 patients instead of 4,000 patients because of conflicting findings from other studies that were published -- so I think that limits what we can take away from this current study. We also know that physiologic testing in the acute setting may overestimate or underestimate the blood flow in that initial hospitalization. There are a lot of things going on in the vascular bed during acute coronary syndromes."

"I would agree with the researchers that we need to see the results of the ongoing COMPLETE-2 trial before we make decisions on how much revascularization needs to be performed in the initial hospitalization, or how much can wait until 30 to 40 days afterwards when we bring the patients back for a further procedure," she said.

For the , Böhm and colleagues enrolled 1,542 patients with STEMI or very-high-risk non-STEMI and multivessel disease who were undergoing primary PCI of the culprit lesion to receive either FFR-guided complete revascularization of non-culprit lesions or no further revascularization. The non-culprit lesion had to have a diameter of 2.5 mm or more and a visually graded stenosis of 50% to 99%.

Of these patients, 764 were assigned to receive FFR-guided complete revascularization and 778 were assigned to receive culprit-lesion-only PCI. At baseline, mean patient age was 65 years, 76% were men, 91% presented with STEMI, and 9% presented with very-high-risk non-STEMI. About half of the patients in each group had hypertension, 34-36% were current smokers, 28-29% were former smokers, 7-10% had a previous MI, and 8-9% had undergone a previous PCI.

Böhm and colleagues noted that the main limitation of the study was that it had to be terminated early for feasibility and ethical reasons, "which resulted in a long duration of follow-up for enough events to accrue."