OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions.

BACKGROUND: Imaging-guided percutaneous coronary intervention (PCI) is associated with better clinical outcomes than angiography-guided PCI. Whether routine optical coherence tomography (OCT) guidance in PCI of lesions involving coronary-artery branch points (bifurcations) improves clinical outcomes as compared with angiographic guidance is uncertain. METHODS: We conducted a multicenter, randomized, open-label trial at 38 centers in Europe. Patients with a clinical indication for PCI and a complex bifurcation lesion identified by means of coronary angiography were randomly assigned in a 1:1 ratio to OCT-guided PCI or angiography-guided PCI. The primary end point was a composite of major adverse cardiac events (MACE), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years. RESULTS: We assigned 1201 patients to OCT-guided PCI (600 patients) or angiography-guided PCI (601 patients). A total of 111 patients (18.5%) in the OCT-guided PCI group and 116 (19.3%) in the angiography-guided PCI group had a bifurcation lesion involving the left main coronary artery. At 2 years, a primary end-point event had occurred in 59 patients (10.1%) in the OCT-guided PCI group and in 83 patients (14.1%) in the angiography-guided PCI group (hazard ratio, 0.70; 95% confidence interval, 0.50 to 0.98; P = 0.035). Procedure-related complications occurred in 41 patients (6.8%) in the OCT-guided PCI group and 34 patients (5.7%) in the angiography-guided PCI group. CONCLUSIONS: Among patients with complex coronary-artery bifurcation lesions, OCT-guided PCI was associated with a lower incidence of MACE at 2 years than angiography-guided PCI. (Funded by Abbott Vascular and others; OCTOBER ClinicalTrials.gov number, NCT03171311.).

Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomised, non-inferiority trial.

BACKGROUND: Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy. METHODS: FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial comparing a QFR-based with an FFR-based diagnostic strategy for patients with intermediate coronary stenosis. Enrolment was performed in 34 centres across 11 European countries. Patients aged 18 years or older with either chronic coronary syndrome or stabilised acute coronary syndrome, and with at least one intermediate non-culprit stenosis (40-90% diameter stenosis by visual estimate; referred to here as a study lesion), were randomly assigned (1:1) to the QFR-guided or the FFR-guided group. Randomisation was done using a concealed web-based system and was stratified by diabetes and presence of a left anterior descending coronary artery study lesion. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months. The predefined non-inferiority margin was 3·4% and the primary analysis was performed in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03729739) and long-term follow-up is ongoing. FINDINGS: Between Nov 6, 2018, and July 21, 2023, 2000 patients were enrolled and randomly assigned to the QFR-guided strategy (1008 patients) or the FFR-guided strategy (992 patients). The median age was 67·3 years (IQR 59·9-74·7); 1538 (76·9%) patients were male and 462 (23·1%) were female. Median follow-up time was 365 days (IQR 365-365). At 12 months, a primary endpoint event had occurred in 67 (6·7%) patients in the QFR group, and in 41 (4·2%) patients in the FFR group (hazard ratio 1·63 [95% CI 1·11-2·41]). The event proportion difference was 2·5% (90% two-sided CI 0·9-4·2). The upper limit of the 90% CI exceeded the prespecified non-inferiority margin of 3·4%. Therefore, QFR did not meet non-inferiority to FFR. A total of 18 (1·8%) patients in each group experienced an adverse procedural event, the most frequent being procedure-related myocardial infarction, which occurred in ten (1·0%) patients in the QFR group and seven (0·7%) in the FFR group. One patient in the QFR group died in relation to the index procedure. INTERPRETATION: The results of the FAVOR III Europe trial do not support the use of QFR if FFR is available to guide revascularisation decisions in patients with intermediate coronary stenosis. This finding could have implications for current clinical guidelines recommending QFR for this purpose. FUNDING: Medis Medical Imaging Systems and Aarhus University.

