An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Optical coherence tomography (OCT) - versus angiography-guided strategy for percutaneous coronary intervention: a meta-analysis of randomized trials.

BACKGROUND: Optical coherence tomography (OCT) guidance in percutaneous coronary intervention (PCI) has been shown to improve procedural outcomes. However, evidence supporting its superiority over angiography-guided PCI in terms of clinical outcomes is still emerging and limited. This study aimed to compare the efficacy and safety of OCT-guided PCI versus angiography-guided PCI in patients with coronary artery disease (CAD). METHODS: A systematic search of electronic databases was conducted to identify randomized control trials (RCTs) comparing the clinical outcomes of OCT-guided and angiography-guided PCI in patients with CAD. Clinical endpoints including all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis and major adverse cardiac events (MACE) were assessed. RESULTS: Eleven RCTs, comprising 2,699 patients in the OCT-guided group and 2,968 patients in the angiography-guided group met inclusion criteria. OCT-guided PCI was associated with significantly lower rates of cardiovascular death(RR 0.56; 95%CI: 0.32-0.98; p = 0.04; I2 = 0%), stent thrombosis(RR 0.56; 95%CI: 0.33-0.95; p = 0.03; I2 = 0%), and MACE (RR 0.79; 95%CI: 0.66-0.95; p = 0.01; I2 = 5%). The incidence of all-cause death (RR 0.71; 95%CI: 0.49-1.02; p = 0.06; I2 = 0%), myocardial infarction (RR 0.86; 95%CI: 0.67-1.10; p = 0.22; I2 = 0%) and TLR (RR 0.98; 95%CI: 0.73-1.33; p = 0.91; I2 = 0%) was non-significantly lower in the OCT-guided group. CONCLUSIONS: Among patients undergoing PCI, OCT-guided PCI was associated with lower incidences of cardiovascular death, stent thrombosis and MACE compared to angiography-guided PCI. TRIAL REGISTRATION: PROSPERO registration number: CRD42023484342.

Safety and efficacy of drug-eluting stents for patients at high risk of bleedings: A network meta-analysis.

INTRODUCTION: Among different coronary stents implanted in High Bleeding Risk (HBR) patients with an indication for short antiplatelet therapy, no comparisons in terms of efficacy have been provided. METHODS: A Network Meta Analysis was performed including all randomized controlled trials comparing different coronary stents evaluated in HBR patients. Major Adverse Cardiovascular Events (MACEs) as defined by each included trial were the primary end point, whereas TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis and total and major (BARC3-5) bleedings were the secondary ones. RESULTS: A total of four studies (ONYX ONE, LEADERS FREE, SENIOR and HBR in BIO-RESORT) including 6637 patients were analyzed with different kind of stents and dual antiplatelet therapy (DAPT) length (1 or 6 months) on 12 months follow-up. About one-third of these patients were defined HBR due to indication for oral anticoagulation. All drug eluting stents (DESs) reduced risk of MACE compared to Bare Metal Stents (BMSs) when followed by a 1-month DAPT. At SUCRA analysis, Orsiro was the device with the highest probability of performing best. Rates of TLR and TVR were significantly lower when using Resolute Onyx, Synergy and BioFreedom stents in comparison to BMS when followed by 1-month DAPT, with Synergy ranking best. Synergy also showed a significantly lower number of stent thrombosis compared to BMS (RR 0.28, 95% CI 0.06-0.93), while Orsiro and Resolute Integrity showed the highest probability of performing best. CONCLUSION: In HBRs patients, all DESs were superior to BMSs in terms of efficacy and safety. Among DESs, Orsiro was the one with the highest ranking in terms of MACE, mainly driven by a reduced incidence of repeated revascularization and stent thrombosis.

The Relationship of Coronary Thrombus Burden and Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Score in Patients With ST-Segment Elevation Myocardial Infarction.

