It is common for patients on antithrombotic medications to undergo endovascular interventions. This study aimed to evaluate the effects of preoperative maintaining antithrombotic medications on perioperative clinical outcomes, especially intraoperative blood transfusion, in patients undergoing these procedures. A total of 5743 patients who underwent endovascular interventions from January 2019 to December 2022 were identified and divided into four groups based on the preoperative antithrombotic medications. Clinical outcomes, including blood transfusion, hematoma and pseudoaneurysm, were analyzed using multivariate logistics regression. Subsequently, patients were stratified according to whether they received blood transfusion. All-cause mortality, adverse cardiovascular events and infectious events were used to evaluate the impact of blood transfusion. The stabilized inverse probability of treatment weights (IPTW) with using propensity score was employed to adjust for covariate imbalance. Compared to patients not receiving any antithrombotic medications, those undergoing dual antiplatelet therapy or anticoagulant therapy exhibited an increased risk of requiring blood transfusion (OR: 2.05, 95%CI: 1.30-3.23; OR: 1.92, 95%CI: 1.22-3.03). Additionally, patients receiving anticoagulant therapy demonstrated a higher risk of hematoma (OR: 2.71, 95% CI: 1.20-6.13). No significant difference in the incidence of pseudoaneurysm was observed. Subgroup analysis indicated that the risk of blood transfusion varied according to the type of anesthesia, number of puncture sites and renal function, with a significant interaction (P < 0.05). Patients who required blood transfusion had significantly higher rate of one-year all-cause mortality (HR: 2.18, 95% CI: 1.10-4.32) and three-month infectious events at three months (HR: 4.92, 95% CI: 1.72-14.06). Preoperative maintaining dual antiplatelet or anticoagulant therapy increased the risk of blood transfusion in endovascular interventions. Blood transfusion was independently associated with increased risk of all-cause mortality and infectious events. Interventional physicians should assess thrombosis and bleeding risks preoperatively, and determine whether to discontinue antithrombotic medications and avoid liberal blood transfusion.
Article
The impact of preoperative maintaining antithrombotic medications for clinical outcomes in patients undergoing non-coronary endovascular interventions
https://doi.org/10.21203/rs.3.rs-4852468/v1
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endovascular interventions
antiplatelet therapy
anticoagulant therapy
blood transfusion
One of the common issues faced by interventional physicians in clinical practice is the perioperative management of patients on anticoagulant and antiplatelet therapy, a domain lacking robust guidelines and well-supported studies1. With the aging population and rising comorbidity rates, the use of anticoagulant and antiplatelet medications for cardiovascular diseases prevention has become widespread2,3. It has been estimated that a significant proportion of patients with cardiovascular and cerebrovascular conditions will require surgery including endovascular interventions.
Endovascular interventions have become pivotal in managing various vascular diseases, ranging from cerebrovascular disorders to peripheral artery disease, due to their minimally invasive nature, reduced trauma, shorter recovery times and lower complication risks4,5. These procedures, performed within blood vessels using specialized instruments, are often classified as low bleeding risk such as coronary angiography, suggesting that antithrombotic medications can be continued perioperatively with minimal or no interruption6. However, endovascular interventions inherently involve vascular puncture, which can lead to vessel damage and complications such as persistent bleeding and hematoma formation at the puncture site. Studies have indicated that arterial puncture was a high-risk bleeding procedure, with the risk significantly higher for femoral access compared to other access sites7.
The bleeding risk associated with various endovascular interventions appears to be related with factors such as the puncture site, vascular condition, instruments used and procedure duration8. Despite the growing number of endovascular interventions performed annually, there remains a paucity of clinical studies specifically examining the impact of preoperative maintaining antithrombotic medications on bleeding risk requiring blood transfusion. Understanding this relationship is crucial for optimizing patient outcomes. Our study aimed to fill this knowledge gap by investigating this relationship with a particular focus on its influence on perioperative blood transfusion. By analyzing data from large urban medical center, we hope to provide evidence-based insights that will inform clinical decision-making and enhance the safety and efficacy of endovascular interventions.
