Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions

• Published in: European heart journal 2008-12, Vol.29 (23), p.2859-2867
• Main Authors: Ferenc, Miroslaw, Gick, Michael, Kienzle, Rolf-Peter, Bestehorn, Hans-Peter, Werner, Klaus-Dieter, Comberg, Thomas, Kuebler, Piotr, Büttner, Heinz Joachim, Neumann, Franz-Josef
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon - methods; Bifurcations; Clinical Research; Coronary Angiography; Coronary disease; Coronary Restenosis - prevention & control; Coronary Stenosis - therapy; Coronary Vessels - surgery; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents - administration & dosage; Male; Restenosis; Sirolimus; Sirolimus - administration & dosage; Stents; Treatment Outcome
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehn455

Aims We investigated whether routine T-stenting reduces restenosis of the side branch as compared with provisional T-stenting in patients with de novo coronary bifurcation lesions. Methods and results Our randomized study assigned 101 patients with a coronary bifurcation lesion to routine T-stenting with sirolimus-eluting stents (SES) in both branches and 101 patients to provisional T-stenting with SES placement in the main branch followed by kissing-balloon angioplasty and provisional SES placement in the side branch only for inadequate results. Primary endpoint was per cent diameter stenosis of the side branch at 9 month angiographic follow-up. Angiographic follow-up in 192 (95%) patients revealed a per cent stenosis of the side branch of 23.0 ± 20.2% after provisional T-stenting (19% with side-branch stent) and of 27.7 ± 24.8% (P = 0.15) after routine T-stenting (98.2% with side-branch stent). The corresponding binary restenosis rates were 9.4 and 12.5% (P = 0.32), prompting re-intervention in 5.0 and 7.9% (P = 0.39), respectively. In the main branch, binary restenosis rates were 7.3% after provisional and 3.1% after routine T-stenting (P = 0.17). The overall 1 year incidence of target lesion re-intervention was 10.9% after provisional and 8.9% after routine T-stenting (P = 0.64). Conclusions Routine T-stenting with SES did not improve the angiographic outcome of percutaneous coronary intervention of coronary bifurcation lesions as compared with stenting of the main branch followed by kissing-balloon angioplasty and provisional side-branch stenting.