INTRAMURAL DRUG-DELIVERY BY DIRECT-INJECTION WITHIN THE ARTERIAL-WALL- FIRST CLINICAL-EXPERIENCE WITH A NOVEL INTRACORONARY DELIVERY-INFILTRATOR SYSTEM

Local drug delivery at the lesion site in patients with coronary arter y disease is being intensively studied to prevent restenosis after per cutaneous coronary intervention. However, the effective penetration of the delivered agents into the vessel wall and delivery time remain co nsiderable problems for all currently existing devices. A unique, new catheter has been invented, the Infiltrator Angioplasty Balloon Cathet er (IABC), which has the capability to allow intramural drug delivery by direct injection within the arterial wall. We describe the first cl inical experience with this catheter. IABC is an angioplasty catheter with 3 lumens: one for inflating the balloon, one central for the guid ewire, and a third for drug delivery. On the surface of the balloon th ere are 3 longitudinal strips of 6 injection needles, which on inflati on stand 0.01 '' high, and are connected to the drug-delivery lumen, W ith inflation of the balloon, the needles penetrate the lesion, allowi ng drug delivery into the media of the vessel wall. We used the IABC i n 17 patients (age = 58 +/- 9 years) undergoing coronary angioplasty. All patients were symptomatic, with significant lesions (13 LAD, 3 LCX , 1 RCA) and documented ischemia. Following initial dilatation with a conventional angioplasty balloon (stenosis from 72 +/- 8% to 26 +/- 14 %, P < 0.001), the IABC was used to infiltrate the lesion with 0.4 mi (6,000 IU) of low-molecular-weight heparin (Fraxiparine(R)). For the d elivery, the IABC was inflated to 1-2 atm for 30-45 s, and the heparin was injected by hand in 5 s. Lesion residual stenosis and morphology remained unchanged after IABC use (26 +/- 14% to 22 +/- 11%, P = NS). In 10 patients, stent placement followed the IABC use. The decision to proceed with stent placement was made after the initial dilatation wi th the conventional balloon, and it was not influenced by the IABC use . Stent placement greatly improved the final result (for the whole pat ient group: 22 +/- 11% to 5 +/- 18%, for the stented patients: 22 +/- 13% to -7 +/- 10%, P < 0.001 for both). Hospital course was uneventful , with no electrocardiogram changes and normal cardiac enzymes for all patients. We have shown that the use of a unique new catheter (IABC) for intramural drug delivery in human patients undergoing coronary ang ioplasty is feasible and safe. This catheter is the first of a new gen eration of catheters and represents a significant step in local drug d elivery. It is very promising as a vehicle to modify plaque behavior a nd potentially influence restenosis after angioplasty. (C) 1997 Wiley- Liss, Inc.