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Background: Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR)., Aims: We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR., Methods: Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR)., Results: A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES., Conclusions: Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

Despite the use of conventional dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), the risk of adverse events remains high among patients with increased thrombotic risk. Until recently, the optimal antiplatelet strategy to balance the ischaemic and bleeding risks in patients who are undergoing complex high-risk PCI has been unclear. The TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI (TAILORED-CHIP) trial is an investigator-initiated, multicentre, prospective randomised trial to evaluate the efficacy and safety of a time-dependent tailored antiplatelet therapy with an early (<6 months post-PCI) escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin) and a late (>6 months post-PCI) de-escalation (clopidogrel monotherapy) in patients undergoing complex high-risk PCI as compared with standard DAPT (clopidogrel plus aspirin for 12 months). Eligible patients had to have at least one high-risk anatomical or procedural feature or clinical characteristic associated with an increased risk of ischaemic or thrombotic events. The primary endpoint was the net clinical outcome, a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, or clinically relevant bleeding (Bleeding Academic Research Consortium type 2, 3, or 5) at 12 months after randomisation. (ClinicalTrials.gov: NCT03465644).

Background: Paclitaxel-coated balloons (PCB) are a viable alternative to drug-eluting stents in the treatment of de novo coronary lesions. Whether sirolimus represents an alternative to paclitaxel for drug-coated balloons remains elusive., Aims: This randomised, controlled, multicentre, non-inferiority trial investigated a novel sirolimus-coated balloon (SCB) with a crystalline coating versus a PCB in de novo coronary lesions., Methods: To compare a novel SCB with a clinically proven PCB, 70 patients with de novo coronary lesions were enrolled at 4 centres in Germany and Switzerland. The primary endpoint was non-inferiority regarding angiographic late lumen loss (LLL) at 6 months, with a predefined margin of δ=0.35 mm. Secondary endpoints included procedural success, major adverse cardiac events, and individual clinical endpoints., Results: Quantitative coronary angiography revealed no differences in baseline parameters. At 6 months, in-segment LLL was 0.04±0.39 mm in the PCB group versus 0.11±0.37 mm in the SCB group (non-significant), respectively. The mean difference between SCB and PCB was 0.07 mm (95% confidence interval: -0.12 to 0.26). Non-inferiority at the predefined margin of 0.35 was shown. Clinical event rates up to 12 months were not different between the groups (3 target lesion revascularisations in the PCB group versus 2 in the SCB group, no myocardial infarctions, no deaths)., Conclusions: The novel SCB showed similar angiographic outcomes in the treatment of de novo coronary disease as compared with a clinically proven PCB (ClinicalTrials.gov: NCT03908450).

Background: Calcified nodules (CNs) are an increasingly important, high-risk lesion subset., Aims: We sought to identify the emergence of new CNs and the relation between underlying plaque characteristics and new CN development., Methods: Patients who had undergone two optical coherence tomography (OCT) studies that imaged the same untreated calcified lesion at baseline and follow-up were included. New CNs were an accumulation of small calcium fragments at follow-up that were not present at baseline. Cardiac death, myocardial infarction (MI), or clinically driven revascularisation related to OCT-imaged, but untreated, calcified lesions were then evaluated., Results: Among 372 untreated calcified lesions, with a median of 1.5 (first and third quartiles: 0.7-2.9) years between baseline and follow-up OCTs, new CNs were observed in 7.0% (26/372) of lesions at follow-up. Attenuated calcium representing residual lipid (odds ratio [OR] 3.38, 95% confidence interval [CI]: 1.15-9.98; p=0.03); log 10 calcium volume index (length×maximum arc×maximum thickness; OR 2.76, 95% CI: 1.10-6.95; p=0.03); angiographic Δangle between systole and diastole, per 10° (OR 2.30, 95% CI: 1.25-4.22; p=0.01); and time since baseline OCT, per year (OR 1.36, 95% CI: 1.05-1.75; p=0.02) were all associated with new CN development. Clinical events were revascularisation and/or MI and were more frequent in lesions with versus without a new CN (29.3% vs 15.3%; p=0.04)., Conclusions: New CNs developed in untreated, lipid-containing, severely calcified lesions with a larger angiographic hinge motion (between systole and diastole), compared with lesions without CNs, and were associated with worse clinical outcomes.

