PRECISE-DAPT Score Research Articles

Clinical outcomes of risk score-guided dual antiplatelet therapy in patients with acute coronary syndrome who underwent percutaneous coronary intervention

Abstract Objective We aimed to investigate the effect of risk score-guided dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) from real-world clinical practice in Korea. Methods 984 patients with ACS undergoing PCI with bioabsorbable-polymer everolimus eluting stent were enrolled from 20 hospitals in the multicenter, observational study. The analysis was conducted on 834 patients who took medications according to risk score-guided DAPT and were follow-up after 1 year. GRACE score and PRECISE-DAPT score were used for risk score-guided DAPT and medication for antiplatelets was conducted as follow (Figure 1). Results The mean age was 64.0 ± 10.5 years, 77.6% were men. 43.7% had acute myocardial infarction, 62.5% hypertension and 37.6% diabetes. Multivessel and left main artery disease were about in 56.2%. Trans-radial PCI was performed in 76.3%. Aspirin was taken in almost all patients (99.1%) and clopidogrel was most frequently prescribed as a DAPT (clopidogrel 64.9%, Ticagrelor 28.1%, prasugrel 6.6%). All-cause mortality and NACE (consisting of all-cause mortality, myocardial infarction, revascularization, stent thrombosis, stroke, and major/minor bleeding) were 1.2%, and 5.4% respectively at 1 year. Stent thrombosis was occurred only in 4 patients (0.5%). Bleeding complications were developed in 19 case (2.3%). Among the bleeding sites, the access site was the most common 7 (0.8%), followed by the gastrointestinal tract 4 (0.5%). Major bleeding was occurred (BARC types 3 to 5 bleeding) in 3 cases (0.4%) and BARC type 2 was most common (1.2%) (Figure 2 and Table 1). Conclusion Bleeding complications and ischemic events were very low in real-world patients with ACS undergoing PCI during 1 year follow-up, when the management was performed according to the risk scoring-guided DAPT.Figure 1Figure 2 and Table 1

Prolonged dual antiplatelet therapy in an extended Phase 3 Cardiac Rehabilitation Program following myocardial infarction

Abstract Background Prolonged dual antiplatelet therapy (P-DAPT) is recommended in selected patients beyond 12 months after myocardial infarction (MI). Several risk scores have been developed to estimate the ischemic and bleeding risk and individualize the decision-making process. Purpose We aim to analyse the factors, including ischemic and bleeding scores, associated with P-DAPT prescription in MI patients submitted to a Cardiac Rehabilitation Program (CRP). Methods Patients with ST-segment elevation MI (STEMI) or occlusion MI (OMI) who were submitted to our CRP underwent Phase 2 CRP and were prospectively included. Patients were followed in an extended Phase 3 CRP, and a follow-up visit was scheduled 12 months after hospital discharge. Baseline and follow-up clinical characteristics and treatment after the 12-months visit were registered, specifically P-DAPT. Ischemic (DAPT score) and bleeding (PRECISE-DAPT and CRUSADE scores) risk scores were retrospectively computed. Predictors of P-DAPT were studied by univariate analysis and multivariable binary logistic regression. The model was tested by area under the curve (AUC) analysis in receiver operating characteristic curves. A p<0.05 was considered statistically significant. Results The cohort comprised 78 patients (mean age 61±11 years, 84.6% male). Anterior and inferior STEMI were the most common presentations (43.6% and 47.4%, respectively). The most prevalent cardiovascular risks factors were hypercholesterolemia (85.9%), hypertension (53.8%), smoking habit (46.2%) and diabetes mellitus (23.1%). P-DAPT was prescribed in 39 (50%) patients beyond 12 months after MI, primarily combining aspirin 100mg o.d. and ticagrelor 60mg b.i.d. (n=33, 84.6%). On multivariate analysis, variables associated with P-DAPT prescription were hypertension (HR 4.92 [1.37-17.68], p=0.02), diabetes mellitus (HR 5.13 [1.09-24.09], p=0.04), multivessel disease (HR 5.54 [1.55-19.79], p=0.008), and stent diameter <3mm (HR 5.46 [1.25-23.78], p=0.02). The predictive power of the model was excellent (AUC 0.88 [0.8-0.96], p<0.001). Ischemic (DAPT score) and bleeding (PRECISE-DAPT and CRUSADE) risk scores were not associated with P-DAPT neither in continuous form nor by using their standard cutoffs (≥2, <25 and >40 points, respectively). Conclusions In a real-life cohort of MI patients undergoing extended Phase 3 Cardiac Rehabilitation, P-DAPT was prescribed in half of the population. Clinical (hypertension and diabetes mellitus) and angiographic (multivessel disease and stent diameter <3mm) variables straightforwardly predict the likelihood of receiving P-DAPT, unlike ischemic and bleeding risk scores. The clinical consequences of this management should be further explored.Prolonged DAPT in Cardiac Rehabilitation