Remotely supervised spirometry versus laboratory-based spirometry during the COVID-19 pandemic: a retrospective analysis.

BACKGROUND: The COVID-19 pandemic has constrained access to spirometry, and the inherent risk of infectious transmission during aerosol-generating procedures has necessitated the rapid development of Remotely Supervised Spirometry (RSS). This innovative approach enables patients to perform spirometry tests at home, using a mobile connected spirometer, all under the real-time supervision of a technician through an online audio or video call. METHODS: In this retrospective study, we examined the quality of RSS in comparison to conventional Laboratory-based Spirometry (LS), using the same device and technician. Our sample included 242 patients, with 129 undergoing RSS and 113 participating in LS. The RSS group comprised 51 females (39.5%) with a median age of 37 years (range: 13-76 years). The LS group included 63 females (55.8%) with a median age of 36 years (range: 12-80 years). RESULTS: When comparing the RSS group to the LS group, the percentage of accurate Forced Expiratory Volume in one second (FEV1) measurements was 78% (n = 101) vs. 86% (n = 97), p = 0.177; for Forced Vital Capacity (FVC) it was 77% (n = 99) vs. 82% (n = 93), p = 0.365; and for both FEV1 and FVC, it was 75% (n = 97) vs. 81% (n = 92), p = 0.312, respectively. CONCLUSIONS: Our findings demonstrate no significant difference in the quality of spirometry testing between RSS and LS, a result that held true across all age groups, including patients aged over 65 years. The principal advantages of remote spirometry include improved access to pulmonary function tests, reduced infectious risk to curtail disease spread, and enhanced convenience for patients.

Renal Dysfunction Increases Risk of Adverse Cardiovascular Events in 5-Year Follow-Up Study of Intermediate Coronary Artery Lesions.

BACKGROUND Progression of chronic coronary syndrome (CCS) is influenced by chronic kidney disease (CKD). This 5-year follow-up study aimed to assess 100 patients with 118 intermediate coronary artery lesions evaluated by fractional flow reserve (FFR) and intravascular imaging stratified according to renal function. MATERIAL AND METHODS This prospective study enrolled patients with intermediate coronary stenosis identified by coronary angiogram. Patients with severe renal dysfunction (estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m²) were excluded from the study. The remaining were divided into 2 groups according to eGFR: 45-60 ml/min/1.73 m² for mild-to-moderate renal dysfunction and >60 ml/min/1.73 m² for no renal dysfunction. We analyzed intermediate-grade stenoses (40-80% as assessed in coronary angiography) with the use of optical coherence tomography (OCT), FFR, and intravascular ultrasound (IVUS). RESULTS Renal dysfunction patients were older (67.7±8.1 vs 63.6±9.7 years, P=0.044). Lesion characteristics, including plaque type and minimal lumen area in OCT, showed no significant differences between the renal dysfunction and no renal dysfunction groups. Thin-cap fibroatheroma, calcific plaques, lipidic plaques, and fibrous plaques had similar prevalence. FFR values and IVUS parameters did not significantly differ between the groups. Over a 5-year follow-up, individuals with mild-to-moderate renal dysfunction had an elevated risk of all-cause mortality and major adverse cardiovascular events in multivariate analyses adjusted for age and sex. CONCLUSIONS Mild-to-moderate renal dysfunction was not associated with significant differences in OCT- and IVUS-derived plaque morphology nor with functional indices characterizing intermediate-grade coronary stenoses. Renal dysfunction was related to a higher risk of all-cause mortality and major adverse cardiovascular events prevalence in 5-year follow-up.

Implementation of Microcirculation Examination in Clinical Practice-Insights from the Nationwide POL-MKW Registry.

Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.

Implementation of a screening and management pathway for chronic obstructive pulmonary disease in patients with atrial fibrillation.

