Prognostic implications of 2018 ESC/EACTS guideline-endorsed high ischaemic risk features on clinical outcomes after PCI with drug-eluting stents
Authors: Wang H , Xu B.O , Gao R , Dou K 
Published: November 2020

Background

Recently, the 2018 ESC/EACTS guidelines on myocardial revascularization have been proposed to standardize the definition of high ischemic events risk (HIR) features. However, the prevalence and the expected ischemic event rate of HIR patients defined by ESC/EACTS-endorsed criteria are currently unknown in the real-world percutaneous coronary intervention practice. We sought to investigate the impact of HIR features on clinical outcomes after drug-eluting stents implantation and whether this effect is influenced by high bleeding risk (HBR).

Methods

Between January 2013 and December 2013, a total of 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. The primary ischemic endpoint was target lesion failure (TLF) (comprising cardiac death, target vessel myocardial infarction, and target lesion revascularization] and the primary bleeding endpoint was clinically relevant bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Guideline-endorsed HIR features were in the present study and definitions were as follows: diffuse (defined as lesion length ≥20 mm) multivessel disease in patients with diabetes, CKD (defined as estimated glomerular filtration rate &lt;60 ml/min/1.73 m2), ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &gt;60 mm, and treatment of CTO, and history of ST-elevation myocardial infarction. HBR was defined based on the highest quartile of PARIS bleeding score (≥6 or &lt;6).

Results

Median follow-up was 29 months. 5149 patients had at least 1 HIR feature (50.6%), who experienced significantly increased risks of TLF (adjusted hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.32–1.93; P&lt;0.001), compared to those with non-HIR features. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HRadjust: 0.85 [0.66–1.09]; P=0.200). By including ESC/EACTS-endorsed HIR criteria as a continuous variable within the same multivariable models, the risk of adverse ischemic events tended to be greater as the number of high-risk procedural characteristics increased (per number of high-risk features increase: for TLF, HRadjust: 1.15, 95% CI: 1.07–1.23; P trend&lt;0.001; for MACE, HRadjust: 1.33, 95% CI: 1.22–1.46; P trend&lt;0.001). There was no statistical interaction between HBR and HIR features in regard to TLF (adjusted Pinteraction=0.855) and clinically relevant bleeding (adjusted Pinteraction=0.269), suggesting a consistent effect within ESC/EACTS-endorsed HIR features. Results were consistent when categorizing patients into HBR according to PARIS bleeding risk score ≥8 points.

Conclusions

ESC/EACTS-endorsed HIR criteria were associated with a substantial risk of ischemic events, with no increase in clinically relevant bleeding in routine clinical practice; and theses associations did not seem to be modified by HBR status.

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences