High Ischemic Risk Research Articles

Impact of intravascular ultrasound in acute myocardial infarction patients at high ischemic risk

Introduction and objectivesEvidence for the role of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in patients at high ischemic risk of acute myocardial infarction (AMI) is lacking. This study aimed to investigate the long-term clinical impact of IVUS-guided PCI in patients at high ischemic risk of AMI. MethodsAmong 13 104 patients with AMI enrolled in the Korea Acute Myocardial Infarction Registry-National Institutes of Health, we selected 8890 patients who underwent successful PCI with second-generation drug-eluting stent implantation and classified them into 2 groups based on whether or not they were at high ischemic risk or not, defined as any of the following: number of stents implanted ≥ 3, 3 vessels treated, ≥ 3 lesions treated, total stent length> 60mm, left main PCI, diabetes mellitus, and chronic kidney disease. The primary outcome was target lesion failure including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 3 years. ResultsIn 4070 AMI patients at high ischemic risk, IVUS-guided PCI (21.6%) was associated with a significantly lower risk of target lesion failure at 3 years (6.7% vs 12.0%; HR, 0.54; 95%CI, 0.41-0.72; P <.001) than angiography-guided PCI. The results were consistent after confounder adjustment, inversed probability weighting, and propensity score matching. ConclusionsIn patients at high ischemic risk of AMI who underwent PCI with second-generation drug-eluting stent implantation, use of IVUS guidance was associated with a significant reduction in 3-year target lesion failure.iCreaT study No. C110016.

Approaches to de-escalation of antiplatelet treatment in stabilized post-myocardial infarction patients with high ischemic risk

ABSTRACT Introduction In patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) with a potent P2Y12 inhibitor is normally recommended for 12 months. However, the greatest anti-ischemic benefit of DAPT occurs early, while most excess bleeding events occur during chronic treatment. De-escalation of DAPT is an emerging treatment strategy for ACS patients. Areas covered This review critically evaluates the evidence for de-escalation based on clinical judgment (i.e. unguided) or guided by either platelet function testing or CYP2C19 genotyping. Ongoing trials and research directions are also discussed. Expert opinion De-escalation of antiplatelet therapy represents a viable therapeutic alternative to standard DAPT for patients after an ACS, aimed at providing a good balance between the risks of thrombosis and bleeding. It is not clear if this approach is better with or without guidance by platelet function testing or genotyping. Also, the benefit versus short DAPT is uncertain. Current guidelines support the de-escalation of DAPT for selected patients who are unsuitable for potent platelet inhibition, a cohort of patients that was not specifically represented in landmark trials of de-escalation. More studies are needed to define the optimal candidates for this strategy.

Differential prognosis of patients candidates for standard, short or prolonged dual antiplatelet treatment discharged after an acute coronary syndrome

Abstract Background Current evidence supports the efficacy of prolonged dual antiplatelet treatment prolonged (DAPT) patients at high-ischemic risk and low bleeding risk. In contrast, several trials have demonstrated the efficacy and safety of short DAPT (1,3 o6 months) in high-bleeding risk (HBR) patients. Nonetheless, 12 months of DAPT is the most commonly strategy recommended in patients discharged after an ACS. Methods We evaluated patterns of DAPT candidates in all patients discharged in single center between 2009 and 2019 after an acute coronary syndrome (ACS). Patients categorized in 3 groups: 1) short-DAPT candidates if they met 1 major o 2 minor criteria for HBR, by the 2019 ARC-HBR criteria; 2) prolonged-DAPT candidates if were not HBR and had recurrent ACS, complex percutaneous coronary interventions or diabetes; 3) standard 12 months DAPT if were not include in the previous 2 groups. We evaluated all-cause and cardiovascular mortality, mayor bleeding (MB), and major cardiovascular events (MACE) after discharge. Results We assessed 3,155 patients discharged after an ACS, mean age was 68.4 (13.0), 25.9% were women, 32.5% had diabetes, 13.2% received complex percutaneous coronary interventions and 40.5% were categorized as HBR. After categorization, 1,277 (40.48%) were candidates for short DAPT, 1,203 (38.1%) for standard 12m DAPT and 675 (21.39%) for prolonged DAPT. After a median follow-up was 1032 days (interquartile range 555–1950), all-cause mortality was 15.8%, cardiovascular mortality 10.5%, 35.9% had a first MACE and 6.2% had at least one MB. As shown in figure 1, patients candidates for short or prolonged DAPT had significantly higher rates of all-cause and cardiovascular mortality as well as MACE. In contrast, higher rate of MB was only increased in patients candidates for short-DAPT (figure 2). Multivariate analysis demonstrated higher risk of MB (sHR: 1.60 95% CI 1.10–2.60; p=0.030) only in patients candidates for short-DAPT. In contrast, candidates for short-DAPT has higher risk of all-cause mortality (HR: 2.92 95% CI 1.95–4.37; p&amp;lt;0.01) and cardiovascular mortality (HR: 3.01 95% CI 1.78–5.32; p&amp;lt;0.01) and MACE (HR: 2.22, 95% CI 1.82–2.70; p&amp;lt;0.01). Similarly, patients candidates for prolonged DAPT had higher risk of all-cause mortality (HR: 1.72 95% CI 1.10–2.69; p=0.002), cardiovascular mortality (HR: 2.47 95% CI 1.39–4.40; p=0.017) and MACE (HR: 1.58 95% CI 1.28–1.95; p&amp;lt;0.001). Conclusions Almost two thirds of patients discharged after an ACS would be candidates for short or prolonged DAPT and these patients are at higher risk of MACE and mortality. Patients candidates for short-DAPT had higher risk of MB through the follow-up. These results might reinforce the need of individual assessment of most optimal DAPT duration in all patients discharged after an ACS. Funding Acknowledgement Type of funding sources: None.