Thirty days clinical outcomes following stent implantation with aspirin-free prasugrel monotherapy in non-ST segment elevation myocardial infarction. Interim report from ASET-Japan pilot study

Abstract Background Dual antiplatelet therapy with a P2Y12 inhibitor, in addition to aspirin, is the standard therapy after percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) to prevent ischemic cardiovascular events. The Acetyl-Salicylic Elimination Trial (ASET) pilot studies conducted in Japan in patients with NSTE-ACS investigated the safety and feasibility of a low-dose prasugrel monotherapy after PCI. Purpose To ensure the safety of the patients, enrolment in the study was implemented only after confirmation of a successful procedure. The abstract reports our interim analysis, aimed at evaluating preliminary safety and feasibility. Methods The ASET-Japan pilot study was designed to explore the feasibility and safety of a low dose of prasugrel monotherapy (3.75mg/day), without adjunctive aspirin, after optimal PCI using Everolimus eluting stent (EES) in Japanese patients with non-ST-segment elevation acute coronary syndromes. The primary endpoint in the ASET-Japan NSTE-ACS (Phase 2) is a 12-month clinical outcome. The study is currently in the follow-up phase. All the target lesions were treated with a platinum-chromium everolimus-eluting stent. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 12-month. If more than 3 events occurred, trial enrollment would have to be terminated by the data and safety monitoring board. Results One hundred one patients were enrolled after successful index PCI and completed a 30 days follow-up. The mean age was 69.1±12.3 years and 75.2% was male. The mean anatomical SYNTAX score was 7.9±4.7. Unstable angina (UAP) and NSTEMI were seen in 24.8% (25/101) and 75.2% (75/101) patients, respectively. According to the Braunwald classification, 8 percent of the patients were categorised as Class IA UAP, 48% as Class IB, 20% as Class IIB, 4% as Class IIIA and 20% as Class IIIB. In NSTEMI patients, the median (IQR) pre-procedural troponin value (cardiac Troponin T or I) was 2.79 (1.12 – 22.27) times the Upper Limit of Normal. According to the PRECISE DAPT score, 36.6% of patients were categorised as High Bleeding Risk (HBR) with scores above 25. At one month, the primary ischemic endpoints of cardiac death, target-vessel spontaneous MI or definite Stent thrombosis did not occur. Two patients (2.0%) had BARC type 3a bleeding. Conclusion Prasugrel monotherapy in the first 30 days following platinum-chromium everolimus-eluting stent deployment is a feasible and safe strategy in NSTE-ACS patients with simple anatomy and successful PCI.

Derivation and Validation of the PRECISE-HBR Score to Predict Bleeding After Percutaneous Coronary Intervention.

Accurate bleeding risk stratification after percutaneous coronary intervention (PCI) is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of high bleeding risk patients. We derived and validated a novel bleeding risk score by augmenting the PRECISE-DAPT score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The derivation cohort comprised 29,188 patients undergoing PCI, of whom 1136 (3.9%) had a Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year, from four contemporary real-world registries and the XIENCE V USA trial. The PRECISE-DAPT score was refitted with a Fine-Gray model in the derivation cohort and extended with the ARC-HBR criteria. The primary outcome was BARC 3 or 5 bleeding within 1 year. Independent predictors of BARC 3 or 5 bleeding were selected at multivariable analysis (p<0.01). The discrimination of the score was internally assessed with apparent validation and cross-validation. The score was externally validated in 4578 patients from the MASTER DAPT trial and 5970 patients from the STOPDAPT-2 total cohort. The PRECISE-HBR score (age, estimated glomerular filtration rate, hemoglobin, white-blood-cell count, previous bleeding, oral anticoagulation, and ARC-HBR criteria) showed an area under the curve (AUC) for 1-year BARC 3 or 5 bleeding of 0.73 (95% CI, 0.71-0.74) at apparent validation, 0.72 (95% CI, 0.70-0.73) at cross-validation, 0.74 (95% CI, 0.68-0.80) in the MASTER DAPT, and 0.73 (95% CI, 0.66-0.79) in the STOPDAPT-2, with superior discrimination than the PRECISE-DAPT (cross-validation: Δ AUC, 0.01; p=0.02; MASTER DAPT: Δ AUC, 0.05; p=0.004; STOPDAPT-2: Δ AUC, 0.02; p=0.20) and other risk scores. In the derivation cohort, a cut-off of 23 points identified 11,414 patients (39.1%) with a 1-year BARC 3 or 5 bleeding risk ≥4%. An alternative version of the score, including acute myocardial infarction on admission instead of white-blood-cell count, showed similar predictive ability. The PRECISE-HBR score is a contemporary, simple 7-item risk score to predict bleeding after PCI, offering a moderate improvement in discrimination over multiple existing scores. Further evaluation is required to assess its impact on clinical practice.

S951 Gastrointestinal Bleeding in Post-PCI Patients on Antiplatelet Therapy and the Predictive Value of the PRECISE-DAPT Score

S951 Gastrointestinal Bleeding in Post-PCI Patients on Antiplatelet Therapy and the Predictive Value of the PRECISE-DAPT Score

Prognostic Value of PRECİSE DAPT Score on Short- and Long-Term Outcomes in MINOCA Patients with Acute Coronary Syndrome.

