Feature | March 17, 2015| Gregory Chodaczek, analyst for Sterne Agee

Key TAVR, Heart Failure Data Presented at ACC 2015

Positive outcomes demonstrated for Medtronic, Edwards; St. Jude Medical showcases success with CardioMEMS

Sterne Agee, ACC, Medtronic, Edwards, St. Jude, TAVR, heart failure

March 17, 2015 — The American College of Cardiology (ACC) hosted its 64th Annual Scientific Session & Expo over the weekend in San Diego, California. Key data from multiple transcatheter aortic valve replacement (TAVR) clinical trials were presented and we believe there was truly no loser between Edwards and Medtronic based on the positive data presented. In addition, St. Jude Medical announced retrospective analysis on CHAMPION data showing significant reduction in mortality rates and heart failure (HF) hospitalizations for heart failure patients with reduced ejection fraction.

Partner I Trial: Five-year data from Cohort A (candidates for surgery but considered high risk) of Edwards' Sapien transcatheter heart valve trial demonstrated equivalent outcomes to traditional open-heart surgery and no structural valve deterioration requiring intervention. The PARTNER series demonstrated TAVR as equivalent to surgery. The authors noted no significant differences in all-cause mortality, cardiovascular mortality, stroke or need for repeat hospitalization. Results reinforce TAVR as an effective treatment for high-risk patients.

Sapien 3 Trial: Edwards announced positive 30-day outcomes for high- and intermediate-risk patients treated with the Sapien 3 transcatheter aortic valve which demonstrated the lowest all-cause mortality rates of any of the PARTNER studies (2.2 percent and 1.1 percent, respectively). In addition, the rates of significant paravalvular leaks were low in each cohort at 3.0 for high-risk and 4.2 for intermediate. Sapien 3 data is the first report on intermediate risk TAVR patients, with more than 1,000 intermediate-risk patients treated with a Sapien 3 valve.

CoreValve U.S. High-Risk Two-Year Data: The CoreValve U.S. High-Risk study is the first and only head-to-head study to show statistically significant survival differences favoring TAVR in aortic stenosis patients who are considered high-risk for surgery. Two-year outcome data found the rate of all-cause mortality significantly lower in TAVR patients than in SAVR patients (22.2 percent vs. 28.6 percent, p=0.04). The rate of stroke was significantly lower in TAVR as compared to surgical aortic valve replacement (SAVR) at two years (10.9 percent vs. 16.6 percent, p=0.05).

CoreValve Evolut-R 30-Day Data: The Evolut R system showed remarkable results at 30-days with no incidents of all-cause mortality or stroke in a high and extreme risk patient population. However, we note that the Evolut R study was a very small study, with 60 patients enrolled. In addition, the pacemaker rate was 11.7 percent.

CHAMPION Trial: St. Jude Medical announced retrospective data analysis from the CHAMPION trial showing that heart failure patients with reduced ejection fraction on optimal doses of guideline directed medical therapy (GDMT) managed by pulmonary artery (PA) pressure monitoring with the CardioMEMS HF System had a 57 percent reduction in mortality and a 43 percent reduction in HF hospitalizations compared with patients on GDMT and managed by the standard of care. This analysis demonstrated that PA pressure monitoring, coupled with GDMT, significantly reduced HF hospitalizations and mortality in patients with reduced ejection fraction.

For more information: www.sterneagee.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init