TCT-18 Deescalation of Antiplatelet Therapy in Stabilized Acute Myocardial Infarction Patients With High Ischemic Risk: Post Hoc Analysis of the TALOS-AMI Trial

TCT-18 Deescalation of Antiplatelet Therapy in Stabilized Acute Myocardial Infarction Patients With High Ischemic Risk: Post Hoc Analysis of the TALOS-AMI Trial

Aspirin with Low-Dose Ticagrelor or with Low-Dose Rivaroxaban for Secondary Prevention: A Cost per Outcome Analysis.

Secondary prevention of cardiovascular events among patients with diagnosed cardiovascular disease and high ischemic risk poses a significant challenge in clinical practice. The combinations of aspirin with low-dose (LD) ticagrelor or LD rivaroxaban have shown superiority in preventing major adverse cardiovascular events (MACE) compared with aspirin treatment alone. The comparative value for money of these two regimens remains unexplored. We analyzed each regimen's annual cost needed to treat (CNT) by multiplying the annualized number needed to treat (aNNT) by the annual cost of each drug. The aNNTs were based on outcome data from PEGASUS TIMI-54 and COMPASS trials. Scenario analyses were performed to overcome variances in terms of population risk. Costs were calculated as 75% of US National Average Drug Acquisition Cost (NADAC), extracted in January 2022. The primary outcome was defined as CNT to prevent one MACE across the two regimens. Secondary value analysis was performed for myocardial infarction (MI), stroke, and cardiovascular death as separate outcomes. The aNNTs to prevent MACE with LD ticagrelor and with LD rivaroxaban were 229 [95% confidence interval (CI) 141-734] and 147 (95% CI 104-252), respectively. At an annual cost of US$3726 versus US$4533, the corresponding CNTs were US$853,254 (95% CI 525,366-2,734,884) with LD ticagrelor and US$666,351 (95% CI 471,432-1,142,316) with LD rivaroxaban. Combining aspirin with LD rivaroxaban provides better value for money than with LD ticagrelor for secondary prevention of MACE.

Thrombelastography Compared with Multiple Impedance Aggregometry to Assess High On-Clopidogrel Reactivity in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

Background: High on-clopidogrel platelet reactivity (HPR) following percutaneous coronary intervention (PCI) is associated with increased ischemic risk. It is unclear whether conventional definitions of HPR apply to patients with concomitant oral anticoagulation (OAC). This study aimed to compare the performance of multiple platelet aggregometry (MEA) and thrombelastography (TEG) to detect HPR in patients with atrial fibrillation (AF) and indication for an OAC. Methods: In this observational single-center cohort study, MEA and TEG were performed in patients with AF with an indication for OAC on day 1 to 3 after PCI. The primary outcome was HPR as assessed by MEA (ADP area under the curve ≥ 46 units [U]) or TEG (MAADP ≥ 47 mm), respectively. The secondary exploratory outcomes were a composite of all-cause death, myocardial infarction (MI) or stroke and bleeding, as defined by the International Society on Thrombosis and Hemostasis, at 6 months. Results: Platelet function of 39 patients was analyzed. The median age was 78 (interquartile range [IQR] was 72–82) years. 25 (64%) patients were male, and 19 (49%) presented with acute coronary syndrome. All patients received acetylsalicylic acid and clopidogrel prior to PCI. Median (IQR) ADP-induced aggregation, MAADP, TRAP-induced aggregation, and MAthrombin were 9 (6–15) U, 50 (43–60) mm, 54 (35–77) U and 65 (60–67) mm, respectively. The rate of HPR was significantly higher if assessed by TEG compared with MEA (25 [64%] vs. 1 [3%]; p < 0.001). Within 6 months, four (10%) deaths, one (3%) MI and nine (23%) bleeding events occurred. Conclusion: In patients with AF undergoing PCI, the rates of HPR detected by TEG were significantly higher compared with MEA. Conventional cut-off values for HPR as proposed by consensus documents may need to be re-evaluated for this population at high ischemic and bleeding risk. Further studies are needed to assess the association with outcomes.

