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 angiographic luminal dimensions after conventional balloon angioplasty (PTCA) without a favorable impact on chronic restenosis. Experimentally, laser and thermal energy enhance binding of heparin to the injured arterial wall and to the thrombus. In view of the anticoagulant, antiproliferative, and antifibrotic activities of the drug, a pilot study was performed to evaluate the potential safety and efficacy of LBA combined with local heparin therapy. Ten patients scheduled for elective PTCA were entered in the study. In each patient, a single lesion was treated with a laser balloon and coated with a heparin film (3000 I.U. at a concentration > 100,000 I.U./gm) immediately after optimal PTCA. The mean minimum luminal diameter and mean percent stenosis of the 10 treated lesions after PTCA were 1.62 +/- 0.39 mm and 37% +/- 9%, respectively. After LBA and local heparin therapy, the mean minimal lumen diameter increased 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 of 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 suggest that LBA and local heparin therapy, with discontinuation of systemic heparin immediately after angioplasty, is a safe treatment modality that yields favorable acute angiographic results.