Stents in Total Occlusion for restenosis Prevention. The multicentre randomized STOP study

Methods and Results Patients with total coronary artery occlusions who had an optimal PTCA result were randomized either to no further treatment or additional stent implantation. The AVE microstent was used and all patients were scheduled for a 1-, 3-, and 6-month clinical follow-up. Repeat coronary angiography to assess the rate and pattern of restenosis was performed at 6 months or earlier if clinically indicated. Ninety-six patients were enrolled in this study. The mean age was 59·310·3 years and 15 were females. Forty-eight patients were randomized to the stent arm, receiving 52 stents (lengths 18–39 mm). Stent implantation was successful in all and there were no major procedure-related complications. Sixty-nine patients (72%) were restudied after 6 months. The binary restenosis rates (50%), in the PTCA arm were 70·9% with a minimal lumen diameter of 1·010·79 mm compared to 42·1% in the stent arm with a minimal lumen diameter of 1·631·02 mm (P=0·034). Reocclusion occurred in 7·9% in the stent group compared to 16·1% in the PTCA group. Restenosis in the PTCA group was focal in 88% of patients and occurred at the point of total obstruction (within 5 mm), compared to diffuse instent restenosis, which occurred in 54% of the patients in the stent group.