A Tailored Antithrombotic Approach for Patients with Atrial Fibrillation Presenting with Acute Coronary Syndrome and/or Undergoing PCI: A Case Series.

The combination of oral anticoagulants (OAC) and dual antiplatelet therapy (DAPT) is the mainstay for the treatment of patients with atrial fibrillation (AF) presenting with acute coronary syndrome (ACS) and/or undergoing PCI. However, this treatment leads to a significant increase in risk of bleeding. In most cases, according to the most recent guidelines, triple antithrombotic therapy (TAT) consisting of OAC and DAPT, typically aspirin and clopidogrel, should be limited to one week after ACS and/or PCI (default strategy). On the other hand, in patients with a high ischemic risk (i.e., stent thrombosis) and without increased risk of bleeding, TAT should be continued for up to one month. Direct oral anticoagulants (DOAC) in triple or dual antithrombotic therapy (OAC and P2Y12 inhibitor) should be favored over vitamin K antagonists (VKA) because of their favorable risk/benefit profile. The choice of the duration of TAT (one week or one month) depends on a case-by-case evaluation of a whole series of hemorrhagic or ischemic risk factors for each patient. Likewise, the specific DOAC treatment should be selected according to the clinical characteristics of each patient. We propose a series of paradigmatic clinical cases to illustrate the decision-making work-up in clinical practice.

Prognostic Value of Metabolic Syndrome in Patients With Non-ST Elevated Myocardial Infarction Undergoing Percutaneous Coronary Intervention.

ObjectiveWe aim to investigate the prognostic effects of metabolic syndrome (MS) on patients with non-ST elevated myocardial infarction (NSTEMI) after percutaneous coronary intervention (PCI).MethodsPatients with NSTEMI undergoing PCI were consecutively collected. According to the presence or absence of MS, they were divided into two groups and followed up for 1 year. The endpoint was major adverse cardiovascular events (MACE), including all-cause death, unstable angina hospitalization, heart failure (HF) hospitalization, non-fatal recurrent myocardial infarction (MI), and target lesion revascularization. Also, six subgroups were made according to gender, age, left ventricular ejection fraction (LVEF), Global Registry of Acute Coronary Events (GRACE) score, hypersensitive troponin (hsTNT), and several diseased vessels. Cox proportional hazard model was adopted to analyze the effect of MS on MACE in all the patients and different subgroups.ResultsA total of 1,295 patients were included in the current analysis and 660 (50.97%) of them had MS. About 88 patients were lost to follow-up, and the overall average follow-up was 315 days. MS was an independent risk factor for MACE (HR 1.714, CI 1.265–2.322, p = 0.001), all-cause death, heart failure (HF) hospitalization, and non-fatal recurrent MI. In the MS component, BMI ≥28 kg/m2 was positively associated with MACE. Subgroup analysis indicated the prognostic value of MS was more striking for patients with the following: age of >60, LVEF of ≤40%, GRACE of >140, multivessel disease, or hsTNT of >0.1 ng/ml.ConclusionsThe MS was a robust adverse prognostic factor in patients diagnosed with NSTEMI, especially among those of older age and at higher ischemic risk. A BMI of ≥28 kg/m2 independently predicted the occurrence of MACE. Prognosis may be improved by controlling abdominal obesity.

Outcomes of Coronary Artery By-Pass Grafting Under Dual Antiplatelet Therapy in ST Elevated Myocardial Infarction.

Patients with recent myocardial infarction (MI) or percutaneous coronary interventions (PCI) have a higher ischemic risk in addition to perioperative bleeding risk when undergoing coronary artery bypass grafting (CABG). Data regarding preoperative dual antiplatelet therapy (DAPT) failed to create a clear recommendation. In the present study, we assessed the relationship between preoperative DAPT use and adverse outcomes, particularly in ST-elevation MI (STEMI) patients. We retrospectively analyzed 748 consecutive patients with STEMI who underwent subsequent CABG surgery. Patients were divided into 2 groups: those on DAPT up to the day before CABG and those discontinued DAPT >5days before CABG. Predictors of in-hospital mortality and major bleeding were analyzed by multivariate analysis. Preoperative DAPT was not associated with in-hospital mortality (Odds Ratio (OR):1.81; 95% Confidence Interval (CI): .89-3.68, P = .10) and major bleeding (OR: 1.15; 95% CI: .63-2.08, P = .65) after multivariate analysis. However, glycoprotein (Gp) 2b/3a inhibitors were independently associated with higher major bleeding rates. Age, shock, and EF (ejection fraction) <30% were associated with in-hospital mortality. Previous MI, Gp 2b/3a inhibitors, and EF <30% were predictors of major bleeding. In conclusion, there were no association between pre-CABG DAPT use and in-hospital mortality and major bleeding.

Safety and Efficacy of Contemporary Drug-Eluting Stents in Patients With ST-Segment Elevation Myocardial Infarction and a High Ischemic Risk.

BackgroundIn patients with ST-elevation myocardial infarction (STEMI) with a high risk of ischemic events, the safety and efficacy of drug-eluting stent (DES) are unclear.MethodsBased on the nationwide, multicenter, prospective registry, we selected 1,592 patients who underwent primary percutaneous coronary intervention (PCI) with everolimus-(EES) and zotarolimus-eluting stent (ZES) for STEMI with a high risk of an ischemic event. The occurrence of target lesion failure (TLF) for 3 years, defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR), was evaluated.ResultsThe prevalence of high ischemic risk features was observed in 43.4% (2,744/6,325) of overall patients with STEMI. Among them, a total of 1,078 and 514 patients were treated with EES and ZES, respectively. At 3 years, the risk of TLF was not significantly different between the two groups (p = 0.93). In addition, the incidence of cardiac death, TV-MI, ID-TLR, and definite/probable stent thrombosis (ST) were also not different between the two groups. Moreover, elderly patients (age > 75 years) and PCI for the left main disease were identified as independent predictors of TLF.ConclusionImplantation of EES or ZES provided comparable clinical outcomes in STEMI patients and high ischemic risks.

C55 DAPT IN ELDERLY PATIENTS WITH STEMI OR VERY HIGH RISK NSTEMI: A RETROSPECTIVE STUDY COMPARING TICAGRELOR VS CLOPIDOGREL

Abstract Background Elderly patients with acute coronary syndrome represent a growing population. The major problem in this population is the balancing of ischemic and bleeding risk. There are poor data from randomized clinical trials on the treatment of acute coronary syndrome in this population. We aim to analyze the best therapeutic strategy in this population. Methods We performed retrospective study at the Cardiology Department, San Carlo Hospital, Potenza.181 patients with an age ≥ 75 years with STEMI or very high risk NSTEMI were selected from 1 January 2018 to 31 December 2019. Exclusion criteria were anticoagulants therapy, end stage renal disease, cancer in progress and cardiogenic shock at clinical presentation. 43 patients had starter dual antiplatelet therapy with acetylsalicylic acid and clopidogrel and 76 with acetylsalicylic acid and ticagrelor. We aimed to evaluate at 12 months follow up the composite endpoints of ischemic stroke and reinfarction, stroke, bleeding events and death. Results At the 12–month follow–up, 15 patients died (all–cause mortality of 12.6%). There were 5 strokes (4% of population), 3 in the Clopidogrel group (6.9%) and 2 in the Ticagrelor group (2.6%) without a statistically significant difference (p 0,7463). The composite endpoint of ischemic events, stroke and reinfarction occurred in 12 patients, 6 in each group, (13.9% in the Clopidogrel group and 7.9% in the Ticagrelor group) but this difference, although indicative, is not statistically significant (p 0.2956). The only statistically significant difference occurred for BARC 2, 3 or 5 bleeding events with a significantly less events in the Clopidogrel group (4.6%) than in Ticagrelor group (18.4%) (p 0, 0345). Conclusion The elderly patient with STEMI or high–risk NSTEMI represent a group of patients with high ischemic risk but also high bleeding risk. The use of clopidogrel in combination with acetylsalicylic acid should be considered to reduce bleeding events without increasing ischemic events.

