European Heart Journal Advance Access originally published online on October 9, 2008
European Heart Journal 2008 29(23):2859-2867; doi:10.1093/eurheartj/ehn455
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Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions
Herz-Zentrum Bad Krozingen, Suedring 15, 79189 Bad Krozingen, Germany
Received 20 May 2008; revised 15 September 2008; accepted 17 September 2008; online publish-ahead-of-print 9 October 2008.
* Corresponding author. Tel: +49 7633 402 3140, Fax: +49 7633 402 9909, Email: miroslaw.ferenc{at}herzzentrum.de/miroslawferenc{at}aol.com
See page 2829 for the editorial comment on this article (doi:10.1093/eurheartj/ehn519)
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.
Key Words: Coronary disease • Bifurcations • Stents • Sirolimus • Restenosis
ClinicalTrials.gov identifier: NCT00288535 [ClinicalTrials.gov] .
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