BACKGROUND: The anticoagulation and risk factors in atrial fibrillation (ATRIA) score is associated with adverse cardiovascular events. However, its relationship with coronary thrombus burden is unclear. Therefore, we aimed to investigate the relationship between the ATRIA score and thrombus burden in patients with ST-segment elevation myocardial infarction (STEMI) who underwent percutaneous coronary intervention (PCI). MATERIALS AND METHODS: The study was designed as a prospective cross-sectional observational study. Our study included 319 patients who were prospectively admitted with STEMI between January 2021 and April 2022. Patients were divided into 2 groups with low thrombus burden (LTB) (grade <3) and high thrombus burden (HTB) (grade ≥3). ATRIA score was calculated and recorded for all patients. ATRIA scores of both groups were compared. RESULTS: In our study, 58.9% (n = 188) of patients in the LTB group and 41% (n = 131) of patients in the HTB group. The ATRIA risk score (p < .001) was significantly higher in the HTB group. In multivariate logistic regression analysis, ATRIA score, glomerular filtration rate, hypertension, abciximab usage, and no-reflow were found to be independent predictors of HTB in STEMI patients undergoing primary PCI. In receiver operating characteristic analysis, ATRIA score >4 had a sensitivity of 66.2% and specificity of 95.2%, and ATRIA score >8 sensitivity of 98% and specificity of 100% predicted HTB. CONCLUSION: In this study, we found that thrombus burden may be associated with ATRIA risk score in patients presenting with STEMI.

Use of the Indigo CAT RX aspiration system during percutaneous coronary intervention.

BACKGROUND: The use of the Indigo CAT RX Aspiration System (Penumbra Inc.) during percutaneous coronary intervention has received limited study. METHODS: We retrospectively examined the clinical, angiographic, and procedural characteristics, outcomes, and follow-up of patients who underwent mechanical aspiration thrombectomy with the Indigo CAT RX system (Penumbra Inc.) at a large tertiary care hospital between January 2019 and April 2023. RESULTS: During the study period, 83 patients (85 lesions) underwent thrombectomy with the Indigo CAT RX. Mean patient age was 64.9 ± 14.48 years and 31.2% were women. The most common presentations were ST-segment elevation myocardial infarction (MI) (66.2%) and non-ST-segment elevation MI (26.5%). A final thrombolysis in MI flow grade of 3 and final myocardial blush grade of 3 were achieved in 76% and 46% of the cases, respectively. Technical success was achieved in 88.9% of the cases that included Indigo CAT RX treatment only, compared with 57.1% of the cases that also included manual aspiration. There were no device-related serious adverse events. At 30-day postprocedure, the incidence of major adverse cardiac events (composite of cardiovascular death, recurrent MI, cardiogenic shock, new or worsening New York Heart Association Class IV heart failure, stroke) was 8.5%: 1.3% stroke (postprocedure, in-hospital), 1.3% MI, 6.1% cardiac death, and 7.5% developed cardiogenic shock. CONCLUSIONS: Use of the Indigo CAT RX system is associated with high technical success and acceptable risk of complications, including stroke.

Long-term outcomes after coronary intervention with biodegradable polymer stents in patients with acute coronary syndromes.