Dual antiplatelet therapy duration after percutaneous coronary intervention using drug eluting stents in high bleeding risk patients: A systematic review and meta-analysis

BackgroundOptimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. MethodsWe searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. ResultsSix randomized trials and 3 propensity-matched studies (n = 16,848) were included in the primary analysis. Compared with L-DAPT (n = 8,422), major bleeding was lower with S-DAPT (n = 8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the 2 groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. ConclusionsAmong HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT. More research is needed to (1) evaluate risks of late ST after 1 to 3 months DAPT among patients with high ischemic and bleeding risks, (2) defining the SAPT of choice after 1 to 3 months DAPT.

Evaluation of the Use of Dual Antiplatelet Therapy beyond the First Year after Acute Coronary Syndrome.

Clinical practice guidelines recommend extending dual antiplatelet therapy (DAPT) beyond 1 year after acute coronary syndrome (ACS) in patients with high ischemic risk and without high bleeding risk. The aim of this study was to identify variables associated with DAPT prolongation in a cohort of 1967 consecutive patients discharged after ACS without thrombotic or hemorrhagic events during the following year. The sample was stratified according to whether DAPT was extended beyond 1 year, and the factors associated with this strategy were analyzed. In 32.2% of the patients, DAPT was extended beyond 1 year. Overall, 770 patients (39.1%) were considered candidates for extended treatment based on PEGASUS criteria and absence of high bleeding risk, and DAPT was extended in 34.4% of them. The presence of a PEGASUS criterion was associated with extended DAPT in the univariate analysis, but not history of bleeding or a high bleeding risk. In the multivariate analysis, a history of percutaneous coronary intervention (odds ratio (OR) = 1.8, 95% confidence interval (CI) 1.4–2.4), stent thrombosis (OR = 3.8, 95% CI 1.7–8.9), coronary artery disease complexity (OR = 1.3, 95% CI 1.1–1.5), reinfarction (OR = 4.1, 95% CI 1.6–10.4), and clopidogrel use (OR = 1.3, 95% CI 1.1–1.6) were significantly associated with extended use. DAPT was extended in 32.2% of patients who survived ACS without thrombotic or hemorrhagic events. This percentage was 34.4% when the candidates were analyzed according to clinical guidelines. Neither the PEGASUS criteria nor the bleeding risk was independently associated with this strategy.

The WOEST2registry : Aprospective registry on antithrombotic therapy in atrial fibrillation patients undergoing percutaneous coronary intervention.

BackgroundPatients on oral anticoagulants (OACs) undergoing percutaneous coronary intervention (PCI) also require aspirin and a P2Y12 inhibitor (triple therapy). However, triple therapy increases bleeding. The use of non-vitamin K antagonist oral anticoagulants (NOACs) and stronger P2Y12 inhibitors has increased. The aim of our study was to gain insight into antithrombotic management over time.MethodsA prospective cohort study of patients on OACs for atrial fibrillation or a mechanical heart valve undergoing PCI was performed. Thrombotic outcomes were myocardial infarction, stroke, target-vessel revascularisation and all-cause mortality. Bleeding outcome was any bleeding. We report the 30-day outcome.ResultsThe mean age of the 758 patients was 73.5 ± 8.2 years. The CHA2DS2-VASc score was ≥ 3 in 82% and the HAS-BLED score ≥ 3 in 44%. At discharge, 47% were on vitamin K antagonists (VKAs), 52% on NOACs, 43% on triple therapy and 54% on dual therapy. Treatment with a NOAC plus clopidogrel increased from 14% in 2014 to 67% in 2019. The rate of thrombotic (4.5% vs 2.0%, p = 0.06) and bleeding (17% vs. 14%, p = 0.42) events was not significantly different in patients on VKAs versus NOACs. Also, the rate of thrombotic (2.9% vs 3.4%, p = 0.83) and bleeding (18% vs 14%, p = 0.26) events did not differ significantly between patients on triple versus dual therapy.ConclusionsPatients on combined oral anticoagulation and antiplatelet therapy undergoing PCI are elderly and have both a high bleeding and ischaemic risk. Over time, a NOAC plus clopidogrel became the preferred treatment. The rate of thrombotic and bleeding events was not significantly different between patients on triple or dual therapy or between those on VKAs versus NOACs.Supplementary InformationThe online version of this article (10.1007/s12471-022-01664-0) contains supplementary material, which is available to authorized users.

