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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EPercutaneous coronary intervention guided by fractional flow reserve plus the best available medical therapy (MT) improves outcomes in patients with stable coronary artery disease compared with optimal MT alone. The benefit is primarily due to a lower rate of rehospitalization for urgent revascularization. These findings, from the Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Therapy versus Optimal Medical Therapy Alone in Patients with Stable Coronary Artery Disease [FAME 2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01132495\u0026amp;atom=%2Fspmdc%2F12%2F13%2F15.atom\u0022\u003ENCT01132495\u003C\/a\u003E] trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECoronary Artery Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EPercutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) plus the best available medical therapy (MT) improves outcomes in patients with stable coronary artery disease (CAD) compared with optimal MT alone. The benefit is primarily due to a lower rate of rehospitalization for urgent revascularization (UR). These findings, from the Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Therapy versus Optimal Medical Therapy Alone in Patients with Stable Coronary Artery Disease [FAME 2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01132495\u0026amp;atom=%2Fspmdc%2F12%2F13%2F15.atom\u0022\u003ENCT01132495\u003C\/a\u003E] trial, were reported by Bernard De Bruyne, MD, PhD, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIn prior studies, PCI has failed to to improve the prognosis for patients with stable CAD. However, Prof. De Bruyne and the FAME 2 investigators hypothesized that PCI plus MT would improve outcomes for patients with stable CAD if the presence of lesions that produced ischemia were confirmed by measurement of FFR. FFR-guided PCI was superior to angiography-guided PCI in the initial FAME trial [Tonino PA et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2009]. The results of FAME 2 were simultaneously published to coincide with the presentation of the study [De Bruyne B et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe researchers measured FFR in patients with stable CAD for whom PCI was being considered. Patients who had at least 1 functionally significant stenosis (FFR \u22640.80) were randomly assigned to FFR-guided PCI plus the best available MT or the best available MT alone. Patients who had no evidence of ischemia (FFR \u0026gt;0.80) were treated with MT alone and were followed in a registry. The primary endpoint was a composite of death, myocardial infarction (MI), or UR. The trial was designed as a superiority study in 1632 patients and powered to test whether FFR-guided PCI resulted in a 30% relative risk reduction of the primary endpoint over an intended average follow-up of 2 years.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAn important first finding was that 27% (n=322) of the patients evaluated for the study had no hemodynamically significant stenosis, and were thus followed in the trial registry. The remaining 73% (n=888) had an FFR \u22640.80 in at least 1 large epicardial artery and were randomly assigned to FFR-guided PCI plus MT (n=447) or MT alone (n=441). The trial was stopped prematurely in January 2012 after 1220 patients were randomized with an average follow-up of 7 months, when the independent Data Safety Monitoring Board judged highly significant differences in the primary endpoint rates between patients randomized to MT alone compared with those who recieved FFR-guided PCI plus MT (4.3% vs 12.7%; HR with PCI, 0.32; 95% CI, 0.19 to 0.53; p\u0026lt;0.001). A large difference in the rate of UR (1.6% vs 11.1%; HR, 0.13; 95% CI, 0.06 to 0.30; p\u0026lt;0.001) was the major factor responsible for the difference in the composite endpoint between the groups. Rates of mortality or MI were infrequent and did not differ significantly between the 2 randomized groups. In the registry, MT alone led to an excellent outcome for patients without FFR-determined ischemia, regardless of the angiographic appearance of the stenoses; the primary endpoint occurred in only 5\/166 (3.0%) patients with FFR \u0026gt;0.80.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EScience Advisors\u0027 Note\u003C\/h2\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EAlthough the reduction in the composite primary endpoint with PCI is provocative, it is worth noting that this observation was predominantly dependent on a difference in the \u201csofter\u201d endpoint of UR, and that the premature termination of this randomized study resulted in the enrollment of only 75% of the patients planned with less than a third of the intended average follow-up. Two additional limitations warrant mention. First, an early signal towards a potential harm as a result of definite or probable stent thrombosis in patients randomized to FFR-guided PCI plus MT (all of whom received a second-generation drug-eluting stent) compared with MT alone (1.1% vs. 0.2% by 12 months; HR with PCI, 4.98; 95% CI, 0.59 to 42.25) could have been better defined with further follow-up and greater event accrual. Second, the non-blinded nature of this study (the patients managed with MT alone did not undergo sham PCI) could have led to a selection bias in referral for \u201curgent\u201d revascularization, with a lower threshold to refer patients to PCI if they had been randomized to optimal MT without PCI. As Dr. William Boden, one of the lead investigators of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [COURAGE] trial, concluded in his editorial to FAME-2, neither FAME-2 with 7 months of mean follow-up or the COURAGE trial with 55 months of mean follow-up showed a reduction with PCI in \u201chard\u201d clinical endpoints, such as death or MI [Boden WE. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012]. Further insight regarding the comparison of PCI with best available MT in patients with stable CAD and moderate-to-severe ischemia may come from the results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial [ISCHEMIA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01471522\u0026amp;atom=%2Fspmdc%2F12%2F13%2F15.atom\u0022\u003ENCT01471522\u003C\/a\u003E].\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/12\/13\/15.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznb1f\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}