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A potent P2Y12 inhibitor-based dual antiplatelet therapy is recommended for up to 1 year in patients with acute coronary syndrome receiving percutaneous coronary intervention (PCI). The greatest benefit of the potent agent is during the early phase, whereas the risk of excess bleeding continues in the chronic maintenance phase. Therefore, de-escalation of antiplatelet therapy might achieve an optimal balance between ischaemia and bleeding. We aimed to investigate the safety and efficacy of a prasugrel-based dose de-escalation therapy. HOST-REDUCE-POLYTECH-ACS is a randomised, open-label, multicentre, non-inferiority trial done at 35 hospitals in South Korea. We enrolled patients with acute coronary syndrome receiving PCI. Patients meeting the core indication for prasugrel were randomly assigned (1:1) to the de-escalation group or conventional group using a web-based randomisation system. The assessors were masked to the treatment allocation. After 1 month of treatment with 10 mg prasugrel plus 100 mg aspirin daily, the de-escalation group received 5 mg prasugrel, while the conventional group continued to receive 10 mg. The primary endpoint was net adverse clinical events (all-cause death, non-fatal myocardial infarction, stent thrombosis, repeat revascularisation, stroke, and bleeding events of grade 2 or higher according to Bleeding Academic Research Consortium [BARC] criteria) at 1 year. The absolute non-inferiority margin for the primary endpoint was 2·5%. The key secondary endpoints were efficacy outcomes (cardiovascular death, myocardial infarction, stent thrombosis, and ischaemic stroke) and safety outcomes (bleeding events of BARC grade ≥2). The primary analysis was in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02193971. From Sept 30, 2014, to Dec 18, 2018, 3429 patients were screened, of whom 1075 patients did not meet the core indication for prasugrel and 16 were excluded due to randomisation error. 2338 patients were randomly assigned to the de-escalation group (n=1170) or the conventional group (n=1168). The primary endpoint occurred in 82 patients (Kaplan-Meier estimate 7·2%) in the de-escalation group and 116 patients (10·1%) in the conventional group (absolute risk difference −2·9%, pnon-inferiority<0·0001; hazard ratio 0·70 [95% CI 0·52–0·92], pequivalence=0·012). There was no increase in ischaemic risk in the de-escalation group compared with the conventional group (0·76 [0·40–1·45]; p=0·40), and the risk of bleeding events was significantly decreased (0·48 [0·32–0·73]; p=0·0007). In east Asian patients with acute coronary syndrome patients receiving PCI, a prasugrel-based dose de-escalation strategy from 1 month after PCI reduced the risk of net clinical outcomes up to 1 year, mainly driven by a reduction in bleeding without an increase in ischaemia. Daiichi Sankyo, Boston Scientific, Terumo, Biotronik, Qualitech Korea, and Dio.

