A randomized trial of elective stenting after balloon recanalization of chronic total occlusions

OBJECTIVES The aim of this study was to assess the role of Wiktor stent imp lantation after recanalization of chronic total coronary occlusions with re gard to the clinical and angiographic outcome after six months. BACKGROUND Beside the common use of stents in clinical practice, the number of stent indications proven by randomized trials is still limited. METHODS Eighty-five patients with a thrombolysis in myocardial infarction g rade 0 chronic coronary occlusion were examined. After standard balloon ang ioplasty, the patients were randomly assigned to stent implantation, or per cutaneous transluminal coronary angioplasty (PTCA) alone (no further interv ention). Quantitative coronary angiography was performed at baseline and af ter six months. RESULTS The minimal lumen diameter did not differ immediately after recanal ization (stent group 1.61 +/- 0.30 mm vs. PTCA group 1.65 +/- 0.36 mm), and increased after stent implantation to 2.51 +/- 0.41 mm. After six months, the stent group still had a significantly greater lumen (1.57 +/- 0.59 vs. 1.06 +/- 0.90 mm; p < 0.01) and a significantly lower restenosis and reoccl usion rate (32% and 3%) compared with the PTCA group (64% and 24%); resteno sis analysis according to treatment was 72% (PTCA) versus 29% (stent, p < 0 .01). Late loss was equal in both groups. At follow-up, the stent patients had a better angina class (p < 0.01), and fewer cardiac events (p < 0.03). A meta-analysis including this trial and three other controlled trials with the Palmaz-Schatz stent showed concordant results. CONCLUSIONS Stent implantation after reopening of a chronic total occlusion provides a better angiographic result, corresponding to a better clinical outcome with fewer recurrence of symptoms and reinterventions after six mon ths. (J Am Coll Cardiol 1999;34:722-9) (C) 1999 by the American College of Cardiology.