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.

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 &gt;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&lt;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 &lt;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 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 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 &gt;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&lt;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 &lt;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 Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial

Circulation ◽  
2020 ◽  
Author(s):  
Hyo-Soo Kim ◽  
Jeehoon Kang ◽  
Doyeon Hwang ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Acute Coronary Syndrome ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Drug Eluting Stents ◽  
Composite Outcome ◽  
Coronary Syndrome ◽  
Durable Polymer ◽  
Percutaneous Coronary ◽  
Drug Eluting

Background: Large scale randomized comparison of drug-eluting stents (DES) based on durable polymer (DP) versus biodegradable polymer (BP) technology is currently insufficient in patients with acute coronary syndrome (ACS). The present study sought to prove the non-inferiority of the DP-DES compared with the BP-DES in such patients. Methods: The HOST-REDUCE-POLYTECH-ACS trial is an investigator-initiated, randomized, open-label, adjudicator-blinded, multicenter, non-inferiority trial which compared the efficacy and safety of DP-DES and BP-DES in patients with ACS. The primary endpoint was patient oriented composite outcome (POCO, a composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization) at 12 months. The key secondary endpoint was device oriented composite outcome (DOCO; a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months. Results: A total of 3413 patients were randomized to receive the DP-DES (1713 patients) and BP-DES (1700 patients). At 12 months, POCO occurred in 5.2% in the DP-DES group and 6.4% in the BP-DES group (Absolute risk difference: -1.2%, P non-inferiority <0.001). The key secondary endpoint, DOCO, occurred less frequently in the DP-DES group (DP-DES vs. BP-DES: 2.6% vs. 3.9%, HR 0.67, 95% CI 0.46-0.98, p=0.038), mostly due to a reduction in target lesion revascularization. The rate of spontaneous non-fatal MI and stent thrombosis were extremely low, with no significant difference between the 2 groups (0.6% vs. 0.8%; p=0.513 and 0.1% vs 0.4%; p=0.174, respectively). Conclusions: In ACS patients receiving percutaneous coronary intervention (PCI), DP-DES was non-inferior to BP-DES with regard to POCO at 12 months after index PCI. Clinical Trial Registration: URL: clinicaltrials.gov Unique identifier: NCT02193971

Percutaneous Coronary Intervention for Complex Bifurcation Lesions

2010 ◽  
Vol 5 (1) ◽  
pp. 58
Author(s):  
Yves Louvard ◽  
Morice Marie-Claude ◽  
Thomas Hovasse ◽  
Thierry Lefèvre ◽  
◽  
...  
Keyword(s):  
Percutaneous Coronary Intervention ◽  
Coronary Intervention ◽  
Side Branch ◽  
Drug Eluting Stents ◽  
Open Angle ◽  
Balloon Inflation ◽  
Percutaneous Coronary ◽  
Drug Eluting ◽  
Bifurcation Lesions ◽  
Stent Diameter

Coronary bifurcations are prone to the development of atherosclerosis. They pose technical difficulties for angioplasty treatment and are a predictor of stent thrombosis and restenosis. Treatment of coronary bifurcations is still subject to debate, especially when the side branch (SB) is large, not easily accessible and narrowed by a long lesion. There is currently no indexed treatment for this type of lesion (Medina classification), as the strategy of provisional SB stenting with drug-eluting stents (DES) has proved to be equally efficient as the dualstent technique. Complex techniques are associated with poor outcome in certain lesion types, such as T-stenting when the angle between the two distal branches is small or the crush and culotte technique in the presence of an open angle. Provisional SB stenting may be used when primary dual stenting is required, with a low risk of failure provided that the following guidelines are implemented: stenting of the main branch through the protected SB with a stent diameter adapted to the distal main branch, immediate optimisation of the proximal stent segment (Finet’s law), guidewire exchange, kissing balloon inflation with non-compliant balloons selected according to the diameter of the distal branches and T-stenting of the SB before final kissing inflation.

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