Laser angioplasty of restenosed coronary stents: Results of a multicenter surveillance trial

OBJECTIVES This study evaluated safety and efficacy of excimer laser angiop lasty for treatment of restenosed or occluded coronary stents. BACKGROUND Balloon angioplasty of in-stent restenosis is limited bq a high recurrence rare. Debulking by laser angioplasty is a novel concept to treat in-stent restenosis, METHODS A total of 440 patients with restenoses or occlusions in 527 stents were enrolled for treatment with concentric or eccentric laser catheters a nd adjunctive balloon angioplasty. RESULTS Laser angioplasty success (less than or equal to 50% diameter steno sis after laser treatment or successful passage with a 2.0-mm or 1.7-mm ecc entric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty suc cess followed by less than or equal to 30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in succes s with respect to lesion length, nor were there differences between small a nd large vessels or native vessels and vein grafts. Success was higher and residual stenosis lower using large or eccentric catheters. Serious adverse events included death (1.6%, not directly laser catheter related), Q-wave myocardial infarction (0.5%), non-Q-wave infarction (2.7%), cardiac tampona de (0.5%) and stent damage (0.5%). Perforations after laser treatment occur red in 0.9% of patients and after balloon angioplasty in 0.2%. Dissections were visible in 4.8% of patients after laser treatment and in 9.3% after ba lloon angioplasty. Reinterventions during hospitalization were necessary in 0.9% of patients; bypass surgery was performed in 0.2%. CONCLUSIONS Excimer laser angioplasty with adjunctive balloon angioplasty i s a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty. (C) 1999 by the A merican College of Cardiology.