Excimer Laser Angioplasty with Adjunctive Balloon Dilatation Versus Balloon Dilatation Alone for the Treatment of In-Stent Restenosis: Results of a Randomized Single-Center Study

Background: Laser ablation of neointimal tissue prior to balloon dilatation has been shown to be a potential treatment modality for restenosis within previously implanted stents. It remains controversial whether this treatment provides superior acute and long-term results compared to conventional balloon dilatation. Methods and Results: Between November 1995 and November 1996, 96 patients with significant (≥ 50%) in-stent restenosis were randomized to receive excimer laser angioplasty with adjunctive balloon dilatation (ELCA + PTC A, n = 47) or PTCA alone (n = 49). Both groups did not differ with regard to gender, clinical history, location of the lesion, reference diameter, or lesion length. Angiographic success was achieved in 46 patients with ELCA + PTCA (98%) and in 48 patients with PTCA alone (98%). In-hospital complications included acute closure in one patient of each group, one CABG, one repeat PTCA, and one non-Q wave MI with ELCA + PTCA, versus two bleeding and one death with PTCA. Clinical follow-up was obtained in all patients, while angiographic follow-up was available in 35 of 47 (ELCA+PTCA) versus 35 of 49 (PTCA) patients with a mean follow-up time of 163 ± 81 days. With ELCA+PTCA, MLD increased from 0.82 ± 0.38 to 1.99 ± 0.33 mm versus 0.81 ± 0.39 mm to 2.07 ± 0.60 mm with PTCA (P = NS). At follow-up, MLD was 1.32 ± 0.60 mm with ELCA + PTCA versus 1.45 ± 0.75 mm with PTCA (P = NS). Late adverse events included nine repeat PTCA with ELCA +PTCA (19%) versus 12 with PTCA (24%), three CABG with ELCA +PTCA (6%) versus two with PTCA (4%), and one death (2%) with PTCA (P = NS). Angiographic restenosis rate was 52% with ELCA + PTCA versus 47% with PTCA alone (P = NS). Conclusion: Our data suggest that excimer laser angioplasty with adjunctive balloon dilatation for the treatment of in-stent restenosis provides similar acute results as plain balloon dilatation and may offer no advantage over PTCA alone with regard to intermediate-term outcomes.