Navigation Links
Assessing the most appropriate duration of dual antiplatelet therapy after coronary stenting
Date:8/30/2011

A randomised multicentre open-label study evaluating the efficacy and safety of prolonged antiplatelet therapy in patients with coronary disease has found that 24 months' duration of dual therapy is no better than six months DAPT in preventing adverse cardiac events.

However, the PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY (PRODIGY) also found a consistently greater risk of haemorrhage in the 24-month dual therapy group according to all prespecified bleeding definitions, including the recently proposed Bleeding Academic Research Consortium classification. The need for transfusion was also increased in the longer treatment group.

The results, said investigator Dr Marco Valgimigli from the University Hospital of Ferrara, Italy, "question the validity of current guideline recommendations - which were based on registry data - that at least 12 months' dual antiplatelet therapy should be pursued after implantation of a drug-eluting stent.

"While we cannot exclude the possibility that a smaller than previously anticipated benefit may still exist in prolonging therapy with clopidogrel for several months after coronary stenting, our study clearly shows that the benefit to risk ratio of prolonged therapy has been over-emphasised."

The PRODIGY study was a 4-by-2 randomised, three-centre open-label clinical trial designed to assess the efficacy and safety of prolonged clopidogrel therapy for up to 24 months in all-comer patients receiving a balanced combination of drug-eluting stents (with various anti-intimal hyperplasia potency and belonging to both first and second generation). Patients were 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction.

More than 2000 patients scheduled for elective, urgent or emergency coronary angioplasty were randomly assigned in a 1:1:1:1 fashion to one of four stent types: everolimus-eluting stent, paclitaxel-eluting stent, zotarolimus-eluting stent or third-generation thin-strut bare metal stent. Randomisation to the four different types, said Dr Valgimigli, was justified by the different safety profile of each, which was meant to ensure that patients in the two main study groups (six versus 24 month dual antiplatelet therapy) received exactly the same stent types. At 30 days, patients in each stent group were then further randomised to either six or 24 months of dual antiplatelet treatment.

The primary objective of the study was to assess whether 24-month dual antiplatelet treatment, consisting of clopidogrel and aspirin after coronary stenting, was associated with a lower cumulative incidence of all-cause mortality, non-fatal myocardial infarction or cerebrovascular accident (the primary outcome) than six-month dual therapy.

Results showed that the cumulative risk of the primary outcome at two years was 10.1% with the 24-month treatment, and 10.0% with the six-month (HR 0.98; 95% CI 0.74-1.29; P=0.91). The individual risks of death, myocardial infarction, cerebrovascular accident or stent thrombosis did not differ between the two groups.

Among the patients receiving long-term dual antiplatelet therapy, there was a roughly two-fold greater risk of type 5, 3 or 2 bleeding events (HR 2.17, 95% CI 1.44-3.22; p=0.00018) as well as type 5 or 3 bleeding events (HR 1.78, 95% CI 1.02-3.13; p=0.037) according to the Bleeding Academic Research Consortium classification. The risks of TIMI-defined major bleeding and red blood cell transfusion were also increased in the 24-month clopidogrel group.

Commenting on the implications of the results, Dr Valgimigli said: " While a formal economic analysis will follow, the results of this study have important implications for heathcare expenditure - for this study shows that prolonging therapy with clopidogrel beyond six months is not only associated with no clinical benefit but also with a significant increase in actionable bleeding events requiring re-hospitalisations and multiple diagnostic and therapeutic resources."


'/>"/>

Contact: Jacqueline Partarrieu
press@escardio.org
33-633-473-335
European Society of Cardiology
Source:Eurekalert

Related medicine news :

1. Assessing the science behind health claims
2. Researchers validate a new test for assessing childrens and teenagers fitness to prevent morbidity
3. Assessing positive outcomes of phase III trials
4. Mortality rates are an unreliable metric for assessing hospital quality, study finds
5. Assessing the value of treatments to increase height
6. Noninvasive diagnostics may offer alternative to liver biopsy for assessing liver fibrosis
7. Inappropriate uses of frozen plasma
8. ESC supports appropriate use of nuclear imaging technology
9. Terminal cancer patients do not receive appropriate radiation therapy
10. Clinical decision support systems help control inappropriate medical imaging, study suggests
11. Long struggle for appropriately processed manufacturer data leads to a new assessment of memantine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
Breaking Medicine Technology: