As anticipated, TCT 2018 had a lot to offer. For the busy FIT, here's my top takeaways.

COAPT

The finding in COAPT that the MitraClip device provided a mortality and hospitalization benefit in patients who underwent transcatheter mitral valve repair (TMVR), vs. medical therapy, was the biggest news for me from TCT 2018. Remember, preliminary results of MITRA-FR, presented just a month ago at ESC Congress 2018, did not show a benefit for death or heart failure hospitalization in patients with functional mitral regurgitation with MitraClip over medical therapy.

In COAPT, MitraClip significantly reduced the primary efficacy endpoint of all hospitalizations over 24 months (35.8 vs. 67.9 percent with medical therapy); number needed to treat of 3.1. Also improved with the device was freedom from device-related complications at 12 months (vs. 88 percent prespecified performance goal). Notable was the significantly lower two-year mortality with MitraClip than medical therapy (29.1 vs. 46.1 percent; hazard ratio [HR], 0.62).

Here's the biggest question: What makes COAPT different from MITRA-FR? Three main differences in COAPT could help explain this: a larger sample size, more severe mitral valve regurgitation and smaller left ventricular end-diastolic volume. We must also recall that operator experience plays a role, but this is hard to measure in both trials.

LEADERS FREE II

With the aim of gaining device registration from the U.S. Food and Drug Administration (FDA) for the BioFreedom polymer-free biolimus A9 drug-coated stent. LEADERS FREE II compared the investigational stent against a bare-metal stent (BMS). Conducted in the U.S., superiority was shown at one year for safety and efficacy in patients at high risk for bleeding (defined as >75 years old, history of anemia, thrombocytopenia, renal failure, liver failure, active cancer, intracranial bleeding or hospitalized for active bleeding). While the results are reassuring and bring hope to these patients requiring coronary intervention, concerns were raised by the investigators and study discussant about the current high rate (20 percent) of BMS use in the U.S.

PORTICO I

The one-year outcomes with the new Portico self-expandable valve for transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis are promising. In 941 patients, all outside the U.S., all-cause mortality was 12.1 percent, cardiovascular death was 6.6 percent and stroke was 2.2 percent. Paravalvular leak was moderate in 2.6 percent of patients, mild in 67.9 percent and trace or not present in 29.5 percent. The need for a new pacemaker was 21.3 percent at one year, up from 18.7 percent at 30 days. These results are consistent with commercially available Evolut R and Sapien 3 valves – leaving us still waiting for newer and better devices that lower the rate of post TAVR pacemakers.

IMPERIAL

Moving to endovascular therapies, IMPERIAL showed the novel paclitaxel-eluting Eluvia stent resulted in better patency at one year, over the FDA-approved Zilver PTX paclitaxel-eluting stent. The primary patency assessed by duplex ultrasound was 86.8 percent with Eluvia and 81.5 percent with Zilver PTX, a difference that met criteria for noninferiority (the primary endpoint). The findings were very convincing and makes a good case for FDA approval of the Eluvia stent. However, the discussant expressed concern that one-year results are not sufficient and longer follow-up is required before Eluvia makes it into practice.

SOLVE-TAVI

Results from SOLVE-TAVI represent a paradigm shift – showing there's no benefit to general anesthesia for patients with severe aortic stenosis undergoing TAVR, with similar safety results at 30 days with local anesthesia. The 2x2 randomized trial examined self-expandable vs. balloon-expandable valves and general vs. local anesthesia, but in essence was an evaluation of type of anesthesia. It should be noted, however, that general anesthesia could be justified for patients requiring a transesophageal echocardiogram during the procedure. Currently, in >90 percent of TAVR procedures, though, a thoracic echocardiogram is sufficient to evaluate the valve function after deployment.

TRIVALVE

This international registry collects information on interventional tricuspid repair for tricuspid regurgitation (TR) using any device. At TCT 2018, an analysis was presented of 249 patients with severe TR (mean age 77; 51 percent women) treated with the MitraClip under off-label/compassionate use programs at 14 centers.

Overall, they had improvements in NYHA class (from III/IV to I/II) and lower mortality and edema at one year – striking results because this is the first time this benefit has been shown with a transcatheter intervention of the tricuspid valve. Moreover, although the device is designed for mitral valve regurgitation, the procedural success rate was high. Of note was the lack of randomization or standardization of therapy and this was a topic of major debate. However, the results are reassuring and can be viewed as a feasibility study to make the case for a larger, more structured trial.

ULTIMATE

IVUS-guided PCI, compared with angiography-guided PCI, was associated with lower incidence of target vessel failure (TVF) at one year in this study of 1,448 individuals at eight centers in China. Furthermore, the TVF rate was threefold higher with suboptimal, vs. optimal, stent placement, despite IVUS guidance. These findings suggest we should "look" after deploying a stent and this visual information can optimize PCI results, directly impacting one year outcomes.

These findings are very intriguing, because IVUS use is low in the U.S. (~20 percent of all PCIs) and in most cases the information from IVUS is not used due to lack of training or operator preference. This may be a call to incorporate training and certification for all interventional cardiology fellows to read and interpret the different intra-coronary imaging modalities before graduation. The variability in coronary imaging across the different catheterization laboratories creates different levels of comfort for understanding these imaging modalities and standardization of training is needed.

PREPARE-CALC

Lesion modification for severely calcified coronary artery disease prior to PCI is a key step for successful results before DES implantation. This trial of 100 patients found that rotational atherectomy, vs. modified balloon angioplasty, was associated with a higher success rate. This has not been shown in previous studies, making these results interesting. The main driver of this greater success was crossover to atherectomy, because of failure of balloon angioplasty to cross or dilate the calcified lesion.

But, questions remain: Are we evaluating lesions properly before considering lesion modification techniques? Should we use more coronary imaging to guide therapy? Are we using the "old" devices the right way now and thus we have better outcomes? How about other atherectomy devices such as orbital atherectomy and laser lithoplasty and how they perform compared with rotation atherectomy?

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This article was authored by M. Chadi Alraies, MD, an interventional and CHIP fellow at Wayne State University, Detroit Medical Center, Detroit Heart Hospital, Detroit, MI.

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