Acute Transient Contrast-Induced Neurologic Deficit as a Complication of Percutaneous Coronary Intervention.

Acute transient contrast-induced neurologic deficit is an uncommon condition triggered by the administration of intra-arterial contrast during angiography. It can present with encephalopathy, cortical blindness, seizures, or focal deficits. This report describes a patient who presented with severe neurologic deficits after percutaneous coronary intervention, with complete symptom resolution within 72 hours.

Ventricular Arrhythmias After Primary Percutaneous Coronary Intervention for STEMI.

Importance: Currently, mortality risk for patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) with an uncomplicated postprocedure course is low. Less is known regarding the risk of in-hospital ventricular tachycardia (VT) and ventricular fibrillation (VF). Objective: To evaluate the risk of late VT and VF after primary PCI for STEMI. Design, Setting, and Participants: This cohort study included adults aged 18 years or older with STEMI treated with primary PCI between January 1, 2015, and December 31, 2018, identified in the US National Cardiovascular Data Registry Chest Pain-MI Registry. Data were analyzed from April to December 2020. Main Outcomes and Measures: Multivariable logistic regression was used to evaluate the risk of late VT (≥7 beat run of VT during STEMI hospitalization ≥1 day after PCI) or VF (any episode of VF≥1 day after PCI) associated with cardiac arrest and associations between late VT or VF and in-hospital mortality in the overall cohort and a cohort with uncomplicated STEMI without prior myocardial infarction or heart failure, systolic blood pressure less than 90 mm Hg, cardiogenic shock, cardiac arrest, reinfarction, or left ventricular ejection fraction (LVEF) less than 40%. Results: A total of 174 126 eligible patients with STEMI were treated with primary PCI at 814 sites in the study; 15 460 (8.9%) had VT or VF after primary PCI, and 4156 (2.4%) had late VT or VF. Among the eligible patients, 99 905 (57.4%) at 807 sites had uncomplicated STEMI. The median age for patients with late VT or VF overall was 63 years (IQR, 55-73 years), and 75.5% were men; the median age for patients with late VT or VF with uncomplicated STEMI was 60 years (IQR, 53-69 years), and 77.7% were men. The median length of stay was 3 days (IQR, 2-7 days) for the overall cohort with late VT or VF and 3 days (IQR, 2-4 days) for the cohort with uncomplicated STEMI with late VT or VF. The risk of late VT or VF was 2.4% (overall) and 1.7% (uncomplicated STEMI). Late VT or VF with cardiac arrest occurred in 674 patients overall (0.4%) and in 117 with uncomplicated STEMI (0.1%). LVEF was the most significant factor associated with late VT or VF with cardiac arrest (adjusted odds ratio [AOR] for every 5-unit decrease ≤40%: 1.67; 95% CI, 1.54-1.85). Late VT or VF events were associated with increased odds of in-hospital mortality in the overall cohort (AOR, 6.40; 95% CI, 5.63-7.29) and the cohort with uncomplicated STEMI (AOR, 8.74; 95% CI, 6.53-11.70). Conclusions and Relevance: In this study, a small proportion of patients with STEMI treated with primary PCI had late VT or VF. However, late VT or VF with cardiac arrest was rare, particularly in the cohort with uncomplicated STEMI. This information may be useful when determining the optimal timing for hospital discharge after STEMI.

Controlled antegrade and retrograde subintimal tracking (CART) for recanalisation of chronic total occlusions.

BACKGROUND: Controlled antegrade and retrograde subintimal tracking (CART) is rarely performed in contemporary chronic total occlusion (CTO) percutaneous coronary intervention (PCI). AIMS: We aimed to analyse the indications, procedural characteristics, and outcomes of CART at a high-volume CTO programme. METHODS: We included all patients undergoing a retrograde CTO PCI in which CART was performed at our institution between January 2019 and November 2023. The primary endpoint was technical success. RESULTS: Of 1,582 CTO PCI, the retrograde approach was performed in 603 procedures (38.1%), and CART was used in 45 cases (7.5%). The mean age was 69.1±10.3 years, 93.3% were male, and prior coronary artery bypass graft surgery was present in 68.9%. The most common target CTO vessel was the right coronary artery (48.9%). Anatomical complexity was high (Multicentre CTO Registry of Japan [J-CTO] score of 3.6±0.9). The most common collateral used for CART was a saphenous vein graft (62.2%). Advanced calcium modification was required in 15.6% of cases. CART was successful in 73.3%. Technical and procedural success was 82.2%. Coronary perforation was diagnosed in 4 subjects (8.9%), but only 1 patient (2.2%) suffered tamponade and required pericardiocentesis. No other in-hospital major adverse cardiac events were diagnosed. CONCLUSIONS: CART is a useful technique in selected, very complex CTOs tackled with the retrograde approach. Success rates were high, while complication rates were low, considering the high anatomical complexity and baseline patient risk.

Quantitative flow ratio versus fractional flow reserve for Heart Team decision-making in multivessel disease: the randomised, multicentre DECISION QFR trial.

BACKGROUND: Vessel-level physiological data derived from pressure wire measurements are one of the important determinant factors in the optimal revascularisation strategy for patients with multivessel disease (MVD). However, these may result in complications and a prolonged procedure time. AIMS: The feasibility of using the quantitative flow ratio (QFR), an angiography-derived fractional flow reserve (FFR), in Heart Team discussions to determine the optimal revascularisation strategy for patients with MVD was investigated. METHODS: Two Heart Teams were randomly assigned either QFR- or FFR-based data of the included patients. They then discussed the optimal revascularisation mode (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) for each patient and made treatment recommendations. The primary endpoint of the trial was the level of agreement between the treatment recommendations of both teams as assessed using Cohen's kappa. RESULTS: The trial included 248 patients with MVD from 10 study sites. Cohen's kappa in the recommended revascularisation modes between the QFR and FFR approaches was 0.73 [95% confidence interval {CI} : 0.62-0.83]. As for the revascularisation planning, agreements in the target vessels for PCI and CABG were substantial for both revascularisation modes (Cohen's kappa=0.72 [95% CI: 0.66-0.78] and 0.72 [95% CI: 0.66-0.78], respectively). The team assigned to the QFR approach provided consistent recommended revascularisation modes even after being made aware of the FFR data (Cohen's kappa=0.95 [95% CI:0.90-1.00]). CONCLUSIONS: QFR provided feasible physiological data in Heart Team discussions to determine the optimal revascularisation strategy for MVD. The QFR and FFR approaches agreed substantially in terms of treatment recommendations.

Impact of previous percutaneous coronary intervention on angiographic and clinical outcomes in patients with ST-segment elevation myocardial infarction.

BACKGROUND: The prognosis of patients with ST-segment elevation myocardial infarction (STEMI) and previous percutaneous coronary intervention (PCI) is uncertain. OBJECTIVE: To evaluate if previous PCI in patients with STEMI increases the risk of major cardiovascular events, and if final epicardial blood flow differs according to the reperfusion strategy. MATERIAL AND METHODS: Observational, longitudinal, comparative sub-study of the PHASE-MX trial that included patients with STEMI and reperfusion within 12 hours of symptom onset, who were classified according to their history of PCI. The occurrence of the composite primary endpoint (cardiovascular death, re-infarction, congestive heart failure and cardiogenic shock) within 30 days was evaluated using Kaplan-Meier estimates, log-rank test and Cox proportional hazards model. Epicardial blood flow was assessed using the TIMI grading system after reperfusion. RESULTS: A total of 935 patients were included; 85.6% were males and 6.9% had a history of PCI; 53% underwent pharmacoinvasive therapy, and 47%, primary PCI. The incidence of the composite primary endpoint at 30 days in patients with a history of PCI was 9.8% vs 13.3% in those with no previous PCI (p = 0.06). Among the patients with previous PCI, 87.1% reached a final TIMI grade 3 flow after primary PCI vs. 75% in the group with pharmacoinvasive strategy (p = 0.235). CONCLUSIONS: A history of PCI does not increase the risk of major cardiovascular events at 30 days; however, it impacted negatively on the final angiographic blood flow of patients that received pharmacoinvasive therapy (compared to primary PCI).

