News | August 31, 2011

Lower Stent Thrombosis Found With Xience Than With Bare Metal Stent

August 31, 2011 — Results of a recent randomized controlled study show the drug-eluting stent Xience V performs well in patients having primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI). It also has a better safety profile than that of bare metal stents.

The EXAMINATION (Evaluation of Xience-V stent in Acute Myocardial INfArcTION) trial was crafted with an "all-comers" design to evaluate the stent in the complex setting of STEMI; it also served provide data that may be applicable to the real world population.

Manel Sabate, M.D., said the first generation drug-eluting stents (DES) had been evaluated in randomized controlled trials in the setting of STEMI, with positive results overall. However, he added, most of these trials lacked "good generalizability" to real world circumstances because of their highly selected inclusion/exclusion criteria. Moreover, no safety and efficacy data exist for the new generation of DES in this high-risk group of patients with STEMI. The all-comers design of the trial applied wide inclusion and few exclusion criteria, "which may result in a more representative sample of the target population".

The study was an investigator-initiated, multi-center, multinational trial involving 1,498 STEMI patients randomized to either a Xience V stent (everolimus-eluting) or cobalt chromium bare metal stent. The primary endpoint was a composite of all-cause death, any recurrent myocardial infarction and any repeat revascularization at one-year follow-up. Individual components of the primary endpoint and stent thrombosis were the main secondary endpoints. Patients included in the trial represented up to 70 percent of all STEMI patients being attended in the centers during the recruitment period, reflecting the "real world" nature of the design.

Results presented during the Hot Line session at the European Society of Cardiology in Paris. It included 98 percent of patients with one-year follow-up data. There was a non-significant trend towards benefit with the Xience-V stent by virtue of a lower rate of new revascularizations during follow-up as compared to the bare metal stents.

In terms of safety, the rates of definite and definite/probable stent thrombosis at one-year follow-up were significantly lower with the Xience V stent as compared to the bare metal stent; this accounted for 0.5 percent (definite) and 0.9 percent (definite or probable) at one year with Xience V and 1.9 percent and 2.6 percent with the bare metal stent (both p=0.01).

"These are the first 'real world' results we have from a randomized trial about the performance of the new generation drug-eluting stents in the high-risk context of STEMI," said Sabate, "and I think we can be reassured over any concerns about stent thrombosis."

For more information: www.escardio.org

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init