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

Miroslaw Ferenc, Michael Gick, Rolf-Peter Kienzle, Hans-Peter Bestehorn, Klaus-Dieter Werner, Thomas Comberg, Piotr Kuebler, Heinz Joachim Büttner, Franz-Josef Neumann, Miroslaw Ferenc, Michael Gick, Rolf-Peter Kienzle, Hans-Peter Bestehorn, Klaus-Dieter Werner, Thomas Comberg, Piotr Kuebler, Heinz Joachim Büttner, Franz-Josef Neumann

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00288535.

Figures

Figure 1
Figure 1
Flow diagram of the Bad Krozingen Bifurcation Study. QCA, quantitative coronary angiography.
Figure 2
Figure 2
Cumulative frequency of per cent diameter stenosis of the side branch at 9 month angiographic follow-up in patients assigned to routine T-stenting (red) or to provisional T-stenting (green). The broken lines indicate the percentage of lesions with (above the line) and without (below the line) restenosis (per cent diameter stenois ≥50%). P-value by two-tailed t-test.
Figure 3
Figure 3
Comparison of maximal per cent diameter stenosis involving the bifurcation irrespective of the site of restenosis (side branch, proximal, or distal main vessel) between the two study groups, before intervention and at 9 month follow-up for the entire cohort and for strata defined by side branch or main branch involvement at 9 month follow-up. The corresponding Medina classifications are given below the graph. Columns represent mean and error bars represent standard deviation.
Figure 4
Figure 4
Kaplan–Meier estimates for freedom from death or myocardial infarction and for freedom from target lesion revascularization in patients assigned to routine T-stenting (red) or to provisional T-stenting (green). P-values by log-rank test.

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