Nejvíce citovaný článek - PubMed ID 29785878
Five-Year Outcomes with PCI Guided by Fractional Flow Reserve
OBJECTIVES: INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. BACKGROUND: Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. METHODS: INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. RESULTS: Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1 year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). CONCLUSION: This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.
- Klíčová slova
- Coronary angiography, Coronary artery disease, Critical limb ischemia, Fractional flow reserve,
- MeSH
- ischemie * terapie diagnóza MeSH
- konzervativní terapie * metody MeSH
- koronární angiografie metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci koronárních tepen * komplikace MeSH
- onemocnění periferních arterií * terapie komplikace diagnóza MeSH
- prospektivní studie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
INTRODUCTION: Up to 50% of patients with ST elevation myocardial infarction (STEMI) have ≥ 50% stenosis in a major non-infarct-related artery. Several studies have evaluated the prognostic value of the completion of revascularization with overall inconclusive results. Selection of the stenoses was based on the angiographic evaluation, invasive hemodynamic measurement or the combined approach. It is unknown whether such a selection provides correlation of comparable patient groups. MATERIAL AND METHODS: We enrolled 51 patients (62.7 ±10.2 years) with acute STEMI and at least one residual (50-90%) stenosis in a non-infarct-related major coronary artery (excluding left main coronary artery). Overall 65 stenoses (67.9 ±10.7%) were evaluated angiographically following primary percutaneous coronary intervention and the hemodynamic significance was estimated with respect to the stenosis severity, caliber of the arterial segment, localization of the stenosis (proximity) as well as the estimated size of the supplied vascular territory. During subsequent hospitalization, invasive measurement of the hemodynamic significance using fractional flow reserve (FFR) was performed to guide the final revascularization strategy (FFR value of ≤ 0.80 considered significant). RESULTS: Based on angiographic evaluation, a total of 44 stenoses would be recommended for treatment, whereas only 31 stenoses were revascularized based on FFR measurement. Moreover, visual evaluation and hemodynamic measurement were discrepant in 27 of 65 (41.5%) stenoses. CONCLUSIONS: We observed a weak correlation between visual angiographic evaluation and invasive hemodynamic measurement. More stents would be implanted based on angiographic evaluation compared to FFR measurement.
UNLABELLED: Clinical benefit of invasive functionally guided revascularization has been mostly investigated and proven for percutaneous coronary intervention. It has never been prospectively evaluated whether a systematic fractional flow reserve (FFR) assessment is also beneficial in guiding coronary artery bypass graft surgery (CABG). The objective of the GRAft patency after FFR-guided versus angiography-guIded CABG (GRAFFITI) trial was to compare an FFR-guided revascularization strategy to the traditional angiography-guided revascularization strategy for patients undergoing CABG. Patients were enrolled with significantly diseased left anterior descending or left main stem and at least one major coronary artery with angiographically intermediate stenosis (30-90% diameter stenosis) that was assessed by FFR. Thereafter, while the FFR values were kept concealed, cardiac surgeons decided their intended procedural strategy based on the coronary angiography alone. At this point, patients underwent 1:1 randomization to either an FFR-guided or an angiography-guided CABG strategy. In case the patient was randomized to angiography-guided arm, cardiac surgeons kept their intended procedural strategy, i.e., CABG was guided solely on the basis of the coronary angiography. In case the patient was randomized to the FFR-guided arm, FFR values were disclosed to the surgeons who revised the surgical protocol according to the functional significance of each coronary stenosis. The primary endpoint of the trial was the rate of graft occlusion at 12 months, assessed by coronary computed tomography or coronary angiography. The secondary endpoints were (1) length of postoperative hospital stay; (2) changes in surgical strategy depending upon FFR results (in FFR-guided group only); and (3) rate of major adverse cardiac and cerebrovascular events, i.e., composite of death, myocardial infarction, stroke, and any revascularization during the follow-up period. This study is the first prospective randomized trial investigating potential clinical benefits, associated with FFR-guided surgical revascularization. TRIAL REGISTRATION: NCT01810224.
- Klíčová slova
- Coronary angiography, Coronary artery bypass graft surgery, Fractional flow reserve, Graft patency,
- MeSH
- cévní protézy * MeSH
- chirurgie s pomocí počítače metody MeSH
- frakční průtoková rezerva myokardu fyziologie MeSH
- jednoduchá slepá metoda MeSH
- koronární angiografie metody MeSH
- koronární bypass metody MeSH
- koronární cévy diagnostické zobrazování patofyziologie chirurgie MeSH
- lidé MeSH
- následné studie MeSH
- nemoci koronárních tepen diagnóza patofyziologie chirurgie MeSH
- prospektivní studie MeSH
- průchodnost cév * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
