Stent implantation versus balloon angioplasty in chronic coronary occlusions: Results from the GISSOC trial

Objectives. In this multicenter, randomized trial we evaluated whether stent implantation after successful recanalization of a chronic coronary occlusion reduced the incidence of restenosis. Background. Percutaneous transluminal coronary angioplasty (PTCA) in chronic total occlusions is associated with a higher rate of angiographic restenosis and reocclusion than PTCA in subtotal stenoses. Preliminary reports have suggested a decreased restenosis rate after stent implantation in coronary total occlusions. Methods. We randomly assigned 110 patients with recanalized total occlusion to Palmaz-Schatz stent implantation, followed by 1 month of anticoagulant therapy versus no other treatment. The primary end point was the minimal lumen diameter (MLD) of the treated segment at follow-up, as determined by quantitative angiography at a core laboratory. Results. Repeat coronary angiography was performed 9 months after the procedure in 88% of patients. The MLD (mean +/- SD) at follow-up was 1.74 +/- 0.88 mm in patients assigned to stent implantation and 0.85 +/- .75 mm in patients assigned to PICA (p < 0.001). Stent implantation was associated with a lower incidence of restenosis (defined as diameter stenosis greater than or equal to 50% at follow-up) (32% vs. 68%, p < 0.001) and reocclusion (8% vs. 34%, p = 0.003) than balloon PICA, Likewise, stent treated patients had less recurrent ischemia (14% vs. 46%, p = 0.002) and target lesion revascularization (5.3% vs. 22%, p = 0.038), but experienced a longer hospital stay. Conclusions. Palmaz-Schatz stent implantation after successful balloon PICA of chronic total occlusions improves the midterm angiographic and clinical outcome and could be the preferred treatment option in selected patients with occluded vessels. (C) 1998 by the American College of Cardiology.