Aspirin vs. Clopidogrel as a Chronic maintenance monotherapy after PCI in patients with high ischemic risk and high bleeding risk: Subgroup analysis of the HOST-EXAM trial

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf on behalf of the HOST-EXAM investigators Background The HOST-EXAM randomized clinical trial recently performed a comparison of clopidogrel monotherapy vs. aspirin monotherapy in patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention (PCI). This study randomized 5,438 patients who maintained dual antiplatelet therapy without clinical events for 6–18 months after PCI with drug-eluting stents (DES) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. During the 24-month follow-up, the primary outcome (a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater) rate was significantly lower in the clopidogrel group (hazard ratio [HR] 0.73 [95% CI 0.59–0.90]; p = 0.0035). However, it is uncertain whether the beneficial effect of clopidogrel will be consistent in patients with high ischemic risk or those with high bleeding risk. Methods This is a post-hoc analysis of the HOST-EXAM trial. A high ischemic risk was defined as those who had at least 1 of the following procedural features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length &amp;gt;60 mm, or left main PCI. Patients with high bleeding risk were defined according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. The co-primary outcome were thrombotic endpoints (a composite of cardiac death, non-fatal myocardial infarction, ischemic stroke, readmission due to acute coronary syndrome, and definite or probable stent thrombosis) and bleeding endpoints (BARC type ≥2 bleeding events) at 24-month follow-up. Results Among the total population, 22.1% had high ischemic risk and 21.4% had high bleeding risk. Complex PCI was not associated with a higher risk of thrombotic endpoints, nor bleeding endpoints. For patients with a high bleeding risk, these patients had a higher risk of both thrombotic endpoints (HR 1.545, 95% CI 0.141-2.092, p = 0.005) and bleeding endpoints (HR 3.418, 95% CI 2.413-4.840, p &amp;lt; 0.001). The primary results focusing on the interaction between high ischemic risk, high bleeding and the antiplatelet regimen will be presented. Conclusion The current post-hoc analysis of the HOST-EXAM trial will evaluate the efficacy of clopidogrel monotherapy vs. aspirin monotherapy during the chronic maintenance period after PCI, in patients with high ischemic risk or those with high bleeding risk.

Risk scores in predicting adverse events after an acute coronary syndrome

Abstract Funding Acknowledgements Type of funding sources: None. Introduction ST-segment elevation myocardial infarction (STEMI) is a serious event that usually occur in patients with cardiovascular risk factors and is associated with great morbidity and mortality. PARIS ischemic risk score and TIMI score were validated to evaluate ischemic risk in STEMI patients who underwent percutaneous coronary intervention (PCI) and to estimate mortality, respectively. Despite these specific purposes, the usefulness of these scores in predicting adverse cardiovascular events (ACE) is unknown. Objectives To assess the prognostic value of PARIS and TIMI scores for cardiovascular events, coronary ischemic events and mortality in patients after STEMI. Methods Retrospective single center cohort study enrolled 103 patients with STEMI diagnosis between 2018 and 2019, during a mean follow-up period 30.30 ± 6.46 months and patients were included regardless of the reperfusion strategy. Primary endpoint (PE) was a composite of acute coronary events (ACE), admissions to the emergency department by heart failure (HF) decompensation or chronic coronary syndrome and HF hospitalization. Secondary endpoint (SE) was ACE. Cardiovascular and non-cardiovascular death was determined. PARIS ischemic risk score was calculated and patients were stratified into low (0-2), intermediate (3-4) or high (≥ 5) ischemic risk categories. TIMI score was also assessed. Results Out of 103 patients with STEMI diagnosis, the median age was 58.15 ± 12.6 years and 85,4% were male. Fifty-seven patients (55.3%) had hypertension, 45 (43.7%) dyslipidemia, 18 (17.5%) diabetes, 17 (15.5%) were obese and seventy-eight patients (75.7%) had history of smoking. Twenty (19.4%) patients had a previous acute coronary syndrome and 15 underwent PCI. Twenty-five (24.3%) patients were included in low PARIS ischemic risk category, 53 (51.5%) in intermediate risk and 20 (19.4%) in high risk category. PE occurred in 16 patient (15.5%) and SE in 7 patients (6.8%). Eight patients died during the follow-up period (7.8%), 4 of cardiovascular causes (50%), 3 of non-cardiovascular causes (37.5%) and 1 of unknown cause. PARIS ischemic risk score showed prognostic value for PE, with an area under the curve (AUC) of 0.65, 95% confidence interval (CI) 0.506-0.806 and p-value 0.039. PARIS score also had predictive value for SE (AUC 0.816, 95% CI 0.604-1.000; p 0.004) as well as TIMI score (AUC 0.738, 95% CI 0.560 – 0.917; p 0.032). Both scores showed a good prognostic value in evaluating all-cause mortality, with a slightly better predictive value for TIMI score (AUC 0.91, 95% CI 0.802 – 1.00) when compared to PARIS score (AUC 0.84, 95% CI 0.685 – 0.987). Conclusion This study revealed that PARIS and TIMI scores have a good discriminatory power to predict prognosis in STEMI patients. According to our study results, these scores could be an interesting tool to determine the likelihood of fatal and non-fatal outcomes, including ACS.