Background: Whether revascularisation (REV) improves outcomes in patients with three-vessel coronary artery disease (3V-CAD) is uncertain., Aims: Our objective was to evaluate outcomes with REV (percutaneous coronary intervention [PCI] or coronary artery bypass graft surgery [CABG]) versus medical therapy in patients with 3V-CAD., Methods: ISCHEMIA participants with 3V-CAD on coronary computed tomography angiography without prior CABG were included. Outcomes following initial invasive management (INV) with REV (PCI or CABG) versus initial conservative management (CON) with medical therapy alone were evaluated. Regression modelling was used to estimate the outcomes if all participants were to undergo prompt REV versus those assigned to CON. Outcomes were cardiovascular (CV) death/myocardial infarction (MI), death, CV death, and quality of life. Bayesian posterior probability for benefit (Pr [benefit]) for 1 percentage point lower 4-year rates with REV versus CON were evaluated., Results: Among 1,236 participants with 3V-CAD (612 INV/624 CON), REV was associated with lower 4-year CV death/MI (adjusted 4-year difference: -4.4, 95% credible interval [CrI] -8.7 to -0.3 percentage points, Pr [benefit]=94.8%) when compared with CON, with similar results for PCI versus CON (-5.8, 95% CrI: -10.8 to -0.5 percentage points, Pr [benefit]=96.4%) and CABG versus CON (-3.7, 95% CrI: -8.8 to 1.5 percentage points, Pr [benefit]=84.7%). Adjusted 4-year REV versus CON differences were as follows: death -1.2 (95% CrI: -4.7 to 2.2) percentage points, CV death -2.3 (95% CrI: -5.5 to 0.8) percentage points, with similar results for PCI and for CABG. The Pr (benefit) for death with REV (PCI or CABG) versus CON was 49-63%. The adjusted 12-month Seattle Angina Questionnaire-7 summary score differences favoured REV: REV versus CON 4.6 (95% CrI: 2.7-6.4) percentage points; PCI versus CON 3.6 (95% CrI: 1.2-5.8) percentage points and CABG versus CON 4.3 (95% CrI: 1.5-6.9) percentage points with high Pr (benefit)., Conclusions: In participants with 3V-CAD, REV (either PCI or CABG) was associated with a lower 4-year CV death/MI rate and improved quality of life, with similar results for PCI versus CON and CABG versus CON. The differences in all-cause mortality between REV and CON were small with wide confidence intervals. (ClinicalTrials.gov: NCT01471522).

Background: Severe aortic stenosis (AS) is associated with left ventricular (LV) remodelling, likely causing alterations in coronary blood flow and microvascular resistance., Aims: We aimed to evaluate changes in absolute coronary flow and microvascular resistance in patients with AS undergoing transcatheter aortic valve implantation (TAVI)., Methods: Consecutive patients with AS undergoing TAVI with non-obstructive coronary artery disease in the left anterior descending artery (LAD) were included. Absolute coronary flow (Q) and microvascular resistance (R μ ) were measured in the LAD using continuous intracoronary thermodilution at rest and during hyperaemia before and after TAVI, and at 6-month follow-up. Total myocardial mass and LAD-specific mass were quantified by echocardiography and cardiac computed tomography. Regional myocardial perfusion (Q N ) was calculated by dividing absolute flow by the subtended myocardial mass., Results: In 51 patients, Q and R were measured at rest and during hyperaemia before and after TAVI; in 20 (39%) patients, measurements were also obtained 6 months after TAVI. No changes occurred in resting and hyperaemic flow and resistance before and after TAVI nor after 6 months. However, at 6-month follow-up, a notable reverse LV remodelling resulted in a significant increase in hyperaemic perfusion (Q N,hyper : 0.86 [interquartile range {IQR} 0.691.06] vs 1.20 [IQR 0.99-1.32] mL/min/g; p=0.008; pre-TAVI and follow-up, respectively) but not in resting perfusion (Q N,rest : 0.34 [IQR 0.30-0.48] vs 0.47 [IQR 0.36-0.67] mL/min/g; p=0.06)., Conclusions: Immediately after TAVI, no changes occurred in absolute coronary flow or coronary flow reserve. Over time, the remodelling of the left ventricle is associated with increased hyperaemic perfusion.

Background: In order to identify coronary lesions that cause myocardial ischaemia and require revascularisation, fractional flow reserve (FFR) is widely recommended. Recently, a method of estimating the FFR using morphological features measured by an imaging device was developed. However, all the previously developed methods are conducted offline, and such analysis takes approximately 10 minutes., Aims: The aim of this present study was to develop an online measurement of the FFR using an intravascular ultrasound (IVUS) quantitative method (IQ-FFR)., Methods: This prospective, single-centre study included coronary lesions that met the following criteria: (1) presence of at least one stenosis (25-99%); (2) both IVUS and FFR measurement performed just before and after stent implantation, with the wire-derived FFR measured with a standard method; and (3) acquisition of clear images throughout the entire coronary branch., Results: We developed an IVUS analysis system that automatically measures the cross-sectional area every 0.5 mm, and we calculated the IQ-FFR. In the prediction study, we calculated the IQ-FFR on the assumption that one stent of arbitrary length and diameter was implanted. After stent implantation, the wire-derived FFR was measured and compared with the calculated IQ-FFR. We compared 270 coronary lesions with stenosis rates of 32-99%. IQ-FFR measurements were strongly correlated with the wire-derived FFR (r=0.896). In the prediction study, the clinical accuracy of predicting whether the FFR would be greater or less than 0.80 after stent implantation was 87.5%., Conclusions: The IQ-FFR is a promising method to identify coronary lesions requiring revascularisation and to predict the FFR after stent implantation.

Percutaneous coronary intervention (PCI) has been most commonly guided by coronary angiography. However, to overcome the inherent limitations of conventional coronary angiography, there has been an increasing interest in the adjunctive tools of intracoronary imaging for PCI guidance. Recently, optical coherence tomography (OCT) has garnered substantial attention as a valid intravascular imaging modality for guiding PCI. However, despite the unparalleled high-resolution imaging capability of OCT, which offers detailed anatomical information on coronary lesion morphology and PCI optimisation, its broad application in routine PCI practice remains limited. Several factors may have curtailed the widespread adoption of OCT-guided PCI in daily practice, including the transitional challenge from intravascular ultrasound (IVUS), the experienced skill required for image acquisition and interpretation, the lack of a uniform algorithm for OCT-guided PCI optimisation, and the limited clinical evidence. Herein, we provide an in-depth review of OCT-guided PCI, involving the technical aspects, optimal strategies for OCT-guided PCI, and the wide application of OCT-guided PCI in various anatomical subsets. Special attention is given to the latest clinical evidence from recent randomised clinical trials with respect to OCT-guided PCI.