AIMS: Chronic obstructive pulmonary disease (COPD) negatively impacts the efficacy of heart rhythm control treatments in patients with atrial fibrillation (AF). Although COPD is recognized as a risk factor for AF, practical guidance about how and when to screen for COPD is not available. Herein, we describe the implementation of an integrated screening and management pathway for COPD into the existing pre-ablation work-up in an AF outpatient clinic infrastructure. METHODS AND RESULTS: Consecutive unselected patients accepted for AF catheter ablation in the Maastricht University Medical Center+ were prospectively screened for airflow limitation using handheld (micro)spirometry at the pre-ablation outpatient clinic supervised by an AF nurse. Patients with results suggestive of airflow limitation were offered referral to the pulmonologist. Handheld (micro)spirometry was performed in 232 AF patients, which provided interpretable results in 206 (88.8%) patients. Airflow limitation was observed in 47 patients (20.3%). Out of these 47 patients, 29 (62%) opted for referral to the pulmonologist. The primary reason for non-referral was low perceived symptom burden. Using this screening strategy 17 (out of 232; 7.3%) ultimately received a diagnosis of chronic respiratory disease, either COPD or asthma. CONCLUSION: A COPD care pathway can successfully be embedded in an existing AF outpatient clinic infrastructure, using (micro)spirometry and remote analysis of results. Although one out of five patients had results suggestive of an underlying chronic respiratory disease, only 62% of these patients opted for a referral. Pre-selection of patients as well as patient education might increase the diagnostic yield and requires further research.

Third-Generation Sirolimus-Eluting Bioresorbable Tyrocore Scaffold Implantation in Patients with ST-Segment Elevation Myocardial Infarction: Baseline and 6-Month OCT and Clinical Outcomes-a FANTOM STEMI Pilot Study.

PURPOSE: The aim of this study was to evaluate the safety and efficacy of the Fantom BRS 6 months after implantation using the optical coherence tomography (OCT) imaging. METHODS: Twenty STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into a prospective, single-arm, serial observational study. The scaffold sizing, positioning and optimisation were guided by OCT imaging. The primary endpoint was device-orientated composite endpoints (DOCE), comprised of cardiac death, target-vessel-related myocardial infarction and target lesion failure. To evaluate the device performance at the scaffold level, we performed a quantitative coronary angiography (QCA) and OCT imaging at 6 months. RESULTS: The primary endpoint did not occur in any patient within the 6-month follow-up. There were no major adverse cardiac events (MACEs) or DOCEs, no cases of scaffold thrombosis, target lesion revascularization and no deaths. In QCA, we observed a decrease in the minimum and mean lumen diameter in the in-scaffold region and in the proximal and distal peri-scaffold region. Similarly, the minimum lumen area and reference vessel diameter had decreased in both QCA and OCT. The OCT imaging showed improvement in the expansion index and malposition rate. CONCLUSION: A serial 6-month OCT imaging after implantation of a third-generation Tyrocore-based bioresorbable coronary scaffold indicated good coverage of the struts with excellent healing of the scaffold, low neointima growth and no signs of neoatherosclerosis.

Assessment of a new KoMaWo electrode-patch configuration accuracy and review of the literature.

INTRODUCTION: Standard 12­lead electrocardiogram (ECG) is a basic element of routine everyday clinical practice. Traditional cardiac monitoring devices are associated with considerable limitations. Adhesive patches, novel digital solutions, may become a useful diagnostic tool for several cardiovascular diseases. MATERIALS AND METHODS: We propose a new variation of ECG electrodes positioning called KoMaWo. 15 consecutive patients presenting with ST segment deviations due to coronary artery disease were enrolled. The accuracy and utility of the new configuration was assessed and compared with the Mason-Likar configuration, as well as with a standard 12­lead ECG recording. The scans were blinded and interpreted by two independent cardiologists. RESULTS: There were no statistically significant differences in morphology, as well as in the duration of individual waves, complexes, segments, and intervals between the scans obtained using all three methods. In a subgroup analysis, with regard to age, body mass and left ventricle ejection fraction (LVEF), KoMaWo was non-inferior to standard ECG with a 0.2 mm margin. DISCUSSION: The role of traditional cardiac monitoring devices is recognized as the gold standard of patient management. However, certain limitations should be considered. Adhesive patches are light-weight, well-tolerated and do not interfere with daily activities of patients. These novel devices allow for extended monitoring, facilitating increased diagnostic accuracy, regarding cardiac arrhythmias. CONCLUSIONS: The KoMaWo configuration is not inferior to standard electrode placement, nor to Mason-Likar configuration, including its ability to capture ST segment deviations. Adhesive patches may become a valid alternative for traditional cardiac monitoring methods.