Wearable devices have evolved as screening tools for atrial fibrillation (AF). A photoplethysmographic (PPG) AF detection algorithm was developed and applied to a convenient smartphone-based device with good accuracy. However, patients with paroxysmal AF frequently exhibit premature atrial complexes (PACs), which result in poor unmanned AF detection, mainly because of rule-based or handcrafted machine learning techniques that are limited in terms of diagnostic accuracy and reliability. This study aimed to develop deep learning (DL) classifiers using PPG data to detect AF from the sinus rhythm (SR) in the presence of PACs after successful cardioversion. We examined 75 patients with AF who underwent successful elective direct-current cardioversion (DCC). Electrocardiogram and pulse oximetry data over a 15-min period were obtained before and after DCC and labeled as AF or SR. A 1-dimensional convolutional neural network (1D-CNN) and recurrent neural network (RNN) were chosen as the 2 DL architectures. The PAC indicator estimated the burden of PACs on the PPG dataset. We defined a metric called the confidence level (CL) of AF or SR diagnosis and compared the CLs of true and false diagnoses. We also compared the diagnostic performance of 1D-CNN and RNN with previously developed AF detectors (support vector machine with root-mean-square of successive difference of RR intervals and Shannon entropy, autocorrelation, and ensemble by combining 2 previous methods) using 10 5-fold cross-validation processes. Among the 14,298 training samples containing PPG data, 7157 samples were obtained during the post-DCC period. The PAC indicator estimated 29.79% (2132/7157) of post-DCC samples had PACs. The diagnostic accuracy of AF versus SR was 99.32% (70,925/71,410) versus 95.85% (68,602/71,570) in 1D-CNN and 98.27% (70,176/71,410) versus 96.04% (68,736/71,570) in RNN methods. The area under receiver operating characteristic curves of the 2 DL classifiers was 0.998 (95% CI 0.995-1.000) for 1D-CNN and 0.996 (95% CI 0.993-0.998) for RNN, which were significantly higher than other AF detectors (P<.001). If we assumed that the dataset could emulate a sufficient number of patients in training, both DL classifiers improved their diagnostic performances even further especially for the samples with a high burden of PACs. The average CLs for true versus false classification were 98.56% versus 78.75% for 1D-CNN and 98.37% versus 82.57% for RNN (P<.001 for all cases). New DL classifiers could detect AF using PPG monitoring signals with high diagnostic accuracy even with frequent PACs and could outperform previously developed AF detectors. Although diagnostic performance decreased as the burden of PACs increased, performance improved when samples from more patients were trained. Moreover, the reliability of the diagnosis could be indicated by the CL. Wearable devices sensing PPG signals with DL classifiers should be validated as tools to screen for AF.

The relationship between luminal stenosis severity and plaque vulnerability in chronic stable angina (CSA) is not well studied. This study aimed to investigate the link between stenosis severity, plaque characteristics, and thrombus prevalence in CSA patients using optical coherence tomography. The 174 lesions (146 patients) with CSA divided into three groups according to the percentage of area stenosis (AS); group A (AS < 50%), group B (50% ≤ AS < 70%), and group C (AS ≥ 70%). Twenty-four lesions of group A, 51 lesions of group B, and 99 lesions from group C were studied. The prevalence of thrombus was 19.0% and it was significantly different among the three groups (none in group A vs. 17.6% in group B vs. 24.2% in group C; P  = 0.024). The more severe the luminal narrowing, the more thrombus occurred, with a higher prevalence at the minimal lumen area site. Additionally greater the area stenosis, the higher the prevalence of lipid-rich plaque, thin cap plaque, macrophage infiltration, and ruptured plaque. In the multivariate analysis, thrombus was independently associated with ruptured plaque (OR = 20.96, CI 8.40–57.69, P  < 0.001), macrophage infiltration (OR = 3.77, CI 1.53–10.72, P  = 0.007), lipid angle (OR = 1.01, CI 1.00–1.01, P  = 0.004), and area stenosis (OR = 1.05, CI 1.02–1.10, P  = 0.002). In patients with CSA, the prevalence of thrombus, as assessed by OCT, is not uncommon. Plaque vulnerability, including thrombus occurrence, increased with the severity of area stenosis and was more prevalent at the minimal lumen site exposed to high shear stress.

To assess the serial changes of de novo coronary lesions treated with paclitaxel-coated balloon (PCB) using intravascular ultrasound virtual histology (IVUS-VH) and fractional flow reserve (FFR). This prospective observational study enrolled 27 patients with coronary artery disease treated with PCB who underwent coronary angiography, IVUS-VH and FFR before, immediately after intervention and at 9 months. 28 de novo lesions were successfully treated with PCB. Angiographic late luminal loss was 0.02 ± 0.27 mm. Mean vessel and lumen areas showed increase at 9 months (12.0 ± 3.5 mm(2) to 13.2 ± 3.9 mm(2), p <0.001; and 5.4 ± 1.2 mm(2) to 6.5 ± 1.8 mm(2), p <0.001, respectively). Although mean plaque area was unchanged (6.6 ± 2.6 mm2 to 6.6 ± 2.4 mm(2), p = 0.269), percent atheroma volume decreased significantly (53.4 ± 7.9% to 49.5 ± 6.4%, p = 0.002). The proportion of plaque compositions including fibrous, fibrofatty, dense calcium and necrotic core by IVUS-VH was unchanged at 9 months. The FFR of the treated lesion was 0.71 ± 0.13 pre-procedure, 0.87 ± 0.06 post-procedure and 0.84 ± 0.06 at follow-up. De novo coronary lesions treated with PCB showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up.

