Feature | October 30, 2013 | Dave Fornell

Medtronic CoreValve U.S. Pivotal Trials Results Reveal Positive Outcome for Patients

CoreValve data shows comparable or better outcomes than Sapien valve

medtronic corevalve cath lab hybrid or heart valve repair study TCT 2013

October 30, 2013 — The first results from the CoreValve U.S. pivotal trial, the first U.S. data presented on the Medtronic CoreValve system, were very positive. The data on the self-expanding transcatheter aortic valve replacement (TAVR) device were presented as a late-breaking clinical trial session of the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) conference. The trial met its primary endpoint in patients who were considered too ill or frail to have their aortic valves replaced through traditional open-heart surgery, with a rate of death or major stroke at one year of 25.5 percent. This result is highly significant (p < 0.0001) as it was 40.7 percent lower in patients treated with the CoreValve system than was expected with standard therapy (a pre-specified performance goal of 43 percent).


At one month, the major stroke rate was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Of the 487 patients enrolled in the study, 471 had an attempted implantation and were designated as the primary "as treated" analysis population. Patients were elderly (83.1 years), and were severely symptomatic (NYHA class III or IV, 91.9 percent). The Society for Thoracic Surgery Predicted Risk of Mortality was 10.3 percent ± 5.6 percent and was > 15 percent in 17.6 percent of patients.


“The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population,” said Jeffrey Popma, M.D., director of interventional cardiology, Beth Israel Deaconess Medical Center, Boston, co-principal investigator and presenter of the trial at TCT. “Not only do the results meet the CoreValve study’s safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve.”


Comparison With Sapien Valve


The device also performed as well or better that the Edwards Lifesciences Sapien valve, which is currently the only U.S. Food and Drug Administration (FDA)-cleared TAVR device in the United States. One-year data from Sapien's PARTNER pivotal FDA trial showed a stroke rate of 6 percent, compared to surgical valve replacement with only 3.2 percent. The higher stroke rate has been the main concern for TAVR, but CoreValve's one-year stroke rate was 4.1 percent, which has caught the attention of market analysts and physicians.


The all-cause mortality rates were comparable, with Sapien at 24.3 percent, CoreValve at 25.5 percent and to surgical valve repair at 26.8 


CoreValve Improved Quality of Life
 
The study also found significant and sustained functional and quality-of-life improvements, with the heart failure symptoms of most patients (90 percent) improving at least one class at one year (as measured by NYHA classification), and quality-of-life scores improving 27.4 points at one year (as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) 100-point scale, in which a 20-point change is considered highly significant).


Overall hemodynamic performance was strong with mean gradients of 8.5 mmHg at one month and 8.8 mmHg at one year, similar to gold standard surgical valves. Paravalvular leak (PVL) rates were low and improved over time with only 11.5 percent of patients having more than mild PVL at one month, which improved to only 4.1 percent at one year. Notably, more than 80 percent of patients with moderate PVL at one month had a reduction in the severity of PVL by one year, an improvement that has not been reported in other major transcatheter aortic valve replacement (TAVR) trials. Furthermore, CoreValve patients with moderate PVL had no greater mortality risk than patients with less PVL.


Major vascular complication rates were low: 8.3 percent at one month and 8.5 percent at one year. Consistent with previous studies on self-expanding technology, the permanent pacemaker rate was 22.2 percent at one month and, importantly, pacemaker implants were not associated with mortality for these patients.


“In the recent past, these patients had no good treatment option and a 50 percent chance of death at one year,” said John Liddicoat, M.D., senior vice president of Medtronic and president of Medtronic's structural heart business. “Along with the clinical community, we are very encouraged by the results in this rigorously conducted trial and look forward to continuing our effort to bring this transformational therapy to patients with life-threatening aortic valve disease in the United States. In particular we wish to commend the 40 enrolling sites and their heart teams for their exceptional commitment to patients and for the meticulous conduct of this trial.”


In the study, 471 patients were treated with the CoreValve system, a self-expanding, low 18 French profile system with three valve sizes (26, 29 and 31 mm) delivered via the femoral artery. Patients were monitored by independent core labs and evaluated against a performance goal developed in partnership with the FDA. In the CoreValve Continued Access Study, 830 extreme-risk patients have been treated with CoreValve system.


Update on FDA review


Medtronic has three FDA IDE trials evaluating the Corevalve for high-risk, extreme-risk and  intermediate-risk surgical patients (SURTAVI Trial). The FDA has determined it will conduct separate reviews for the trial’s extreme-risk and high-risk studies. Upon reviewing the CoreValve trial’s results for extreme-risk patients, the FDA determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve system for this patient group without the need for an external expert panel.


Medtronic anticipates receiving FDA approval of CoreValve system for extreme-risk patients by the end year 2014. It is widely expected the CoreValve will become the second TAVR device to achieve FDA clearance.  


The Rocky Road Ahead


As with the "stent wars" in the late 1990s through the past decade where key stent vendors were involved in extensive patent litigation and counter suits to block competition, the same is already happening in Europe with TAVI devices and it is expected to spill over into the U.S. market. 


In September, a German injunction against sales of Medtronic's CoreValve went into effect, the result of a patent challenge by Edwards Lifesciences. The District Court of Mannheim ruled that Medtronic is infringing Edwards' Spenser patent for transcatheter heart valve technology and issued an injunction prohibiting the sale of CoreValve and CoreValve Evolut systems in Germany, and ordered a recall of these products
 
Since receiving CE mark in 2007, the CoreValve system has been implanted in more than 45,000 patients in more than 60 countries. 
 
New Directions
 

In October, Medtronic announced the first European implants in the CoreValve Evolut R clinical study, which will evaluate the safety and effectiveness of the CoreValve Evolut R recapturable system. This recapture-enabled valve and delivery system is designed to advance deliverability and valve performance while providing the option to recapture and reposition the CoreValve Evolut R valve during deployment, if needed, while performing TAVR.
 

Related Content

European interventional cardiology market, drug-eluting stents, Abbott Laboratories, Boston Scientific, Medtronic

Boston Scientific's Eluvia drug-eluting vascular stent system. Image courtesy of Boston Scientific.

Feature | Stents| July 31, 2015
According to a new report on the Europe market for interventional cardiology by iData Research, drug-eluting stents...
Navidea, Mass General, Tc99m-tilmanocept, vulnerable plaque, cardiovascular disease, Harvard
News | Radiopharmaceuticals and Tracers| July 30, 2015
Navidea Biopharmaceuticals Inc. announced plans to move forward with a joint study of the ability of Tc99m-tilmanocept...
Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | Robotic Systems| July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
MSCs, stem cells, end-stageheart failure, retrograde, coronary sinus,
News | Stem Cell Therapies| July 29, 2015
A new clinical trial to test how a high dose of stem cells delivered via a method called retrograde coronary sinus...
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
Feature | Heart Valve Repair| July 28, 2015
Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped...
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | Atherectomy Devices| July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
heart failure, Adaptive CRT trial, AdaptivCRT algorithm, readmissions
News | Heart Failure| July 22, 2015
Heart failure patients had a significantly lower chance of being readmitted within 30 days of discharge when treated...
Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA
News | Heart Valve Repair| July 22, 2015
Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.
News | Cath Lab| July 22, 2015
The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company...
Overlay Init