ANTECEDENTES: El pronóstico de los pacientes con infarto agudo de miocardio con elevación del segmento ST (IAMCEST) y antecedente de intervención coronaria percutánea (ICP) es incierto. Objetivos: Evaluar si la ICP previa en pacientes con IAMCEST incrementa el riesgo de eventos cardiovasculares mayores y si el flujo final epicárdico varía según la estrategia de reperfusión. MATERIAL Y MÉTODOS: Subestudio de PHASE-MX, observacional, longitudinal y comparativo, de pacientes con IAMCEST reperfundidos en menos de 12 horas de iniciados los síntomas, divididos conforme el antecedente de ICP. El acaecimiento del criterio de valoración principal (muerte cardiovascular, reinfarto, insuficiencia cardíaca y choque cardiogénico) dentro de los 30 días se comparó con estimaciones de Kaplan-Meier, prueba de rangos logarítmicos y modelo de riesgos proporcionales de Cox. El flujo epicárdico final se evaluó con el sistema de clasificación del flujo TIMI después de la reperfusión. RESULTADOS: Se incluyeron 935 pacientes, 85.6 % del sexo masculino, 6.9 % de los cuales tenía antecedente de ICP; 53 % recibió terapia farmacoinvasiva y 47 %, ICP primaria. La incidencia del criterio de valoración principal en pacientes con ICP previa fue de 9.8 % versus 13.3 % en aquellos sin ese antecedente (p = 0.06); 87.1 % de los pacientes con ICP previa obtuvo flujo final de grado TIMI 3 versus 75 % del grupo con estrategia farmacoinvasiva (p = 0.235). CONCLUSIONES: El antecedente de ICP no incrementa el riesgo de eventos cardiovasculares mayores a los 30 días en pacientes con IAMCEST; sin embargo, impacta negativamente en el flujo sanguíneo angiográfico final de los pacientes que recibieron terapia farmacoinvasiva (en comparación con ICP primaria).

Ten-Year Outcome of Recanalization or Medical Therapy for Concomitant Chronic Total Occlusion After Myocardial Infarction.

BACKGROUND: The EXPLORE (Evaluating Xience and Left Ventricular Function in PCI on Occlusions After STEMI) trial was the first and only randomized trial investigating chronic total occlusion (CTO) percutaneous coronary intervention (PCI) early after primary PCI for ST-segment-elevation myocardial infarction, compared with medical therapy for the CTO. We performed a 10-year follow-up of EXPLORE to investigate long-term safety and clinical impact of CTO PCI after ST-segment-elevation myocardial infarction, compared with no-CTO PCI. METHODS AND RESULTS: In EXPLORE, 302 patients post-ST-segment-elevation myocardial infarction with concurrent CTO were randomized to CTO PCI within ≈1 week or no-CTO PCI. We performed an extended clinical follow-up for the primary end point of major adverse cardiac events, consisting of cardiovascular death, coronary artery bypass grafting, or myocardial infarction. Secondary end points included all-cause death, angina, and dyspnea. Median follow-up was 10 years (interquartile range, 8-11 years). The primary end point occurred in 25% of patients with CTO PCI and in 24% of patients with no-CTO PCI (hazard ratio [HR], 1.11 [95% CI, 0.70-1.76]). Cardiovascular mortality was higher in the CTO PCI group (HR, 2.09 [95% CI, 1.10-2.50]), but all-cause death was similar (HR, 1.53 [95% CI, 0.93-2.50]). Dyspnea relief was more frequent after CTO PCI (83% versus 65%, P=0.005), with no significant difference in angina. CONCLUSIONS: This 10-year follow-up of patients post-ST-segment-elevation myocardial infarction randomized to CTO PCI or no-CTO PCI demonstrated no clinical benefit of CTO PCI in major adverse cardiac events or overall mortality. However, CTO PCI was associated with a higher cardiovascular mortality compared with no-CTO PCI. Our long-term data support a careful weighing of effective symptom relief against an elevated cardiovascular mortality risk in CTO PCI decisions. REGISTRATION: URL: https://www.trialregister.nl; Unique identifier: NTR1108.

Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention for acute myocardial infarction with cardiogenic shock.

The benefits of intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) in the clinical context of cardiogenic shock (CS) complicating acute myocardial infarction are lacking. We aimed to investigate the impact of IVUS-guided PCI in patients with AMI and CS. From the pooled data based on a series of Korean AMI registries during 2011-2020, we identified 1418 consecutive patients who underwent PCI with second generation drug-eluting stent (DES) for AMI and CS. The primary endpoint was the 1-year rate of target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction, and ischemic-driven target lesion revascularization. In total, 294 (20.7%) and 1124 (79.3%) underwent IVUS-guided and angiography-guided PCI with second generation DES implantation, respectively. The 1-year TLF was not significantly different between groups after IPTW analysis (hazard ratio 0.93, 95% confidence interval 0.65-1.34, p = 0.70). Additionally, the adjusted landmark analysis for TLF at 30 days and between 30 days and 1 year after PCI demonstrated no significant difference between the groups. In conclusion, in patients with AMI and CS who underwent PCI with second-generation DES, IVUS-guided PCI did not improve the 1-year TLF compared with angiography-guided PCI.Registration: URL:  http://cris.nih.go.kr . KCT0000863 and KCT0008355.

[Influence of chronic obstructive pulmonary disease on hospital outcomes of percutaneous coronary interventions in patients with acute coronary syndrome].

AIM: To evaluate the impact of chronic obstructive pulmonary disease (COPD) on hospital outcomes of percutaneous coronary interventions (PCI) in patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: A cohort prospective study of the COPD effect on mortality and coronary microvascular obstruction (CMVO, no-reflow) development after PCI in ACS was carried out. 626 patients admitted in 2019-2020 were included, 418 (67%) - men, 208 (33%) - women. Median age - 63 [56; 70] years. Myocardial infarction with ST elevation identified in 308 patients (49%), CMVO - in 59 (9%) patients (criteria: blood flow <3 grade according to TIMI flow grade; perfusion <2 points according to Myocardial blush grade; ST segment resolution <70%). 13 (2.1%) patients died. Based on the questionnaire "Chronic Airways Diseases, A Guide for Primary Care Physicians, 2005", 2 groups of patients were identified: 197 (31%) with COPD (≥17 points) and 429 (69%) without COPD (<17 points). Groups were compared on unbalanced data (÷2 Pearson, Fisher exact test). The propensity score was calculated, and a two-way logistic regression analysis was performed. The data were balanced by the Kernel "weighting" method, logistic regression analysis was carried out using "weighting" coefficients. Results as odds ratio (OR) and 95% confidence interval. RESULTS: The conducted research allowed us to obtain the following results, depending on the type of analysis: 1) analysis of unbalanced data in patients with COPD: OR death 3.60 (1.16-11.12); p=0.03; OR CMVO 0.65 (0.35-1.22); p=0,18; 2) two-way analysis with propensity score: OR death 3.86 (1.09-13.74); p=0.04; OR CMVO 0.61 (0.31-1.19); p=0.15; 3) regression analysis with "weight" coefficients: OR death 12.49 (2.27-68.84); p=0.004; OR CMVO 0.63 (0.30-1.33); p=0.22. CONCLUSION: The presence of COPD in patients with ACS undergoing PCI increases mortality and does not affect the incidence of CMVO.

In-hospital versus after-discharge complete revascularization in patients with ST segment elevation myocardial infarction and multivessel disease. REVIVA-ST trial.