Thrombotic vs. Bleeding Events of Interruption of Dual Antiplatelet Therapy within 12 Months among Patients with Stent-Driven High Ischemic Risk Definition following PCI.

Background There is a paucity of real-world data regarding the clinical impact of dual antiplatelet therapy (DAPT) interruption (temporary or permanent) among patients at high ischemic risk. The aim of this study was to assess the risk of cardiovascular events after interruption of DAPT in high-risk PCI population. Methods This study used data from the Fuwai PCI registry, a large, prospective cohort of consecutive patients who underwent PCI. We assessed 3,931 patients with at least 1 high ischemic risk criteria of stent-related recurrent ischemic events proposed in the 2017 ESC guidelines for focused update on DAPT who were free of major cardiac events in the first 12 months. The primary ischemic endpoint was 30-month major adverse cardiac and cerebrovascular events, and the key safety endpoints were BARC class 2, 3, or 5 bleeding and net adverse clinical events. Results DAPT interruption within 12 months occurred in 1,122 patients (28.5%), most of which were due to bleeding events or patients' noncompliance to treatment. A multivariate Cox regression model, propensity score (PS) matching, and inverse probability of treatment weighting (IPTW) based on the propensity score demonstrated that DAPT interruption significantly increased the risk of primary ischemic endpoint compared with prolonged DAPT (3.9% vs. 2.2%; Cox-adjusted hazard ratio (HR): 1.840; 95% confidence interval (CI): 1.247 to 2.716; PS matching-HR: 2.049 [1.236–3.399]; IPTW-adjusted HR: 1.843 [1.250–2.717]). This difference was driven mainly by all-cause death (1.8% vs. 0.7%) and MI (1.3% vs. 0.5%). Furthermore, the rate of net adverse clinical events (4.9% vs. 3.2%; Cox-adjusted HR: 1.581 [1.128–2.216]; PS matching-HR: 1.639 [1.075–2.499]; IPTW-adjusted HR: 1.554 [1.110–2.177]) was also higher in patients with DAPT interruption (≤12 months), whereas no significant differences between groups were observed in terms of BARC 2, 3, or 5 bleeding. These findings were consistent across various stent-driven high-ischemic risk subsets with respect to the primary ischemic endpoints, with a greater magnitude of harm among patients with diffuse multivessel diabetic coronary artery disease. Conclusions In patients undergoing high-risk PCI, interruption of DAPT in the first 12 months occurred infrequently and was associated with a significantly higher adjusted risk of major adverse cardiovascular events and net adverse clinical events. 2017 ESC stent-driven high ischemic risk criteria may help clinicians to discriminate patient selection in the use of long-term DAPT when the ischemic risk certainly overcomes the bleeding one.

A Novel Multiple Risk Score Model for Prediction of Long-Term Ischemic Risk in Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: Insights From the I-LOVE-IT 2 Trial.

Backgrounds: A plug-and-play standardized algorithm to identify the ischemic risk in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) could play a valuable step to help a wide spectrum of clinic workers. This study intended to investigate the ability to use the accumulation of multiple clinical routine risk scores to predict long-term ischemic events in patients with CAD undergoing PCI.Methods: This was a secondary analysis of the I-LOVE-IT 2 (Evaluate Safety and Effectiveness of the Tivoli drug-eluting stent (DES) and the Firebird DES for Treatment of Coronary Revascularization) trial, which was a prospective, multicenter, and randomized study. The Global Registry for Acute Coronary Events (GRACE), baseline Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX), residual SYNTAX, and age, creatinine, and ejection fraction (ACEF) score were calculated in all patients. Risk stratification was based on the number of these four scores that met the established thresholds for the ischemic risk. The primary end point was ischemic events at 48 months, defined as the composite of cardiac death, nonfatal myocardial infarction, stroke, or definite/probable stent thrombosis (ST).Results: The 48-month ischemic events had a significant trend for higher event rates (from 6.61 to 16.93%) with an incremental number of risk scores presenting the higher ischemic risk from 0 to ≥3 (p trend < 0.001). In addition, the categories were associated with increased risk for all components of ischemic events, including cardiac death (from 1.36 to 3.15%), myocardial infarction (MI) (from 3.31 to 9.84%), stroke (3.31 to 6.10%), definite/probable ST (from 0.58 to 1.97%), and all-cause mortality (from 2.14 to 6.30%) (all p trend < 0.05). The net reclassification index after combined with four risk scores was 12.5% (5.3–20.0%), 9.4% (2.0–16.8%), 12.1% (4.5–19.7%), and 10.7% (3.3–18.1%), which offered statistically significant improvement in the performance, compared with SYNTAX, residual SYNTAX, ACEF, and GRACE score, respectively.Conclusion: The novel multiple risk score model was significantly associated with the risk of long-term ischemic events in these patients with an increment of scores. A meaningful improvement to predict adverse outcomes when multiple risk scores were applied to risk stratification.

