Two‐year outcomes after deployment of XIENCE V everolimus‐eluting stents in patients undergoing percutaneous coronary intervention of bifurcation lesions: A report from the SPIRIT V single arm study

Abstract

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi-vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30-day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non-bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.

Differential Factors for Predicting Outcomes in Left Main versus Non-Left Main Coronary Bifurcation Stenting

“…Results of studies comparing one- with two-stenting techniques using second-generation DESs for coronary bifurcation lesions showed vast discrepancies. In the RESOLUTE ALL COMERS trial for 382 patients and the bifurcation substudy of the SPIRIT V for 492 patients, the rate of cardiovascular events was significantly higher in the two-stent technique, even with second-generation DESs [ 9 , 15 , 16 ]. In contrast, some studies reported favorable outcomes of the two-stenting technique compared to one-stent technique.…”

Long-term outcome and chest pain in patients with true versus non-true bifurcation lesions treated with second-generation drug-eluting stents in the TWENTE trial

“…These findings were confirmed by a retrospective study in 319 patients, who were treated with Xience for TBL, showing favorable angiographic and 1-year clinical outcomes in patients treated with a 2-stent technique [30]. Despite the overall favorable outcome of bifurcation treatment with second-generation DES, there has been a higher incidence of periprocedural MI [13, 14, 27]. …”

Bifurcation Coronary Intervention is Associated with Higher Mortality and Complications

“…17 Additionally, a report from the SPIRIT V single-arm study found that 30-day rates of death, myocardial infarction, and target vessel revascularization were higher in patients with bifurcation lesions PCI. 18 This increase in risk was found to persist well beyond 30 days, as Grundeken et al found increased risk of death, myocardial infarction, and target vessel revascularization at the 5-year time point. 19 When the results of these previous studies are compared alongside those of our study, it is clear that PCI of bifurcation lesions carries a much higher risk than non-bifurcation lesions (Figure 1).…”