Background: Recent observations in silico and in vivo reported that, during proximal optimisation technique, drug-eluting stents (DES) elongate, challenging conventional wisdom. The interaction between plaque morphology and radial expansion is well established, but little is known about the impact of plaque morphology on elongation., Aims: We aimed to assess the longitudinal mechanical behaviour of contemporary DES in vivo and evaluate the relationship between post-percutaneous coronary intervention (PCI) stent elongation and lesion morphology, as assessed with optical coherence tomography (OCT)., Methods: Patients treated with OCT-guided PCI to left main or left anterior descending artery bifurcations, between July 2017 and March 2022, from the King's Optical coherence Database Analysis Compendium were included. Patients were excluded if there were overlapping stents, if they had undergone prior PCI, or if there was inadequate image quality. Lesions were characterised as fibrocalcific, fibrous or lipid-rich by pre-PCI OCT. Following stent post-dilatation, stent expansion and final stent length were assessed. The primary outcome was the percentage change in stent length from baseline., Results: Of 501 eligible consecutive patients from this period, 116 were included. The median age was 66 years (interquartile range [IQR] 57-76), 31% were female, and 53.4% were treated for an acute coronary syndrome. A total of 50.0% of lesions were classified as fibrocalcific, 6.9% were fibrous, and 43.1% were lipid-rich. The change in relative stent length was 4.4% (IQR 1.0-8.9), with an increase of 3.1% (IQR 0.5-6.3) in fibrocalcific lesions, 3.3% (IQR 0.5-5.9) in fibrous lesions, and 6.4% (IQR 3.1-11.1) in lipid-rich plaque (p=0.006). In multivariate regression modelling, lipid-rich plaque was an independent predictor of stent elongation (odds ratio 3.689, 95% confidence interval: 1.604-8.484)., Conclusions: Contemporary DES elongate following implantation and post-dilatation, and this is significantly mediated by plaque morphology. This is an important consideration when planning a strategy for DES implantation.

Background: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss., Aims: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns., Methods: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing., Results: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm 2 to 4.75 mm 2 ; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months., Conclusions: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.

The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging.

Background: Complete revascularisation is supported by recent trials in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) without cardiogenic shock. However, the optimal timing of non-culprit lesion revascularisation is currently debated., Aims: This prespecified analysis of the BioVasc trial aims to determine the effect of immediate complete revascularisation (ICR) compared to staged complete revascularisation (SCR) on clinical outcomes in patients with STEMI., Methods: Patients presenting with STEMI and MVD were randomly assigned to ICR or SCR. The primary endpoint was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1-year post-index procedure., Results: Between June 2018 and October 2021, 608 (ICR: 305, SCR: 303) STEMI patients were enrolled. No significant differences between ICR and SCR were observed at 1-year follow-up in terms of the primary endpoint (7.0% vs 8.3%, hazard ratio [HR] 0.84, 95% confidence interval [CI]: 0.47-1.50; p=0.55): all-cause mortality (2.3% vs 1.3%, HR 1.77, 95% CI: 0.52-6.04; p=0.36), myocardial infarction (1.7% vs 3.3%, HR 0.50, 95% CI: 0.17-1.47; p=0.21), unplanned ischaemia-driven revascularisation (4.1% vs 5.0%, HR 0.80, 95% CI: 0.38-1.71; p=0.57) and cerebrovascular events (1.4% vs 1.3%, HR 1.01, 95% CI: 0.25-4.03; p=0.99). At 30-day follow-up, a trend towards a reduction of the primary endpoint in the ICR group was observed (ICR: 3.0% vs SCR: 6.0%, HR 0.50, 95% CI: 0.22-1.11; p=0.09). ICR was associated with a reduction in overall hospital stay (ICR: median 3 [interquartile range {IQR} 2-5] days vs SCR: median 4 [IQR 3-6] days; p<0.001)., Conclusions: Clinical outcomes at 1 year were similar for STEMI patients who had undergone ICR and those who had undergone SCR.