Myocardial infarction with non-obstructive coronary arteries (MINOCA) constitutes a significant subset of acute myocardial infarctions (AMI) with uncertain prognostic markers. Early risk assessment is crucial to identify MINOCA patients at risk of adverse outcomes. This study aimed to evaluate the predictive capacity of the PRECISE-DAPT score in assessing short- and long-term prognoses in MINOCA patients presenting with ST-segment elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI). Among 741 MINOCA patients, the PRECISE-DAPT score was computed to analyze its association with in-hospital and follow-up major adverse cardiovascular events (MACE). Parameters showing significance in MACE (+) groups underwent statistical analysis: univariate logistic regression for in-hospital events and univariate Cox regression for follow-up events. For statistical significance, a predefined level of α = 0.05 was adopted. Parameters demonstrating significance proceeded to multiple logistic regression for in-hospital events and multivariate Cox regression for follow-up events. In-hospital MACE occurred in 4.1% of patients, while 58% experienced follow-up MACE. Hemoglobin levels and the PRECISE-DAPT Score were identified as independent parameters for in-hospital MACE. Furthermore, ejection fraction (EF%) and the PRECISE-DAPT Score emerged as independent predictors of follow-up MACE. The study revealed that a higher PRECISE-DAPT score was significantly associated with increased risks of both in-hospital and long-term major adverse cardiovascular events in MINOCA patients presenting with acute coronary syndrome (ACS), underscoring the score's potential in risk stratification for this patient cohort. _ PRECISE-DAPT score predicts MACE risk in MINOCA patients. _ Hemoglobin level and PRECISE-DAPT score predict in-hospital MACE. _ Ejection fraction and PRECISE-DAPT score predict long-term MACE.

Supporting appropriate use of extended dual antiplatelet therapy post-myocardial infarction based on an innovative 12-month ticagrelor virtual service.

Extended dual antiplatelet therapy (DAPT) with ticagrelor and aspirin is recommended in selected cases after myocardial infarction (MI) but not widely deployed in practice. This study assessed an innovative, cardiology pharmacist-led virtual service for determining eligibility for extended DAPT among patients completing 12 months of initial DAPT in primary care following MI. Within this model, potentially eligible individuals are reviewed virtually by a cardiology pharmacist for suitability for extended DAPT with reduced-dose ticagrelor [60 mg twice daily (BD)] for up to 3 years. Eligibility is guided by the PEGASUS-TIMI 54 trial criteria (aged ≥50 years and having ≥1 high-risk feature for further ischaemic events). This is balanced against potential ineligibility driven primarily by bleeding risk, assessed using PRECISE-DAPT score. The final recommendation is sent to primary care to action. The present work is a retrospective evaluation of patients referred to the service between July 2018 and December 2021. A total of 200 patients were included [n = 131 (65.5%) male; mean age: 69.4 ± 9.5 years]. Of these, 79 (39.5%) were recommended for extended DAPT based on the balance of risks for further ischaemic events vs. bleeding. Sixty-three patients on high-dose DAPT (ticagrelor 90 mg BD)-which is inappropriate beyond 12 months-were reassigned to reduced-dose DAPT or aspirin monotherapy. This virtual clinic played a key role in medicines optimisation, enabling appropriate patients to benefit from extended DAPT while offsetting bleeding risk. The model could be adapted locally for use elsewhere.

The four-item PRECISE-DAPT score identifies coronary artery bypass grafting patients with increased risk for post-discharge major bleeding.

Early identification of patients with increased bleeding risk increases the possibility to individualize antithrombotic treatment. We validated the PRECISE-DAPT score, originally developed to estimate bleeding risk in patients on dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), in coronary artery bypass grafting (CABG) patients. All patients who underwent first time, isolated CABG in Sweden 2009-2020 and survived until discharge were included. The four-item PRECISE-DAPT score, based on age, estimated glomerular filtration rate, preoperative haemoglobin concentration, and previous spontaneous bleeding, was calculated in patients discharged on DAPT (n=6838), or antiplatelet monotherapy (n=15406). High bleeding risk was defined as a score≥25 in accordance with previous studies and major bleeding as hospitalization due to bleeding. Associations were assessed by C-statistics and Cox regression models.Major bleeding occurred during the first postoperative year in 130 patients (1.9%) in the DAPT group, and in 197 patients (1.3%) in the monotherapy group. The score identified 32.9% of the patients in the DAPT group and 38.2% in monotherapy groups as having high bleeding risk. The area under the ROC-curve for the score was 0.67 (95%CI 0.62-0.72) for DAPT and 0.71 (0.67-0.74) for monotherapy. The hazard ratio for high bleeding risk vs. very low risk was 4.14 (2.07-8.26) for DAPT patients, and 4.95 (2.61-9.39) for monotherapy patients, both p<0.001. The PRECISE-DAPT identifies patients with increased risk for major bleeding after discharge following CABG with moderate accuracy. The accuracy is comparable to what previously has been reported for patients after PCI.

