LASER BALLOON ANGIOPLASTY COMBINED WITH LOCAL INTRACORONARY HEPARIN-THERAPY - IMMEDIATE AND SHORT-TERM FOLLOW-UP RESULTS

Laser balloon angioplasty (LBA) has been shown to acutely increase ang iographic luminal dimensions after conventional balloon angioplasty (P TCA) without a favorable impact on chronic restenosis. Experimentally, laser and thermal energy enhance binding of heparin to the injured ar terial wall and to the thrombus. In view of the anticoagulant, antipro liferative, and antifibrotic activities of the drug, a pilot study was performed to evaluate the potential safety and efficacy of LBA combin ed with local heparin therapy. Ten patients scheduled For elective PTC A were entered in the study. In each patient a single lesion was treat ed with a laser balloon and coated with a heparin film (3000 IU at a c oncentration >100,000 IU/gm) immediately after optimal PTCA. The mean minimum luminal diameter and mean percent stenosis of the 10 treated l esions after PTCA were 1.62 +/- 0.39 mm and 37% +/- 9%, respectively. After LBA and local heparin therapy, the mean minimal lumen diameter i ncreased to 2.01 +/- 0.34 mm (p < 0.01) and the mean percent stenosis decreased to 20% +/- 10% (p < 0.01). Systemic heparin was discontinued immediately after the procedure in all patients. Acute or inhospital complications, either major or minor, occurred in none (0%) of the 10 patients (95% confidence interval 0% to 31%); all were discharged home on the day after the procedure. All patients remained well and free o f cardiac symptoms For at least 2 months after the procedure. However, restenosis developed in six (60%) of the 10 patients (95% confidence interval 26% to 88%) 2 to 6 months after the procedure. The results su ggest that LBA and local heparin therapy, with discontinuation of syst emic heparin immediately after angioplasty, is a safe treatment modali ty that yields favorable acute angiographic results.