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COMPARE-ACUTE: FFR-guided complete revascularization linked to lower risk for adverse events
WASHINGTON — In patients with STEMI and multivessel disease, complete revascularization guided by fractional flow reserve was associated with reduced adverse events compared with PCI of an infarct-related artery only, according to data presented by Pieter Smits, MD, PhD.
“Approximately 50% of STEMI patients have multivessel disease at presentation,” Smits, of Maasstad Ziekenhuis in Rotterdam, the Netherlands, said during his presentation of the COMPARE-ACUTE results at the American College of Cardiology Scientific Session. “What to do with these noninfarct-related artery lesions and when remain an unresolved clinical dilemma.”
In COMPARE-ACUTE, Smits and colleagues examined whether the strategy of FFR-guided treatment of noninfarct-related coronary lesions in the acute setting was superior to revascularization of the infarct-related artery only in patients with STEMI and multivessel disease.
The researchers enrolled 885 patients who had undergone primary PCI of an infarct-related artery at 24 sites in 12 countries in Europe and Asia. Immediately after undergoing PCI, stable patients were randomly assigned in a 2:1 ratio to receive FFR-guided assessment of other arteries but no further revascularization (n = 590) or FFR-guided assessment and, when indicated by an FFR score of 0.8 or lower, complete revascularization (n = 295).
Elective, clinically indicated PCI performed within 45 days of the initial procedure based on symptoms or stress tests in the infarct-related-artery-only treatment group
were excluded from the analysis.
After FFR assessment, 54.1% of lesions in the FFR-guided complete revascularization group and 47.9% of the infarct-only revascularization group had FFR scores of 0.8 or lower. On average, procedural time was 6 minutes longer (P = .001) and contrast volume was 22 mL greater (P = .007) with FFR-guided complete revascularization vs. infarct-related artery-only revascularization.
The primary outcome, defined as a composite of all-cause mortality, nonfatal MI, revascularization and cerebrovascular events at 12 months, occurred in 7.8% of patients who underwent FFR-guided complete revascularization vs. 20.5% of patients who underwent infarct-related artery-only revascularization (HR = 0.35; 95% CI, 0.22-0.55). Risk for death (1.3% vs. 1.7%; HR = 0.8; 95% CI, 0.25-2.56) and MI (2.4% vs. 4.7%; HR = 0.5; 95% CI, 0.22-1.13) were similar between treatment arms, but risk for repeat revascularization was significantly lower with FFR-guided complete revascularization (6.1% vs. 17.5%; HR = 0.32; 95% CI, 0.2-0.54). Cerebrovascular events occurred in 0% of the FFR-guided complete revascularization group and 0.7% of the infarct-related artery-only treatment group.
Additionally, patients who underwent FFR-guided complete revascularization vs. infarct-related artery-only revascularization had a lower risk for net adverse clinical events, defined as the composite of cardiac death, MI, any revascularization, stroke and major bleeding (8.5% vs. 29.5%; HR = 0.25; 95% CI, 0.16-0.38), according to the data. They also had lower risk for hospitalization for heart failure, unstable angina and chest pain (4.4% vs. 8%; HR = 0.54; 95% CI, 0.29-0.99) and lower risk for any revascularization (6.4% vs. 27.3%; HR = 0.47; 95% CI, 0.29-0.76).
“In multivessel STEMI patients, FFR-guided coronary revascularization of noninfarct-related lesions in the acute phase of primary PCI significantly reduced the risk of the composite MACCE outcome, as compared with the treatment of the infarct-related artery only,” Smits said, noting that the reduction was primarily driven by a decreased need for subsequent revascularization.
During a panel discussion, Nils P. Johnson, MD, MS, of McGovern Medical School at University of Texas Health in Houston, praised COMPARE-ACUTE as a “big step forward” in determining how to approach this patient subset.
“A major strength is that these lesions were truly clinically intermediate — exactly in the middle of the diagnostic gray zone,” he said. Its major weakness, however, was the inclusion of revascularization in the primary endpoint.
“The question is whether this is something that patients are going to want to have and that health care systems are going to want to pay for,” Johnson said. “If you move to an FFR-guided strategy, you need to pay for extra wires and an increased rate of additional PCI by about two- to threefold. That would be useful to do if we can show that there’s a reduction in hard endpoints like death or MI.”
Smits told Cardiology Today’s Intervention that the FFR-guided approach will be cost-effective.
“I strongly believe that with this acute FFR-guided approach we will save money, because many noninfarct lesions do not need treatment (stents) if FFR negative and, by doing an all-in-one FFR-guided procedure, there is no need for additional staged procedures,” he said. “Lastly, patients will like it because they don't need to come back for a staged procedure and they can be secure on the table that the other lesions need no treatment if FFR-negative, or were justifiably treated if FFR-positive. Furthermore, this FFR guidance strategy can also help in the heart team discussion if the anatomy is complex.”– by Melissa Foster
References:
Smits P, et al. Late-Breaking Clinical Trials: Interventional. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.
Smits P, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1701067.
Disclosure: The study was funded by Abbott Vascular and St. Jude Medical. Smits reports receiving consultant fees, honoraria and/or research grants from AbbVie, Medinol, St. Jude and Terumo. Johnson reports financial ties with Boston Scientific, St. Jude Medical and Volcano Corporation.
Editor’s Note: This article was updated on March 21, 2017 with further discussion on cost.
Perspective
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This was a very important trial because it demonstrates that additional FFR-guided nonculprit PCI, immediately following culprit PCI for STEMI, improves clinical outcomes. Whether or not to treat and the timing of treatment of nonculprit lesions during STEMI remains a debate. Prior studies (eg, PRAMI, CvLPRIT and DANAMI-3-PRIMULTI) have shown a range of outcomes. This trial strengthens the evidence base that it’s going to be useful to treat significant nonculprit lesions that are present in the setting of STEMI.
One aspect that wasn’t evaluated in this study but remains an open question is whether the deferring nonculprit FFR-guided PCI for a few days might be a safer option for STEMI patients. There is still a concern that when nonculprit lesions are treated in the setting of STEMI, there may be extra contrast use or additional ischemia, which can be harmful to certain patients with STEMI. It is important to note that patients excluded from this trial included those with advanced HF, left main CAD, chronic total occlusion and suboptimal culprit PCI outcomes.
The primary benefit of this study appears to be that of fewer repeat revascularizations, rather than hard events such as death or MI. The study may have been underpowered for these latter endpoints. For patients meeting the inclusion criteria, this study is attractive because treating the culprit and nonculprit lesions at the same time is efficient and avoids a repeat second invasive procedure. However, another consideration is that interventionalists who adopt FFR-guided nonculprit PCI during STEMI cases may now experience longer case times, which could affect workflow and staffing for such emergency cases.
Perspective
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Although it will probably not change guidelines at this point, COMPARE-ACUTE offers more data and information suggesting that it’s reasonable for clinicians to consider pressure-wire FFR of the noninfarct arteries in patients who present with STEMI or acute MI and let that guide them as to whether or not those arteries that were not involved in the MI but are significant or seriously blocked should also undergo PCI or stenting at that same time.
The study basically shows that it’s safe to perform this additional procedure. Also, it shows that if the procedure is performed and it guides the clinician toward putting additional stents in other arteries at the time of the original MI, those patients actually do better over time and have fewer combined events like recurrent MI, need for other interventions or revascularization, fewer strokes and fewer overall combined endpoints.