Navigation Links
American Heart Association Late-Breaking Clinical Trial Report: New Reversible Oral Drug Reduces Cardiac Events in Primary PCI Patients
Date:11/15/2009

Study highlights:

-STEMI (heart attack) patients had fewer cardiac events with a new reversible oral anti-platelet drug compared to standard treatment with an irreversible agent. This was associated with reduced cardiovascular and all cause mortality.

-No increase in major bleeding incidents was reported.

ORLANDO, Fla., Nov. 15 /PRNewswire-USNewswire/ -- Acutely ill heart attack patients who received both aspirin and a new reversible oral anti-platelet medication had fewer cardiac events than patients on aspirin and the most commonly used, irreversible anti-platelet drug, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

In the PLATelet Inhibition and Patient Outcomes (PLATO) trial, a subset of 8,430 patients who were in the midst of ST-elevation heart attacks (STEMI) and were scheduled for primary percutaneous coronary intervention (PCI) with stenting received the investigational drug ticagrelor or clopidogrel in addition to aspirin. Participants for the randomized, double-blind trial were recruited from 862 sites in 43 countries between 2006 and 2008.

The ticagrelor group suffered fewer cardiovascular events from the onset of the trial, and the benefits continued the longer patients took the drug during the year-long follow-up, said Philippe Gabriel Steg, M.D., lead investigator of the study. "The results are very clear and actually very consistent with the overall trial results of the larger PLATO trial, namely that there's a reduction in the primary endpoint -- a composite of incidence of heart attack, stroke or vascular death -- with no increase in major bleeding complications compared to clopidogrel," said Steg, professor of cardiology and director of the coronary care unit at Hopital Bichat-Claude Bernard in Paris, France.

Bleeding is usually a concern with new antiplatelet agents. Since ticagrelor is a more potent agent than one of the American Heart Association/American College of Cardiology guidelines recommended medications, clopidogrel, bleeding was a concern. "The good news is that there was no sign of increased major bleeding regardless of how we defined it," he said.

Following up to one year, 9.3 percent of the ticagrelor group met the primary endpoint, compared to 11 percent of the clopidogrel group -- a 15 percent relative risk reduction for the investigational group. The patients in Steg's analysis had STEMI and were scheduled to receive primary PCI -- also known as angioplasty -- and stenting during the acute phase of their heart attacks. The 4,201 patients randomized to the test group received 180 milligrams (mg) of ticagrelor during PCI, followed by 90 mg twice daily for six to 12 months. The other 4,229 patients received 300 mg of clopidogrel with a provision for an additional 300 mg during PCI, followed by 75 mg daily for six to 12 months. All patients in the trial also received daily aspirin therapy.

"STEMI is really the most acute form of coronary disease and represents roughly 40 percent of the patient group enrolled in the larger PLATO trial," Steg said. "It is a common condition, and it is a high-risk condition for which the standard of care, clopidogrel, has clear drawbacks."

"Clopidogrel's drawbacks include a slower onset of effectiveness, which is not suited to the need for rapid effect in STEMI, and a modest and inconsistent anti-platelet effect -- many patients respond well, but a sizeable unresponsive group remains at high risk of blood clots despite therapy," Steg said. Clopidogrel also binds permanently to the platelets' P2Y12 receptors, so its effect lasts seven to 10 days after the medication is stopped. In contrast, ticagrelor's effect is direct and reversible, he said. "With ticagrelor, there is an actual disassociation between the drug and the P2Y12 receptor so that the drug does not bind permanently to the receptor, and the receptor and the platelet can regain function, with normal platelet clotting ability returning in about four days, which may explain the absence of increased bleeding with ticagrelor," Steg said. "However, ticagrelor does have off-target effects, which probably explain a side effect more commonly seen with ticagrelor than clopidogrel: dyspnea, or breathlessness, which affected 12.9 percent of ticagrelor patients and 8.3 percent of the clopidogrel group."

Overall mortality was reduced with ticagrelor -- from 6.0 percent to 4.9 percent, a relative reduction of risk of 18 percent. Likewise, the risk of new myocardial infarction and the risk of stent thrombosis were also reduced. "Furthermore, the benefit is not solely achieved during the acute phase, the first 30 days after angioplasty, but the benefit accrues over time so that the longer you treat, the greater the difference in event rates," Steg said. "There is a strong rationale to prefer this new agent both in the acute (first 30 days) and in the late phase after a heart attack."

Study funded by: AstraZeneca (manufacturer of the investigational drug).

Co-authors are: Richard C. Becker, M.D.; Christopher P. Cannon, M.D.; Hakan Emanuelsson, M.D., Ph.D.; Robert A. Harrington, M.D.; Jay Horrow, M.D.; Steen Husted, M.D., D.Sc.; Hugo Katus, M.D.; Robert F. Storey, M.D., D.M.; Lars C. Wallentin, M.D., Ph.D.

Disclosures: Research grant: Sanofi-Aventis, Servier Speakers bureau: Boehringer-Ingelheim, BMS, GSK, Medtronic, Sanofi-Aventis, Servier, The Medicines Company. Consulting/advisory board: Astellas, AstraZeneca, Bayer, Boehringer-Ingelheim, BMS, Endotis, GSK, Medtronic, MSD, Nycomed, Sanofi-Aventis, Servier, and The Medicines Company.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.americanheart.org/corporatefunding.

NR09 - 1162 (SS09/PLATO Steg)

SOURCE American Heart Association


'/>"/>
SOURCE American Heart Association
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016  Kindred ... focused on saving and improving the lives of pets, ... Technical Section of the New Animal Drug Application (NADA) ... the pivotal field study (KB0120) of Zimeta for the ... by the Company. --> ...
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016   ... the advancement of new health technologies, announced today " ... outstanding achievements in health tech over the past ten ... For nearly a decade, Health 2.0 has served ... and showcased and connected with thousands of technologies, companies, ...
(Date:2/11/2016)... 11, 2016  MiMedx Group, Inc. (NASDAQ: MDXG ... membrane and other birth tissues, human skin and bone, ... market advanced products and therapies, announced today that it ... Healthcare Conference in New York , ... Michael J. Senken , Chief Financial Officer and ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... Dr. Sadati’s recent feature in ... Along with performing procedures, the magazine also highlights that Dr. Sadati has pioneered ... of the most common procedures he performs is his natural facelift. “As people ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... The president ... DoD Military Health System but would shift more of the cost burden to military ... TRICARE-reform plan laid out in the defense budget as including limited quantifiable benefit fixes ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... and women’s health, is pleased to announce the promotions of Allison Kelly to ... team, Steve Catone to executive vice president of North American capital sales, and ...
(Date:2/11/2016)... Laurel, NJ (PRWEB) , ... February 11, 2016 ... ... announces the call for nominations seeking candidates for the Board of Commissioners. Individuals ... with passion, skills and experience with diversity of clinical practice settings and across ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... of a master charity program created to assist the people of their local ... closely with nonprofit organizations and community leaders. Their hope is to bring awareness ...
Breaking Medicine News(10 mins):