Individualizing Dual Antiplatelet Therapy (DAPT) Duration Based on Bleeding Risk, Ischemic Risk, or Both: An Analysis From the DAPT Study

BackgroundGuidelines recommend individualization of dual antiplatelet therapy (DAPT) duration. Whether to guide decisions based on bleeding risk, ischemic risk or a combination is not known. AimsTo compare a bleeding prediction model, an ischemic prediction model, and the DAPT score in guiding DAPT duration. Methods11,648 patients in the DAPT Study were categorized into higher and lower risk using a bleeding model, an ischemic model, and the DAPT score. Effect of 30 vs. 12 months of DAPT on bleeding events, ischemic events, and the combination (net-adverse clinical events [NACE]) was assessed. ResultsAmong patients stratified with the bleeding model, 30 vs. 12 months of DAPT resulted in similar ischemic and bleeding event rates. With the ischemic model, however, higher risk patients had a greater reduction in ischemic events with extended duration of DAPT (difference in risk differences [DRD]: −2.6%, 95% CI: −3.9 to −1.3%; p < 0.01), and a smaller increase in bleeding (DRD: −1.0%, 95% CI: −2.1–0.0%; p = 0.04). Similarly, high DAPT score patients had a greater reduction in ischemic events with extended DAPT duration (DRD: −2.4%, 95%: CI: −3.6 to −1.1%; p < 0.01) and a smaller increase in bleeding (DRD: −1.2%, 95%: CI: −2.2–0.0%; p = 0.02). Although NACE was similar for bleeding risk groups, NACE was significantly reduced with extended DAPT in the higher ischemic risk and high DAPT score groups. ConclusionsIn this low-bleeding risk population, stratifying patients based on predicted ischemic risk and the DAPT score best discerned benefit versus harm of extended DAPT duration on ischemic events, bleeding events, and NACE. Condensed abstractDuration of dual antiplatelet therapy (DAPT) should be guided by an individualized risk assessment. Bleeding risk tools have emerged to identify patients at high bleeding risk for whom truncated DAPT therapy may be safest. In a lower bleeding risk population, however, whether DAPT duration should be guided by bleeding risk, ischemic risk, or a combination is unknown.In this analysis, implementation of a score based on ischemic risk prediction and the DAPT score (a combination of ischemic and bleeding risk) best predicted ischemic events, bleeding events, and net-adverse clinical events (NACE).

The relationship between symptom onset-to-needle time and ischemic outcomes in patients with acute myocardial infarction treated with primary PCI: Observations from Prague-18 Study

ObjectivesBased on previous studies with clopidogrel, the time between acute myocardial infarction (AMI) symptoms onset and primary percutaneous coronary intervention (PCI) was proven as important prognostic factor. Our aim was to assess the relationship between symptoms onset to needle time (SNT) and procedural results and the occurrence of ischemic endpoints in primary angioplasty patients treated with potent P2Y12 inhibitors. MethodsA total of 1,131 out of 1,230 patients randomized to the Prague-18 study (prasugrel vs. ticagrelor in primary PCI) were divided into a high and a low-risk group. The effect of defined SNT on patients' ischemic endpoints and prognosis by their risk status at admission was tested. ResultsThe median SNT was 3.2 hours. Longer SNTs resulted in a more frequent incidence of TIMI flow <3 post PCI (p=0.015). There were significant differences in the occurrence of the combined ischemic endpoint among the compared SNT groups at 30 days (p=0.032), and 1 year (p=0.011), with the highest incidence in the ≤1 h SNT group of patients. "Latecomers" (SNT>4 hs) in the high-risk group experienced more reinfarction within 1 year [OR (95% CI) 3.23 (1.09–9.62) p=0.035]; no difference was found in the low-risk group. ConclusionsIn the era of intense antithrombotic medication, stratification of MI patients undergoing primary angioplasty, based on initial ischemic risk assessment affected prognosis more than symptom onset to needle time. Longer time delay was significantly related to increased incidence of ischemic events and all-cause mortality only in patients with high ischemic risk.