INTRODUCTION: Complete revascularization (CR) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD), is associated with a reduction in major adverse cardiovascular events (MACE). However, there is uncertainty about whether nonculprit-lesion revascularization should be performed, during index hospitalization or delayed, especially regarding health care resources utilization. In this study, we aimed to evaluate the impact of in-hospital nonculprit-lesion revascularization vs. delayed (after discharge) revascularization on the length of index hospitalization. METHODS: In this single-center study, we randomly assigned patients with STEMI and MVD who underwent successful culprit-lesion PCI to a strategy of either CR during in-hospital admission or a delayed CR after discharge. The first primary endpoint was the length of hospital stay. The second endpoint was the composite of cardiovascular death, myocardial infarction or ischemia-driven revascularization at 12 months (MACE). RESULTS: From January 2018 to December 2022, we enrolled 258 patients (131 allocated to CR during in-hospital admission and 127 to an after-discharge CR). We found a significant reduction in the length of hospital stay in those assigned to after-discharge CR strategy [4 days (3-5) versus 7 days (5-9); p = 0.001]. At 12-month of follow-up, no differences were found in the occurrence of MACE, 7 (5.34%) patients in in-hospital CR and 4 (3.15%) in after-discharge CR strategy; (hazard ratio, 0.59; 95% confidence interval, 0.17 to 2.02; p = 0.397). CONCLUSIONS: In STEMI patients with MVD, an after-discharge CR strategy reduces the length of index hospitalization without an increased risk of MACE after 12 months of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04743154.

Impacts of the COVID-19 Pandemic on the CODE ST-Segment Elevation Myocardial Infarction Program: A Quantitative and Qualitative Analysis.

BACKGROUND: The code ST-segment elevation myocardial infarction (STEMI) program is an operational standard of integrated service for STEMI patients carried out by Dr. Cipto Mangunkusumo Hospital. The emerging coronavirus disease 2019 (COVID-19) outbreak brought about many changes in the management of healthcare services, including the code STEMI program. This study aimed to evaluate the healthcare service quality of the Code STEMI program during the COVID-19 pandemic based on the Donabedian concept.  Methods: This was a mixed-methods study using quantitative and qualitative analyses. It was conducted at the Dr. Cipto Mangunkusumo Hospital, a national referral hospital in Indonesia. We compared the data of each patient, including response time, clinical outcomes, length of stay, and cost, from two years between 2018-2020 and 2020-2022 as the pre-COVID-19 code STEMI and COVID-19 Code STEMI periods, respectively. Interviews were conducted to determine the quality of services from the perspectives of stakeholders. RESULTS: A total of 195 patients participated in the study: 120 patients in pre-COVID-19 code STEMI and 75 patients in COVID-19 code STEMI. Our results showed that there was a significant increase in patient's length of stay during the COVID-19 pandemic (4 days vs. 6 days, p < 0.001). Meanwhile, MACE (13% vs. 11%, p = 0.581), the in-hospital mortality rate (8% vs. 5%, p = 0.706), door-to-wire crossing time (161 min vs. 173 min, p = 0.065), door-to-needle time (151 min vs. 143 min p = 0.953), and hospitalization cost (3,490 USD vs. 3,700 USD, p = 0.945) showed no significant changes. In terms of patient satisfaction, patients found code STEMI during COVID-19 to be responsive and excellent. CONCLUSION: The implementation of the code STEMI program during the COVID-19 pandemic revealed that modified pathways were required because of the COVID-19 screening process. According to the Donabedian model, during the pandemic, the code STEMI program's healthcare service quality decreased because of a reduction in efficacy, effectiveness, efficiency, and optimality. Despite these limitations attributed to the pandemic, the code STEMI program was able to provide good services for STEMI patients.

Efficacy and Safety of Long-Term Dual Antiplatelet Therapy: A Systematic Review and Meta-Analysis.

