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Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe and efficacious way of ischemia testing for patients with stable angina. The new recently ESC guidelines have strongly suggested a FFR based approach for patients with stable angina, also for those with challenging lesions like left main disease, severe multivessel stenosis for heart failure patients and those with single remaining vessels although left main disease and an ejection fraction less than 30% are exclusion criteria of the randomized controlled trials on this topic. Consequently the investigators performed a prospective multicenter study to understand the safety and efficacy of a FFR based approach for these patients.
The present is a multicenter prospective study enrolling all patients with stable angina and/or documented ischemia presenting with:
In all of these patients FFR (Fractional Flow Reserve) will be performed according to guidelines and stenting will be performed or deferred according to the result of this test. Other techniques, like iFR, IVUS and OCT will be left at the operators' choice and will be recorded. MACE (a composite end point of death, myocardial infarction and target vessel revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | patients with stable angina and/or documented ischemia presenting with:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Flow Reserve, Myocardial | Procedure | The ratio of maximum blood flow to the myocardium with coronary stenosis present, to the maximum equivalent blood flow without stenosis. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | composite end point of death, myocardial infarctio, target vessel revascularization and target lesion revascularization, stent thrombosis | 3 years |
| TVF (only for deferred lesion) | composite of cardiac death,myocardial infarction and target vessel revascularization due to deferred lesion | 1 and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death | and also cardiac death as a separate outcome | 1 and 2 years |
| TLR | 1 and 2 years | |
| AMI |
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Inclusion Criteria:
Exclusion Criteria:
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patients with stable angina
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabrizio D'Ascenzo | Turin | 10100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25179764 | Result | Layland J, Oldroyd KG, Curzen N, Sood A, Balachandran K, Das R, Junejo S, Ahmed N, Lee MM, Shaukat A, O'Donnell A, Nam J, Briggs A, Henderson R, McConnachie A, Berry C; FAMOUS-NSTEMI investigators. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J. 2015 Jan 7;36(2):100-11. doi: 10.1093/eurheartj/ehu338. Epub 2014 Sep 1. | |
| 25176289 |
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| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| 1 and 2 years |
| Result |
| De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. |
| 25173339 | Result | Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available. |
| 19144937 | Result | Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611. |
| 29937300 | Derived | Barbero U, D'Ascenzo F, Campo G, Kleczynski P, Dziewierz A, Menozzi M, Jimenez Diaz VA, Cerrato E, Raposeiras-Roubin S, Ielasi A, Rognoni A, Fineschi M, Kanji R, Jaguszewski MJ, Picchi A, Ando G, Soraci E, Mancone M, Sardella G, Calcagno S, Gallo F, Huczek Z, Krakowian M, Verardi R, Montefusco A, Omede P, Lococo M, Moretti C, D'Amico M, Rigattieri S, Gaita F, Rinaldi M, Escaned J. Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A prospective multicentre study. Int J Cardiol. 2018 Nov 1;270:107-112. doi: 10.1016/j.ijcard.2018.06.013. Epub 2018 Jun 8. |