Cardiovascular News 51—September edition

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MitraClip makes “absolutely no difference” for the prognosis of secondary mitral valve regurgitation The first randomised controlled trial to compare percutaneous edge-to-edge repair (MitraClip, Abbott) with medical therapy alone in patients with secondary mitral regurgitation (to heart failure) has shown no evidence that the percutaneous device provides benefit in terms of prognosis. These findings indicate that regurgitation may be a marker of worse prognosis in heart failure rather than a cause.

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tudy investigator JeanFrancois Obadia (Hôpital Cardiovasculaire, Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Lyon, France), speaking in a Hot Line session at the 2018 European Society of Cardiology (ESC) Congress (25–29 August, Munich, Germany), said it was “well established” that there was “a strong correlation between mitral regurgitation severity and prognosis”. He added that while this had led to therapies (both surgical and percutaneous) that aimed to reduce regurgitation, there was no evidence that reducing regurgitation would improve prognosis. According to Obadia, both European and US guidelines recognise the lack of data in this area and have called for randomised controlled trials. Therefore, the aim of MITRA-FR (Percutaneous repair with the MitraClip for severe functional/secondary mitral regurgitation) was to address this issue and evaluate the safety and efficacy of the MitraClip procedure in a randomised setting. In the study, 307 patients with secondary mitral regurgitation were randomised to receive a MitraClip device (152) or to receive medical therapy alone (152 after three patients were excluded because of problems with obtaining informed consent). The primary endpoint was a composite

Jean-Francois Obadia

of all-cause mortality and unplanned hospitalisation for heart failure at 12 months and secondary endpoints included the individual components of the primary endpoint, death from cardiovascular causes, and survival from major adverse cardiac events (MACE). In an intention-to-treat analysis, the rate of the primary endpoint was 54.6% for the MitraClip group and 51.1% for the control group; a non-significant difference (p=0.53). The rates of the individual components of the primary endpoint—allcause mortality (24.3% and 22.4%, respectively) and unplanned hospi-

talisation for heart failure (48.7% vs. 47.4%, respectively)—were similar between groups as were the rates for the other secondary endpoints (cardiovascular death and MACE). A per-protocol analysis, which excluded 14 patients in the interventional group who did not ultimately receive the device, was performed and its results were consistent with the findings of the intention-to-treat analysis. Obadia said: “We found absolutely no difference in terms of the primary endpoint of all-cause mortality and unplanned hospitalisation; there was not even a trend towards a difference. We performed a subgroup analysis to see if there would be trend somewhere but there was not. Not even when we analysed the results according to severity of regurgitation.” However, he noted that the study was not powered to detect smaller differences between subgroups (MITRA-FR was only powered to detect a substantial effect in the primary outcome). “Although our overall findings are very strong, we have to be careful about making conclusions about the efficacy of the device for subgroups as they were small. Potentially, future studies could explore the efficacy of MitraClip in selected patients,” he added. Continued on page 2

Matt Börjesson: Exercise after MI

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Olaf Wendler: Profile

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More evidence that FFRCT is an effective approach for identifying patients who do not require further intervention

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jarne L Nørgaard (Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark) and colleagues report in the Journal of the American College of Cardiology (JACC) that the use of computer-derived fractional flow reserve (FFRCT, HeartFlow Analysis, HeartFlow) in patients with intermediate stenosis—based on computed tomography (CT) angiography—is effective for differentiating patients who do not require further diagnostic testing or intervention from higher risk patients. Nørgaard et al have previously shown that FFRCT has “high and improved” diagnostic performance compared with anatomical

interpretation with CT angiography alone. However, in this new study, they comment: “Clinical outcome data in patients undergoing CT angiogram testing with FFRCT guidance are sparse”. Therefore, the purpose of the present study was to assess the clinical outcomes and safety using a diagnostic strategy including first-line coronary CT angiogram and selecting FFRCT in real-world patients with suspected Continued on page 2


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Cardiovascular News 51—September edition by BIBA Publishing - Issuu