PCI complexity and risk of adverse events in relation to high bleeding risk among patients receiving drug-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wang ◽  
B.O Xu ◽  
D Zhang ◽  
R Gao ◽  
K Dou
Keyword(s):  
Adverse Events ◽  
Cox Regression ◽  
Bleeding Risk ◽  
Drug Eluting Stents ◽  
Funding Source ◽  
Medical Sciences ◽  
Cox Regression Analysis ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
High Bleeding Risk

Abstract Background The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score. Methods Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P<0.001), compared with non-complex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279). Conclusions Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

scholarly journals PCI complexity and cardiovascular risk in relation to high bleeding risk among patients receiving drug-eluting Stents: insight from China Fuwai PCI registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H.Y Wang ◽  
R.L Gao ◽  
B Xu ◽  
A Kirtane ◽  
K Dou
Keyword(s):  
Cox Regression ◽  
Bleeding Risk ◽  
Drug Eluting Stents ◽  
Major Adverse Cardiovascular Events ◽  
Funding Source ◽  
Medical Sciences ◽  
Cox Regression Analysis ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
High Bleeding Risk

Abstract Background The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score. Methods Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion requiring a rotablator system. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results The median duration of follow-up was 30 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P<0.001), compared with non-complex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279). Conclusions Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences;National Natural Science Foundation of China

scholarly journals Percutaneous Coronary Intervention Complexity and Risk of Adverse Events in relation to High Bleeding Risk among Patients Receiving Drug-Eluting Stents: Insights from a Large Single-Center Cohort Study

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Hao-Yu Wang ◽  
Yang Wang ◽  
Dong Yin ◽  
Run-Lin Gao ◽  
Yue-Jin Yang ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Adverse Events ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Cox Regression Analysis ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
High Bleeding Risk

Background/Aim. The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including stratification according to HBR estimated by PARIS bleeding risk score. Methods. Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) (composite of cardiac death, myocardial infarction, definite/probable stent thrombosis, and target lesion revascularization), and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results. The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio (HR): 1.63, 95% confidence interval (CI): 1.38–1.92; P<0.001), compared with noncomplex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279). Conclusions. Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk, and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.

scholarly journals Prognostic implications of 2018 ESC/EACTS guideline-endorsed high ischaemic risk features on clinical outcomes after PCI with drug-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Wang ◽  
B.O Xu ◽  
R Gao ◽  
K Dou
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Clinical Outcomes ◽  
Bleeding Risk ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Funding Source ◽  
Medical Sciences ◽  
Drug Eluting ◽  
Ischemic Events

Abstract 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

scholarly journals One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
David E. Kandzari ◽  
Ajay J. Kirtane ◽  
Stephan Windecker ◽  
Azeem Latib ◽  
Elvin Kedhi ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Antiplatelet Therapy ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Drug Eluting Stents ◽  
Randomized Controlled ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
High Bleeding Risk

Background: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients. Methods: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention. Results: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% ( P <0.001). Conclusions: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier NCT03647475.

scholarly journals Drug-coated Balloons or Drug-eluting Stents – Determining an Optimum Strategy for Patients with High Bleeding Risk

2020 ◽  
Vol 14 (2) ◽  
pp. 100
Author(s):  
Natasha H Corballis ◽  
Tha H Nyi ◽  
Vassilios S Vassiliou ◽  
Simon C Eccleshall ◽  
◽  
...  
Keyword(s):  
Bleeding Risk ◽  
Drug Eluting Stents ◽  
Optimum Strategy ◽  
Drug Eluting ◽  
High Bleeding Risk

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