Background: Transfemoral access is often used when large-bore guide catheters are required for percutaneous coronary intervention (PCI) of complex coronary lesions, especially when large-bore transradial access is contraindicated. Whether the risk of access site complications for these procedures may be reduced by ultrasound-guided puncture is unclear., Aims: We aimed to show the superiority of ultrasound-guided femoral puncture compared to fluoroscopy-guided access in large-bore complex PCI with regard to access site-related Bleeding Academic Research Consortium 2, 3 or 5 bleeding and/or vascular complications requiring intervention during hospitalisation., Methods: The ULTRACOLOR Trial is an international, multicentre, randomised controlled trial investigating whether ultrasound-guided large-bore femoral access reduces clinically relevant access site complications compared to fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions., Results: A total of 544 patients undergoing complex PCI mandating large-bore (≥7 Fr) transfemoral access were randomised at 10 European centres (median age 71; 76% male). Of these patients, 68% required PCI of a chronic total occlusion. The primary endpoint was met in 18.9% of PCI with fluoroscopy-guided access and 15.7% of PCI with ultrasound-guided access (p=0.32). First-pass puncture success was 92% for ultrasound-guided access versus 85% for fluoroscopy-guided access (p=0.02). The median time in the catheterisation laboratory was 102 minutes versus 105 minutes (p=0.43), and the major adverse cardiovascular event rate at 1 month was 4.1% for fluoroscopy-guided access and 2.6% for ultrasound-guided access (p=0.32)., Conclusions: As compared to fluoroscopy-guided access, the routine use of ultrasound-guided access for large-bore transfemoral complex PCI did not significantly reduce clinically relevant bleeding or vascular access site complications. A significantly higher first-pass puncture success rate was demonstrated for ultrasound-guided access., Clinicaltrials: gov identifier: NCT04837404.

Background: The treatment of in-stent restenosis (ISR) after drug-eluting stent (DES) implantation remains challenging in current clinical practice., Aims: The study was conducted to investigate a novel biolimus-coated balloon (BCB) for the treatment of coronary DES-ISR compared with the best-investigated paclitaxel-coated balloon (PCB)., Methods: This was a prospective, multicentre, randomised, non-inferiority trial comparing a novel BCB with a clinically proven PCB for coronary DES-ISR. The primary endpoint was in-segment late lumen loss (LLL) at 9 months assessed by an independent core laboratory. Baseline and follow-up optical coherence tomography were performed in a prespecified subgroup of patients., Results: A total of 280 patients at 17 centres were randomised to treatment with a BCB (n=140) versus a PCB (n=140). At 9 months, LLL in the BCB group was 0.23±0.37 mm compared to 0.25±0.35 mm in the PCB group; the mean difference between the groups was -0.02 (95% confidence interval [CI]: -0.12 to 0.07) mm; p-value for non-inferiority<0.0001. Similar clinical outcomes were also observed for both groups at 12 months. In the optical coherence tomography substudy, the neointimal area at 9 months was 2.32±1.04 mm 2 in the BCB group compared to 2.37±0.93 mm 2 in the PCB group; the mean difference between the groups was -0.09 (95% CI: -0.94 to 0.76) mm 2 ; p=non-significant., Conclusions: This head-to-head comparison of a novel BCB shows similar angiographic outcomes in the treatment of coronary DES-ISR compared with a clinically proven PCB. (ClinicalTrials.gov: NCT04733443).

Background: There are limited data about determinant factors of target lesion failure (TLF) in lesions after percutaneous coronary intervention (PCI) using a drug-coated balloon (DCB) for de novo coronary artery lesions, including optical coherence tomography (OCT) findings., Aims: The present study aims to investigate the associated factors of TLF in de novo coronary artery lesions with DCB treatment., Methods: We retrospectively enrolled 328 de novo coronary artery lesions in 328 patients who had undergone PCI with a DCB. All lesions had been treated without a stent, and both pre- and post-PCI OCT had been carried out. Patients were divided into two groups, with or without TLF, which was defined as a composite of culprit lesion-related cardiac death, myocardial infarction, and target lesion revascularisation, and the associated factors of TLF were assessed., Results: At the median follow-up period of 460 days, TLF events occurred in 31 patients (9.5%) and were associated with patients requiring haemodialysis (HD; 29.0% vs 10.8%), with a severely calcified lesion (median maximum calcium arc 215° vs 104°), and with the absence of OCT medial dissection (16.1% vs 60.9%) as opposed to those without TLF events. In Cox multivariable logistic regression analysis, HD (hazard ratio [HR]: 2.26, 95% confidence interval [CI]: 1.00-5.11; p=0.049), maximum calcium arc (per 90°, HR: 1.34, 95% CI: 1.05-1.72; p=0.02), and the absence of post-PCI medial dissection on OCT (HR: 8.24, 95% CI: 3.15-21.6; p<0.001) were independently associated with TLF., Conclusions: In de novo coronary artery lesions that received DCB treatment, factors associated with TLF were being on HD, the presence of a severely calcified lesion, and the absence of post-PCI medial dissection.

Background: The hyperaemic stenosis resistance (HSR) index was introduced to provide a more comprehensive indicator of the haemodynamic severity of a coronary lesion. HSR combines both the pressure drop across a lesion and the flow through it. As such, HSR overcomes the limitations of the more traditional fractional flow reserve (FFR) or coronary flow reserve (CFR) indices., Aims: We aimed to identify the diagnostic and prognostic value of HSR and evaluate the clinical implications., Methods: Patients with chronic coronary syndromes (CCS) and obstructive coronary artery disease were selected from the multicentre ILIAS Registry. For this study, only patients with combined Doppler flow and pressure measurements were included., Results: A total of 853 patients with 1,107 vessels were included. HSR more accurately identified the presence of inducible ischaemia compared to FFR and CFR (area under the curve 0.71 vs 0.66 and 0.62, respectively; p<0.005 for both). An abnormal HSR measurement was an independent and important predictor of target vessel failure at 5-year follow-up (hazard ratio 3.80, 95% confidence interval: 2.12-6.73; p<0.005). In vessels deferred from revascularisation, HSR seems to identify more accurately those vessels that may benefit from revascularisation rather than FFR and/or CFR., Conclusions: The present study affirms the theoretical advantages of the HSR index for the detection of ischaemia-Âinducing coronary lesions in a large CCS population. (Inclusive Invasive Physiological Assessment in Angina Syndromes Registry [ILIAS Registry], ClinicalTrials.gov: NCT04485234).