Resting distal to aortic pressure ratio and fractional flow reserve discordance affects the diagnostic performance of quantitative flow ratio: Results from an individual patient data meta-analysis.

OBJECTIVE: To evaluate the diagnostic performance of quantitative flow ratio (QFR) related to fractional flow reserve (FFR) and resting distal-to-aortic pressure ratio (resting Pd/Pa) concordance. BACKGROUND: QFR is a method for computation of FFR based on standard coronary angiography. It is unclear how QFR is performed in patients with discordance between FFR and resting pressure ratios (distal-to-aortic pressure ratio [Pd/Pa]). MATERIALS AND METHODS: The main comparison was the diagnostic performance of QFR with FFR as reference stratified by correspondence between FFR and resting Pd/Pa. Secondary outcome measures included distribution of clinical or procedural characteristics stratified by FFR and resting Pd/Pa correspondence. RESULTS: Four prospective studies matched the inclusion criteria. Analysis was performed on patient level data reaching a total of 759 patients and 887 vessels with paired FFR, QFR, and resting Pd/Pa. Median FFR was 0.85 (IQR: 0.77-0.90). Diagnostic accuracy of QFR with FFR as reference was higher if FFR corresponded to resting Pd/Pa: accuracy 90% (95% CI: 88-92) versus 72% (95% CI: 64-80), p < .001, and sAUC 0.95 (95% CI: 0.92-0.96) versus 0.73 (95% CI: 0.69-0.77), p < .001. Resting Pd/Pa and FFR discordance were related to age, sex, hypertension, and lesion severity. CONCLUSION: Diagnostic performance of QFR with FFR as reference is reduced for lesions with discordant FFR (≤0.80) and resting Pd/Pa (≤0.92) measurements.

Home self-monitoring in patients with asthma using a mobile spirometry system.

BACKGROUND: Self-management is an appealing strategy for prevention of asthma exacerbations. This study aimed to evaluate the feasibility and safety of a portable spirometer for unsupervised home spirometry measurements among patients with asthma. METHODS: A multi-center, prospective, single-arm, open study recruited 86 patients with controlled or partly controlled asthma (41 women, 38.6 ± 10.4 y/o and 45 men, 36.2 ± 12.1 y/o). After a training session, patients performed daily spirometry at home with the AioCare® mobile spirometry system. Each spirometry examination was recorded and evaluated according to the ATS/ERS acceptability and repeatability criteria. The primary endpoint was defined as three or more acceptable examinations in any given seven-day period (+/- 1 day) during any of the three weeks of the study. The system allowed for online review of measurements by physicians/nurses to provide feedback to patients. RESULTS: Of 78 patients with complete data, 67 (86%) achieved the primary endpoint. Seventy-five (96%) participants used the device correctly once or more, and 10 (13%) patients succeeded every single day over the three-week follow-up. The rate of acceptable spirometry examinations differed between the sites (p = 0.013). Retraining was required in 20 of 62 (32%) eligible patients, and successful in 8 individuals (40%). Satisfaction with the AioCare® system was high, 90% of respondents perceived it as useful and user-friendly. CONCLUSIONS: Self-monitoring of asthma with a connected mobile spirometer is feasible, safe and satisfactory for patients with asthma. It remains to be established whether unsupervised home spirometry measurements may improve early diagnosis and outcomes of self-management in cases of exacerbation or loss of asthma control.