BACKGROUND: Patients with acute coronary syndromes (ACS) may have worse outcomes after percutaneous coronary intervention compared to patients without ACS. AIMS: To compare 5-year efficacy and safety outcomes in patients with and without ACS treated with biodegradable polymers, the ultrathin strut sirolimus-eluting Orsiro stent (O-SES) or the biolimus-eluting Nobori stent (N-BES). METHODS: The Scandinavian Organisation for Randomized Trials with Clinical Outcome VII is a randomized trial comparing O-SES and N-BES in an all-comer setting. Of 2525 patients, 1329 (53%) patients had ACS and 1196 (47%) patients were without ACS. Endpoints were target lesion failure (TLF) (a composite of cardiac death, target lesion myocardial infarction, or target lesion revascularization) and definite stent thrombosis within 5 years. RESULTS: At 5-year follow-up, TLF did not differ significantly between patients with and without ACS (12.3% vs. 13.2%; rate ratio (RR) 1.00; 95% confidence interval (CI): 0.70-1.44), whereas the risk of definite stent thrombosis was increased in patients with ACS (2.3% vs. 1.3; RR: 2.01 [95% CI: 1.01-3.98]). In patients with ACS, the rate of TLF was similar between O-SES and N-BES (12.4% vs. 12.3%; RR: 1.02; 95% CI: 0.74-1.40). The reduced risk of definite stent thrombosis in O-SES treated ACS patients within the first year (0.2% vs. 1.6%; RR: 0.12; 95% CI: 0.02-0.93) was not maintained after 5 years (1.8% vs. 2.7%; RR: 0.77; 95% CI: 0.37-1.63). CONCLUSION: Patients with ACS had an increased risk of stent thrombosis regardless of the stent type used. Long-term outcomes were similar for ACS patients treated with O-SES or N-BES at 5 years.

Mechanisms of Very Late Stent Thrombosis in Japanese Patients as Assessed by Optical Coherence Tomography.

BACKGROUND: Although very late stent thrombosis (VLST) remains an important concern, the underlying etiology and clinical characteristics are not fully elucidated in Japanese patients who undergo intravascular imaging-guided percutaneous coronary intervention (PCI) regularly. METHODS: We identified 50 VLST lesions (bare-metal stent [BMS] [n = 16], first-generation drug-eluting stent [DES] [n = 14] and newer-generation DES [n = 20]) in patients managed in our institutes. The underlying mechanism of VLST was assessed by optical coherence tomography (OCT), and the major etiology of each lesion was determined. The aim of this study was to explore the mechanisms of VLST of BMSs and DESs in Japanese patients. RESULTS: The median duration since stent implantation was 10 years (range: 1-20). The most frequent etiology of VLST was neoatherosclerotic rupture (44%), followed by neointimal erosion (24%). Edge disease (10%) and evagination (10%) were similarly observed. Malapposition (8%) was deemed to be acquired late by looking at intravascular imaging from the index procedure. Uncovered struts (2%) and in-stent calcified nodule (2%) were the least frequent etiologies. Regardless of etiology, signs of neoatherosclerosis were present in most lesions (82%). Most patients received single (68%) or dual (8%) antiplatelet therapy or oral anticoagulation alone (4%), whereas a considerable proportion of patients discontinued medication (20%). Regarding the treatment strategy, drug-coated balloon was the most frequent strategy (56%), followed by implantation of newer DESs (34%). CONCLUSIONS: Various mechanisms have been identified in Japanese patients with VLST. In these patients, biological responses seemed to be more relevant than the index procedure-related factors.

Mitigating the risk of flow deterioration by deferring stent optimization in STEMI patients with large thrombus burden: Insights from a prospective cohort study.

OBJECTIVES: It is uncertain, if omitting post-dilatation and stent oversizing (stent optimization) is safe and may decrease the risk for distal thrombus embolization (DTE) in STEMI patients with large thrombus burden (LTB). BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) with stenting, (DTE) and flow deterioration are common and increase infarct size leading to worse outcomes. METHODS: From a prospective registry, 74 consecutive STEMI patients with LTB undergoing pPCI with stenting and intentionally deferred stent optimization were analyzed. Imaging data and outcomes up to 2 years follow-up were analyzed. RESULTS: Overall, 74 patients (18% females) underwent deferred stent optimization. Direct stenting was performed in 13 (18%) patients. No major complications occurred during pPCI. Staged stent optimization was performed after a median of 4 (interquartile range (IQR) 3; 7) days. On optical coherence tomography, under-expansion and residual thrombus were present in 59 (80%) and 27 (36%) cases, respectively. During deferred stent optimization, we encountered no case of flow deterioration (slow or no-reflow) or side branch occlusion. Minimal lumen area (mm2) and stent expansion (%) were corrected from 4.87±1.86mm to 6.82±2.36mm (p<0.05) and from 69±18% to 91±12% (p<0.001), respectively. During follow-up, 1 patient (1.4%) required target lesion revascularization and 1 (1.4%) patient succumbed from cardiovascular death. CONCLUSIONS: Among STEMI patients with LTB, deferring stent optimization in the setting of pPCI appears safe and potentially mitigates the risk of DTE. The impact of this approach on infarct size and clinical outcomes warrants further investigation in a dedicated trial.

