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Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

Several potentially practice-changing late-breaking clinical trial results on a variety of topics greeted attendees at Transcatheter Cardiovascular Therapeutics (TCT) 2018, held September 21 to 25 in San Diego.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

Among the highlights of TCT 2018:

  • COAPT Resurrects MitraClip in HF With Mitral Regurgitation
  • Split Decision on Renal Denervation for Resistant Hypertension
  • IMPERIAL: Slow-Eluting Stent Outpaces Standard for Fem-Pop Lesions
  • BIONYX: "Ridiculous" (in a Good Way) Results With Novel Stent
  • Patient–Prosthesis Mismatch Common in TAVR, Survival Suffers
  • ABSORB Trials: Bioresorbable Vascular Scaffold Still Not Up to Snuff
  • ReCre8: Polymer-Free Drug-Eluting Stent Passes 1-Year Test

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

COAPT Stuns, Resurrects MitraClip in HF With Mitral Regurgitation

After neutral results in a European trial, the MitraClip (Abbott) roared back with substantial reductions in key clinical outcomes in patients with heart failure (HF) and moderate to severe or severe secondary mitral regurgitation in the COAPT trial. Use of the MitraClip on top of guideline-directed medical therapy (GDMT) reduced the risk for HF hospitalizations within 24 months by 47% vs GDMT alone, reported coprincipal investigator Gregg W. Stone, MD, Columbia University Medical Center, New York City. The number needed to treat to prevent one HF hospitalization with MitraClip was 3.1. The rate of freedom from device-related complications at 12 months was 96.6%, easily passing the 88.0% target. The risk for all-cause death was cut by 38%, with a number needed to treat of 6. "As such, MitraClip is the first therapy shown to improve the prognosis of patients with HF by reducing secondary mitral regurgitation due to LV dysfunction," said Stone. "The results are obviously important and very impactful, not only because of the relative improvement but because of the absolute improvements in a very-high-risk group that prior to this trial had really no therapeutic alternatives," he added.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

Split Decision on Renal Denervation for Resistant Hypertension

A randomized head-to-head comparison of three different renal denervation approaches appears to give the edge to ultrasound ablation of the main renal arteries in patients with resistant hypertension. The reduction in daytime ambulatory systolic blood pressure (BP) at 3 months was 13.2 mm Hg with ultrasound ablation, 8.3 mm Hg with radiofrequency (RF) ablation of the main renal arteries and branches, and 6.5 mm Hg with RF ablation of the main renal arteries. Only the difference between the ultrasound and RF main artery groups reached statistically significance. Daytime diastolic BP reductions followed a similar pattern but were less pronounced. All three approaches — ultrasound ablation using the Paradise catheter (ReCor Medical) and both RF ablations using the Symplicity Spyral catheter (Medtronic) – had a favorable safety profile in the RADIOSOUND-HTN study, said principal investigator Philipp Lurz, MD, PhD, University of Leipzig, Germany. "The results are encouraging but it is too early to prefer one technology over the other," Lurz said. However, "it seems when you have very complex anatomy, the spiral catheter might be the easier one to use because it is low-profile and it is less stiff."

The REDUCE HTN-REINFORCE trial, however, also reported here, was stopped early for futility with just 51 patients enrolled, and results showed no significant difference between renal denervation using the Vessix catheter (Boston Scientific) and a sham procedure for the primary end point of ambulatory BP at 8 weeks.

At 6 months though, 52% of those actively treated achieved an office BP below 140 mm Hg, compared with just 12% in the sham group, and mean office systolic and diastolic blood pressures were 11.4 mm Hg and 5.4 mm Hg lower, respectively, in the denervation group (P = .037).

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

IMPERIAL: Slow-Eluting Stent Outpaces Standard for Fem-Pop Lesions

A novel stent with sustained paclitaxel release provided better target-vessel patency at 1 year against the standard paclitaxel-eluting stent for the treatment of femoropopliteal artery lesions, in the first such head-to-head comparison. The 12-month primary patency rate was 86.8% for Eluvia (Boston Scientific) and 77.5% for Zilver PTX (Cook Medical). This met the 10% noninferiority margin set for the IMPERIAL trial and prompted a prespecified post hoc analysis for superiority, which also was achieved. Patients treated with Eluvia rather than Zilver PTX had half the rates of clinically driven target lesion revascularization and stent thrombosis, according to the late-breaking results. Eluvia has a biostable fluorinated polymer matrix that releases paclitaxel out to 1 year, whereas the polymer-free Zilver PTX rapidly delivers paclitaxel that remains in arterial tissue through 2 months. "There were no safety signals; it was clearly effective — at least as effective, and more effective, frankly, than the predicate — so I'd be shocked if it didn't get approved,'' said principal investigator William A. Gray, MD, Lankenau Heart Institute, Wynnewood, Pennsylvania. The noninferiority trial was designed to support US approval of Eluvia, which received a CE mark in 2016.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