Predicting New-Onset Atrial Fibrillation in Patients with Coronary Artery Bypass Graft: the Precise-Dapt Score

&lt;b&gt;Aim:&lt;/b&gt;&amp;nbsp;Postoperative new-onset atrial fibrillation (POAF) after isolated coronary artery bypass graft surgery (CABG) is associated with adverse events. The Predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score is used to predict the bleeding risk after dual antiplatelet therapy and has been associated with arrhythmias in recent years. Therefore, the present study sought to investigate the association between the PRECISE-DAPT score and POAF after coronary artery bypass graft surgery.&lt;br /&gt; &lt;b&gt;Materials and Methods:&lt;/b&gt;&amp;nbsp;350 patients who underwent CABG were retrospectively screened. After exclusion criteria, 135 patients were included in the study. A total of 135 patients who underwent on-pump CABG were divided into two groups: patients with POAF and those without POAF. The PRECISE-DAPT score was calculated for each patient, and intergroup comparisons of the calculated scores were performed.&lt;br /&gt; &lt;b&gt;Results:&lt;/b&gt;&amp;nbsp;POAF was detected in 66 patients out of 135. Patients with POAF had longer hospital stays. PRECISE-DAPT score was higher in the patients with POAF compared to the patients without POAF (p&amp;lt;0.001). PRECISE-DAPT score was determined to be a predictor of POAF after CABG (odds ratio [OR]: 1.305; 95% confidence interval [CI]: 1.268–2.030; p&amp;lt;0.001).&amp;nbsp;The PRECISE-DAPT score for POAF risk had a sensitivity of 60% and a specificity of 79% at cut-off values of 14.5 and above.&lt;br /&gt; &lt;b&gt;Conclusion:&lt;/b&gt;&amp;nbsp;An increased PRECISE-DAPT score may be used as a predictive score for POAF that may develop during hospital stay after on-pump CABG.

Bleeding risk prediction after acute myocardial infarction-integrating cancer data: the updated PRECISE-DAPT cancer score.

This study assessed the impact of incorporating cancer as a predictor on performance of the PRECISE-DAPT score. A nationally linked cohort of ST-elevation myocardial infarction patients between 1 January 2005 and 31 March 2019 was derived from the UK Myocardial Ischaemia National Audit Project and the UK Hospital Episode Statistics Admitted Patient Care registries. The primary outcome was major bleeding at 1 year. A new modified score was generated by adding cancer as a binary variable to the PRECISE-DAPT score using a Cox regression model and compared its performance to the original PRECISE-DAPT score. A total of 216 709 ST-elevation myocardial infarction patients were included, of which 4569 had cancer. The original score showed moderate accuracy (C-statistic .60), and the modified score showed modestly higher discrimination (C-statistics .64; hazard ratio 1.03, 95% confidence interval 1.03-1.04) even in patients without cancer (C-statistics .63; hazard ratio 1.03, 95% confidence interval 1.03-1.04). The net reclassification index was .07. The bleeding rates of the modified score risk categories (high, moderate, low, and very low bleeding risk) were 6.3%, 3.8%, 2.9%, and 2.2%, respectively. According to the original score, 65.5% of cancer patients were classified as high bleeding risk (HBR) and 21.6% were low or very low bleeding risk. According to the modified score, 94.0% of cancer patients were HBR, 6.0% were moderate bleeding risk, and no cancer patient was classified as low or very low bleeding risk. Adding cancer to the PRECISE-DAPT score identifies the majority of patients with cancer as HBR and can improve its discrimination ability without undermining its performance in patients without cancer.

The PRECISE-DAPT Score as a Predictor of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

The PRECISE-DAPT Score as a Predictor of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Ischaemic and haemorrhagic risk distribution in real-life patients with acute coronary syndromes

Background Effective treatment of non-ST-segment elevation acute coronary syndromes (NSTEACS) requires careful assessment of both ischaemic and bleeding risks. We aimed to analyse risk distribution and evaluate antiplatelet prescription behaviours in real-life settings. Methods Data from 1100 NSTEACS patients in Buenos Aires, Argentina, from the Buenos Aires I Registry, with a 15-month follow-up, were analysed. In-hospital and 6-month GRACE scores, CRUSADE, and Precise DAPT scores were calculated. Results The mean age was 65.4 ± 11.5 years with a majority being male (77.2%). In-hospital mortality was 2.7%, primarily due to cardiovascular causes (1.8%). Bleeding events occurred in 20.9% of patients, with 4.9% classified as ≥ BARC 3. Predominance of low bleeding (71.3%) and ischaemic (55.8%) risks on admission was observed. At 6 months, the low-risk Precise category (70.9%) and GRACE (44.1%) categories prevailed. Linear correlation analysis showed a moderately positive correlation (r = 0.61, p < .05) between ischaemic–haemorrhagic risks. Regarding the prescription of antiplatelet agents, in the low ischaemic–haemorrhagic risk group, there was a predominance of aspirin + clopidogrel (41.2%) over other high-potency antiplatelet regimens (aspirin + ticagrelor or prasugrel). In the low ischaemic and high haemorrhagic risk group, aspirin and clopidogrel were also predominant (58%). Conclusions Our analysis underscores the significant relationship between ischaemic and haemorrhagic risks during NSTEACS hospitalisation. Despite the majority of patients falling into the low-intermediate risk category, the prescription of P2Y12 inhibitors in real-life settings does not consistently align with these risks.

