Intracoronary stenting and angiographic results - Strut thickness effect on restenosis outcome (ISAR-STEREO) trial

Background-Increased thrombogenicity and smooth muscle cell proliferative r esponse induced by the metal struts compromise the advantages of coronary s tenting. The objective of this randomized, multicenter study was to assess whether a reduced strut thickness of coronary stents is associated with imp roved follow-up angiographic and clinical results. Methods and Results-A total of 651 patients with coronary lesions situated in native vessels >2.8 mm in diameter were randomly assigned to receive 1 o f 2 commercially available stents of comparable design but different thickn ess: 326 patients to the thin-strut stent (strut thickness of 50 mum) and 3 25 patients to the thick-strut stent (strut thickness of 140 mum). The prim ary end point was the angiographic restenosis (greater than or equal to 50% diameter stenosis at follow-up angiography). Secondary end points were the incidence of reinterventions due to restenosis-induced ischemia and the co mbined rate of death and myocardial infarctions at 1 year. The incidence of angiographic restenosis was 15.0% in the thin-strut group and 25.8% in the thick-strut group (relative risk, 0.58; 95% CI, 0.39 to 0.87; P=0.003). Cl inical restenosis was also significantly reduced, with a reintervention rat e of 8.6% among thin-strut patients and 13.8% among thick-strut patients (r elative risk, 0.62: 95% CI, 0.39 to 0.99, P=0.03). No difference was observ ed in the combined 1-year rate of death and myocardial infarction. Conclusions - The use of a thinner-strut device is associated with a signif icant reduction of angiographic and clinical restenosis after coronary arte ry stenting. These findings may have relevant implications for the currentl y most widely used percutaneous coronary intervention.