Background: Thin-cap fibroatheroma (TCFA) lesions are associated with a high risk of future major adverse cardiovascular events. However, the impact of other optical coherence tomography-detected vulnerability features (OCT-VFs) and their interplay with TCFA in predicting adverse events remains unknown., Aims: We aimed to evaluate the individual as well as the combined prognostic impact of OCT-VFs in predicting the incidence of the lesion-oriented composite endpoint (LOCE) in non-ischaemic lesions in patients with diabetes mellitus (DM)., Methods: COMBINE OCT-FFR (ClinicalTrials.gov: NCT02989740) was a prospective, double-blind, international, natural history study that included DM patients with ≥1 non-culprit lesions with a fractional flow reserve>0.80 undergoing systematic OCT assessment. OCT-VFs included the following: TCFA, reduced minimal lumen area (r-MLA), healed plaque (HP), and complicated plaque (CP). The primary endpoint, LOCE - a composite of cardiac mortality, target vessel myocardial infarction, or clinically driven target lesion revascularisation up to 5 years - was analysed according to the presence of these OCT-VFs, both individually and in combination., Results: TCFA, r-MLA, HP and CP were identified in 98 (25.3%), 190 (49.0%), 87 (22.4%), and 116 (29.9%) patients, respectively. The primary endpoint rate increased progressively from 6.3% to 55.6% (hazard ratio 15.2, 95% confidence interval: 4.53-51.0; p<0.001) in patients without OCT-VFs as compared to patients with concomitant HP, r-MLA, CP, and TCFA. The coexistence of TCFA with other OCT-VFs resulted in an increased risk of the LOCE at 5 years., Conclusions: In DM patients with non-ischaemic lesions, TCFA was the strongest predictor of future LOCE events. However, lesions that present additional OCT-VFs are associated with a higher risk of adverse events than OCT-detected TCFA alone. Further randomised studies are warranted to confirm these findings and their potential clinical implications.

Background: Compared with thin-strut durable-polymer drug-eluting stents (DP-DES), ultrathin-strut biodegradable-polymer sirolimus-eluting stents (BP-SES) improve stent-related clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Reduced stent strut thickness is hypothesised to underlie these benefits, but this conjecture remains unproven., Aims: We aimed to assess the impact of strut thickness on stent healing and clinical outcomes between ultrathin-strut and thin-strut BP-SES., Methods: First, we performed a preclinical study of 8 rabbits implanted with non-overlapping thin-strut (diameter/thickness 3.5 mm/80 μm) and ultrathin-strut (diameter/thickness 3.0 mm/60 μm) BP-SES in the infrarenal aorta. On day 7, the rabbits underwent intravascular near-infrared fluorescence optical coherence tomography (NIRF-OCT) molecular-structural imaging of fibrin deposition and stent tissue coverage, followed by histopathological analysis. Second, we conducted an individual data pooled analysis of patients enrolled in the BIOSCIENCE and BIOSTEMI randomised PCI trials treated with ultrathin-strut (n=282) or thin-strut (n=222) BP-SES. The primary endpoint was target lesion failure (TLF) at 1-year follow-up, with a landmark analysis at 30 days., Results: NIRF-OCT image analyses revealed that ultrathin-strut and thin-strut BP-SES exhibited similar stent fibrin deposition (p=0.49) and percentage of uncovered stent struts (p=0.63). Histopathological assessments corroÂborated these findings. In 504 pooled randomised trial patients, TLF rates were similar for those treated with ultrathin-strut or thin-strut BP-SES at 30-day (2.5% vs 1.8%; p=0.62) and 1-year follow-up (4.3% vs 4.7%; p=0.88)., Conclusions: Ultrathin-strut and thin-strut BP-SES demonstrate similar early arterial healing profiles and 30-day and 1-year clinical outcomes.

Background: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique., Aims: We aimed to assess the impact of different calcium morphologies on IVL efficacy., Methods: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions., Results: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm 2 vs 6.2±2.1 mm 2 ; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm 2 ; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%., Conclusions: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Background: Late lumen enlargement (LLE) - a positive remodelling phenomenon - after drug-coated balloon (DCB) angioplasty for stable coronary disease contributes to a lower restenosis rate. However, lesion characteristics promoting LLE remain unclear., Aims: This study aimed to investigate predictive lesion characteristics for LLE using serial optical frequency domain imaging (OFDI) following DCB angioplasty for de novo coronary artery lesions., Methods: This retrospective, single-centre observational study included patients with angina pectoris who underwent paclitaxel-coated balloon angioplasty without stenting under OFDI guidance as well as follow-up OFDI. OFDI endpoints were lumen volume, plaque phenotype, and procedure-associated dissection. LLE was defined as a ≥10% increase in the lumen volume of the treated lesion at follow-up., Results: Between August 2016 and December 2019, among patients with successful DCB angioplasty, 108 lesions (83 patients) had available follow-up imaging after a median of 6.1 months. LLE was detected in 44 (40.7%) lesions. Fibrous/fibrocalcific and layered plaques had significantly larger lumen volumes at follow-up than immediately after the index procedure, whereas lipid plaques exhibited no significant difference. Medial dissection with an arc >90° revealed an increased lumen volume. Multivariate analysis showed that layered plaques (odds ratio [OR] 8.73, 95% confidence interval [CI]: 1.92-39.7; p=0.005) and medial dissection with an arc >90° (OR 4.65, 95% CI: 1.63-13.3; p=0.004) were independent LLE predictors., Conclusions: Layered plaques and extensive medial dissection after DCB angioplasty were associated with higher LLE occurrence in de novo coronary lesions. These findings may be clinically applicable to DCB therapeutic strategies based on plaque features.

