title: Safety and efficacy of lesion preparation with the AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry.
abstract: OBJECTIVE
  Left main interventions require optimal initial results for good clinical outcome. Lesion preparation with the AngioSculpt Scoring Balloon (ASB) combined with the provisional T-stenting technique, if proven safe, might lead to better lumen gain and better clinical outcome. The aim of this registry was to investigate the safety and efficacy of the ASB as an option for lesion preparation in unprotected left main interventions (ULMI).
  
  
  RESULTS
  Out of the all-comers unprotected left main registry (ULMI ALSTER), 47 patients with elective ULMI fulfilled the inclusion criteria for this study. The endpoints were acute lumen gain and 12-month MACCE. The drop-out rate was 4%. The provisional T-stenting technique was used in 97% of distal ULMI. The interventions were grouped according to use of ASB with an in-house, historical no-ASB patient control group. Lumen gain was 1.63±0.12 mm in the ASB group (n=34) and 1.35±0.12 mm in the no-ASB group (n=8, p=0.26), respectively. The use of the ASB was safe. Intravascular ultrasound (IVUS) data for 21 patients showed numerically greater lumen area gain of 3.14±0.33 mm2 in the ASB group compared to 2.33±0.88 mm2 with the conventional technique. TLR/TVR was 6.6% overall. Twelve-month MACCE was 12.5% (4/32) for ASB and 15.4% (2/13) in the historical control group.
  
  
  CONCLUSIONS
  Adding ASB lesion preparation to the standard provisional T-stenting technique for ULMI is feasible and safe. Low TLR and TVR rates were observed. Lesion preparation led to a numerically larger lumen gain; the data allow valid power statistics to show this approach as leading to improved outcome in a possible randomised trial.
authors.affiliation: Division of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Schmidt
authors.forename: Silja
authors.initials: S
authors.lastname: Hansen
authors.forename: Felix
authors.initials: F
authors.lastname: Meincke
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005858:Germany; D065386:Historically Controlled Study; D006801:Humans; D008297:Male; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional