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:10/13/2017)... , ... October 13, 2017 , ... “The Journey: From ... every danger possible to save lost souls in the Philippines. “The Journey: From the ... is a dedicated teacher of the Bible. She has taught all ages and currently ...
(Date:10/12/2017)... ... , ... Planet Fitness, one of the largest and fastest growing franchisors and ... flagship location in Covington, LA at 401 N. U.S. Highway 190, in January of ... Depot in the Holiday Square shopping center. Its location allows it to serve both ...
(Date:10/12/2017)... ... 12, 2017 , ... Asante, a nationally recognized health system ... their existing home health joint venture through an agreement, effective October 1, 2017, ... venture home health company with Asante, delivering clinically integrated care, for the past ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, ... In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the ... have extremely low property-tax rates, which contributes to the relatively lower cost of ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017  PMD ... OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... strategic hub service that expedites and streamlines patient and ... Spiro PD 2.0, and wellness management services.  ... medical device used to measure lung function for a ...
(Date:9/12/2017)... , Sept. 12, 2017   EcoVadis , the leading platform for ... the first annual edition of its Global CSR Risk and Performance Index. ... by EcoVadis, based on Scorecard Ratings that analyzed nearly 800,000 data points ... ... ...
(Date:9/9/2017)... ... ... Monday, September 18 th .The Brain Tumor Foundation (BTF) begins a week-long ... BTF,s Mobile MRI Unit – a 70 Ft. ... brings its nationwide initiative, the Road to Early Detection Sponsor-A-City Campaign to ...
Breaking Medicine Technology: