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Medtronic Stent Gets CE Mark Label Update for One Month of DAPT
European Label Update Highlights Safety of Medtronic's Drug-Eluting Stent;
'No Increased Risk' for Patients Who Must Stop Dual Antiplatelet Therapy (DAPT) After 30 Days
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Medtronic's Resolute Integrity Drug-Eluting Stent |
March 4, 2013 -- Medtronic, Inc. (NYSE: MDT) today announced that its Resolute Integrity drug-eluting stent has received CE Mark approval for a labeling update to read, "...patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis."
The Conformité Européenne decision was based on an analysis of 5,000 patients enrolled in the RESOLUTE Clinical Program, which at one year showed no stent thrombosis in the 907 patients who discontinued dual antiplatelet therapy (DAPT) after one month. Additionally there were no stent thromboses in 816 patients who stopped after three months. Initial data from this analysis were first presented at the annual TCT Meeting in Miami last October by Prof. Sigmund Silber, M.D., director of the Heart Centre at the Isar in Munich, Germany. In the past year, both Boston Scientific and Abbott have received CE Mark approvals to indicate a low risk after a minimum of three months of dual antiplatelet therapy; today's announcement makes Medtronic's flagship drug-eluting stent the only DES with this one-month CE Mark safety update.
Medtronic notes that this labeling update approval applies only to countries that accept the CE Mark and is not applicable for the U.S. and others. Medtronic also noted to Angioplasty.Org that the company supports the current guideline recommendations for a six to twelve month duration of DAPT, and that physicians are the ultimate decision-makers as to how long a patient is required to stay on DAPT
Duration of DAPT After Drug-Eluting Stents is the "Big Question"
Ever since stent thrombosis concerns surfaced with the first generation of drug-eluting stents in 2006, the interventional cardiology community has been focused on the proper duration of antiplatelet therapy, a drug combination that consists of aspirin plus a thienopyridine, such as clopidogrel (Plavix), or more recently prasugrel (Effient) or ticagrelor (Brilinta). Initial DES approvals had called for six months of DAPT but, when increased incidents of stent thrombosis (blood clots inside the stent) started to be seen, the FDA and the various professional guidelines committees decided to extend the DAPT duration recommendation to one year. This initial recommendation was made in the face of a lack of evidence as to whether one year or more would allay this problem. But because stent thrombosis, while a very low frequency event, is a serious complication resulting in heart attack or death more than one-third of the time, the one year recommendation was instituted.
In an attempt to answer this question, a massive study of over 20,000 patients (called the DAPT Trial) is currently looking at whether 12 or 30 months of DAPT changes the outcomes in patients. However, in the meantime, 2nd and 3rd generation stents have come on the market, all of which have shown significant advances in both efficacy and safety. Clinical trials of these devices have shown very low stent thrombosis rate at one year and the current crop of drug-eluting stents are considered as safe or safer than the earlier bare metal versions. For more information and background on these issues, see Angioplasty.Org's article from last year, "Drug Eluting Stents Are Safe."
The Problem of Early Cessation of DAPT
Several issues for patients arose in the wake of the one-year recommendation: it is difficult, if not impossible, for patients who are on antiplatelet therapy to undergo many types of surgery, because of bleeding risks. Also, some patients cannot tolerate these drugs, or develop hypersensitivities to them, or encounter bleeding or serious gastric adverse events. Additionally, some patients, either due to economic or personal reasons are at risk for low compliance for an entire year of DAPT therapy, although the economic issue has become less crucial with the expiration of the Plavix patient and the advent of generic versions of clopidogrel.
As a result, cardiologists have tended to implant the older, and possibly less effective, bare metal stents in patients who may need to have major surgery in the next year, or in patients who may not comply with the duration of DAPT for other reasons.
For this group of patients, and their physicians, the revised safety labeling for the newer generation of stents may provide assistance in making these decisions. While the CE Mark update is not a recommendation, per se, for prescribing only one month of DAPT when a Resolute Integrity stent is implanted, it can provide some piece of mind for those patients who, for one reason or another, must stop taking these medications. These are not rare issues. In the RESOLUTE Clinical Program of 5,000 patients, one in five patients stopped DAPT within the first three months after implantation (and none of these patients encountered stent thrombosis from the point of cessation up to one year).
Medtronic states that additional information about this labeling update will be presented at this weekend's ACC.13 meeting by Dr. Ajay Kirtane of NewYork-Presbyterian Hospital/Columbia University Medical Center.
This morning's press release from Medtronic, Inc. follows:
Medtronic Approved to Update Resolute Integrity Stent's 'CE' Mark Labeling on Dual Antiplatelet Therapy
Interruption or Discontinuation After One Month Following Implant Procedure Posed 'Low and No Increased Risk' of Stent Thrombosis at One Year in Clinical Studies
March 4, 2013 -- Minneapolis -- Of relevance to the clinical practice of interventional cardiology, Medtronic, Inc. (NYSE: MDT) announced today that it has received regulatory approval to update the CE (Conformité Européenne) mark labeling for the Resolute Integrity drug-eluting stent with new information on one month of dual antiplatelet therapy (DAPT), the shortest minimum duration referenced on the label for any device of its kind. The updated labeling states: "One year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those who interrupted or discontinued DAPT any time after one month. While physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis."
This labeling update applies to product distributed in countries that accept the CE mark. It does not apply to product distributed beyond these countries, including the United States.
Dual antiplatelet therapy –– the combination of acetylsalicylic acid (ASA) and a thienopyridine like clopidogrel –– reduces the risk of stent thrombosis, the formation of a blood clot inside the stented arterial segment; but long-term use of antiplatelet agents increases the risk of bleeding complications. Balancing these risks remains a challenge.
Dual antiplatelet therapy guidelines for patients who receive a drug-eluting stent differ by geographic region, but generally recommend daily compliance for six to 12 months. For a variety of reasons, however, some patients interrupt or discontinue their DAPT early, which raises safety concerns.
"An independent analysis of data on nearly 5,000 patients from the global RESOLUTE Clinical Program who received a Resolute drug-eluting stent shows that the greatest risk of stent thrombosis due to DAPT interruption is within the first 30 days of the implant procedure," explained Prof. Sigmund Silber, M.D., director of the Heart Centre at the Isar in Munich, Germany. "It also shows that DAPT interruption after 30 days is associated with a low risk of stent thrombosis and no increased risk for cardiac death or target vessel myocardial infarction."
Prof. Silber, a member of the ESC 2010 guidelines committee for myocardial revascularization, presented this analysis at TCT 2012, which took place in Miami in October. Ajay Kirtane, M.D., an interventional cardiologist at NewYork-Presbyterian Hospital/Columbia University Medical Center, plans to present additional analysis during ACC.13, which is scheduled to take place in San Francisco from March 9–11.
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.
Reported by Burt Cohen, March 4, 2013
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