Consecutive or selectively included high bleeding risk patients in the MASTER DAPT screening log and trial

AimsScreening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. Methods and resultsAll consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). ConclusionsThe HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.

PRECISE-DAPT, ARC-HBR, or Simplified Clinical Evaluation for the Prediction of Major Bleeding After Percutaneous Coronary Intervention in older Patients

Elderly patients have been remarkably under-represented in bleeding risk cohorts. Thus, the PRECISE-DAPT and ARC-HBR scores are not validated in older adults. Therefore, we sought to evaluate the PRECISE-DAPT and ARC-HBR scores in an exclusively elderly population and furthermore assess the prognostic value of a truly simplified clinical evaluation (SCE), consisting of only 3 binary clinical variables (hemoglobin <11g/dL, prior bleeding and anticipated use of anticoagulants). This is a retrospective analysis of the prospective single-center Elderly-HCD registry. Consecutive patients of ≥75 years of age that underwent percutaneous coronary intervention in the period of 2012-2019 were included. The primary endpoint was post discharge bleeding (PDB) at 12 months follow-up, defined according to the BARC 3/5 criteria. A total of 693 patients with a mean age of 81 (± 4.4) years were included in the study and 60 (6.8%) patients met the primary endpoint. The PRECISE-DAPT and ARC-HBR scores did not significantly predict PDB in Cox-regression models (HR: 1.65 (0.78-3.42) and 1.46 (0.72-4.24), respectively), whereas the SCE outperformed both scores (HR: 2.47 (1.34-4.49)). All 3 scores exhibited a moderate discriminatory potential as determined by ROC-curve analysis (AUCs 0.601, 0.621 and 0.616, respectively) with no significant differences when comparing either of them. The SCE showed an IDI of 0.25, p=0.02 (SCE vs ARC-HBR) and 0.24, p=0.01 (SCE vs PRECISE-DAPT); with NRI of 6.54%, p=0.37 and 7.12%, p=0.43, respectively. In conclusion, both the PRECISE-DAPT score and ARC-HBR criteria showed insufficient predictive value in older adults. A truly SCE, consisting of 3 easily accessible variables, not only provides equal discriminatory potential but also demonstrates superior predictive value as determined by cox-regression models. This makes it a highly appealing tool for risk stratification, pending its evaluation in larger prospective studies.

Prevention of Perioperative Bleeding in Patients With Chronic Limb-Threatening Ischemia

Materials and methods: At stage I, we retrospectively studied histories and outpatient medical records of 766 patients with chronic limb-threatening ischemia (from 2006 to 2020) to identify hemorrhagic complications and potential risk factors for their development. We analyzed the effectiveness of different scores for assessment of the bleeding risk. Based on the obtained data, measures to prevent hemorrhagic complications in this cohort of patients were improved. During stage II, 114 patients with 1 or several risk factors for major bleeding underwent surgery between 2021 and 2023. We used the proposed and improved preventive measures for all the patients. Follow-up periods were during the hospital stay and in 6 and 12 months.Results: At stage I, 44 (5.74%) patients were found to have hemorrhagic complications in the early postoperative period: retroperitoneal hematoma, bleeding from an operating wound, and pulsating hematoma (15.9%); gastrointestinal hemorrhage (31.8%); gross hematuria (13.7%), and hemorrhagic stroke (6.8%). The most significant risk factors for bleeding were endovascular intervention using brachial and femoral approaches (P = .000), hybrid intervention (P = .000), dual antiplatelet therapy (P = .014), surgery duration above 60 minutes (P = .001), triple antithrombotic therapy (P = .001), and significant vascular calcification (P = .023). The PRECISE-DAPT score has proven to be of prognostic value (P = .073; odds ratio, 2.88). At stage II, due to the proposed preventive measures, bleeding that required blood transfusion was found in 5 (4.38%) of 114 patients: of them, 1 (0.9%) patient had acute coronary syndrome. There were no major amputations, whereas 3 (2.63%) patients underwent minor amputation. In 6 and 12 months of the follow-up, the total frequency of major cardiovascular complications (cardiac death, myocardial infarction), major and minor amputation was 0.9% and 2.6%, 0% and 1.75%, and 0.9% and 2.6%, respectively.Conclusions: Surgical treatment of patients with chronic limb-threatening ischemia and risk factors for hemorrhagic complications who underwent surgery with the proposed preventive measures demonstrated high efficiency in reducing the number of hemorrhages and associated cardiac complications and low frequency of major and minor amputations in the long-term follow-up.