BACKGROUND: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a standard therapy in patients with ischemic vascular diseases (IVD) including coronary artery, cerebrovascular and peripheral arterial diseases, although the optimal duration of this treatment is still debated. Previous meta-analyses reported conflicting results about the effects of long-term and short-term as well as non-DAPT use in various clinical settings. Herein, we conducted a comprehensive meta-analysis to assess the efficacy and safety of different durations of DAPT. METHODS: We reviewed relevant articles and references from database, which were published prior to April 2023. Data from prospective studies were processed using RevMan5.0 software, provided by Cochrane Collaboration and transformed using relevant formulas. The inclusion criteria involved randomization to long-term versus short-term or no DAPT; the endpoints included at least one of total or cardiovascular (CV) mortalities, IVD recurrence, and bleeding. RESULTS: A total of 34 randomized studies involving 141 455 patients were finally included. In comparison with no or short-term DAPT, long-term DAPT reduced MI and stroke, but did not reduce the total and CV mortalities. Meanwhile, bleeding events were increased, even though intracranial and fatal bleedings were not affected. Besides, the reduction of MI and stroke recurrence showed no statistical significance between long-term and short-term DAPT groups. CONCLUSION: Long-term DAPT may not reduce the mortality of IVD besides increasing bleeding events, although reduced the incidences of MI and stroke early recurrence to a certain extent and did not increase the risk of fatal intracranial bleeding.

Differential Use of Glycoprotein IIb/IIIa Inhibitors with Bivalirudin in Patients with STEMI Undergoing PCI: A Systematic Review and Meta-Analysis.

AIM: The efficacy and safety of bivalirudin when used concurrently with glycoprotein IIb/IIIa inhibitors (GPI) is uncertain. In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) and to explore the impact of differential use (greater and balanced) of GPI. METHODS: Online databases were queried from inception to March 2023 to identify eight randomized controlled trials (n = 22,483) for inclusion. The primary outcomes included all-cause mortality, major bleeding, major adverse cardiovascular events (MACE), and net adverse clinical events (NACE). Secondary efficacy endpoints included cardiac death, reinfarction, stent thrombosis (ST), and stroke. Data were pooled using a random-effects model to derive risk ratios (RRs) and 95% confidence intervals (CIs). RESULTS: When compared to heparin, bivalirudin was associated with a significant reduction in all-cause mortality (RR 0.83; 95% CI 0.72-0.97; P = 0.02), major bleeding (RR 0.73; 95% CI 0.57-0.93; P = 0.01), cardiac death (RR 0.79; 95% CI 0.66-0.94; P = 0.01), and NACE (RR 0.80; 95% CI 0.72-0.89; P < 0.0001). However, while the bivalirudin arm showed an increased likelihood of ST in the greater GPI subgroup (RR 1.70; 95% CI 1.13-2.56; P = 0.01), it was associated with a decreased likelihood of ST in the balanced GPI subgroup (RR 0.40; 95% CI 0.24-0.65; P = 0.0003). CONCLUSION: Overall, our findings suggest that bivalirudin may be a more efficacious intervention than heparin for reducing certain adverse events in patients with STEMI undergoing primary PCI.

The effect of sitting baduanjin in patients with ST-segment elevation acute myocardial infarction after percutaneous coronary intervention: A quasi-experimental study.

BACKGROUND: Early cardiac rehabilitation plays a crucial role in the recovery of patients with ST-segment elevation acute myocardial infarction (STEMI) following percutaneous coronary intervention (PCI). This study sought to determine the effect of a program of sitting Baduanjin exercises on early cardiac rehabilitation. OBJECTIVE: The goal of this study was to investigate the effects of sitting Baduanjin exercises on cardiovascular and psychosocial functions in patients with STEMI following PCI. METHODS: This quasi-experimental study employed a randomized, non-equivalent group design. Patients in the intervention group received daily sitting Baduanjin training in addition to a series of seven-step rehabilitation exercises, whereas those in the control group received only the seven-step rehabilitation training, twice daily. Differences in heart rate variability (HRV) indicators, exercise capacity (Six-Minute Walking Distance; 6-MWD), anxiety (Generalized Anxiety Disorder-7; GAD-7), and depression (Patient Health Questionnaire-9; PHQ-9) between the two study groups during hospitalization were analyzed. RESULTS: Patients in the intervention group exhibited lower rates of abnormalities in the time domain and frequency domain parameters of HRV. The median scores of GAD-7 and PHQ-9 in both groups were lower than those at the time of admission, with the intervention group exhibiting lower scores than the control group (P < 0.001; P < 0.001, respectively). The 6-MWD after the intervention was greater in the intervention group compared to the control group (P = 0.014). CONCLUSIONS: We found that sitting Baduanjin training has the potential to enhance HRV, cardiac function, and psychological well-being in patients with STEMI after PCI. This intervention can potentially improve the exercise capacity of a patient before discharge.

