Fractional flow reserve versus solely angiography-guided revascularisation in coronary artery disease. Systematic review and meta-analysis
Abstract
Background: Subsequent randomized controlled trials (RCTs) comparing the clinical outcomes of fractional flow reserve (FFR)-guided and angiography-guided revascularisation in patients with coronary artery disease (CAD) yielded inconsistent results.
Aims: This study aimed to assess head to head whether FFR-guided revascularisation reduces the rates of hard clinical endpoints in comparison with the angiography-guided approach alone.
Methods: This systematic review was conducted through June 2024 at Embase, Clinicaltrials.gov, Cochrane Library, and EBSCO. Only RCTs that evaluated stable and unstable CAD and acute myocardial infarction (MI) were included. Eight RCTs involving 4713 patients were included in the meta-analysis.
Results: FFR guidance was associated with a reduction of MI (risk ratio (RR), 0.75 [95% confidence interval (Cl), 0.58–0.96], p=0.02) and lower rate of revascularisation (standardised mean difference - 0.12, [95% Cl, -0.14–0.09], p<00001). There were no differences between FFR-guided and angio-guided revascularisation in major adverse cardiovascular events (MACE) (RR, 0.84 [95% Cl, 0.69–1.02], p=0.08), all-cause mortality (RR, 1.00 [95% Cl, 0.58–1.74], p=0.99), and unplanned revascularisation (RR, 0.89 [95% Cl, 0.72–1.10], p=0.28).
Conclusions: FFR-driven revascularisation was associated with a significantly lower rate of MI for entire population and also in the acute coronary syndrome (ACS) subset. These results were achieved with a substantially less revascularisations compared with solely angiographic guidance.
References
- De Bruyne B, Pijls NHJ, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012; 367(11): 991–1001.
- Pijls NHJ, Fearon WF, Tonino PAL, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease. J Am Coll Cardiol. 2010; 56(3): 177–184.
- Neumann FJ, Sousa-Uva M. 'Ten commandments' for the 2018 ESC/EACTS Guidelines on Myocardial Revascularization. Eur Heart J. 2019; 40(2): 79–80.
- Virani S, Newby L, Arnold S, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023; 148(9): e9–e119.
- Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022; 145(3): e4–e17.
- Byrne R, Rossello X, Coughlan JJ, et al. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023; 44(38): 3720–3826.
- Stables RH, Mullen LJ, Elguindy M, et al. Routine pressure wire assessment versus conventional angiography in the management of patients with coronary artery disease: the RIPCORD 2 trial. Circulation. 2022; 146(9): 687–698.
- Lee JM, Kim HK, Park KH, et al. Fractional flow reserve versus angiography-guided strategy in acute myocardial infarction with multivessel disease: A randomized trial. Eur Heart J. 2023; 44(6): 473–484.
- Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021: n71.
- Grant J, Hunter A. Measuring inconsistency in knowledgebases. J Intell Inf Sys. 2006; 27(2): 159–184.
- Chapter 8: Assessing risk of bias in a randomized trial. Cochrane Training. https://training.cochrane.org/handbook/current/chapter-08 (July 16, 2024).
- Ansari MT, Tsertsvadze A, Moher D. Grading quality of evidence and strength of recommendations: A perspective. PLoS Med. 2009; 6(9): e1000151.
- Park SH, Jeon KH, Lee JM, et al. Long-term clinical outcomes of fractional flow reserve-guided versus routine drug-eluting stent implantation in patients with intermediate coronary stenosis: Five-year clinical outcomes of DEFER-DES trial. Circ Cardiovasc Interv. 2015; 8(12): e002442.
- Gallone G, Angelini F, Fortuni F, et al. Angiography- vs. physiology-guided complete revascularization in patients with ST-elevation myocardial infarction and multivessel disease: who is the better gatekeeper in this setting? A meta-analysis of randomized controlled trials. Eur Heart J Qual Care Clin Outcomes. 2020; 6(3): 199–200.