Impact of the completeness of revascularization and high bleeding risk status in acute coronary syndrome patients with multi-vessel disease: A retrospective analysis.

To investigate the long-term mortality of acute coronary syndrome (ACS) patients with multivessel disease according to the level of completeness of revascularization (CR) and high-bleeding risk (HBR) status. This retrospective study collected the data of ACS patients with multivessel disease who underwent percutaneous coronary intervention between May 2018 and February 2019. Complete to reasonable revascularization (CR) was defined by the residual Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery score (RSS) of 0 to ≤8. The HBR was defined by the PRECISE-DAPT score ≥25. The all-cause death at 36 months according to the CR and HBR status. A total of 209 patients with 743 lesions were included in the analysis. The median follow-up was 3.6 years. Patients with CR had lower event rates than ICR (4.5 vs. 11.5 per 100 patient-year, HR 0.39, 95% CI 0.22-0.70), p = 0.002). Similar observations were noted when compared between non-HBR and HBR (3.9 vs. 11.1 per 100 patient-year, HR 0.35, 95% CI 0.18-0.64, p < 0.001). Kaplan-Meier analysis revealed that all-cause death was highest among those in the ICR/HBR (40.5%) followed by ICR/non-HBR (28.6%), CR/non-HBR (28.3%) and the lowest among the CR/HBR group (7.1%), log-rank p = <0.001. No significant interaction was observed between the two factors regarding all-cause death (p = 0.10 for interaction). In ACS patients with MVD, the achievement of CR was associated with reducing mortality rates and consistency irrespective of the HBR status. (Trial Registration: TCTR20211222003).

Validation of the PRECISE-DAPT score in a population-based sample of patients undergoing percutaneous coronary intervention with stent implantation

Abstract Background Dual antiplatelet therapy (DAPT) after coronary stenting reduces the risk of recurrent ischemia but increases bleeding risk. The PRECISE-DAPT score was developed using data from clinical trials to identify individuals at high bleeding risk who may benefit from shorter DAPT duration. Although use of the PRECISE-DAPT score is recommended in clinical guidelines, its applicability to patients seen in routine clinical practice is uncertain. Purpose To assess the performance of the PRECISE-DAPT score in a population-based cohort of patients undergoing coronary stenting. Methods We calculated the PRECISE-DAPT score in patients enrolled in the Swedish register of cardiac care (SWEDEHEART) who underwent coronary stenting and received DAPT in an urban region in Sweden between January 1, 2013, and December 31, 2018. Patients were followed from day 30 after discharge after coronary stenting until a bleeding event (TIMI major/minor bleeding using ICD-codes for bleeding and data on changes in hemoglobin levels from healthcare registers), an ischemic event (myocardial infarction/ischemic stroke), discontinuation of DAPT, death, 12 months after stenting, or end of study period. We assessed the score’s discrimination and estimated rates of bleeding and ischemic events in groups of patients categorized using the score’s decision rule for "high bleeding risk" (score ≥25). We then compared bleeding rates in groups of patients categorized based on their score with those observed in the clinical trials used to derive the PRECISE-DAPT score. Results Of the 8,348 patients (mean (SD) age 67 (11) years; 27% women) included in the study, 2,001 (24%) were categorized as "high bleeding risk" (Figure 1). The PRECISE-DAPT score had a moderate discrimination (c-statistic 0.64, 95% CI, 0.56– 0.71) for bleeding. Patients with "high bleeding risk", compared to those not at "high bleeding risk", had a higher rate of bleeding (2.0 vs 0.9 events per 100 patient years; hazard ratio 2.17, 95% CI 1.29–3.65) and a higher rate of ischemic events (12.8 vs 9.0 events per 100 patient years; hazard ratio, 1.33, 95% CI 1.10–1.61). Patients with "high bleeding risk" in our study population had lower rates of bleeding as compared with those at "high bleeding risk" in the clinical trials used to derive the score. Rates of bleeding in other risk categories were largely similar to those in the clinical trials. (Figure 2). Conclusion In a population-based cohort from routine clinical practice in Sweden, the PRECISE-DAPT score identified patients with increased bleeding risk, although those patients also had an increased ischemic risk. Differences in bleeding rates among those categorized as "high bleeding risk" across patient populations may mean that the absolute risk differences in bleeding risk for short vs long DAPT duration demonstrated in the clinical trials used to derive the PRECISE-DAPT score may not be directly applicable to patients seen in routine clinical practice.