Ticagrelor alone versus ticagrelor plus aspirin from month 1 to month 12 after percutaneous coronary intervention in patients with acute coronary syndromes (ULTIMATE-DAPT): a randomised, placebo-controlled, double-blind clinical trial.

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce. The aim of this trial was to assess whether the use of ticagrelor alone, compared with ticagrelor plus aspirin, could reduce the incidence of clinically relevant bleeding events without an accompanying increase in major adverse cardiovascular or cerebrovascular events (MACCE). METHODS: In this randomised, placebo-controlled, double-blind clinical trial, patients aged 18 years or older with an acute coronary syndrome who completed the IVUS-ACS study and who had no major ischaemic or bleeding events after 1-month treatment with dual antiplatelet therapy were randomly assigned to receive oral ticagrelor (90 mg twice daily) plus oral aspirin (100 mg once daily) or oral ticagrelor (90 mg twice daily) plus a matching oral placebo, beginning 1 month and ending at 12 months after percutaneous coronary intervention (11 months in total). Recruitment took place at 58 centres in China, Italy, Pakistan, and the UK. Patients were required to remain event-free for 1 month on dual antiplatelet therapy following percutaneous coronary intervention with contemporary drug-eluting stents. Randomisation was done using a web-based system, stratified by acute coronary syndrome type, diabetes, IVUS-ACS randomisation, and site, using dynamic minimisation. The primary superiority endpoint was clinically relevant bleeding (Bleeding Academic Research Consortium [known as BARC] types 2, 3, or 5). The primary non-inferiority endpoint was MACCE (defined as the composite of cardiac death, myocardial infarction, ischaemic stroke, definite stent thrombosis, or clinically driven target vessel revascularisation), with an expected event rate of 6·2% in the ticagrelor plus aspirin group and an absolute non-inferiority margin of 2·5 percentage points between 1 month and 12 months after percutaneous coronary intervention. The two co-primary endpoints were tested sequentially; the primary superiority endpoint had to be met for hypothesis testing of the MACCE outcome to proceed. All principal analyses were assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT03971500, and is completed. FINDINGS: Between Sept 21, 2019, and Oct 27, 2022, 3400 (97·0%) of the 3505 participants in the IVUS-ACS study were randomly assigned (1700 patients to ticagrelor plus aspirin and 1700 patients to ticagrelor plus placebo). 12-month follow-up was completed by 3399 (>99·9%) patients. Between month 1 and month 12 after percutaneous coronary intervention, clinically relevant bleeding occurred in 35 patients (2·1%) in the ticagrelor plus placebo group and in 78 patients (4·6%) in the ticagrelor plus aspirin group (hazard ratio [HR] 0·45 [95% CI 0·30 to 0·66]; p<0·0001). MACCE occurred in 61 patients (3·6%) in the ticagrelor plus placebo group and in 63 patients (3·7%) in the ticagrelor plus aspirin group (absolute difference -0·1% [95% CI -1·4% to 1·2%]; HR 0·98 [95% CI 0·69 to 1·39]; pnon-inferiority<0·0001, psuperiority=0·89). INTERPRETATION: In patients with an acute coronary syndrome who had percutaneous coronary intervention with contemporary drug-eluting stents and remained event-free for 1 month on dual antiplatelet therapy, treatment with ticagrelor alone between month 1 and month 12 after the intervention resulted in a lower rate of clinically relevant bleeding and a similar rate of MACCE compared with ticagrelor plus aspirin. Along with the results from previous studies, these findings show that most patients in this population can benefit from superior clinical outcomes with aspirin discontinuation and maintenance on ticagrelor monotherapy after 1 month of dual antiplatelet therapy. FUNDING: The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and the Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. TRANSLATION: For the Mandarin translation of the abstract see Supplementary Materials section.