Study design and patients
In this retrospective cohort study, consecutive patients with endovascular interventions were identified by reviewing the databases from the large urban medical center, Nanjing Drum Tower Hospital, from January 1, 2019 to December 31, 2022. This study was conducted in accordance with the Declaration of Helsinki. Approval for the study was obtained from the Ethics Committee of Nanjing Drum Tower Hospital (2023-117-02), and the requirement for informed consent was waived due to the retrospective nature of the study. All methods performed in accordance with the relevant guidelines and regulations.
Specific endovascular interventions referred to the procedures of percutaneous puncture under the guidance of imaging equipment, in which instruments such as puncture needles, special catheters and guide wires were introduced into the blood vessels for therapeutic purposes. The procedures (cerebrovascular interventions, aortic aneurysm repair, peripheral artery disease interventions, splanchnic artery interventions, etc.) were classified according to the international classification of diseases (ICD-10), as detailed in Supplementary Table Ⅰ.
Exclusion criteria include: (1) Patients who discontinued antithrombotic medications before the procedures. (2) Patients receiving both antiplatelet and anticoagulant medications simultaneously. (3) Percutaneous coronary interventions, typically preceded by a loading dose of antiplatelet medications such as aspirin, clopidogrel and ticagrelor. (4) Endovascular interventions for angiography. (5) Endovascular interventions performed via venous access. (6) Open surgeries and endovascular interventions performed simultaneously. (7) Endovascular interventions involving the use of thrombolytic medications.
Patients who had been taking antithrombotic medications did not discontinued prior to the procedures. For the procedures, briefly, the puncture site was identified and an incision was made to expose the vessel. Systemic heparinization was performed with heparin and the activated clotting time (ACT) value was monitored to achieve about two times the normal value. Then the arterial sheaths were inserted by puncture in the target vessel.
The antithrombotic medications were carefully reviewed and documented. According to the preoperative antithrombotic medications, patients were classified into four groups: (1) those not receiving any antithrombotic therapy (Non-ATT). (2) those receiving single antiplatelet therapy (SAPT), such as aspirin, clopidogrel, etc.. (3) those receiving dual antiplatelet therapy (DAPT), such as aspirin and clopidogrel, aspirin and ticagrelor, etc.. (4) those receiving anticoagulant therapy (ACT), such as warfarin, rivaroxaban, dabigatran, etc..
Covariates
The demographic characteristics (age, gender, BMI), comorbidities (hypertension, diabetes, vascular disease, immune disease, congestive heart failure), vascular access, number of puncture sites, sheath size, anesthesia type, duration of procedure and laboratory indexes were used to describe the baseline characteristics of study population. Immune disease mainly referred to systemic vasculitis that involved the aorta and its branch arteries, which led to wall thickening, stenosis or aneurysm of involved arteries, such as Takayasu arteritis9. Vascular disease, a systemic condition with atherosclerosis as the common pathological feature, can manifest as coronary artery disease, cerebrovascular disease or peripheral artery disease, etc., or a combination of two or more vascular bed diseases. Renal function was estimated by calculating estimated glomerular filtration rate (eGFR) using Cockcroft-Gault formula, with eGFR categorized into five grades: ≥90 mL/min/1.73m2, 60-89 mL/min/1.73m2, 30-59 mL/min/1.73m2, 15-29 mL/min/1.73m2 and <15 mL/min/1.73m2. The vascular access for endovascular intervention included femoral artery, popliteal artery, tibiofibular artery, radial artery, brachial artery, axillary artery and carotid artery. The choice of vascular access depended on various factors, including the nature of the procedure, patient anatomy and condition, physician expertise and considerations for minimizing complications. The introducer sheath was a thin, flexible tube designed to facilitate the insertion of medical instruments or devices into the body, serving as a conduit through which other tools, such as guide wire or catheter, can be safely guided into the target area. The size of an introducer sheath was determined by its diameter (French size). Anesthesia types were categorized into local and general anesthesia. Local anesthesia involved numbing a specific area to block sensation and pain during a medical procedure. General anesthesia induced a state of unconsciousness and unresponsiveness to pain during surgery or other invasive procedures.