BIONYX: "Ridiculous" (in a Good Way) Results With Novel Stent

In the BIONYX trial, a thin composite wire strut durable polymer-based drug-eluting stent (Resolute Onyx, Medtronic) was found to be noninferior to the bioresorbable polymer-coated sirolimus-eluting Orsiro stent (Biotronik) for the primary composite end point of target-vessel failure, a composite of cardiac death, target-vessel-related myocardial infarction, and clinically driven target-vessel revascularization at 1 year in all comers, reported Clemens von Birgelen, MD, PhD, Thorax Centrum Twente, Enschede, the Netherlands. Both the Resolute Onyx and Orsiro devices were associated with a low rate of stent thrombosis, but the 0.1% rate seen with Resolute Onyx, compared with 0.7% for Orsiro, was called "ridiculously low" by invited discussant Stuart Spencer, senior executive editor of The Lancet, where the results were published to coincide with presentation here.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

Patient–Prosthesis Mismatch Common in TAVR, Survival Suffers

Severe prosthesis–patient mismatch (PPM) occurs in more than 10% of patients after transcatheter aortic valve replacement (TAVR) and increases the risk for death but not stroke, according to the largest study to date. Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, the study team identified 62,125 patients who underwent TAVR from January 2014 to March 2017, and linked 37,470 patients who were 65 years of age at the time of treatment to Medicare administrative claims data. Severe and moderate cases of PPM were present in 12.1% and 24.6% of patients, respectively, reported Howard C. Herrmann, MD, Perelman School of Medicine, University of Pennsylvania, Philadelphia. "We've identified a problem and I think the awareness is really the first step in trying to fix it," said Herrmann. "We spend a lot of time in heart-team meetings looking at CT scans for annular dimensions, their vascular access, but we don't really talk too much about severe PPM or the risk for that. I think this allows us to start calculating that, to predict it on the basis of patients' factors and what prosthesis we might be choosing for a patient," and "to think about alternatives," he added.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

ABSORB Trials: Bioresorbable Vascular Scaffold Still Not Up to Snuff

Results from two randomized controlled trials of a bioresorbable vascular scaffold (BVS) that has been withdrawn from the market call into question the wisdom of continued development of the technology. The ABSORB IV trial — a rigorously controlled study designed to overcome problems that might have marred results of earlier trials of the Absorb everolimus-eluting BVS (Abbott Vascular) — showed that Absorb was noninferior to Abbott's metal Xience everolimus-eluting stent for the primary end point of target lesion failure (TLF) at 30 days and the secondary end points of TLF and angina at 1 year. But despite the more careful patient selection and improved implantation techniques used in ABSORB IV, both 1-month and 12-month rates of myocardial infarction (MI), ischemia-drive target lesion revascularization, and device thrombosis were all higher with Absorb, reported Gregg W. Stone, MD, Columbia University Medical Center, New York City. In the COMPARE-ABSORB trial, pitting the same two stents against each other in high-risk patients with complex lesions, Absorb also met the primary end point of noninferiority for TLF at 12 months, but at the cost of significantly higher target-vessel MI and definite or probable scaffold thrombosis.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

ReCre8: Polymer-Free Drug-Eluting Stent Passes 1-Year Test

A new polymer-free amphilimus-eluting stent was noninferior to a permanent-polymer zotarolimus-eluting stent for target lesion failure (TLF) at 12 months in an all-comers population in the physician-initiated ReCre8 study. The TLF rate was 6.2% with Alvimedica's polymer-free Cre8 stent and 5.6% with Medtronic's Resolute Integrity stent (noninferiority P = .0086), reported Pieter R. Stella, MD, PhD, University Medical Center, Utrecht, the Netherlands. The nonindustry-sponsored study of 1532 European patients is the first head-to-head comparison between the two drug-eluting stents in an all-comer patient population. Equally compelling were two exploratory subanalyses that examined the safety of short-duration dual-antiplatelet therapy, and whether the polymer-free stent could deliver on the promise of positive outcomes in patients with diabetes.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

LEADERS FREE II Supports Biolimus Stent for High-Risk Patients

Results from the pivotal LEADERS FREE II trial suggest that the BioFreedom (Biosensors) polymer-free biolimus A9–coated stent for patients with not only blocked coronary arteries but a high risk of bleeding is a step closer to potential US regulatory approval. LEADERS FREE showed that in a European population, high-bleeding-risk patients who received this biolimus-coated stent vs a bare metal stent (both with only 30 days of dual antiplatelet therapy) had better 1-year efficacy and safety outcomes. The device has been available in Europe since 2013. Now, LEADERS FREE II shows similar findings in patients in North America. That is, "by enrolling more than half of the patients in North America, LEADERS FREE II supports the generalizability of the findings of both studies to patients on both sides of the Atlantic," said coprincipal investigator Mitchell W. Krucoff, MD, Duke University, Durham, North Carolina. The trial also sounds an alarm for current practice at some US centers, Krucoff said. The LEADERS FREE trials suggest, he said, "that our intuitive behavior in practice of putting bare-metal stents in patients whom we know are at high bleeding risks...is actually a safety signal that we're potentially doing harm."