Highlights BoxThis study aimed to evaluate the ability of patients with asthma to perform high-quality daily spirometry examinations at home with using the AioCare^® mobile spirometry system. The study showed that unsupervised home spirometry is safe and feasible in patients with asthma. Most patients used the device on most days of the study, and nearly 90% of all patients achieved the primary endpoint. There were no device-related adverse events.

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study.

BACKGROUND: There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus-eluting bioresorbable scaffold (BRS), in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. METHODOLOGY: Ten STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end-point was the device-oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. RESULTS: The primary-end point, defined as DOCE, did not occur in any patient within the 30-day follow-up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in-device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 µm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. CONCLUSIONS: This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up.

Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.

AIMS: The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel. METHODS AND RESULTS: Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups. CONCLUSION: Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.

Diagnostic performance of quantitative flow ratio in prospectively enrolled patients: An individual patient-data meta-analysis.

OBJECTIVES: We aimed to provide robust performance estimates for quantitative flow ratio (QFR) in assessment of intermediary coronary lesions. BACKGROUND: Angiography-based functional lesion assessment by QFR may appear as a cost saving and safe approach to expand the use of physiology-guided percutaneous coronary interventions. QFR was proven feasible and showed good diagnostic performance in mid-sized off-line and on-line studies with fractional flow reserve (FFR) as reference standard. METHODS: We performed a collaborative individual patient-data meta-analysis of all available prospective studies with paired assessment of QFR and FFR using the CE-marked QFR application. The main outcome was agreement of QFR and FFR using a two-step analysis strategy with a multilevel mixed model accounting for study and center level variation. RESULTS: Of 16 studies identified, four studies had prospective enrollment and provided patient level data reaching a total of 819 patients and 969 vessels with paired FFR and QFR: FAVOR Pilot (n = 73); WIFI II (n = 170); FAVOR II China (n = 304) and FAVOR II Europe-Japan (n = 272). We found an overall agreement (mean difference 0.009 ± 0.068, I2 = 39.6) of QFR with FFR. The diagnostic performance was sensitivity 84% (95%CI: 77-90, I2 = 70.1), specificity 88% (95%CI: 84-91, I2 = 60.1); positive predictive value 80% (95%CI: 76-85, I2 = 33.4), and negative predictive value 95% (95%CI: 93-96, I2 = 75.9). CONCLUSIONS: Diagnostic performance of QFR was good with FFR as reference in this meta-analysis of high quality studies. QFR could provide an easy, safe, and cost-effective solution for functional evaluation of coronary artery stenosis.

Guided de-escalation of DAPT in acute coronary syndrome patients undergoing percutaneous coronary intervention with BVS implantation: a post-hoc analysis from the randomized TROPICAL-ACS trial.

To investigate the safety and efficacy of an early platelet function testing (PFT)-guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVS). Early DAPT de-escalation is a new non-inferior alternative to 12-months DAPT in patients with biomarker positive ACS treated with stent implantation. In this post-hoc analysis of the TROPICAL-ACS trial, which randomized 2610 ACS patients to a PFT-guided DAPT de-escalation (switch from prasugrel to clopidogrel) or to control group (uniform prasugrel), we compared clinical outcomes of patients (n = 151) who received a BVS during the index PCI. The frequency of the primary endpoint (cardiovascular death, myocardial infarction, stroke or BARC ≥ 2 bleeding) was 8.8% (n = 6) in the de-escalation group vs. 12.0% (n = 10) in the control group (HR 0.72, 95% CI 0.26-1.98, p = 0.52) at 12 months. One early definite stent thrombosis (ST) occurred in the control group (day 19) and 1 possible ST (sudden cardiovascular death) in the de-escalation group (day 86), both despite prasugrel treatment and in a background of high on-treatment platelet reactivity assessed at day 14 after randomization (ADP-induced platelet aggregation values of 108 U and 59 U, respectively). A PFT-guided DAPT de-escalation strategy could potentially be a safe and effective strategy in ACS patients with BVS implantation but the level of platelet inhibition may be of particular importance. This hypothesis-generating post-hoc analysis requires verification in larger studies with upcoming BVS platforms.

