title: The RESTART project: high-dose atorvastatin helps control RESTenosis AfteR sTenting procedures at high risk for restenosis. Results from a prospective study and a matched control group comparison.
abstract: OBJECTIVE
  The long-term results of bare stenting in complex procedures are troubled by a high incidence of restenosis. The use of drug-eluting stents lead to excellent long-term angiographic results, but require, long-term antithrombotic treatment to prevent stent thrombosis. We evaluated the efficacy of high-dose atorvastatin as an adjuvant in limiting clinical and angiographic restenosis after bare stenting procedures which carry an high risk of restenosis.
  
  
  RESULTS
  Between November 2003 and February 2004, 91 consecutive patients (with 152 target lesions) underwent successful interventional procedures with bare stents (158 stents; 1.7 stent/patient). The patients were included in the study in the presence of at least one of the following criteria: diabetes mellitus (14.6%); acute myocardial infarction (8.8%); lesion length >15 mm (27.5%); lesion in vessels with a reference diameter of <2.5 mm (24.2%); >2 treated lesions (58.2%); side-branch lesions (3.3%). All patients were started on atorvastatin (80 mg/day) on the day of the procedure, and continued receiving it for at least nine months.Six of the 91 patients (6.5%) experienced a clinical restenosis and underwent target lesion revascularisation; a further two underwent re-PTCA due to progressive atherosclerosis in untreated sites. Seventy-one patients (78.0%; 125 stents) were followed up with angiography after a mean 8.5 months (7-10 months): binary angiographic restenosis was observed in 18/71 patients (25.3%) (in-stent restenosis 21.1%; in-segment restenosis 4.2%), and 17/125 stents (13.6%).We matched 122 lesions (125 stents) from the present population with a reference group of 600 consecutive lesions treated at the Ospedale Maggiore della Carità in Novara during the same period of time, but without high-dose statin treatment: 88 lesions (94 stents) were successfully matched on the basis of the clinical and angiographic variables of diabetes, acute myocardial infarction, treated vessel, reference diameter and lesion length. The incidence of late loss was significantly lower in the atorvastatin group (p=0.027).
  
  
  CONCLUSIONS
  The RESTART prospective study showed that the adjunct of atorvastatin 80 mg leads to excellent clinical and angiographic outcomes. These results were confirmed in a matched lesion comparison.
authors.affiliation: Cath Lab, Ospedale San Giovanni-Addolorata, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Imola
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Corvo
authors.forename: Carmelo
authors.initials: C
authors.lastname: Cernigliaro
authors.forename: Tamer
authors.initials: T
authors.lastname: Fouadi
authors.forename: Vito
authors.initials: V
authors.lastname: Ramazzotti
authors.forename: Alessandro
authors.initials: A
authors.lastname: Manzoli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pappalardo
authors.forename: Maria
authors.initials: M
authors.lastname: Cera