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.

Background: In the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial, among participants with stable coronary artery disease, the risk of cardiac events was similar between an invasive (INV) strategy of angiography and coronary revascularisation and a conservative (CON) strategy of initial medical therapy alone. Outcomes according to participant sex were not reported., Aims: We aimed to analyse the outcomes of ISCHEMIA by participant sex., Methods: We evaluated 1) the association between participant sex and the likelihood of undergoing revascularisation for participants randomised to the INV arm; 2) the risk of the ISCHEMIA primary composite outcome (cardiovascular death, any myocardial infarction [MI] or rehospitalisation for unstable angina, heart failure or resuscitated cardiac arrest) by participant sex; and 3) the contribution of the individual primary outcome components to the composite outcome by participant sex., Results: Of 5,179 randomised participants, 1,168 (22.6%) were women. Female sex was independently associated with a lower likelihood of revascularisation when assigned to the INV arm (adjusted odds ratio 0.75, 95% confidence interval [CI]: 0.57-0.99; p=0.04). The INV versus CON effect on the primary composite outcome was similar between sexes (women: hazard ratio [HR] 0.96, 95% CI: 0.70-1.33; men: HR 0.90, 95% CI: 0.76-1.07; p interaction =0.71). The contribution of the individual components to the composite outcome was similar between sexes except for procedural MI, which was significantly lower in women (9/151 [5.9%]) than men (67/519 [12.9%]; p=0.01)., Conclusions: In ISCHEMIA, women assigned to the INV arm were less likely to undergo revascularisation than men. The effect of an INV versus CON strategy was consistent by sex, but women had a significantly lower contribution of procedural MI to the primary outcome.

Background: Drug-coated balloons (DCBs) are important treatment options for coronary artery disease; however, randomised controlled trials comparing various DCB technologies are sparse, and further investigations are needed., Aims: This preclinical study aimed to histologically and biologically compare the drug effects and safety of a low-dose paclitaxel-coated DCB (PCB; AGENT), a regular-dose PCB (SeQuent Please NEO) and a sirolimus-coated DCB (SCB; MagicTouch)., Methods: The DCBs were inflated in the healthy iliac arteries of 18 rabbits, which were euthanised after 28 days. The treated iliac arteries and distal skeletal muscles were histopathologically evaluated, and drug concentrations were measured., Results: In the histopathological evaluation, the medial smooth muscle cell loss score regarding depth, an indicator of drug efficacy, was significantly higher with AGENT and SeQuent Please NEO than with MagicTouch (4.0 [3.6-4.0] vs 3.7 [3.7-4.0] vs 2.2 [2.0-2.4]), with significant differences in comparisons between AGENT and MagicTouch (p<0.01) and between SeQuent Please NEO and MagicTouch (p<0.01). AGENT and SeQuent Please NEO showed comparable drug concentrations in the treated artery (p=0.61). In contrast, the drug concentrations in distal skeletal muscles were the highest for MagicTouch, followed by SeQuent Please NEO and AGENT (28.07 [13.19-52.46] ng/mg vs 0.66 [0.22-3.76] ng/mg vs 0.25 [0.04-3.23] ng/mg, respectively)., Conclusions: This study demonstrated that PCBs might have higher efficacy and lower drug concentrations in distal skeletal muscles than the MagicTouch SCB. The efficacy of the AGENT low-dose PCB and the SeQuent Please NEO regular-dose PCB was comparable.

The coronary sinus Reducer (CSR) is an hourglass-shaped device which creates an artificial stenosis in the coronary sinus. Whilst placebo-controlled data show an improvement in angina, these results are unreplicated and are the subject of further confirmatory research. The mechanism of action of this unintuitive therapy is unknown. The Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia, and Microvascular Resistance (ORBITA-COSMIC) trial is a randomised, placebo-controlled, double-blind trial investigating the efficacy of the CSR. Patients with (i) established epicardial coronary artery disease, (ii) angina on maximally tolerated antianginal medication, (iii) evidence of myocardial ischaemia and (iv) no further options for percutaneous coronary intervention or coronary artery bypass grafting will be enrolled. Upon enrolment, angina and quality-of-life questionnaires, treadmill exercise testing and quantitative stress perfusion cardiac magnetic resonance (CMR) imaging will be performed. Participants will record their symptoms daily on a smartphone application throughout the trial. After a 2-week symptom assessment phase, participants will be randomised in the cardiac catheterisation laboratory to CSR or a placebo procedure. After 6 months of blinded follow-up, all prerandomisation tests will be repeated. A prespecified subgroup will undergo invasive coronary physiology assessment at prerandomisation and follow-up. The primary outcome is stress myocardial blood flow on CMR. Secondary outcomes include angina frequency, quality of life and treadmill exercise time. (ClinicalTrials.gov: NCT04892537).

