A Review of Bleeding Risk with Impella-supported High-risk Percutaneous Coronary Intervention

Background: Bleeding is a common complication of percutaneous coronary intervention (PCI), leading to significant morbidity, mortality, and cost. While several risk models exist to predict post-PCI bleeding risk, however these existing models produce a single estimate of bleeding risk anchored at a single point in time. These models do not update the risk estimates as new clinical information emerges, despite the dynamic nature of risk. Objective: We sought to develop models that update estimates of patient risk of bleeding over time, enabling a dynamic estimate of risk that incorporates evolving clinical information, and to demonstrate updated predictive performance by incorporating this information. Methods: Using data available from the National Cardiovascular Data Registry (NCDR) CathPCI, we trained 6 different XGBoost tree-based machine learning models to estimate the risk of bleeding at key decision points: 1) choice of access site, 2) prescription of medication prior to PCI, and 3) the choice of closure device. Results: We included 2,868,808 PCIs; 2,314,446 (80.7%) prior to 2014 for training and 554,362 (19.3%) remaining for validation. Discrimination improved from an AUROC of 0.812 (95% Confidence Interval: 0.812-0.812) using only presentation variables to 0.845 (0.845-0.845) using all variables. Among 123,712 patients classified as low risk by the initial model, 14,441 were reclassified as moderate risk (1.4% experienced bleeds), while 723 patients were reclassified as high risk (12.5% experienced bleeds). Among 160,165 patients classified as high risk by the initial model, there were 40 patients reclassified to low risk (0% experienced bleeds), and 43,265 patients reclassified to moderate risk (2.5% experienced bleeds). Conclusion: Accounting for the time-varying nature of data and capturing the association between treatment decisions and changes in risk provide up-to-date information that may guide individualized care throughout a hospitalization.

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Abstract 13581: Prognostic Value of the Patterns of Non-adherence to Anti-platelet Regimen in Stented Patients (PARIS) Bleeding Risk Score for Long Term All-cause and Cardiac Mortalities After Percutaneous Coronary Intervention

Circulation ◽

10.1161/circ.142.suppl_3.13581 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Joh Akama ◽

Takeshi Shimizu ◽

Takuya Ando ◽

Fumiya Anzai ◽

Yuuki Muto ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

High Risk ◽

Risk Score ◽

Prognostic Value ◽

Bleeding Risk ◽

Risk Groups ◽

Coronary Intervention ◽

Bleeding Events ◽

Percutaneous Coronary

Background: The Patterns of non-Adherence to Anti-Platelet Regimen in Stented Patients (PARIS) bleeding risk score has been proposed to predict the risk of bleeding events after percutaneous coronary intervention (PCI). However, the prognostic value of the PARIS bleeding risk score for long term all-cause and cardiac mortalities has not been evaluated. Therefore, we aimed to evaluate the predictive value of the PARIS bleeding risk score for all-cause and cardiac mortalities after PCI. Methods and Results: Consecutive 1061 patients, who had admitted to our hospital and performed or undergone PCI, were divided into 3 groups based on PARIS bleeding risk score: low (n = 113), intermediate (n = 420) and high risk groups (n = 528). We compared comorbidities and characteristics of patients among 3 groups. Furthermore, we prospectively followed up all-cause and cardiac mortalities. Clinical characteristics of 3 groups were as follows: mean age (low, intermediate and high risk groups; 56.5, 65.6 and 73.9 years, P < 0.001, respectively), prevalence of chronic kidney disease (2.7%, 24.2% and 67.8%, P < 0.001), atrial fibrillation (8.2%, 8.9% and 21.6%, P < 0.001) and peripheral artery disease (3.1%, 9.1% and 22.1%, P < 0.001). During the mean follow-up period of 1809 days, there were 205 deaths and 64 cardiac deaths. The Kaplan-Meier analysis revealed that both all-cause and cardiac mortalities were highest in high risk group among 3 groups (P < 0.001 and P < 0.001, respectively, Figure). In multivariable Cox proportional hazard analysis adjusted for confounding factors, PARIS bleeding score was an independent predictor of both all-cause and cardiac mortalities (adjusted hazard ratio 1.27 and 1.21 per 1 point increase, P < 0.001 and P = 0.004, respectively). Conclusion: The PARIS bleeding risk score showed significant prognostic values for all-cause and cardiac mortalities in patients after PCI.

