Fractional Flow Reserve-Guided PCI versus Medical Therapy in
Stable Coronary Disease

J 2012

Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease

DE BRUYNE, Bernard; Nico H. J. PIJLS; Bindu KALESAN; Emanuele BARBATO; Pim A. L. TONINO et al.

Základní údaje

Originální název

Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease

Autoři

Vydání

New England Journal of Medicine, USA, MASSACHUSETTS MEDICAL SOC, 2012, 0028-4793

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 51.658

Označené pro přenos do RIV

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1056/NEJMoa1205361

UT WoS

000308649100005

Klíčová slova anglicky

OUTCOMES UTILIZING REVASCULARIZATION; ARTERY-DISEASE; CLINICAL-OUTCOMES; RANDOMIZED-TRIAL; CONSERVATIVE TREATMENT; FOLLOW-UP; INTERVENTION; STENOSIS; METAANALYSIS; ANGIOPLASTY

Příznaky

Mezinárodní význam

Změněno: 23. 4. 2014 15:12, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

BACKGROUND The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone. METHODS In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, <= 0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event. CONCLUSIONS In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.)

Citovat

DE BRUYNE, Bernard; Nico H. J. PIJLS; Bindu KALESAN; Emanuele BARBATO; Pim A. L. TONINO; Zsolt PIROTH; Nikola JAGIC; Sven MOBIUS-WINCKLER; Gilles RIOUFOL; Nils WITT; Petr KALA; Philip MACCARTHY; Thomas ENGSTROM; Keith G. OLDROYD; Kreton MAVROMATIS; Ganesh MANOHARAN; Peter VERLEE; Ole FROBERT; Nick CURZEN; Jane B. JOHNSON; Peter JUENI a William F. FEARON. Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease. New England Journal of Medicine. USA: MASSACHUSETTS MEDICAL SOC, 2012, roč. 367, č. 11, s. 991-1001. ISSN 0028-4793. Dostupné z: https://doi.org/10.1056/NEJMoa1205361.

@article{1076477,
   author = {De Bruyne, Bernard and Pijls, Nico H. J. and Kalesan, Bindu and Barbato, Emanuele and Tonino, Pim A. L. and Piroth, Zsolt and Jagic, Nikola and MobiusandWinckler, Sven and Rioufol, Gilles and Witt, Nils and Kala, Petr and MacCarthy, Philip and Engstrom, Thomas and Oldroyd, Keith G. and Mavromatis, Kreton and Manoharan, Ganesh and Verlee, Peter and Frobert, Ole and Curzen, Nick and Johnson, Jane B. and Jueni, Peter and Fearon, William F.},
   article_location = {USA},
   article_number = {11},
   doi = {https://doi.org/10.1056/NEJMoa1205361},
   keywords = {OUTCOMES UTILIZING REVASCULARIZATION; ARTERY-DISEASE; CLINICAL-OUTCOMES; RANDOMIZED-TRIAL; CONSERVATIVE TREATMENT; FOLLOW-UP; INTERVENTION; STENOSIS; METAANALYSIS; ANGIOPLASTY},
   language = {eng},
   issn = {0028-4793},
   journal = {New England Journal of Medicine},
   title = {Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease},
   volume = {367},
   year = {2012}
}

TY  - JOUR
ID  - 1076477
AU  - De Bruyne, Bernard - Pijls, Nico H. J. - Kalesan, Bindu - Barbato, Emanuele - Tonino, Pim A. L. - Piroth, Zsolt - Jagic, Nikola - Mobius-Winckler, Sven - Rioufol, Gilles - Witt, Nils - Kala, Petr - MacCarthy, Philip - Engstrom, Thomas - Oldroyd, Keith G. - Mavromatis, Kreton - Manoharan, Ganesh - Verlee, Peter - Frobert, Ole - Curzen, Nick - Johnson, Jane B. - Jueni, Peter - Fearon, William F.
PY  - 2012
TI  - Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease
JF  - New England Journal of Medicine
VL  - 367
IS  - 11
SP  - 991-1001
EP  - 991-1001
PB  - MASSACHUSETTS MEDICAL SOC
SN  - 00284793
KW  - OUTCOMES UTILIZING REVASCULARIZATION
KW  - ARTERY-DISEASE
KW  - CLINICAL-OUTCOMES
KW  - RANDOMIZED-TRIAL
KW  - CONSERVATIVE TREATMENT
KW  - FOLLOW-UP
KW  - INTERVENTION
KW  - STENOSIS
KW  - METAANALYSIS
KW  - ANGIOPLASTY
N2  - BACKGROUND The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone. METHODS In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, <= 0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization. RESULTS Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary end-point event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event. CONCLUSIONS In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.)
ER  -

DE BRUYNE, Bernard; Nico H. J. PIJLS; Bindu KALESAN; Emanuele BARBATO; Pim A. L. TONINO; Zsolt PIROTH; Nikola JAGIC; Sven MOBIUS-WINCKLER; Gilles RIOUFOL; Nils WITT; Petr KALA; Philip MACCARTHY; Thomas ENGSTROM; Keith G. OLDROYD; Kreton MAVROMATIS; Ganesh MANOHARAN; Peter VERLEE; Ole FROBERT; Nick CURZEN; Jane B. JOHNSON; Peter JUENI a William F. FEARON. Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease. \textit{New England Journal of Medicine}. USA: MASSACHUSETTS MEDICAL SOC, 2012, roč.~367, č.~11, s.~991-1001. ISSN~0028-4793. Dostupné z: https://doi.org/10.1056/NEJMoa1205361.

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