Overall, the primary endpoint was 35.8 vs. 67.9 percent per patient-year in the device vs. control groups, respectively. The rate of freedom from device-related complications at 12 months was 96.6 percent in the device group, compared with a prespecified performance goal of 88.0 percent. Death from any cause within 24 months was observed in 29.1 vs. 46.1 percent in the device vs. control groups, respectively.

Study findings suggest "transcatheter mitral leaflet approximation with the MitraClip was safe, provided durable reduction in MR, reduced the rate of [heart failure] hospitalizations, and improved survival, quality-of-life and functional capacity during 24-month follow-up," said Gregg W. Stone, MD, FACC, who presented on behalf of the researchers. "As such, the MitraClip is the first therapy shown to improve the prognosis of patients with HF by reducing secondary MR due to LV dysfunction."

However, Stone and colleagues highlighted that longer-term follow-up is needed to "fully characterize the safety and efficacy of the device." In addition, it is unclear whether other transcatheter-based or surgical approaches could have similar results, and/or whether the MitraClip could have similar benefits in less or more critically ill patients or those with lesser degrees of MR severity.

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The mean increases in the primary endpoint of 6MWD at six months were 83 m in the PADN group and 15 m in the sildenafil group. Additionally, for the secondary endpoint of change in PVR, PADN was associated with significantly lower PVR compared with the sildenafil group. The findings from a post-hoc analysis also associated PADN plus standard medical therapy with a significantly lower rate of clinical worsening. (16.7 vs. 40 percent; p=0.014). Hang Zhang, MD, et al., noted there were seven all-cause deaths and two cases of pulmonary embolism by study end.

"PADN is associated with significant improvements in hemodynamic and clinical outcomes in patients with CpcPH," researchers said. However, they noted given the small sample size that "further studies are warranted to define its precise role in the treatment of this patient population."

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Results at one year showed Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates and myocardial infarction of 12.1 percent, 6.6 percent, 2.2 percent and 2.5 percent, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6 percent of patients with no severe leakage, while new pacemaker rates were 18.7 percent and 21.3 percent for pacemaker naïve patients at 30 days and one year, respectively. Functional class, exercise capacity and quality of life significantly improved from baseline to one year.

"Overall, the study outcomes confirm the high safety, hemodynamic performance and clinical improvement provided by the THV system at one year," said Søndergaard and colleagues. The "results provide important information on the new THV and are expected to help clinicians understand the performance profile of the device which is similar to other current TAVR technologies."

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Overall, the study met both of its co-primary endpoints. A vulnerable patient-level analysis, after adjustment, showed the risk of experiencing non-culprit major adverse cardiovascular events within 24 months was 18 percent higher with each 100 unit increase in maxLCBI4mm. Specifically, a patient with max LCBI4mm >400 was at 87 percent higher risk than a patient with <400 max LCBI4mm. In terms of vulnerable plaque-level analysis, the risk of experiencing an event in a coronary segment within 24 months was 45 percent higher with each 100 unit increase in max LCBI4mm. For example, a coronary segment with maxLCBI4mm >400 was at a 411 percent higher risk than a segment with <400 max LCBI4mm.

"Multivessel NIRS can be easily and safely performed to assess and identify vulnerable patients and vulnerable plaques," said Waksman. He also noted that future studies for the use of NIRS-guided therapy should be conducted to address and mitigate the high risk of these patients and arteries.

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Of the 836 lesions, QFRs were analyzable in 71.0 percent. Researchers noted the diagnostic performance of QFR to predict binary wire-based ischemia "was substantial" with a positive predictive value of 85.9 percent. Independent predictors for diagnostic discordance were lesions in side branches, involvement of bifurcation/trifurcation and small vessel. At the two-year patient-oriented composite endpoint, fSSQFR appropriately reclassified 26.1 percent of patients at high/intermediate risk to low-risk (net reclassification improvement 0.32; p<0.001) – higher than that of classic anatomical SYNTAX score (0.68 vs. 0.56; p=0.002).

"The functional SYNTAX score derived from QFR has the potential to further refine the prognostic risk estimation in a less-invasive fashion," the researchers said. Further investigations are warranted into the "impact of the fSSQFR on the treatment decision of a heart team for patients with 3VD using angiographic acquisition guideline for QFR," they added.

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In presenting the results, Holger Thiele, MD, said the Corevalve Evolut R was shown to be equivalent to the Edwards Sapien 3 with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Permanent pacemaker implantation rates were higher in both groups (22.9 percent with Evolut R vs. 19.0 percent with Sapien 3). Thiele and colleagues also noted the potential for a higher stroke rate with the balloon-expandable valve.

In terms of anesthesia strategy, local anesthesia with conscious sedation was found to be equivalent to general anesthesia with respect to the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment and acute kidney injury. Researchers also noted general anesthesia was associated with a higher rate of catecholamine use but did not affect procedure times, valve-related outcomes or clinical outcomes.

Thiele, et al., note that registry data to date has suggested lower mortality and morbidity, shorter ICU and hospitals stays, as well as shorter procedure times, with local anesthesia. The SOLVE-TAVI findings add to the limited clinical trial research currently available regarding safety and efficacy.

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When compared with ABSORB III, overall ABSORB IV results showed that nearly eliminating treatment of very small vessels substantially reduced the scaffold thrombosis rate in the Absorb BVS group, as well as the Xience CoCr-EES group. Additionally, angina recurred in a relatively high, but nearly identical rate, in both groups. Stone, et al., said they observed a "bimodal pattern suggesting contributions from incomplete revascularization, restenosis, and possibly non-CAD-related mechanisms."

Researchers noted 30-day and one-year rates of myocardial infarction, ischemia-driven TLF and device thrombosis tended to be higher with Absorb BVS vs. Xience CoCr-EES, despite improved patient and lesion selection and technique.

They suggest longer-term follow-up is needed to understand the true safety and efficacy profile of BVS during the first three years and beyond its complete bioresorption.

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