Evidence supporting the use of coronary physiology as an adjunct to coronary angiography to guide percutaneous coronary interventions has accumulated over the past 25 years. The fractional flow reserve has dominated this evolving physiological guidance of coronary intervention and its use is supported by large clinical outcome trials. However, despite clinical practice guidelines advocating its use in most patients with coronary stenosis who are eligible for coronary intervention, the uptake of a physiology-guided approach remains limited. The use of non-hyperaemic coronary pressure measurements to guide coronary interventions was introduced in an attempt to simplify the routine application of coronary physiology-guided intervention in daily practice. Over the past decade, a large scientific effort has focused on the development of several non-hyperaemic pressure ratios. In this Review, we detail the basic principles of coronary physiology in non-hyperaemic conditions, the rationale for the use of non-hyperaemic coronary pressure measurements for stenosis evaluation, the current evidence base for the available non-hyperaemic coronary pressure ratios, the basis for the discordance between non-hyperaemic coronary pressure ratios and fractional flow reserve, and the potential advantages of these new parameters over fractional flow reserve.Non-hyperaemic pressure measurements have emerged as a useful tool to guide coronary interventions and are recommended as a substitute for fractional flow reserve (FFR). In this Review, van de Hoef and colleagues explain the rationale for the use of non-hyperaemic pressure ratios instead of FFR for stenosis evaluation.

ObjectiveTo assess the distribution of pressure and shear-related forces acting on atherosclerotic plaques and their association with lesion characteristics using coronary CT angiography (cCTA)-based computational fluid dynamics (CFD) model of epicardial coronary arteries.MethodsPatient-specific models of epicardial coronary arteries were reconstructed from cCTA in 80 patients (12 women, 63.8±9.0 years). The pressure and wall shear stress (WSS) in left anterior descending coronary arteries were assessed using CFD. High-risk plaques were defined as the presence of at least one of the following adverse plaque characteristics: low-density plaque, positive remodelling, napkin-ring sign and spotty calcification.ResultsAt resting condition, 39.5% of stenotic segments (% diameter stenosis 52.3±14.4%) were exposed to high WSS (>40 dyne/cm2). When the stenotic lesion was subdivided into three segments, the distribution of WSS was different from that of pressure change and its magnitude was highest at minimal lumen area (p<0.001). High pressure gradient, proximal location, small lumen and short length were independent determinants of WSS (all p<0.05). The plaques exposed to the highest WSS tertile had a significantly greater proportion of high-risk plaques. The addition of WSS to % diameter stenosis significantly improved the measures of discrimination and reclassification of high-risk plaques (area under the curves from 0.540 to 0.718, p=0.031; net reclassification index 0.827, p<0.001).ConclusionsThe cCTA-based CFD method can improve the identification of high-risk plaques and the risk stratification for coronary artery disease patients by providing non-invasive measurements of WSS affecting coronary plaques.

ImportanceFractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is generally considered to reflect residual disease. Yet the clinical relevance of post-PCI FFR after drug-eluting stent (DES) implantation remains unclear.ObjectiveTo evaluate the clinical relevance of post-PCI FFR measurement after DES implantation.Data SourcesMEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched for relevant published articles from inception to June 18, 2022.Study SelectionPublished articles that reported post-PCI FFR after DES implantation and its association with clinical outcomes were included.Data Extraction and SynthesisPatient-level data were collected from the corresponding authors of 17 cohorts using a standardized spreadsheet. Meta-estimates for primary and secondary outcomes were analyzed per patient and using mixed-effects Cox proportional hazard regression with registry identifiers included as a random effect. All processes followed the Preferred Reporting Items for Systematic Review and Meta-analysis of Individual Participant Data.Main Outcomes and MeasuresThe primary outcome was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel myocardial infarction (TVMI), and target vessel revascularization (TVR). The secondary outcome was a composite of cardiac death or TVMI at 2 years.ResultsOf 2268 articles identified, 29 studies met selection criteria. Of these, 28 articles from 17 cohorts provided data, including a total of 5277 patients with 5869 vessels who underwent FFR measurement after DES implantation. Mean (SD) age was 64.4 (10.1) years and 4141 patients (78.5%) were men. Median (IQR) post-PCI FFR was 0.89 (0.84-0.94) and 690 vessels (11.8%) had a post-PCI FFR of 0.80 or below. The cumulative incidence of TVF was 340 patients (7.2%), with cardiac death or TVMI occurring in 111 patients (2.4%) at 2 years. Lower post-PCI FFR significantly increased the risk of TVF (adjusted hazard ratio [HR] per 0.01 FFR decrease, 1.04; 95% CI, 1.02-1.05;P < .001). The risk of cardiac death or MI also increased inversely with post-PCI FFR (adjusted HR, 1.03; 95% CI, 1.00-1.07,P = .049). These associations were consistent regardless of age, sex, the presence of hypertension or diabetes, and clinical diagnosis.Conclusions and RelevanceReduced FFR after DES implantation was common and associated with the risks of TVF and of cardiac death or TVMI. These results indicate the prognostic value of post-PCI physiologic assessment after DES implantation.

Introduction Fractional flow reserve (FFR) measured after percutaneous coronary intervention (PCI) has been identified as a surrogate marker for vessel related adverse events. FFR can be derived from standard coronary computed tomography angiography (CTA). Moreover, the FFR derived from coronary CTA (FFRCT) Planner is a tool that simulates PCI providing modeled FFRCT values after stenosis opening. Aim To validate the accuracy of the FFRCT Planner in predicting FFR after PCI with invasive FFR as a reference standard. Methods Prospective, international and multicenter study of patients with chronic coronary syndromes undergoing PCI. Patients will undergo coronary CTA with FFRCT prior to PCI. Combined morphological and functional evaluations with motorized FFR hyperemic pullbacks, and optical coherence tomography (OCT) will be performed before and after PCI. The FFRCT Planner will be applied by an independent core laboratory blinded to invasive data, replicating the invasive procedure. The primary objective is to assess the agreement between the predicted FFRCT post‐PCI derived from the Planner and invasive FFR. A total of 127 patients will be included in the study. Results Patient enrollment started in February 2019. Until December 2020, 100 patients have been included. Mean age was 64.1 ± 9.03, 76% were males and 24% diabetics. The target vessels for PCI were LAD 83%, LCX 6%, and RCA 11%. The final results are expected in 2021. Conclusion This study will determine the accuracy and precision of the FFRCT Planner to predict post‐PCI FFR in patients with chronic coronary syndromes undergoing percutaneous revascularization.

Limited data are available regarding comparative prognosis after percutaneous coronary intervention (PCI) versus deferral of revascularization in patients with intermediate stenosis with abnormal fractional flow reserve (FFR) but preserved coronary flow reserve (CFR). From the International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713), a total of 330 patients (338 vessels) who had coronary stenosis with FFR ≤ 0.80 but CFR > 2.0 were selected for the current analysis. Patient-level clinical outcome was assessed by major adverse cardiac events (MACE) at 5 years, a composite of all-cause death, target-vessel myocardial infarction (MI), or target-vessel revascularization. Among the study population, 231 patients (233 vessels) underwent PCI and 99 patients (105 vessels) were deferred. During 5 years of follow-up, cumulative incidence of MACE was 13.0% (31 patients) without significant difference between PCI and deferred groups (12.7% vs. 14.0%, adjusted HR 1.301, 95% CI 0.611–2.769, P  = 0.495). Multiple sensitivity analyses by propensity score matching and inverse probability weighting also showed no significant difference in patient-level MACE and vessel-specific MI or revascularization. In this hypothesis-generating study, there was no significant difference in clinical outcomes between PCI and deferred groups among patients with intermediate stenosis with FFR ≤ 0.80 but CFR > 2.0. Further study is needed to confirm this finding. Clinical Trial Registration: International Collaboration of Comprehensive Physiologic Assessment Registry (NCT03690713; registration date: 10/01/2018).