Study outcomes
The primary efficacy outcome was transfusion of whole blood or red blood cells. Indications for transfusion were determined by the attending physicians, with institutional guidelines recommended transfusion at a serum hemoglobin < 8 g/L10. The secondary efficacy outcomes consisted of postoperative hematoma and pseudoaneurysm at the puncture site. Hematoma, typically induced by trauma, results from the rupture of blood vessels and subsequent blood leakage into adjacent tissues, forming a coagulated mass whose size varies with the severity of the trauma and extent of hematoma. Pseudoaneurysm, in contrast to true aneurysms which involve permanent dilation of the vessel wall, arises from a breach in the vessel wall, causing blood to extravasate and form a sac-like structure composed of fibrous tissue and thrombosis. Clinical presentations may include pain, a pulsatile mass, or symptoms of compression on adjacent structures.
The clinical outcomes used to analyze the prognostic impact of blood transfusion were one-year all-cause mortality, one-year adverse cardiovascular events and three-month infectious events. All-cause mortality was defined as death from any cause. Adverse cardiovascular events encompassed a composite of myocardial infarction, ischemic stroke, or death from cardiovascular causes. Infectious events were classified as either: (1) microbiologically defined infections (patients with a clinical syndrome and compatible microbiology result for an infection); (2) clinically defined infections (patients with a clinical syndrome consistent with an infectious origin or etiology, but with no compatible microbiological results).
Statistical Analysis
In the cohort of 5743 patients, 802 (13.96%) patients had missing data in at least one of eGFR, platelet, hemoglobin and fibrinogen. Missing data was imputed using multiple imputation by chained equations in R statistical software, resulting in multiple imputed datasets with pooled odds ratios (OR) values. The outcomes between groups were analyzed using multiple logistic regression, with the Non-ATT group serving as the reference, which were reported as OR values with corresponding 95% confidence intervals (CI). Complete data was utilized for subsequent sensitivity analysis. P-value < 0.05 was considered significant.
The risk of blood transfusion in specified subgroups was defined by age (<70 years and ≥70 years), vascular disease, anesthesia type, numbers of puncture sites, sheath size (<7 F or ≥7 F) and renal function (eGFR ≥90 mL/min/1.73m2, eGFR 30-89 mL/min/1.73m2 and eGFR <30 mL/min/1.73m2). For subgroup analysis, multivariable Cox proportional hazards regression was used to evaluate the clinical outcomes. The significance of interaction between antithrombotic therapies and subgroups was defined as P-for-interaction < 0.05.
To analyze the impact of blood transfusion on one-year all-cause mortality, adverse cardiovascular events and three-month infectious events, the methods of multiple imputation and inverse probability weighting were performed. The propensity score method, which simulated the effect of a randomized clinical trial in observational cohort study was used to estimate the clinical outcomes between patients who received blood transfusion and those who did not. The propensity score was calculated using logistic regression to estimate the probability of receiving antithrombotic medications based on observed covariates. Then stabilized inverse probability of treatment weights (IPTW) derived from the propensity scores was used to adjust for measured covariates, thereby creating a pseudo dataset by preserving sample size. To assess the performance before and after stabilized IPTW, we compared the covariates using standardized mean difference (SMD), with differences > 10% regarded as imbalanced. Weighted incidence rate (IR) per 100 person-years (PY) was calculated. The risk of clinical outcomes was analyzed by survival analysis with Kaplan-Meier method and the log-rank test for univariate analysis or Cox proportional hazard regression models for multivariate analysis, expressed as hazard ratio (HR) and 95% CI.
Patient characteristics
Between January 2019 and December 2022, a total of 5743 patients with endovascular interventions were included in this study. Baseline characteristics of the patients were presented in Table 1. Generally, patients receiving antithrombotic therapy were older, had a higher proportion of comorbidities and local anesthesia. Conversely, patients not receiving antithrombotic therapy had a higher proportion of multiple puncture sites, upper limb or carotid artery access and abnormal laboratory indexes. Patients receiving anticoagulant therapy had the shortest duration of procedure. The application of sheath larger than 7 F was lowest in patients receiving dual antiplatelet therapy.
Clinical outcomes
The incidence rate and adjusted OR values of clinical outcomes between the groups were presented in Figure 1. Patients receiving dual antiplatelet therapy and anticoagulant therapy had a higher risk of blood transfusion compared to those not receiving any antithrombotic medications. The highest incidence rate of blood transfusion was observed in the DAPT group (OR: 2.05, 95%CI: 1.30-3.23), followed by the ACT group (OR: 1.92, 95%CI: 1.22-3.03). The OR and 95%CI for blood transfusion among specifical antithrombotic medications compared to patients not receiving antithrombotic medication were detailed in supplementary Table Ⅱ. Compared with the non-ATT group, only ACT group demonstrated an increased risk of hematoma (OR: 2.71, 95%CI: 1.20-6.13). There was no significant difference in the incidence of pseudoaneurysm between the groups. Sensitivity analysis using complete data showed results consistent with those derived from the multiple imputed datasets (Supplementary Table Ⅲ).
