Abstract

From January 1996 until February 1997 6,376 patients were treated by our group with PTCA and 3,859 (60.5%) received one or several stents. An angiographic followup was achieved in 63% of the patients with 1,267 experiencing restenosis (32.8%). Of those being treated with re-PTCA 302 were randomly selected for further analysis. In-stent-restenosis was treated with rotablator in 8 patients (2.7%), with eximer laser in 21 (7.0%) and with another stent in 48 patients (15.9%). 225 patients (74.4%) of this subselection were treated with balloon-angioplasty only. Mean patient age was 63 +/- 10.2 years, 401 stents had been implanted (42.5% Wiktor, 13.7% Jomed Sito, 12.3% ACS Multlink, 9.5% GR II, and some others), the number of stents per patient was 1.68, mean stent length 28.5 mm, mean stent diameter 3.01 +/- 0.3 mm, the time since implantation 142 +/- 76 days. The recurrence appeared as restenosis in 199 patients (88.4%) and as a chronic stent occlusion in 26 (11.6%). In-stent-restenosis was discovered in 94.7% within the stent and was of focal appearance (restenosic lesion of < or = 5 mm) in 28.5% and diffuse (> 5 mm) in 71.5%. Balloondilatation (balloon:artery = 1:1; maximal pressure 11.7 +/- 3.3 bar) was successfull in 98% of the stenotic lesions and in 18/26 of the chronically occluded stents (definition of success: residual stenosis < 50%, no major complications). The stenosis decreased from 82.2% to 20.5% (12.8% in focally stenosed vessels and 23.6% in diffuse restenosis). Complications were death in 0.9%, Q-MI in 0% CABG in 0.9%, Non-Q-MI in 2.4%, subacute stent thrombosis in 0.5% and groin bleeding in 1.8%. A clinical follow up after 151.7 +/- 87.7 days was achieved in 98.6% and an angiographic follow up in 69.1% of the patients: 1.9% had died (2/4 due to noncardiac disease), no MI, 6.2% CABG and 31% PTCA (TLR 37.2%). A second restenosis within the stents ocurred in 27.9% of those with focal disease and in 44.3% of those with diffuse in stent restenosis. CONCLUSIONS: Restenosis within stents may occurr in about 30% of unselected patients. In 2/3 these stenoses appear diffuse and in 10% they appear as chronic occlusions. Re-PTCA with balloons is rather simple with a high success rate (even in chronic stent occlusions) and a low complication rate. The incidence of a second restenosis is acceptably high in focal lesions but appears unacceptable in patients with diffuse in-stent-restenosis. Thus the indication for stenting should be restricted to patients with clear cut advantage over balloon-angioplasty alone, e.g. threatening closure, chronic occlusion, old savenous veingraft and proximal LAD stenosis.