Pattern of dual antiplatelet use and 12-month outcomes stratified by bleeding and ischemic risk in acute coronary syndrome patients undergoing percutaneous coronary intervention

Abstract Background There is a need to understand real-world antiplatelet usage in different risk group patients to provide insights into personalised approach to acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). Purpose We aimed to evaluate patterns and outcomes of antiplatelet therapy use in ACS patients undergoing PCI according to their bleeding and ischemic risks. Methods We retrospectively analysed 3,577 consecutive ACS patients who underwent urgent or emergent PCI from 16 hospitals in between Jan 2016 to Dec 2020. Patients were stratified according to their (i) bleeding risk using PRECISE-DAPT score ≥25 as high (HBR) and &amp;lt;25 as low bleeding risk (LBR) and further by (ii) ischemic risk if any one of the following: diffuse multi-vessel disease, chronic kidney disease, ≥3 stents implanted or lesions treated, total stented length &amp;gt;60mm, chronic total occlusion and history of STEMI is present as high ischemic risk (HIR) or absent as low ischemic risk (LIR). Pattern of dual-antiplatelet (aspirin plus clopidogrel or ticagrelor) use and 12-month outcomes including major bleeding, recurrent MI and cardiovascular (CV) death were compared between HBR, LBR, HIR and LIR groups. Independent predictors of antiplatelet therapy use and clinical events were identified using multi-variate analysis. Results Of 3,577 patients, 25.6% (n=914) are HBR and 74.4% (n=2663) LBR. 86.5% (793/914) of HBR patients also had HIR. Overall usage of aspirin plus clopidogrel was 48.4% and ticagrelor 48.3%. Usage of ticagrelor was significantly higher in LBR (54.0%) compared to HBR (31.8%) patients (p&amp;lt;0.01) but not significantly different between HIR (30.4%) and LIR (41.3%) patients (p=NS). HBR was an independent predictor against ticagrelor use with odds ratio of 0.48 (95% confidence interval 0.38 to 0.60). Aspirin plus ticagrelor compared to aspirin plus clopidogrel was associated with significantly lower recurrent MI rates in both HBR (9.3% vs. 22.7%) and LBR (3.0% vs. 6.0%, both p&amp;lt;0.01) patients, higher bleeding risk in HBR (1.7% vs. 0.5%, p&amp;lt;0.01) but not in LBR (0.6% vs 0.9%, p=NS) and no significant differences in CV death rates in both HBR (3.4% vs. 5.3%) and LBR (1.0% vs. 0.9%, both p=NS) at 12-months. Conclusions In our cohort of ACS patients undergoing PCI, a quarter have HBR of which majority also have HIR. Patients’ bleeding risk was a stronger determinant of dual-antiplatelet therapy choice than ischemic risk. Aspirin and ticagrelor was associated with significantly lower recurrent MI rates irrespective of bleeding risk but high major bleeding rates in HBR but not LBR patients. Our results support personalised approach to dual-antiplatelet therapy use based on bleeding risk.

Parsimonious versus extensive score: can we simplify bleeding risk stratification after percutaneous coronary intervention without losing specificity?

Abstract Background/Introduction Prediction of bleeding risk in patients receiving dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has been repeatedly attempted and resulted in multiple risk models. To promote the adoption and use of risk stratification among clinicians, a consortium in the South East of the Netherlands, the "ZON-HR", has created a simple binary variant of the existing logistic models. This model includes commonly available factors which can be incorporated into the PCI report to generate stratification. In this "parsimonious" model, high bleeding risk (HBR) is stratified according to: history of intracranial haemorrhage, previous spontaneous bleeding, Hb &amp;lt; 11 g/dL, eGFR&amp;lt; 30. Purpose We aimed to perform an external validation of our model for bleeding risk and to demonstrate its discriminative value in comparison with the PRECISE DAPT score, an acknowledged risk score. Methods We performed a post hoc analysis of the GLOBAL LEADERS trial, a multicenter randomized trial, comparing ticagrelor monotherapy after one month of DAPT with standard DAPT after PCI. We stratified the patients for HBR according to the ZON-HR or a PRECISE-DAPT score ≥ 25. Bleeding events one year after PCI were compared in the entire population and in subgroups for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), Ticagrelor monotherapy and DAPT. Results Of the 15968 patients included in GLOBAL LEADERS, 1059 patients were excluded due to missing variables required for either model. Among the 14909 patients, 17% had HBR according to the PRECISE DAPT score, 4% according to ZON-HR and 3% according to both. Bleeding events occurred in 8.5% and 13% of HBR defined by PRECISE DAPT or ZON-HR respectively. Patients with HBR according to both models showed 13% bleedings as opposed to 5% in non-HBR. Table 1 presents the sensitivity and specificity. Regression analysis (figure 1) demonstrated that patients with HBR according to either model have significantly more bleedings. This was also significant in all subgroups except for ACS patients receiving standard DAPT when the ZON-HR model was used. Conclusion The ZON-HR model is more conservative compared to the PRECISE DAPT score as depicted by the sensitivity and specificity. This can be explained by the larger number of risk factors used in the PRECISE DAPT score that cumulatively contributes to the sensitivity as opposed to the binary ZON-HR model which is more specific. However, the survival curves and hazard ratios showed good predictive value of both models for bleeding risk in the overall population.Table 1.Figure 1.