Subgroup analysis
The results of subgroup analysis were presented in Figure 2. When 70 years was used as a cutoff to define age subgroups, both DAPT in the subgroup of age < 70 years and ACT in the subgroup of age ≥ 70 years increased the risk of blood transfusion compared to patients not receiving antithrombotic medication. There was no evident interaction between age subgroup and antithrombotic therapies (P-for-interaction = 0.548). Although the risk of blood transfusion varied among different antithrombotic therapies in vascular disease and sheath size subgroups, no significant interactions were observed. For the anesthesia type stratification, DAPT and ACT were associated with a higher risk of blood transfusion in patients receiving local anesthesia, unlike those receiving general anesthesia (P-for-interaction < 0.001). Compared to Non-ATT group, DAPT and ACT were associated with an increased risk of blood transfusion in patients with more than three puncture sites, similar in patients with eGFR < 30 mL/min/1.73m2. Significant interactions were noted between these subgroups and antithrombotic therapies (P-for-interaction = 0.035 or P-for-interaction = 0.014).
Impact of blood transfusion on clinical outcomes
During the hospitalization, 202 patients (3.52%) received blood transfusion. Baseline characteristics of the patients were presented in Supplementary Table Ⅳ. After IPTW, baseline characteristics of patients were well balanced between the two groups. Patients receiving blood transfusion versus those who did not, had markedly higher rates of one-year all-cause mortality (HR: 2.18, 95%CI: 1.10-4.32) and three-month infectious events (HR: 4.92, 95%CI: 1.72-14.06), while no significant differences were observed in terms of adverse cardiovascular events (Figure 3, Figure 4).
Endovascular intervention in patients receiving anticoagulant or antiplatelet medications was unavoidable, but data guiding interventional physicians in the perioperative management of those patients were still limited to retrospective series primarily focused on non-interventional procedures1. With advancements in endovascular techniques, complex conditions such as aortic dissection and abdominal aortic aneurysm, previously treated with open surgeries, can be better managed. However, there were minimal data on procedure-specific bleeding risk in this patient population, precluding an accurate assessment of perioperative bleeding risk.
Endovascular interventions typically required puncturing through the skin and tissues to access the target blood vessel. Incorrect puncture techniques or inappropriate puncture locations could damage surrounding tissues and blood vessels, leading to hematoma and blood oozing, and thereby necessitating blood transfusion11. Studies have shown that blood transfusion was independently associated with increased risk of worse clinical outcomes12, 13. Strict transfusion strategies and individualized antiplatelet or anticoagulant therapy were critical for improving prognosis. Current studies on the impact of antiplatelet or anticoagulant therapy on bleeding and blood transfusion mainly focused on surgical cardiac surgery and non-cardiac surgery. Aspirin and aspirin combined with clopidogrel increased surgical blood loss by 2.5% to 20% and 30% to 50%, respectively14. The addition of clopidogrel to aspirin markedly increased bleeding rates, although most studies have been conducted in the context of cardiac surgery with complete intraoperative heparinization under cardiopulmonary bypass15. A retrospective study examined the effects of preoperative aspirin on bleeding and transfusion in cardiac surgery16. It found that in patients undergoing CABG, valve, or combined CABG/valve surgery, preoperative aspirin within 5 days of surgery was associated with an increased risk of blood transfusion. However, in non-cardiac surgery, the situation was less obvious. A Mayo Clinic study showed that in patients undergoing vascular, orthopedic and visceral surgery after coronary stent implantation, the transfusion rates were 38.5% in the control group and 42.6% in the dual antiplatelet therapy group with no significant difference17. Anticoagulant therapy similarly increased the risk of perioperative transfusion18,19. Endovascular interventional procedures, which differentiated from traditional surgical procedures, employed minimally invasive techniques. With the complexity of interventional procedures for aortic, peripheral and intracranial arteries, the risk of major bleeding was increased for arterial interventional procedures that required prolonged procedures or involved complex vascular structures. Even then, the general consensus from the survey on perioperative use of antithrombotic medications indicated that most interventionalists did not discontinue antithrombotic medications before surgery.