Background: Outcomes after percutaneous coronary intervention (PCI) for de novo ostial right coronary artery (RCA) lesions are poor., Aims: We used intravascular ultrasound (IVUS) to clarify the morphological patterns of de novo ostial RCA lesions and their associated clinical outcome., Methods: Among 5,102 RCA IVUS studies, 170 de novo ostial RCA stenoses (within 3 mm from the aorto-ostium) were identified. These were classified as 1) isolated ostial lesions (no disease extending beyond 10 mm from the ostium and without a calcified nodule [CN]); 2) ostial CN, typically with diffuse disease (disease extending beyond 10 mm); and 3) ostial lesions with diffuse disease but without a CN. The primary outcome was target lesion failure (TLF: cardiac death, target vessel myocardial infarction, definite stent thrombosis, and ischaemia-driven target lesion revascularisation)., Results: The prevalence of an isolated ostial lesion was 11.8% (n=20), 47.6% (n=81) were ostial CN, and 40.6% (n=69) were ostial lesions with diffuse disease. Compared to ostial lesions with diffuse disease, isolated lesions were more common in women (75.0% vs 42.0%; p=0.01), and CN were associated with older age (median [first, third quartile] 76 [70, 83] vs 69 [63, 81] years old; p=0.002). The Kaplan-Meier rate of TLF at 2 years was significantly higher in patients with CN (21.6%) compared to diffuse lesions (8.2%) (p=0.04), and patients with isolated lesions had no events. A multivariable Cox proportional hazard model revealed that CN were significantly associated with TLF (hazard ratio 6.63, 95% confidence interval: 1.28-34.3; p=0.02)., Conclusions: Ostial RCA lesions have specific morphologies - detectable by IVUS - that may be associated with long-term clinical outcomes.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients.

Background: Target lesion failure (TLF) remains an issue with contemporary drug-eluting stents. The dual-therapy sirolimus-eluting and CD34 antibody-coated COMBO stent (DTS) was designed to improve early healing., Aims: We aimed to compare the 3-year outcomes of the DTS and the sirolimus-eluting Orsiro stent (SES) in all-comer patients treated with percutaneous coronary intervention., Methods: The SORT OUT X trial is a prospective multicentre randomised clinical trial with a registry-based follow-up comparing DTS and SES. The primary endpoint, TLF, is a composite of cardiac death, myocardial infarction or target lesion revascularisation (TLR)., Results: A total of 3,146 patients were randomised to treatment with the DTS (1,578 patients) or the SES (1,568 patients). At 3 years, an intention-to-treat analysis showed that 155 patients (9.8%) who were assigned the DTS and 118 patients (7.5%) who were assigned the SES met the primary endpoint (incidence rate ratio for TLF=1.33, 95% confidence interval: 1.04-1.70; p=0.02). This difference was caused by a significantly higher TLF rate in the DTS group compared to the SES group within the first year, which was mainly explained by a higher incidence of TLR in the DTS group compared to the SES group. Of note, the TLF rates were almost identical from 1 year to 3 years in both stent groups., Conclusions: At 3 years, the SES was superior to the DTS, mainly because the DTS was associated with an increased risk of TLF within the first year but not from 1 to 3 years., Clinicaltrials: gov: NCT03216733.

Background: The quantitative flow ratio (QFR) identifies functionally ischaemic lesions that may benefit more from percutaneous coronary intervention (PCI) than from medical therapy., Aims: This study investigated the association between QFR and myocardial infarction (MI) as affected by PCI versus medical therapy., Methods: All vessels requiring measurement (reference diameter ≥2.5 mm and existence of at least one stenotic lesion with diameter stenosis of 50-90%) in the FAVOR III China (5,564 vessels) and PANDA-III trials (4,471 vessels) were screened and analysed for offline QFR. The present study reported clinical outcomes on a per-vessel level. Interaction between vessel treatment and QFR as a continuous variable was evaluated for the threshold of 2-year MI estimated by Cox proportional hazards model., Results: Compared with medical therapy at 2 years, PCI reduced the MI risk in vessels with a QFR ≤0.80 (3.0% vs 4.6%) but increased the MI risk in vessels with a QFR>0.80 (3.6% vs 1.2%). Additionally, continuous QFR showed an inverse association with spontaneous MI (hazard ratio [HR] 0.89, 95% confidence interval [CI]: 0.79-0.99; p=0.04) that was reduced by PCI compared to medical therapy (HR 0.26, 95% CI: 0.17-0.40; p<0.0001). The interaction indicated a net benefit for PCI over medical therapy to reduce total MI beginning at QFR ≤0.64., Conclusions: The present study demonstrated a continuous, inverse relationship between the QFR value of a vessel and its subsequent risk for MI, and PCI, compared to medical therapy, reduced this risk beginning at a QFR value of 0.64. These novel findings provide physicians with an angiographic tool for optimising vessel selection for PCI.

