Ulrich Speck PhD, Presenter: Nothing to Disclose

Bruno Scheller, Abstract Co-Author: Nothing to Disclose

Claudia Abramjuk MD, Abstract Co-Author: Nothing to Disclose

Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. Their efficacy is believed to depend on the sustained release of antiproliferative drugs. Animal studies by our group indicate persistent efficacy of drugs even after very short exposure of the vessel wall. Paclitaxel added to an angiographic contrast medium (CM) and paclitaxel-coated balloon catheters were tested as an alternative option for transferring the drug to the vessel wall.

Paclitaxel was solved in CM or coated on balloons. Adherence to non-inflated balloons was determined after directing the catheter into coronary arteries of pigs. Stents were crimped on paclitaxel coated balloons. 5-6 pigs each received 2 coronary stents applying slight overstretch by using either (a) uncoated balloons, bare stents and plain CM or (b) the same but paclitaxel in CM or (c) paclitaxel-coated PTCA balloons with premounted bare stents and plain CM or (d) commercial premounted Cypher stents and plain CM. Restenosis was assessed 4 weeks later by angiography and histomorphometry.

Treatment was successful in all animals. No adverse events were observed which could be assigned to paclitaxel in the CM or balloon coating. Reangiography indicated pronounced restenosis in the control group and least restenosis in the animals which were treated with the coated balloon. Histomorphometry confirmed the efficacy of the 3 routes of drug delivery with the most impressive effect of the coated balloonsControl / CM+paclitaxel / coated balloon/ Cypher:Vessel diameter [mm]: 3.13±0.22/ 3.10±0.14/ 2.98±0.23/ 3.11±0.25; Luminal area [mm˛]: 2.25±0.97/ 2.96±0.96/ 4.81±0.62/ 3.51±1.40; Neointimal area [mm˛]: 5.14±1.50/ 4.31±1.00/ 2.42±0.28/ 2.93±1.41

Paclitaxel added to CM or coated on PTCA catheters are effective in restenosis inhibition in the porcine coronary overstretch model. Non-stent based drug delivery may avoid some problems due to stent coating and provide additional flexibility in restenosis inhibition.

U.S.: Association with Schering AG, Berlin, pharmaceutical company

Speck, U, Scheller, B, Abramjuk, C, Restenosis Inhibition by Non-stent-based Local Drug Delivery: Efficacy and Tolerance in Pigs.  Radiological Society of North America 2004 Scientific Assembly and Annual Meeting, November 28 - December 3, 2004 ,Chicago IL. http://archive.rsna.org/2004/4410811.html