Age and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients undergoing percutaneous coronary intervention: results from the randomized TROPICAL-ACS trial.

Aims: Guided de-escalation of P2Y12-inhibitor treatment was recently identified as an effective alternative treatment strategy in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention. Safety and efficacy of this strategy may differ in relation to patient's age. This pre-specified analysis of the TROPICAL-ACS trial aimed to assess the impact of age on clinical outcomes following guided de-escalation of antiplatelet treatment in ACS patients. Methods and results: Patients were randomly assigned in a 1:1 fashion to either standard treatment with prasugrel for 12 months (control group) or to a guided de-escalation regimen (1 week prasugrel followed by 1 week clopidogrel and platelet function testing guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). We used Cox regression models to assess the associations of age on clinical endpoints and interactions. In younger patients (age ≤70, n = 2240), the 1 year incidence of the primary endpoint (cardiovascular death, myocardial infarction, stroke, or bleeding ≥ grade 2 according to Bleeding Academic Research Consortium criteria) was significantly lower in guided de-escalation vs. control group [5.9% vs. 8.3%; hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.51-0.96; P = 0.03, number needed to treat = 42]. In elderly patients (age >70, n = 370), the absolute risk of events was higher without significant differences between guided de-escalation vs. control group (15.5% vs. 13.6%; HR 1.17, 95% CI 0.69-2.01; P = 0.56). When the impact of age, as a continuous variable, was analysed on outcomes after guided de-escalation vs. control treatment, an increasing relative risk reduction was observed in the primary endpoint by decreasing age (Pint = 0.02), due to significant reductions in bleeding. Conclusion: Treatment effects of guided de-escalation for P2Y12 inhibitors depend on patient's age with younger patients deriving a significant net clinical benefit. Although the safety and efficacy of guided de-escalation in the elderly was similar to uniform prasugrel therapy, this should be further investigated due to the limited sample size of this group.

Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial.

BACKGROUND: Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT). METHODS: In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. FINDINGS: Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (pnon-inferiority=0·0004; hazard ratio [HR] 0·81 [95% CI 0·62-1·06], psuperiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; pnon-inferiority=0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%) in the control group (HR 0·82 [95% CI 0·59-1·13]; p=0·23). INTERPRETATION: Guided de-escalation of antiplatelet treatment was non-inferior to standard treatment with prasugrel at 1 year after PCI in terms of net clinical benefit. Our trial shows that early de-escalation of antiplatelet treatment can be considered as an alternative approach in patients with acute coronary syndrome managed with PCI. FUNDING: Klinikum der Universität München, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo.

Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER).

Background: Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome. Methods and Design: OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non­ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results. Implications: A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.

Incidence, Predictors and Impact of Severe Periprocedural Bleeding According to VARC-2 Criteria on 1-Year Clinical Outcomes in Patients After Transcatheter Aortic Valve Implantation.

