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

Abstract

OBJECTIVESThe aim of this study was to assess the role of Wiktor stent implantation after recanalization of chronic total coronary occlusions with regard to the clinical and angiographic outcome after six months.BACKGROUNDBeside the common use of stents in clinical practice, the number of stent indications proven by randomized trials is still limited.METHODSEighty-five patients with a thrombolysis in myocardial infarction grade 0 chronic coronary occlusion were examined. After standard balloon angioplasty, the patients were randomly assigned to stent implantation, or percutaneous transluminal coronary angioplasty (PTCA) alone (no further intervention). Quantitative coronary angiography was performed at baseline and after six months.RESULTSThe minimal lumen diameter did not differ immediately after recanalization (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 reocclusion rate (32% and 3%) compared with the PTCA group (64% and 24%); restenosis 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.CONCLUSIONSStent 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 months.