Background: Long-term data concerning the efficacy of different polymer-coating strategies of new-generation drug-eluting stents (DES) in patients with coronary artery calcification (CAC) are scant., Aims: We aimed to investigate 10-year outcomes by degree of CAC after new-generation DES implantation with different polymer-coating strategies., Methods: We analysed individual patient and lesion characteristics of patients randomised to treatment with polymer-free sirolimus-eluting, biodegradable-polymer sirolimus-eluting and permanent-polymer zotarolimus- or everolimus-eluting stents. Endpoints of interest at 10 years were all-cause mortality, myocardial infarction (MI), target lesion revascularisation (TLR) and definite or probable stent thrombosis (ST) according to the degree of CAC (no, mild, moderate or severe) and coating strategy (polymer-free vs biodegradable-polymer vs permanent-polymer)., Results: A total of 4,953 patients with 6,924 lesions were included. No, mild, moderate or severe CAC was present in 24.5%, 41.8%, 25.8% and 8.0% of patients, respectively. At 10-year follow-up, overall event rates were high, with an incremental increase according to the degree of CAC (all-cause mortality: no 25.3%, mild 32.1%, moderate 41.7%, severe CAC 46.5%; adjusted [adj.] p=0.004; TLR: no 17.4%, mild 16.5%, moderate 19.8%, severe CAC 28.7%; adj. p=0.001; MI: no 4.9%, mild 5.9%, moderate 6.0%, severe CAC 10.5%; adj. p=0.02; and ST: no 1.3%, mild 1.4%, moderate 1.8%, severe CAC 3.6%; adj. p=0.57). In patients with moderate-severe CAC, event rates were comparable, regardless of the DES polymer-coating strategy., Conclusions: At 10 years after PCI with new-generation DES, there was an incremental increase in adverse events by degree of coronary calcification. These detrimental effects do not seem to be impacted by different polymer-coating strategies.

Background: While intravascular imaging guidance during percutaneous coronary intervention (PCI) improves outcomes, routine intravascular imaging usage remains low, in part due to perceived inefficiency and safety concerns.  Aims: The LightLab (LL) Initiative was designed to evaluate whether implementing a standardised optical coherence tomography (OCT) workflow impacts PCI safety metrics and procedural efficiency., Methods: In this multicentre, prospective, observational study, PCI procedural data were collected over 2 years from 45 physicians at 17 US centres. OCT-guided PCI incorporating the LL workflow (N=264), a structured algorithm using routine pre- and post-PCI OCT imaging, was compared with baseline angiography-only PCI (angio) (N=428). Propensity score analysis identified 207 matched procedures. Outcomes included procedure time, radiation exposure, contrast volume, device utilisation, and treatment strategy., Results: Compared with angiography alone, LL workflow OCT-guided PCI increased the median procedural time by 9 minutes but reduced vessel preparation time (2 min LL workflow vs 3 min angio; p<0.001) and resulted in less unplanned additional treatment (4% LL workflow vs 10% angio; p=0.01). With LL workflow OCT guidance, fewer cineangiography views were needed compared to angiography guidance, leading to decreased radiation exposure (1,133 mGy LL workflow vs 1,269 mGy angio; p=0.02), with no difference in contrast utilisation between groups (p=0.28). Furthermore, LL workflow OCT guidance resulted in fewer predilatation balloons and stents being used, more direct stent placement, and greater stent post-dilatation than angiography-guided PCI., Conclusions: The incorporation of a standardised pre- and post-PCI OCT imaging workflow improves procedural efficiency and safety metrics, at a cost of a modestly longer procedure time.

Background: The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled., Aims: The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population., Methods: COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years., Results: Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001)., Conclusions: OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up., Clinicaltrials: gov: NCT02989740.

Background: The integrative implications of quantitative and qualitative plaque characteristics on clinical outcomes and therapeutic guidance have not been fully investigated., Aims: We aimed to investigate the combined prognostic value of quantitative and qualitative plaque measures and their interactions with treatment modalities and physiological lesion severity., Methods: Among 697 vessels from 458 patients who underwent fractional flow reserve (FFR)-guided treatment, quantitative high-risk plaque (qn-HRP; plaque burden ≥70% and minimum lumen area <3.3 mm 2 ) and qualitative HRP (ql-HRP; low-attenuation plaque or positive remodelling) were defined on coronary computed tomography angiography (CCTA). The primary endpoint was the vessel-oriented composite outcome (VOCO; a composite of cardiac death, myocardial infarction, or revascularisation)., Results: The mean baseline FFR was 0.85±0.12, and 25.8% underwent percutaneous coronary intervention (PCI) during the index procedure. In medically treated lesions, both qn-HRP and ql-HRP were associated with an increased risk of VOCO (p<0.05). Relative to the lesions with qn-HRP(-)/ql-HRP(-),those with qn-HRP(+)/ql-HRP(+) showed a higher risk of VOCO (hazard ratio [HR] 8.36, 95% confidence interval [CI]: 2.86-24.44). The PCI group showed a lower risk for VOCO than the medical treatment group (HR 0.31, 95% CI: 0.11-0.91) in lesions with qn-HRP(+)/ql-HRP(+). This difference was consistent in lesions with an FFR of 0.81-0.90 (HR 0.19, 95 CI: 0.04-0.90), but not in those with an FFR of>0.90., Conclusions: In non-ischaemic lesions, ql-HRP and qn-HRP showed a synergistic impact on risk assessment and had prognostic interactions with FFR and treatment modalities. Therefore, they need to be integrated into risk stratification and the optimisation of a treatment strategy., Clinicaltrials: gov: NCT04037163.