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CLINICAL STUDIES

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

¹ Medical Clinic, Department of Cardiology, University Hospital Eppendorf, Hamburg, Germany
² Hospital Santa Cruz, Lisbon, Portugal
³ Department of Medicine, Christian-Albrechts University, Kiel, Germany
⁴ Cardiovascular Center Bethanien, Frankfurt, Germany
⁵ University Hospital San Carlos, Madrid, Spain
⁶ German Heart Institute, Berlin, Germany
⁷ Clementinen Hospital, Hannover, Germany
⁸ Catharina Hospital, Eindhoven, The Netherlands
⁹ Clinique Pasteur, Toulouse, France
^{j 10}Humboldt-University Berlin, Franz Volhard Clinic, Berlin, Germany
^{k 11}St. George Hospital, Hamburg, Germany
^{l 12}Clinique de Essey, Nancy, France
^{m 13}Clinique du Bois de Verrieres, Antony, France
^{n 14}University Hospital, University of Bonn, Bonn, Germany
^{o 15}St. Thomas’ Hospital, London University, London, England, United Kingdom
^{p 16}University Clinic, Göttingen, Germany
^{q 17}Sahlgrenska University Hospital, Gotenburg, Sweden
^{r 18}Siegburg Hospital, Siegburg, Germany
^{s 19}Prince Sultan Cardiac Center, Riyadh, Saudi Arabia
^{t 20}Centro Cuore Columbus, Milan, Italy
^{u 21}Sharyati Hospital, Tehran, Iran
^{v 22}Antonius Hospital, Nieuwegein, The Netherlands
^{w 23}University Hospital, Essen, Germany
^{x 24}Washington Hospital Center, Washington, D.C., USA
^{y 25}Harefield Hospital, Harefield, England, United Kingdom
^{z 26}Rambam Medical Center, Haifa, Israel
^{* 27}University Hospital Ghent, Ghent, Belgium
²⁸Spectranetics, Inc., Nieuwegein, The Netherlands
²⁹Wegscheider Biometry and Statistics, Inc., Berlin, Germany
^{¶ 30}University Hospital Dijkzigt, Thoraxcenter, Erasmus University, Rotterdam, The Netherlands

Reprint requests and correspondence: C.W. Hamm, MD, Kerckhoff Heart Center, Dept. of Cardiology, Benekestr. 2-8, 61231 Bad Nauheim, Germany
christian.hamm{at}kerckhoff.med.uni-giessen.de

OBJECTIVES

This study evaluated safety and efficacy of excimer laser angioplasty for treatment of restenosed or occluded coronary stents.

BACKGROUND

Balloon angioplasty of in-stent restenosis is limited by a high recurrence rate. 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 and adjunctive balloon angioplasty.

RESULTS

Laser angioplasty success (50% diameter stenosis after laser treatment or successful passage with a 2.0-mm or 1.7-mm eccentric laser catheter) was achieved in 92% of patients. Adjunctive balloon angioplasty was performed in 99%. Procedural success (laser angioplasty success followed by 30% stenosis with or without balloon angioplasty) was 91%. There was neither a significant difference in success with respect to lesion length, nor were there differences between small and 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 tamponade (0.5%) and stent damage (0.5%). Perforations after laser treatment occurred 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 balloon 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 is a safe and efficient technology to treat in-stent restenoses. These data justify a randomized comparison with balloon angioplasty.

Abbreviations and Acronyms   ACT = activated clotting time   CK = creatine kinase   PTCA = percutaneous transluminal coronary angioplasty

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