Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial.
BACKGROUND
The Prostar  XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar  XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation.


OBJECTIVE
The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar  XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem.


METHODS
This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar  XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing.


RESULTS
Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar  XL and conventional manual compression groups in the EDEN trial.


CONCLUSIONS
We conclude that the Prostar  XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures.
The Department of Cardiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3 Nakamichi Higashinari Osaka-City, Osaka, Japan. yuya0728@m3.kcn.ne.jp
Kenya
K
Nasu
Etsuo
E
Tsuchikane
Satoru
S
Sumitsuji
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000150:complications / Q000628:therapy; D004434:Early Ambulation; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000209:etiology; D011183:Postoperative Complications / Q000209:etiology; D013537:Sutures; D013997:Time Factors; D016896:Treatment Outcome