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TWILIGHT: A Randomized Trial of Ticagrelor Monotherapy Versus Ticagrelor Plus Aspirin Beginning at 3 Months in High-risk Patients Undergoing Percutaneous Coronary Intervention

US Cardiology Review ◽

10.15420/usc.2019.02 ◽

2020 ◽

Vol 14 ◽

Author(s):

Johny Nicolas ◽

Usman Baber ◽

Roxana Mehran

Keyword(s):

Percutaneous Coronary Intervention ◽

High Risk ◽

Antiplatelet Therapy ◽

Dual Antiplatelet Therapy ◽

Coronary Intervention ◽

Bleeding Events ◽

High Risk Patients ◽

Risk Of Death ◽

Percutaneous Coronary ◽

Risk Patients

A P2Y12 inhibitor-based monotherapy after a short period of dual antiplatelet therapy is emerging as a plausible strategy to decrease bleeding events in high-risk patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT), a randomized double-blind trial, tested this approach by dropping aspirin at 3 months and continuing with ticagrelor monotherapy for an additional 12 months. The study enrolled 9,006 patients, of whom 7,119 who tolerated 3 months of dual antiplatelet therapy were randomized after 3 months into two arms: ticagrelor plus placebo and ticagrelor plus aspirin. The primary endpoint of interest, Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, occurred less frequently in the experimental arm (HR 0.56; 95% CI [0.45–0.68]; p<0.001), whereas the secondary endpoint of ischemic events was similar between the two arms (HR 0.99; 95% CI [0.78–1.25]). Transition from dual antiplatelet therapy consisting of ticagrelor plus aspirin to ticagrelor-based monotherapy in high-risk patients at 3 months after percutaneous coronary intervention resulted in a lower risk of bleeding events without an increase in risk of death, MI, or stroke.

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Use of Impella 2.5 device for hemodynamic support during a High Risk Unprotected Left main percutaneous coronary intervention

10.25239/shj/vol5/no1/casereport2 ◽

2017 ◽

Vol 5 (1) ◽

Author(s):

Ahmed Ahmed

Keyword(s):

Percutaneous Coronary Intervention ◽

High Risk ◽

Coronary Intervention ◽

Left Main ◽

Hemodynamic Support ◽

Percutaneous Coronary

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Faculty Opinions recommendation of Bleeding risk associated with 1 year of dual antiplatelet therapy after percutaneous coronary intervention: Insights from the Clopidogrel for the Reduction of Events During Observation (CREDO) trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1158593.618791 ◽

2009 ◽

Author(s):

Ian Beales

Keyword(s):

Percutaneous Coronary Intervention ◽

Antiplatelet Therapy ◽

Dual Antiplatelet Therapy ◽

Bleeding Risk ◽

Coronary Intervention ◽

Percutaneous Coronary

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Sex-based outcomes in contemporary antiplatelet therapy trials

Open Heart ◽

10.1136/openhrt-2021-001761 ◽

2021 ◽

Vol 8 (2) ◽

pp. e001761

Author(s):

Mirvat Alasnag ◽

Tara L Jones ◽

Yasmin Hanfi ◽

Nicola Ryan

Keyword(s):

High Risk ◽

Antiplatelet Therapy ◽

Bleeding Risk ◽

Coronary Intervention ◽

Representation Of Women ◽

Percutaneous Coronary ◽

Risk Patients ◽

High Risk Populations ◽

High Bleeding Risk ◽

Randomised Controlled

Balancing ischaemic and bleeding risks in high-risk populations undergoing percutaneous coronary interventions has become an everyday dilemma for clinicians. It is particularly difficult to make decisions concerning combinations and duration of antiplatelet regimens in women given the poor representation of women in trials that have shaped current practice. Several contemporary landmark trials have recently been presented at the American College of Cardiology. The trials included the Harmonising Optimal Strategy for Treatment of coronary artery diseases-EXtended Antiplatelet Monotherapy, Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention and the TicAgrelor versus CLOpidogrel in Stabilised Patients With Acute Myocardial Infarction. In this article, we summarise the main findings of these trials and include the The Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk (LEADERS FREE) in search for evidence based best practices for women patients. Although some of these trials had prespecified a subanalysis of sex differences, women constituted only 17%–30% of participants making sex-specific analyses challenging. Data suggest that women benefit from de-escalation to both ticagrelor and clopidogrel monotherapy. However, given the increased bleeding risks observed in women further randomised controlled trials are necessary to determine the most appropriate combination and duration of dual antiplatelet therapy as well as maintenance single antiplatelet therapy.

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