Navigation Links
Results of the PEPCAD-DES trial reported at TCT 2011
Date:11/11/2011

SAN FRANCISCO, CA NOVEMBER 11, 2011 A clinical trial of patients with restenosis in drug-eluting stents (DES) in native coronary arteries found that treatment with paclitaxel-coated balloon angioplasty demonstrated superior results over plain old uncoated-balloon angioplasty (POBA). Results from the PEPCAD-DES clinical trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The incidence of drug-eluting stent restenosis (DES-ISR) remains frequent due to the continuous increase in DES implantations. Treatment of in-stent restenosis (ISR) with an additional stent implantation adds another metal layer within the coronary arteries, abolishing the physiologic vasoreactivity of the vessel. Drug-eluting stents significantly reduce the occurrence of restenosis and the subsequent need for repeat vascularization.

Paclitaxel eluting-balloon angioplasty has been shown to be superior to POBA for the treatment of ISR in bare-metal stents (BMS). Whether it is also effective in ISR of different drug-eluting stents has not been extensively studied so far. The PEPCAD DES trial compared the efficacy of the paclitaxel-eluting balloon catheter for treatment of ISR in DES in native coronary arteries to uncoated balloon angioplasty to methodologically assess the efficacy of the balloon mediated drug coating.

This randomized, multicenter, single blinded trial was conducted at six centers and included 110 patients with ISR of DES in multiple stent types. They were divided into two treatment groups: 72 for drug-coated balloon (DCB) angioplasty and 38 for POBA to achieve 90% power. Inclusion criteria were: lesion in native coronary artery, DES restenosis of sirolimus-eluting, everolimus-eluting, or paclitaxel-eluting stents, indication for percutaneous coronary intervention, reference diameter ranging from 2.5 mm to 3.5 mm and a lesion length less or equal to 22 mm. Exclusion criteria were: acute myocardial infarction, chronic total occlusions, lesions in bypass grafts or bifurcations, multiple lesions in the target vessel, left main lesions, ISR in BMS, and/or contraindications for acetylsalicylic acid or clopidogrel.

The length of the balloon in both treatment groups was chosen to overlap the stenotic segment at least 2 mm at the proximal and distal margin. Dual antiplatelet therapy was prescribed for three months in both treatment groups. All patients were scheduled for control angiography at six months. Quantitative coronary analysis was performed in a blinded fashion relative to the treatment groups. The final angiographic follow-up was completed in September 2011.

The primary endpoint was six-month late lumen loss. In the POBA group, late lumen loss was 1.03 0.77; and in the DCB group, late lumen loss was 0.43 0.61. The rate of target lesion revascularization was 36.8% in the POBA group and 15.3% in the DCB group. The rate of major adverse cardiac events (MACE) was 50% in the POBA group and 16.7% in the DCB group.

"Results of this trial showed that for treatment of drug-eluting stent restenosis, a paclitaxel-coated balloon compared with a balloon angioplasty alone showed significantly lower late loss, a significantly lower binary restenosis rate, significantly less major adverse cardiac events, and no definite vessel thrombosis," said lead investigator Harald Rittger, MD from the University of Erlangen in Germany.


'/>"/>

Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

Related medicine news :

1. Results of the STACCATO Trial reported at TCT 2011
2. Results of the DEB-AMI Trial reported at TCT 2011
3. Results of the RIFLE STEACS clinical trial reported at TCT 2011
4. Results of the PARTNER Trial Cohort B 2-year follow up presented at TCT 2011
5. Results of the PARTNER Trial Cohort A cost effectiveness analysis reported
6. Combination epigenetic therapy clinical trial results
7. Results of the PARIS registry Reported at TCT 2011
8. Results of the TRIGGER-PCI trial reported at TCT 2011
9. Results of rapid gene trial reported at TCT 2011
10. Results of the BRIDGE trial reported at TCT 2011
11. First results of Angiomax (bivalirudin) vs. heparin in transcatheter aortic valve interventions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... CA (PRWEB) , ... June 27, 2016 , ... ... College District , the only authorized OSHA Training Institute Education Center headquartered in ... by protecting their workers from extreme heat at their worksites. Employers with ...
(Date:6/27/2016)... California (PRWEB) , ... June 27, 2016 , ... "FCPX ... fully customizable inside of Final Cut Pro X," said Christina Austin - CEO of ... unique style. Final Cut Pro X users can now reveal the media ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... professionals, announced today its affiliation with Tennessee Counseling Association. This new ... network of the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... today announced its strategic partnership with Connance, a healthcare industry leader providing ... companies’ proven, proprietary technology combine to provide health systems, hospitals and ambulatory ...
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... ... cutting edge technology to revolutionize the emergency ambulance transport experience for the millions ... aware of how Uber has disrupted the taxi industry through the use of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016 Research and Markets has ... by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), ... Parenteral) - Global Forecast to 2021" report to ... The global pharmaceutical excipients market is projected to reach ... 6.1% in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, 2016 ... Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, the ... announced today online at www.diabetesscholars.org by the ... diabetes stand in the way of academic and community ... Foundation,s scholarship program since 2012, and continues to advocate ...
Breaking Medicine Technology: