Percutaneous Coronary Intervention Research Articles

Association between in-hospital haemoglobin drop with or without overt bleeding and long-term clinical outcomes after percutaneous coronary intervention

Abstract Background Periprocedural bleeding complications remain a significant issue in patients undergoing percutaneous coronary intervention (PCI). Although most bleeding complications are defined by the degree of haemoglobin drop, prognostic implications of haemoglobin drop without clinically overt bleeding remain unclear. Purpose We aimed to investigate the association between haemoglobin drop after PCI and long-term prognosis, stratified by the occurrence of clinically overt bleeding. Methods Consecutive patients discharged after PCI between September 2008 to June 2018 from Keio Cardiovascular PCI multicenter prospective registry in Japan were analyzed. Patients were categorized into four groups: those with overt bleeding with haemoglobin drop, those with overt bleeding without haemoglobin drop, those without overt bleeding with haemoglobin drop, and those without overt bleeding nor haemoglobin drop. The pre- and post-PCI haemoglobin were defined as the lowest value within 72 hours before and after PCI. We defined the haemoglobin drop as the value obtained by subtracting the pre-PCI haemoglobin value from the post-PCI haemoglobin value equal to or greater than 3.0 g/dL. The primary outcome was the 2-year composite of major adverse cardiovascular events (MACE): all-cause mortality, acute coronary syndrome, heart failure hospitalization, or stroke. Cox proportional models were used to assess the association between the haemoglobin drop and the clinical outcomes. Results Among the 6,013 patients [mean age 68 years and 78% male], 52 (0.9%) had overt bleeding with haemoglobin drop, 45 (0.7%) had overt bleeding without haemoglobin drop, 497 (8.3%) had haemoglobin drop without overt bleeding, and 5,419 (90.1%) had neither. At the two-year follow-up, patients with overt bleeding, both with and without haemoglobin drop had higher rates of MACE compared to those without overt bleeding, with and without haemoglobin drop (28.8% vs. 20.0% vs. 11.8% vs. 10.5%, respectively). Patients with overt bleeding with haemoglobin drop were associated with increased risks of MACE compare to those without overt bleeding without haemoglobin drop (HR: 2.19, 95% CI: 1.26-3.81, P=0.01). Conversely, patients without overt bleeding with haemoglobin drop and patients with overt bleeding without haemoglobin drop were not associated with increased risk of MACE (HR:1.19, 95% CI: 0.88-1.63, P=0.26, and HR: 0.62, 95% CI: 0.29-1.31, P=0.21, respectively). The spline curve showed a significant correlation between haemoglobin drop and MACE in patients with overt bleeding. However, for patients without overt bleeding, the correlation was attenuated. Conclusions Patients with haemoglobin drop with overt bleeding were significantly associated with long-term prognosis, but no association was observed among those with haemoglobin drop without overt bleeding. Our findings prompt a reevaluation of the current criteria for classifying bleeding complications.Figure

Thirty days clinical outcomes following stent implantation with aspirin-free prasugrel monotherapy in non-ST segment elevation myocardial infarction. Interim report from ASET-Japan pilot study

Abstract Background Dual antiplatelet therapy with a P2Y12 inhibitor, in addition to aspirin, is the standard therapy after percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) to prevent ischemic cardiovascular events. The Acetyl-Salicylic Elimination Trial (ASET) pilot studies conducted in Japan in patients with NSTE-ACS investigated the safety and feasibility of a low-dose prasugrel monotherapy after PCI. Purpose To ensure the safety of the patients, enrolment in the study was implemented only after confirmation of a successful procedure. The abstract reports our interim analysis, aimed at evaluating preliminary safety and feasibility. Methods The ASET-Japan pilot study was designed to explore the feasibility and safety of a low dose of prasugrel monotherapy (3.75mg/day), without adjunctive aspirin, after optimal PCI using Everolimus eluting stent (EES) in Japanese patients with non-ST-segment elevation acute coronary syndromes. The primary endpoint in the ASET-Japan NSTE-ACS (Phase 2) is a 12-month clinical outcome. The study is currently in the follow-up phase. All the target lesions were treated with a platinum-chromium everolimus-eluting stent. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 12-month. If more than 3 events occurred, trial enrollment would have to be terminated by the data and safety monitoring board. Results One hundred one patients were enrolled after successful index PCI and completed a 30 days follow-up. The mean age was 69.1±12.3 years and 75.2% was male. The mean anatomical SYNTAX score was 7.9±4.7. Unstable angina (UAP) and NSTEMI were seen in 24.8% (25/101) and 75.2% (75/101) patients, respectively. According to the Braunwald classification, 8 percent of the patients were categorised as Class IA UAP, 48% as Class IB, 20% as Class IIB, 4% as Class IIIA and 20% as Class IIIB. In NSTEMI patients, the median (IQR) pre-procedural troponin value (cardiac Troponin T or I) was 2.79 (1.12 – 22.27) times the Upper Limit of Normal. According to the PRECISE DAPT score, 36.6% of patients were categorised as High Bleeding Risk (HBR) with scores above 25. At one month, the primary ischemic endpoints of cardiac death, target-vessel spontaneous MI or definite Stent thrombosis did not occur. Two patients (2.0%) had BARC type 3a bleeding. Conclusion Prasugrel monotherapy in the first 30 days following platinum-chromium everolimus-eluting stent deployment is a feasible and safe strategy in NSTE-ACS patients with simple anatomy and successful PCI.

Cangrelor versus no cangrelor during percutaneous coronary intervention in hemodynamically unstable patients: a cohort study on benefits and risks

Abstract Background Cangrelor is an intravenous P2Y12 inhibitor which, according to the European guidelines, may be considered for administration in acute coronary syndrome during percutaneous coronary intervention (PCI). Little is known regarding benefits and risks of such administration in hemodynamically unstable patients. Purpose To investigate the effects of cangrelor versus no cangrelor during PCI regarding major adverse cardiac events (MACE), in-hospital bleeding, and all-cause mortality in patients with cardiogenic shock and/or cardiac arrest. Methods The study population was extracted from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and included patients with cardiogenic shock or cardiac arrest undergoing PCI during the years 2016-2022. Propensity score matching (PSM) was used to create comparable groups. After matching, all variables used for calculating propensity score were balanced (standardized mean difference<0.1). Outcomes were MACE within 30 days, in-hospital bleeding, and all-cause mortality within 30 days. Risk ratios (RR) with 95% confidence intervals (CI) were calculated. When RR deviated from the null, the risk difference (RD) was determined. Results In all, 2,100 (66%) out of 3,206 patients with cardiogenic shock and/or cardiac arrest were included in the PSM analyses (median age: 69 years; 76% male; 78% ST-elevation myocardial infarction (STEMI)). Comparing cangrelor versus no cangrelor in this matched set of patients, the RR was 0.93 (95% CI: 0.84; 1.04) for MACE; 1.51 (1.02; 2.25) for in-hospital bleeding, with an RD of 1.9 percentage points (0.10; 3.7); and 0.93 (0.82; 1.04) for all-cause mortality (Table). In the PSM analysis regarding patients with cardiogenic shock, 1,098 (60%) out of 1,815 patients were included (median age: 71 years; 68% male; 82% STEMI). For these patients, RR was 0.85 (95% CI: 0.74; 0.97) for MACE, with an RD of -7.5 percentage points (-1.6; -13); 1.31 (0.82; 2.09) for in-hospital bleeding; and 0.83 (0.72; 0.95) for all-cause mortality, with an RD of -8.0 percentage points (-2.2; -14). In the PSM analysis regarding patients with cardiac arrest, 1,388 (76%) out of 1,827 patients were included (median age: 67 years; 81% male; 75% STEMI). RR was 0.98 (95% CI: 0.86; 1.12) for MACE; 1.53 (0.95; 2.49) for in-hospital bleeding; and 0.98 (0.86; 1.13) for all-cause mortality. Conclusion For patients with cardiogenic shock, but not for patients with cardiac arrest, administration of cangrelor versus no cangrelor during PCI was associated with a reduction in both MACE and all-cause mortality, with numbers needed to treat of 14 and 13, respectively. Overall, for patients with cardiogenic shock or cardiac arrest, administration of cangrelor versus no cangrelor during PCI was associated with an increased risk of in-hospital bleeding with a number needed to harm of 53.

Usage patterns and outcomes of drug coated ballons at a tertiary care center - a cohort analysis in 462 patients

Abstract Background The usage of drug coated ballons (DCB) in percutaneous coronary interventions (PCI) is rising. Initially applied in in-stent restenosis (ISR), wider clinical applications especially in de novo lesions (DNL) are discussed. Here we aim to assess the pattern of usage as well as the clinical and angiographic outcomes associated with DCB. Methods For this analysis we included all patients treated with DCB during PCI, at a tertiary care centre between 01/2015 and 12/2021. Cath lab results of all patients were screened to assess the DCB indication. Patients were followed up until 09/2022 to assess clinical as well as angiographic complications. Results A total of 7608 interventions were carried out between 2015 and 2021, in 462 (6.1%) a DCB was used. The median follow-up time were 3.1 years (IQR 1.6 to 4.4 years), the median age of our patient population was 66 (IQR 58-75) and 24.7% (n=114) were female. There were 92 of 462 (19.9%) cases including a DNL preparation, 335 (72.5%) cases treating an ISR, in 6 (1.3%) cases both, DNL and ISR were treated, and in 29 (6.3%) cases DCB were used for other reasons (e.g. pre-/ postdilatation in coronary stenting). The mean DCB inflation diameter was significantly higher in ISR with 3.50mm (IQR 3.0-3.5mm) compared to DNL with 2.50mm (2.00-2.50mm, p-value <0.001 ) While the number of DCBs used is rising over time (179 cases [38.7%] in 2015-2018, 283 cases [61.3%] in 2019-2021), the proportion of de novo lesions showed no significant difference (37/179 [20.7%] in 2015-2018, 61/282 [21.6%] in 2019-2021, p-value 0.806, Figure 1). