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 withrecanalized 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 PTCA (p < 0.001). Stent implantation was associated with a lower incidence of restenosis (defined as diameter stenosis > or =50% at follow-up) (32% vs. 68%, p < 0.001) and reocclusion (8% vs. 34%, p = 0.003) than balloon PTCA. 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 PTCA of chronic total occlusions improves the midterm angiographic and clinical outcome and could be the preferred treatment option in selected patients with occluded vessels.
RCT Entities:
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 PTCA (p < 0.001). Stent implantation was associated with a lower incidence of restenosis (defined as diameter stenosis > or =50% at follow-up) (32% vs. 68%, p < 0.001) and reocclusion (8% vs. 34%, p = 0.003) than balloon PTCA. 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 PTCA of chronic total occlusions improves the midterm angiographic and clinical outcome and could be the preferred treatment option in selected patients with occluded vessels.
Authors: Vladimír Dzavík; Christopher E Buller; Gerard Devlin; Ronald G Carere; G B John Mancini; Warren J Cantor; Pawel E Buszman; James M Rankin; Carlos Vozzi; John R Ross; Sandra Forman; Bruce A Barton; A Gervasio A Lamas; Judith S Hochman Journal: Catheter Cardiovasc Interv Date: 2009-05-01 Impact factor: 2.692