There are differences in reporting bleeding complications after transcatheter aortic valve implantation (TAVI), which is a consequence of the lack of consensus for their definition. Furthermore, the amount of data on the impact of peri-procedural bleeding on the mid-term prognosis is still limited. The aim of this study was to investigate the incidence, predictors, and impact of life-threatening and major bleedings as defined by the Valve Academic Research Consortium 2 (VARC-2) in patients after TAVI over the mid-term prognosis.Consecutive patients who underwent TAVI from March 2010 to December 2013 were included. All data were classified according to the VARC-2 criteria. We assessed the incidence and the predictors of serious bleeding events (SBE), defined as life-threatening/disabling (LT/D) or major bleeding, and analyzed their impact on 30-day and 1-year clinical outcome.A total of 129 patients were included (79.1 ± 8.3 years; mean EuroSCORE = 17.8 ± 12.7). The SBE occurred in 25 patients (19.4%), of which 9 (7.0%) had LT/D and 16 (12.4%) had major bleeding. Trans-subclavian (TS) access (OR 4.38, 95% CI 2.13-14.29, P = 0.01) and diabetes (OR 2.93, 95% CI 1.08-7.93, P = 0.03) were identified as independent predictors of SBE. Patients with SBE had higher 30-day mortality (20.0% versus 4.0% P = 0.02) and 1-year mortality (40.0% versus 11.1%, P < 0.002). SBE independently predicted 1-year, all-cause mortality (HR 5.88, 95% CI 1.7319,94, P = 0.005).SBE are frequent after TAVI and are associated with decreased short and mid-term survival. Diabetes and TS access are independent risk factors for SBE.

A 12-month angiographic and optical coherence tomography follow-up after bioresorbable vascular scaffold implantation in patients with ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD). METHODS: We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed a paired analysis of the corresponding frames at baseline and follow-up. RESULTS: At 12 months, the OCT follow-up showed a decrease in the mean lumen area (8.29 ± 1.53 mm(2) vs. 6.82 ± 1.57 mm(2) , P < 0.001), but no significant change in the mean scaffold area (8.49 ± 1.53 mm(2) vs. 8.90 ± 1.51 mm(2) ). Significant decreases in malapposed strut ratio (4.9 ± 8.65% vs. 0.4 ± 1.55%, P < 0.001) and malapposition area (0.29 ± 0.60 mm(2) 0.08 ± 0.32 mm(2) , P = 0.002) were observed. A nonhomogenous proliferation of neointima was revealed with a symmetry index of 0.15 (0.08-0.27), a mean neointima thickness of 203 µm (183-249) and mean neointima area of 2.07 ± 0.51 mm(2) . The quantitative coronary angiography showed late lumen loss of 0.08 ± 0.23 mm and no significant change in the minimal lumen diameter (P = 0.11). There were no major adverse cardiovascular events (MACE), except for one nontarget vessel revascularization. CONCLUSIONS: The OCT revealed a favorable healing pattern after BVS implantation in a STEMI population.

30-day Spirometry Holter method design and prospective observational study.

Asthma underdiagnosis and overdiagnosis remain significant problems for healthcare systems worldwide and indicate considerable pain points with current guidelines and diagnostic methods; therefore, new, targeted approaches seem crucial. This study introduces a novel spirometry-based approach using digital tools for objective asthma diagnosis support. This was a single-centre (Warsaw Medical University, Poland) prospective cohort study. It included adults with suspected asthma per GINA 2020, without confirmed obstruction in ambulatory spirometry. Patients were equipped and trained with a portable spirometer with built-in manoeuvre quality features AioCare® (HealthUp, Poland). The protocol included twice-daily spirometry examinations over four weeks and symptom reporting in the mobile app. The number of obstructions detected, probability of finding obstruction over time, spirometry values' variability, technical correctness, and reported symptoms were evaluated. 26 patients enrolled (14 females, mean age 37.6 years old, BMI 24.7 kg/m^2), with a primary outcome of observed obstruction in 42% of participants (3.08 per patient, 95%CI: 0.78-5.37). The detection probability of obstruction plateaued at 100% within the first 21 days of monitoring. Diurnal PEF and FEV1 variability were exceeded (≥ 10%) in 73% and 66% of patients, respectively. 88% of participants performed over half of their tests correctly. 85% of patients reported symptoms at least once. The Spirometry Holter is a novel and feasible tool for monitoring airway limitation variability in line with GINA guidelines. It shows promise in objectively supporting asthma diagnoses in treatment-naive patients lacking documented prior obstruction.