Background: Bifurcation 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.
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.
Methods: Literature searches in Medline, Cochrane Library, Web of Science and Embase were conducted to identify prospective clinical trials from January 2007-July 2017.
Results: 602 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%.
Conclusions: To 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.
Intravascular ultrasound-guided interventions in coronary artery disease: a systematic literature review, with decision-analytic modelling, of outcomes and cost-effectiveness.
