Two-Stent vs. Provisional Stenting for Bifurcation Lesions
- One-year results from the DEFINITION II trial showed that a two-stent technique resulted in a significant reduction in TLF and TLR among complex bifurcation lesions defined by the DEFINITION criteria.
- Current 3-year analysis shows no additional benefit after 1 year.
What are differences in target lesion failure (TLF) at 3 years after planned two-stent versus provisional stenting (PS) for complex coronary bifurcation lesions using the DEFINITION (Definitions and Impact of Complex Bifurcation Lesions on Clinical Outcomes After Percutaneous Coronary Intervention Using Drug-Eluting Stents) criteria?
A total of 653 patients with complex coronary bifurcation lesions were randomly assigned to either two-stent group or PS group in the DEFINITION II trial and were followed for 3 years. The primary endpoint was the occurrence of TLF at 3 years. Stent thrombosis was the safety endpoint.
At 3 years, TLF occurred in 52 patients (16.0%) in the PS group and in 34 (10.4%) patients in the two-stent group (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.41-0.97; p = 0.035), driven mainly by increased target vessel myocardial infarction (8.0% vs. 3.7%; HR, 0.45; 95% CI, 0.23-0.89; P= 0.022) and target lesion revascularization (8.3% vs. 4.3%; HR, 0.50; 95% CI, 0.26-0.96; p = 0.038). There was no difference in TLF between the two groups between year 1 and year 3.
For patients with complex coronary bifurcations who reach 1-year post-procedure without experiencing endpoint events, there is still a risk for future events. The type of procedure performed initially is no longer a future event risk determinant.
The two-stent technique resulted in significant reduction in TLF and TLR after 1 year among complex lesions defined by the DEFINITION criteria (any one major criterion: single-branch [SB] lesion length ≥10 mm or SB diameter stenosis ≥70% for distal left main or >90% for non–left main or any two minor risk factors: moderate to severe calcification, multiple lesions, bifurcation angle <45°, main vessel reference vessel diameter <2.5 mm, thrombus-containing lesions, and multi-vessel lesion length ≥25 mm). The current 3-year analysis shows no continued benefit of the two-stent technique beyond 1 year. Trial findings are limited by minimal intravascular ultrasound use (25%) to guide percutaneous coronary intervention.
Keywords: Constriction, Pathologic, Coronary Stenosis, Drug-Eluting Stents, Myocardial Infarction, Myocardial Revascularization, Percutaneous Coronary Intervention, Risk Factors, Thrombosis, Ultrasonography, Interventional, Vascular Calcification
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