- Archilletti F, Ricci F, Pelliccia F, et al. Coronary angiography- or fractional flow reserve-guided complete revascularization in multivessel disease STEMI: A Bayesian hierarchical network meta-analysis. Int J Cardiol. 2023; 370: 122–128.
- Puymirat E, Cayla G, Simon T, et al. Multivessel PCI guided by FFR or angiography for myocardial infarction. N Engl J Med. 2021; 385(4): 297–308.
- Hong D, Lee SH, Lee J, et al. Cost-effectiveness of fractional flow reserve-guided treatment for acute myocardial infarction and multivessel disease: a prespecified analysis of the FRAME-AMI randomized clinical trial. JAMA Netw Open. 2024; 7(1): e2352427.
- Gibson CM, Ryan KA, Murphy SA, et al. Impaired coronary blood flow in nonculprit arteries in the setting of acute myocardial infarction. J Am Coll Cardiol. 1999; 34(4): 974–982.
- Mehta SR, Wood DA, Storey RF, et al. Complete revascularization with multivessel PCI for myocardial infarction. N Engl J Med. 2019; 381(15): 1411–1421.
- Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015; 65(10): 963–972.
- Engstrøm T, Kelbæk H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015; 386(9994): 665–671.
- Smits PC, Laforgia PL, Abdel-Wahab M, et al. Fractional flow reserve-guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017; 376(13): 1234–1244.
- Gallone G, Angelini F, Fortuni F, et al. Angiography- vs. physiology-guided complete revascularization in patients with ST-elevation myocardial infarction and multivessel disease: who is the better gatekeeper in this setting? A meta-analysis of randomized controlled trials. Eur Heart J Qual Care Clin Outcomes. 2020; 6(3): 199–200.
- Sardella G, Lucisano L, Garbo R, et al. Single-staged compared with multi-staged PCI in multivessel NSTEMI patients: the SMILE trial. J Am Coll Cardiol. 2016; 67(3): 264–272.
- Rathod KS, Koganti S, Jain AK, et al. Complete versus culprit-only lesion intervention in patients with acute coronary syndromes. J Am Coll Cardiol. 2018; 72(17): 1989–1999.
- Kaziród-Wolski K, Sielski J, Gąsior M, et al. Factors affecting short- and long-term survival of patients with acute coronary syndrome treated invasively using intravascular ultrasound and fractional flow reserve: Analysis of data from the Polish Registry of Acute Coronary Syndromes 2017-2020. Kardiol Pol. 2023; 81(3): 265–272.
- Parikh RV, Liu G, Plomondon ME, et al. Utilization and outcomes of measuring fractional flow reserve in patients with stable ischemic heart disease. J Am Coll Cardiol. 2020; 75(4): 409–419.
- Westra J, Andersen BK, Campo G, et al. Diagnostic performance of in-procedure angiography-derived quantitative flow reserve compared to pressure-derived fractional flow reserve: the FAVOR II Europe-Japan study. J Am Heart Assoc. 2018; 7(14).
- Masdjedi K, Tanaka N, Van Belle E, et al. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention. 2022; 17(18): 1498–1505.
- Collet C, Onuma Y, Sonck J, et al. Diagnostic performance of angiography-derived fractional flow reserve: a systematic review and Bayesian meta-analysis. Eur Heart J. 2018; 39(35): 3314–3321.
- Dębski MA, Kruk M, Bujak S, et al. Benefits of the selective invasive strategy guided by CTA and CTA-derived fractional flow reserve in patients with coronary artery disease. Kardiol Pol. 2023; 81(3): 252–258.
- Thuesen AL, Riber LP, Veien KT, et al. Health-related quality of life and angina in fractional flow reserve- versus angiography-guided coronary artery bypass grafting: FARGO trial (Fractional flow reserve versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021; 14(6): e007302.
- Toth G, Bruyne BDe, Kala P, et al. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019; 15(11): e999–e1005.