In this study, both dual antiplatelet and anticoagulant therapy increased the risk of blood transfusion in patients after adjusting for covariates such as age, comorbidities, relevant laboratory index and procedure details. The disparity between these findings and the bleeding risk associated with perioperative antithrombotic medications in current open surgical procedures may be attributed to the fact that endovascular interventions cause less tissue damage, with bleeding primarily concentrated at the puncture site of the blood vessel. Although access site bleeding was the common complication of interventional procedures, it could be affected by multiple factors such as age, cardiovascular risk factors, anticoagulant/antiplatelet medications, access sites and the size of sheath8. Therefore, bleeding caused by the procedures may range from minor to major bleeding requiring blood transfusion.
Moreover, the blood transfusion risks of different antithrombotic therapies varied among different patient populations such as anesthesia type, number of puncture sites and eGFR grade. General anesthesia can cause vasodilation, reducing blood pressure, and can also relax muscles to decrease the tension during surgical procedures. For the procedures under local anesthesia, the application of anesthetics can cause vasoconstriction and instead increase the risk of intraoperative bleeding. Therefore, the risk of intraoperative bleeding appeared to be lower with general anesthesia compared to local anesthesia20. The number of puncture sites required for endovascular interventional procedures depended on factors such as the specific type of surgery and the vascular anatomy. Usually, endovascular intervention, such as common coronary angiography, only required a single puncture in the femoral artery or radial artery. However, some interventional procedures, such as those involving the simultaneous management of multiple blood vessel branches or complex aortic stent implantation, may require multiple puncture sites, thereby increasing the risk of bleeding21. Renal insufficiency can lead to abnormal platelet function and metabolic disorders of coagulation factors, especially in patients with uremia, who were more prone to intraoperative bleeding. Additionally, medications that were primarily eliminated by renal excretion could accumulate excessively in patients with renal insufficiency, thereby increasing the risk of bleeding 22.
Although antiplatelet or anticoagulant therapy improved patient outcomes by reducing thrombotic events at the expense of increased risk of bleeding complications. Balancing the clinical outcomes of these risks in the perioperative period was crucial. In our study, blood transfusion did not increase the incidence of adverse cardiovascular events in postoperative patients, which may be due to the continuation of antithrombotic medications postoperatively, whereas all-cause mortality as well as infectious events were significantly increased. According to the results, antithrombotic therapy can be transiently interrupted in special patients when the thromboembolic risk was not high, especially for patients who received dual antiplatelet and anticoagulant therapy. Therefore, it is incorrect to assume that endovascular interventions inherently carry a low risk of bleeding. Individualized assessment of the procedure-specific details is essential to accurately determine whether antithrombotic therapy needs to be discontinued preoperatively.
The main limitations of our study are single-center experience and retrospective study design, which could introduce bias and limitations in data quality and completeness. The accuracy of data collected retrospectively depended on the quality of medical records, coding practices and documentation standards, which may vary between different medical institutions. However, the antithrombotic therapies were performed largely in accordance with the recent clinical guidelines. The main strengths of our study were the real-life patient cohort and the large sample size of data, as well as a detailed overview of the baseline characteristics, surgical details and laboratory indexes.
Preoperative dual antiplatelet or anticoagulant therapy increased the risk of blood transfusion in patients undergoing endovascular interventions. This finding also demonstrated the value of medication screening, as a component of perioperative risk management for reducing the risks of medication-related complications, even for endovascular interventions that have been considered as “low risk”.
Competing interests
The authors declare no competing interests
Author contributions
Baoyan Wang designed and implemented the study. Min Lu and Jiaqi Li performed the experiments, wrote the manuscript. Huanyu Ni and Baoyan Wang critically revised and edited the manuscript. All authors reviewed and approved the final manuscript.
Funding
This study was supported by grants from the National Natural Science Foundation of China (81900427), Clinical Trials from the Affiliated Drum Tower Hospital, Medical School of Nanjing University (2021-LCYJ-PY-19).
Data availability
The data underlying this article will be shared on reasonable request to the corresponding author.
Supplemental Material
Supplemental material for this article is available online.
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No competing interests reported.