Departments of Cardiology, University Hospital (E.V.B.); EA2693, Lille-II-University (E.V.B.); Hôpital Louis Pradel, Lyon (G.R.); INSERM 1060 CARMEN, Claude Bernard University Lyon1 (G.R,); Clinique Sainte Clotilde, Saint Denis de la Réunion (C.P., K.B.); CHU La Timone, Marseille (T.C.); CHU Mondor, Créteil (E.T., S.C.); CH d'Annecy, Annecy (L.B.); C.H.I.T.S. Hôpital Sainte Musse, Toulon (D.B.); Centre Hospitalier Haguenau, Haguenau (M.H.); Hôpital de la Croix-Rousse, Lyon (C.B., R.D.); Institut Pasteur de Lille-INSERM (J.D.), Université Pierre et Marie Curie - Paris 6 (Y.E.H.), Hôpital lariboisière (G.S.), Paris; Centre Hospitalier Valence, Valence (C.B.); Hôpital Albert Schweizer, Colmar (N.L.); Centre Hospitalier La Durance, Avignon (P.B.); Centre Hospitalier Amiens Sud, Amiens (L.L.); and Hopital Privé d'Antony, Antony, France (P.D.).
Circulation. 2014 Jan 14;129(2):173-85. doi: 10.1161/CIRCULATIONAHA.113.006646. Epub 2013 Nov 19.
There is no large report of the impact of fractional flow reserve (FFR) on the reclassification of the coronary revascularization strategy on individual patients referred for diagnostic angiography.
The Registre Français de la FFR (R3F) investigated 1075 consecutive patients undergoing diagnostic angiography including an FFR investigation at 20 French centers. Investigators were asked to define prospectively their revascularization strategy a priori based on angiography before performing the FFR. The final revascularization strategy, reclassification of the strategy by FFR, and 1-year clinical follow-up were prospectively recorded. The strategy a priori based on angiography was medical therapy in 55% and revascularization in 45% (percutaneous coronary intervention, 38%; coronary artery bypass surgery, 7%). Patients were treated according to FFR in 1028/1075 (95.7%). The applied strategy after FFR was medical therapy in 58% and revascularization in 42% (percutaneous coronary intervention, 32%; coronary artery bypass surgery, 10%). The final strategy applied differed from the strategy a priori in 43% of cases: in 33% of a priori medical patients, in 56% of patients undergoing a priori percutaneous coronary intervention, and in 51% of patients undergoing a priori coronary artery bypass surgery. In reclassified patients treated based on FFR and in disagreement with the angiography-based a priori decision (n=464), the 1-year outcome (major cardiac event, 11.2%) was as good as in patients in whom final applied strategy concurred with the angiography-based a priori decision (n=611; major cardiac event, 11.9%; log-rank, P=0.78). At 1 year, >93% patients were asymptomatic without difference between reclassified and nonreclassified patients (Generalized Linear Mixed Model, P=0.75). Reclassification safety was preserved in high-risk patients.
This study shows that performing FFR during diagnostic angiography is associated with reclassification of the revascularization decision in about half of the patients. It further demonstrates that it is safe to pursue a revascularization strategy divergent from that suggested by angiography but guided by FFR.
目前尚无大型研究报告指出，冠状动脉血流储备分数（FFR）对接受诊断性冠状动脉造影的患者的血运重建策略的再分类有何影响。
法国 FFR 注册研究（R3F）纳入了 20 个法国中心的 1075 例连续患者，这些患者均接受了诊断性冠状动脉造影检查和 FFR 检查。研究者在进行 FFR 检查之前，前瞻性地要求他们根据冠状动脉造影术预先确定血运重建策略。前瞻性记录最终血运重建策略、FFR 再分类策略和 1 年临床随访情况。根据冠状动脉造影术预先确定的策略，55%的患者接受药物治疗，45%的患者接受血运重建（经皮冠状动脉介入治疗，38%；冠状动脉旁路移植术，7%）。1075 例患者中有 1028 例（95.7%）根据 FFR 接受了治疗。FFR 后应用的策略为药物治疗 58%，血运重建 42%（经皮冠状动脉介入治疗，32%；冠状动脉旁路移植术，10%）。最终应用的策略与预先确定的策略不同，占 43%：33%的预先药物治疗患者，56%的预先行经皮冠状动脉介入治疗患者，51%的预先行冠状动脉旁路移植术患者。根据 FFR 进行治疗并与基于血管造影的预先决定不符的重新分类患者（n=464），其 1 年结局（主要心脏不良事件，11.2%）与最终应用策略与基于血管造影的预先决定一致的患者（n=611；主要心脏不良事件，11.9%；对数秩检验，P=0.78）相同。1 年后，>93%的患者无症状，重新分类患者与未重新分类患者之间无差异（广义线性混合模型，P=0.75）。高危患者的重新分类安全性得到了保留。
本研究表明，在诊断性冠状动脉造影期间进行 FFR 检查与约一半患者的血运重建决策再分类相关。进一步证明，根据 FFR 指导而不是血管造影术指导，采取与血管造影术建议不同的血运重建策略是安全的。