The PRECISE-DAPT Score as a Predictor of Constrast Induced Nephropathy in Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Abstract Background In the ACS population, there are inherent difficulties in rapidly assessing CIN risk and instigating prophylactic measures. Moreover, these procedures often use increased contrast volume and the patients are more likely to be haemodynamically compromised, increasing their risk of renal impairment. This was a prospective observational cohort study conducted on 200 patients with acute coronary syndrome (ACS), and undergoing percutaneous coronary intervention (PCI); to evaluate the predictive value of PRECISE DAPT score for the development of contrast induced nephropathy (CIN). Aim of the Work To evaluate the predictive value of PRECISE DAPT score for the development of CIN in ACS patients undergoing PCI, and compare its predictive power to Mehran score, and to contrast volume/eGFR ratio. Patients and Methods A total of 200 patients who were diagnosed with ACS and undergoing PCI, were recruited from Ain Shams University Hospitals and enrolled in the study. The primary endpoint was the development of CIN after PCI. CIN defined as an increase of &amp;gt; 25%, and/or &amp;gt; 0.5 mg/dl in serum creatinine at 3-5 days after PCI when compared to baseline value. Results The median age of all patients was (55) years, the majority (74.5%) of patients were males; while (25.5%) were females; (6.5%) of patients had positive family history of CAD, (35.5%) had DM, (42%) had HTN, (18.5%) had Dyslipidemia, (10%) had history of anemia, and (10.5%) had previous indexed MI The median Contrast volume was 180 ml, the median duration of procedure was (50 min). LAD was the culprit artery in (65.5%) of cases, RCA in (21.5%) of cases, LCX in (13 %) of cases. (10.5%) of patients suffered post procedural CIN (n = 21), (3%) of patients had No reflow, (4.5%) had Major bleeding, (27.5%) had Minor bleeding, and (25%) had Acute Heart Failure. The average Mehran score was 5 (range from 1 to 28), the average PRECISE DAPT score was 18(range from 2 to 60), PRECISE-DAPT score showed excellent predictive value for CIN development (AUC = 0.91, 95% CI = 0.86 to 0.94, P &amp;lt; 0.0001). Best cut-off is score &amp;gt;27 (sensitivity = 85.7%, 95% CI = 63.7% - 97.0%, specificity = 87.7%, 95% CI = 82.0% - 92.1%; Jindex = 0.73). PRECISE-DAPT was superior to both Mehran score (ΔAUC = 0.12, P = 0.018) and CV/eGFR (ΔAUC = 0.19, 95%, P = 0.018). There was no statistically significant difference between Mehran and CV/eGFR. (ΔAUC = 0.07, P = 0.304). Conclusion PRECISE-DAPT score showed excellent predictive value in predicting the development of (CIN) in ACS population, AUC = 0.91 (P &amp;lt; 0.0001). Best cut-off is score &amp;gt; 27 (sensitivity = 85.7%, specificity = 87.7%), exceeding Mehran score and CV/eGFR ratio. Validation of Mehran score in ACS was achieved. It showed good predictive value, AUC = 0.79 (P &amp;lt; 0.0001). Best cut-off is Mehran score &amp;gt; 6 (sensitivity = 81.0%, specificity = 67.6%). There is no statistically significant difference between Mehran and CV/eGFR. Logistic regression analysis showed that; serum creatinine level pre-PCI, wall motion score index, LAD infarction, and PRECISE DAPT score; all had an independent effect on increasing the probability of CIN occurrence; with significant statistical difference (p &amp;lt; 0.05 for all). Abbreviations ACEI: Angiotensin-converting enzyme inhibitor; ACS: Acute coronary syndrome; AHA: American Heart Association; AKI: Acute kidney injury; AMI: Acute myocardial infarction; CI-AKI: Contrast-induced acute kidney injury; CIN: Contrast-induced nephropathy; CK-MB: Creatine kinase myocardial band; CM: Contrast media; CV/GFR: Contrast Volume/eGFR Ratio: Estimated Glomerular Filtration Rate.; DBP: Diastolic blood pressure; DM: Diabetes mellitus; EF: Ejection fraction; Gp: Glycoprotein; Hb: Hemoglobin; HOCM: High osmolar contrast media; IABP: Intra-aortic balloon; IQR: Inter-quartile range; LAD: Left anterior descending artery; LCX: Left circumflex coronary; MAP: Mean arterial blood pressure. MI: myocardial infarction.; MBG: Myocardial blush grade; MINOCA: Myocardial infarction in the absence of obstructive coronary artery disease; NSTEMI: Non-ST elevation myocardial infarction; PCI: Percutaneous coronary intervention; PLT: Platelets; RCA: Right coronary artery; ROC curve: Receiver operating characteristic analysis; SD: Standard deviation; STEMI: ST-segment elevation myocardial infarction; SYNTAX: Synergy Between PCI With Taxus and Cardiac Surgery; TIMI: Thrombolysis in Myocardial Infarction; TLC: Total leucocytic count