Abstract
BackgroundBifurcation lesions represent 15–20% of all patients undergoing a percutaneous coronary intervention (PCI) for coronary artery disease. The provisional 1-stent stenting strategy is the preferred strategy to treat bifurcation lesions. Other strategies used to treat bifurcation lesions include 2-stent complex stenting strategies and the Tryton Side Branch Stent® (TSB)—a dedicated side-branch stent for bifurcation lesions, which gained FDA approval in March 2017.ObjectivesTo conduct a systematic literature review of the safety and effectiveness of three stenting strategies (provisional, complex, and Tryton Side Branch Stent®) for bifurcation lesions with a side-branch diameter ≥2.25 mm, undergoing PCI.MethodsLiterature searches in Medline, Cochrane Library, Web of Science and Embase were conducted to identify prospective clinical trials from January 2007–July 2017.Results602 articles were identified. Nine articles (6275 patients) met all inclusion criteria. Seven studies (5282 patients) compared provisional to complex stenting strategies. Two studies (993 patients) compared provisional to the TSB. Outcomes of interest reported were target vessel failure in 2 studies, major adverse cardiac event (MACE) (cardiac death, all myocardial infarction, ischemic driven target legion revascularization TLR) in 5 studies. For target vessel failure, the provisional strategy ranged from 5.6% to 15.6 %; complex at 7.2% (one study); and TSB from 11.3% to 17.4%. For MACE, provisional strategy ranged from 8%–13.2%; complex from 11.9%–15.2%; and TSB from 8.2%–18.6%.ConclusionsTo our knowledge, this is the first review comparing three bifurcation lesion stenting strategies. Significant heterogeneity in the study design of the nine studies reviewed prevented a meta-analysis. A clinical trial comparing the TSB to both the provisional and complex strategies would provide better inference on the safety and effectiveness when comparing strategies.
Highlights
Bifurcation lesions represent 15-20% of all patients undergoing a percutaneous coronary intervention (PCI) for coronary artery disease
A 2015 clinical trial found that patients undergoing PCI with true bifurcation lesions—defined as lesions affecting both the MV vessel and the ostium of the side branch (SB), Medina classification 1, 1, 1; 1, 0, 1; or 0, 1, 1, involving a SB reference vessel diameter (RVD) of ≥ 2.3 mm—had worse clinical outcomes than patients without true bifurcation lesions
This study demonstrated an 18% reduction in SB in-segment diameter stenosis among patients treated with the Tryton Side Branch Stent® (TSB) compared to patients treated by the provisional stenting strategy
Summary
Bifurcation lesions represent 15-20% of all patients undergoing a percutaneous coronary intervention (PCI) for coronary artery disease. Objectives: To conduct a systematic literature review of the safety and effectiveness of three stenting strategies (provisional, complex, and Tryton Side Branch Stent®) for bifurcation lesions with a side-branch diameter ≥2.25 mm, undergoing PCI. Seven studies (5282 patients) compared provisional to complex stenting strategies. The provisional strategy ranged from 5.6% to 15.6 %; complex at 7.2% (one study); and TSB from 11.3% to 17.4%. 20% of coronary artery disease (CAD) patients who undergo a percutaneous coronary intervention (PCI) have a bifurcation lesion, e.g., a plaque buildup at the crux of the main branch (MB) vessel and its side branch (SB) vessel.. The data did not support overturning the consensus that the provisional strategy is the recommended approach. The anatomy and the severity of the lesion, are important factors to take into account when deciding whether to use a provisional or a complex strategy. A 2015 clinical trial found that patients undergoing PCI with true bifurcation lesions—defined as lesions affecting both the MV vessel and the ostium of the SB, Medina classification 1, 1, 1; 1, 0, 1; or 0, 1, 1, involving a SB reference vessel diameter (RVD) of ≥ 2.3 mm—had worse clinical outcomes than patients without true bifurcation lesions. The authors strongly recommend differentiating the two types of bifurcation lesions in future studies.
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