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Local and systemic delivery of low molecular weight heparin following PTCA: Acute results and 6-month follow-up of the initial clinical experience with the porous balloon (PILOT-study)

✍ Scribed by Oberhoff, Martin ;Baumbach, Andreas ;Hermann, Thomas ;Diehl, Claudia ;Maier, Rita ;Athanasiadis, Anastasios ;Herdeg, Christian ;Bohnet, Armin ;Haase, Karl K. ;Voelker, Wolfram ;Baildon, Reinhard ;Veldhof, Susan ;Karsch, Karl R.


Publisher
John Wiley and Sons
Year
1998
Tongue
English
Weight
96 KB
Volume
44
Category
Article
ISSN
0098-6569

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✦ Synopsis


The purpose of this study was to assess safety and feasibility of intracoronary delivery of reviparin using a porous balloon following percutaneous transluminal coronary angioplasty.

The 2.7 mm porous balloon used in this study had 35 holes arranged in a spiral pattern. Eighteen patients (male n ‫؍‬ 10, female n ‫؍‬ 8, age 63 ؎ 9 years) undergoing successful PTCA in coronary arteries with a vessel diameter of 2.5 to 3.0 mm determined by online QCA (LAD ‫؍‬ 11, RCX ‫؍‬ 3, RCA ‫؍‬ 4) were included. They received a bolus of 7,000 anti-Xa-IU reviparin followed by local delivery of 1,500 anti-Xa-IU in 4 ml with an injection pressure of 2 atm. The patients received additionally 10500 anti-Xa-units intravenously during the following 24 hours and a daily dose of 7000 anti-Xa-units reviparin subcutaneously for the following 28 days. Angiograms were obtained before and after PTCA, directly after local delivery, at 24 hours postintervention and after 6 months.

The primary success rate was 100%. Quantitative coronary angiography showed a minimum luminal diameter of 0.42 ؎ 0.14 mm before PTCA, 1.87 ؎ 0.45 after PTCA, 1.67 ؎ 0.43 after LDD, 1.63 ؎ 0.46 after 24 hours, and 1.06 ؎ 0.6 after 6 months. Angiographic follow-up was obtained in all patients. No major complications occurred during the 6-month follow-up period. The angiographic restenosis rate was 28% (5/18) at follow-up.

This study demonstrates safety and feasibility of local intracoronary delivery of reviparin with a porous balloon following PTCA even in smaller diameter coronary arteries.