Perhaps the most anticipated data for Medtronic will be from the first U.S.-based CoreValve trials of a self-expanding transcatheter heart valve in patients suffering from severe aortic stenosis. Currently the only system approved for use by the FDA is the first generation Sapien system, manufactured by Edwards. Both the Sapien and CoreValve have been available in Europe for several years and the numbers of patients being treated with this non-surgical approach to aortic valve replacement has been growing steadily each year.
Another hot topic will be renal denervation (RDN), a new method of treating hypertensive patients who do not adequately respond to medications. No RDN device is currently approved for use in the U.S. (several are in Europe) but Medtronic's Symplicity clinical trial program in the U.S. started early on and, if successful, will result in Medtronic offering the first such device approved by the F.D.A.
Finally, the ongoing topic of drug-eluting stents will see more information presented about optimal length of dual antiplatelet therapy as well as a new DES "match-up." Dr. Fausto Feres of Brazil will present the results of the OPTIMIZE study in which patients receiving the Endeavor zotarolimus-eluting stent discontinued DAPT at either 3 months or 12 months. If there are no safety or efficacy differences in these groups, the OPTIMIZE trial will add to the evidence that, at least with some second and third generation drug-eluting stents, a full year of DAPT may not be necessary, thus reducing costs and bleeding risks. For more information on the OPTIMIZE study, read Angioplasty.Org's interview with Dr. Fausto Feres.
A second major late-breaking clinical trial involving Medtronic stents will be the DUTCH PEERS (a.k.a. TWENTE II). The original TWENTE trial compared Medtronic's Resolute stent with Abbott's XIENCE and showed no difference in outcomes between the two (this was last measured at two years). On Thursday a new trial will be presented by the same Dutch research team, comparing Medtronic's Resolute Integrity with Boston Scientific's Promus Element -- both so-called third generation drug-eluting stents.
The company press release from Medtronic, Inc. follows:
Medtronic to Unveil CoreValve U.S. Pivotal Trial Results at TCT 2013
Late Breaking Clinical Trial Features the First U.S. Data of Novel Self-Expanding Transcatheter Valve at Premier Interventional Cardiology Meeting
Other Late-Breakers Feature New Clinical Data on Endeavor and Resolute Drug-Eluting Stents; Three Year Results of Symplicity HTN-2 Study to be Presented
October 17, 2013 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT) today announced its schedule of notable sessions that will be presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium in San Francisco, including the highly-anticipated clinical outcomes from the Extreme Risk Study of the CoreValve U.S. Pivotal Trial.
The CoreValve Pivotal Trial presentation will kick-off the annual medical meeting's late-breaking clinical trials sessions this year, on the morning of Tuesday, Oct. 29.
"Unveiling the CoreValve U.S. Pivotal Trial data for the first time is a significant milestone as we work toward bringing more therapy options to patients in the U.S.," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business at Medtronic. "This study will provide vital information for physicians and their U.S. patients, many of whom have had no good option for treating their aortic stenosis."
Thursday's late-breaking clinical trials session includes two presentations involving Medtronic drug-eluting stents:
- Conducted in Brazil, the OPTIMIZE study compared one-year outcomes in patients who received the Endeavor drug-eluting stent (DES) and stayed on dual antiplatelet therapy (DAPT) for either three or 12 months. It is the largest prospective randomized controlled trial (RCT) to examine DAPT discontinuation at three months after implantation of any DES.
- Conducted in the Netherlands, the DUTCH PEERS study compared one-year outcomes in patients who received either the Resolute Integrity DES or the Promus Element DES from Boston Scientific. It is the first prospective RCT of "third-generation" drug-eluting stents.
At an oral presentation at TCT, the three-year follow-up results from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation, will be presented.
The following presentations related to Medtronic therapies appear in chronological order in U.S. Pacific Daylight Time:
Tuesday 29 October
9:00 a.m. - 9:30 a.m. / TCT Press Conference for journalists with press credentials presented by the Cardiovascular Research Foundation (CRF)
Location: Moscone South, Room 300
- 9:10 a.m. / CoreValve Extreme Risk: A Prospective Study of Transcatheter Aortic Valve Replacement with a Self-Expanding Transcatheter Heart Valve in Patients with Severe Aortic Stenosis
10:35 a.m. - 11:45 a.m. / Plenary Session IV. Late Breaking Clinical Trials I
Location: Main Arena
- 11:05 a.m. / CoreValve Extreme Risk: A Prospective Study of Transcatheter Aortic Valve Replacement with a Self-Expanding Transcatheter Heart Valve in Patients with Severe Aortic Stenosis
1:00 p.m. - 2:30 p.m. / Special Sessions
Location: Moscone North, Lower Level, Room 131
- CoreValve US Pivotal Extreme Risk Study: Overview and In-Depth Analyses
1:00 p.m. - 3:15 p.m. / Oral Abstract: Renal Denervation and Endovascular Intervention
Location: Moscone West, 3rd Floor, Room 3022
- 1:00 p.m. / 3-Year HTN-2 Results
4:00 p.m. - 5:00 p.m. / Medtronic Analyst and Investor Briefing
Location: Webcast
- An update on the Medtronic Catheter Based Therapies business (this event is not part of the official TCT Annual Scientific Sessions)
Thursday 31 October
9:30 a.m. - 10:40 a.m. / Plenary Session XVI. Late Breaking Clinical Trials III
Location: Main Arena
- 9:30 a.m. / Featured Trial of the Day: OPTIMIZE: A Prospective, Randomized Trial of Three Months vs. 12 Months of Dual Antiplatelet Therapy After PCI
- 10:20 a.m. / DUTCH PEERS (TWENTE II): A Prospective, Randomized, "All-Comers" Trial of Zotarolimus-Eluting Stents vs. Everolimus-Eluting Coronary Stents
The CoreValve System and the Symplicity Catheter System are not currently approved for commercial use in the United States and are undergoing clinical trials in the U.S. The Resolute Integrity DES obtained FDA approval in 2012 and, along with the Endeavor DES, is commercially available in the United States.
TCT Analyst and Investor Briefing
Medtronic will host a webcast to provide an update on its Catheter Based Therapies business during the Transcatheter Cardiovascular Therapeutics (TCT) Conference on Tuesday, Oct. 29, 2013, in San Francisco beginning at 4:00 p.m. PDT. The webcast will feature remarks from Medtronic management, including a review of the results from the Extreme Risk study of its CoreValve U.S. Pivotal Trial. A live audio webcast of the presentation will be available on Oct. 29, 2013, by clicking on the Investors link on the Medtronic home page at http://www.medtronic.com. Within 24 hours of the webcast, a replay will be available under the Events and Presentations page in the Investors section of the Medtronic website. This event is not part of the official TCT Annual Scientific Session.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