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

TALENT: Indian-Made Supraflex DES Flexes Muscle Against Xience

The ultrathin Supraflex sirolimus-eluting stent, made in India, hit its primary noninferiority end point against the workhorse Xience everolimus-eluting stent in an all-comer patient population in the TALENT trial. At 12 months, the composite end point of cardiac death, target-vessel myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) occurred in 4.9% of patients treated with Supraflex (Sahajanand Medical Technologies) and 5.3% treated with Xience (Abbott Vascular). This met the noninferiority margin of 4%, but even when this "somewhat generous margin" was dropped to 2.12%, "the P value is still there; so very robust type of data," said study chair Patrick W. Serruys, MD, PhD, Imperial College London. A per-protocol analysis showed no significant differences between Supraflex and Xience in the primary end point components of cardiac death and MI but did show a 61% relative reduction in TLR favoring Supraflex. "The study results have important implications in countries with capped stent prices, such as India, and in some European countries with competitive pricing and different models of healthcare cost savings," said Serruys, adding, "Market competitiveness may influence future decisions on which stent to use."

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

FAST-FFR: FFR From Angiography Accuracy Similar to Pressure Wire

Fractional-flow reserve values derived from routine coronary angiography (FFRangio) are highly sensitive, specific, and accurate at predicting FFR derived via coronary pressure wire, results of the FAST-FFR trial show. "FFRangio may provide an easier and potentially faster method for performing physiology-guided assessment of the overall coronary angiogram with similar accuracy to the reference standard, coronary pressure wire-based FFR," said investigator William F. Fearon, MD, Stanford University School of Medicine in California. "This may translate into a greater percentage of patients undergoing physiologic guidance for revascularization decisions and, ultimately, improve long-term outcomes," he said. Fearon admitted being surprised by the results. "As a coronary physiologist, we don't believe the angiogram. That's why we measure with a pressure wire, so I was definitely impressed with how high the accuracy was."

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

SOLVE-TAVI: TAVR Safe With Either of Two Valves, Two Types of Anesthesia

In the SOLVE-TAVI study, intermediate- to high-risk patients who underwent transcatheter aortic valve implantation (TAVR) had equally good safety and efficacy outcomes with two types of second-generation valves and two types of anesthesia. The study enrolled more than 400 patients with symptomatic aortic stenosis who were scheduled to undergo TAVR and randomized them first to receive a self-expandable CoreValve Evolut R valve (Medtronic) or a balloon-expandable SAPIEN 3 valve (Edwards), and second to undergo local or general anesthesia. The findings show that "the latest-generation valves are technically so well developed that we can use either valve," said Holger Thiele, MD, Leipzig University Hospital, Germany. Moreover, although "there are still many people, particularly anesthesiologists, who believe that general anesthesia may be safer," this study shows that "local anesthesia is as good as general anesthesia," he said. B. Hadley Wilson, MD, Sanger Heart & Vascular Institute–Charlotte and the UNC School of Medicine, Chapel Hill, North Carolina, agreed that "now we can feel comfortable that we can pick the best valve that we think will fit our patients and not have [safety] concerns."

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

PADN-5: Ablation Reduces Pulmonary Hypertension in HF

Patients with combined pre- and postcapillary pulmonary hypertension (CpcPH) secondary to left-sided heart failure (HF) who underwent a pulmonary artery denervation (PADN) procedure had significant improvements in hemodynamic and clinical outcomes at 6 months, compared with patients who underwent a sham procedure, in the PADN-5 trial. Among 98 patients with CpcPH assigned to receive either pulmonary denervation or sildenafil plus a sham procedure, PADN was associated with significantly better 6-minute walk distance and significantly lower pulmonary vascular resistance at 6 months, reported Shao-Liang Chen, MD, Nanjing Medical University, China. The benefits of PADN were seen in patients with both ejection-fraction-preserved HF and ejection-fraction-reduced HF, he noted. The investigators hypothesized that pulmonary artery denervation targets overactivation of sympathetic nerves in patients with HF and pulmonary hypertension.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

Indirect Annuloplasty Device Reduces Mitral Regurgitation

Results of a sham-controlled randomized trial of an indirect mitral annuloplasty system showed significant reductions in functional mitral regurgitation (FMR) after 1 year of follow-up in patients with heart failure and secondary mitral regurgitation. In an intention-to-treat analysis, the mean change in regurgitant volume at 1 year among 55 patients who received the Carillon mitral contour system device (Cardiac Dimensions) was –7.1 mL, a reduction of 22%, compared with an increase of 3.3 mL (8%) in patients who underwent a sham procedure, reported Horst Sievert, MD, CardioVascular Center, Frankfurt, Germany. REDUCE FMR was positive despite significant challenges and the investigators' fears that it would flop, Sievert said. Challenges included the unexpected finding that the patient population had less severe disease than that seen in most other heart failure trials. "This wasn't intended; it happened because patients were not screened by the core lab before they were enrolled in the trial, but the end of the trial was positive, which means, despite including patients with less severe MR, still we saw an effect, which is actually a good thing to see," Sievert said.

Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

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Top News From TCT 2018: Slideshow

Patrice Wendling; Darbe Rotach; Neil Osterweil; Marlene Busko; Megan Brooks | October 15, 2018 | Contributor Information

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