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Analysis Of Medtronic Stent Finds Early Cessation Of Dual Antiplatelet Therapy Caused No Increased Risk Of Blood Clots To One Year
More than 900 Patients in RESOLUTE Clinical Program Interrupted or Discontinued DAPT After 30 Days Following Implant Procedure
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October 22, 2012 -- Minneapolis and Miami -- Interrupting dual antiplatelet therapy after 30 days following the implantation of a Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) caused no increase in rates of stent thrombosis at one year, according to a new analysis of the global RESOLUTE clinical program presented today at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

Prof. Sigmund Silber, MD
Prof. Sigmund Silber, MD
"This analysis adds provocative new insight to ongoing discussions about the minimal duration of dual antiplatelet therapy required to safeguard patients with the latest generation drug-eluting stents," said the presenter, Prof. Sigmund Silber, M.D., director of the Heart Centre at the Isar in Munich, Germany. "For those patients with a Resolute stent who interrupted dual antiplatelet therapy after just one month following the implant procedure 末 which in this cohort was not always for medical indications 末 there appears to be no additional risk of stent thrombosis through one year of follow up."

Prof. Silber continued, "On such an important topic, it bears restating that clinicians should consider all of the available evidence on dual antiplatelet therapy and, based on their medical judgment, make the most appropriate decisions for each of their patients. As always, patient safety is of paramount importance."

The global RESOLUTE clinical program consisted of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries across Europe, Asia, the Pacific Rim, the Middle East, Africa, Latin America and North America. In total, the program enrolled 5,130 patients who received a Resolute drug-eluting stent.

The new analysis of dual antiplatelet therapy interruption included data on nearly 5,000 patients for whom the relevant information was available and used the Academic Research Consortium (ARC) definitions of stent thrombosis.

The analysis was performed to examine the one-year rates of stent thrombosis in patients whose dual antiplatelet therapy was interrupted after one month and three months following their implant procedure. More than two-thirds of the patients in the analysis permanently discontinued dual antiplatelet therapy:

  • 907 patients interrupted or discontinued their dual antiplatelet therapy after one month. None of these patients (0.0 percent) experienced ARC definite/probable stent thrombosis through one year of follow-up.

  • 816 patients interrupted or discontinued their dual antiplatelet therapy after three months. Similarly, none of these patients (0.0 percent) experienced ARC definite/probable stent thrombosis through one year of follow-up.

Dual antiplatelet therapy 末 the combination of aspirin and thienopyridine, a class of blood thinners 末 reduces the risk of stent thrombosis, but long-term use of antiplatelet drugs carries its own risks, including bleeding complications. Based on the available evidence, current clinical guidelines recommend dual antiplatelet therapy for up to one year following drug-eluting stent implantation.

Sometimes, patients with drug-eluting stents interrupt their dual antiplatelet therapy on the advice of their physician, usually because of a required medical procedure, within the first year of receiving their implant; their physician understands that doing so reduces the risk of bleeding complications surrounding the required medical procedure but is generally thought to expose them to a higher acute risk of stent thrombosis.

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 末 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.

Source: Medtronic, Inc.