Acute myocardial infarction due to coronary embolism caused by a metastatic mass from lung cancer.

BACKGROUND: Acute arterial embolism due to tumor embolus is a rare complication in cancer patients, even rarer is lung tumor embolization leading to acute myocardial infarction. We report a patient who had a diagnosis of acute myocardial infarction(AMI)which was brought on by a coronary artery embolism by a metastatic lung cancer tumor. Clinicians need to be aware that tumor embolism can result in AMI. CASE PRESENTATION: An 80-yeal-old male patient presented with persistent chest pain for 2 h and his electrocardiogram(ECG)showed anterior ST-segment elevation myocardial infarction. Instead of implanting a stent, thrombus aspiration was performed. Pathological examination of coronary artery thrombosis showed that a few sporadic atypical epithelial cells were scattered in the thrombus-like tissue. Combined with immune phenotype and clinical history, metastatic squamous cell carcinoma is more likely. CONCLUSIONS: We report a rare case of a patient who was diagnosed of AMI due to a coronary artery embolism by a metastatic mass from lung cancer. Since there is no evidence-based protocol available for the treatment of isolated coronary thrombosis, we used thrombus aspiration to treat thrombosis rather than implanting a stent.

Prognostic value and clinical usefulness of PIANO score in patients undergoing primary percutaneous coronary intervention.

BACKGROUND: In our previous study, the PIANO score was constructed to predict the occurrence of no-reflow phenomenon in patients undergoing primary percutaneous coronary intervention (PCI). In the current analysis, we sought to evaluate the prognostic value and clinical usefulness of the PIANO score in this population. METHODS: Patients with acute myocardial infarction (AMI) undergoing primary PCI were consecutively enrolled and followed up in this register. The endpoint of interest was all-cause mortality at 2 years after the procedure. The clinical benefits of thrombus aspiration (TA) during primary PCI in certain subgroups were also evaluated as exploratory analyses. RESULTS: A total of 2100 patients were identified, and 54.3% had high (≥8) PIANO score. After 2-year follow-up, patients with high PIANO score had higher risk of all-cause mortality after adjustment for propensity score (6.7% vs. 3.1%, adjusted hazard ratio = 2.11 [1.21-3.68], p = 0.008), especially in the first month (adjusted hazard ratio = 2.33 [1.17-4.65], p = 0.017). Restricted cubic spline analysis indicated the linear association between the PIANO score and 2-year all-cause mortality (nonlinear p = 0.556). Further analysis demonstrated that TA did not reduce all-cause mortality in the overall patients, as well as in those with visible thrombus, high thrombus burden, or occlusive lesions. However, the PIANO score defined "high-risk" (PIANO score ≥ 8) patients could benefit from it. CONCLUSIONS: The PIANO score had potential prognostic value in patients with AMI undergoing primary PCI. It might also be helpful for identifying patients who would benefit from TA. These observations require further confirmation in future studies.

De-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention: a Consensus Statement from an international expert panel on coronary thrombosis.

Conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y purinoceptor 12 (P2Y12) inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. De-escalation of DAPT intensity can reduce bleeding without increasing ischaemic events and can be guided by platelet function testing or genotyping. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. However, these two strategies have not yet been compared in a head-to-head clinical trial. In this Consensus Statement, we summarize the evidence base for these treatment approaches, provide guidance on the assessment of ischaemic and bleeding risks, and provide consensus statements from an international panel of experts to help clinicians to optimize these DAPT approaches for individual patients to improve outcomes.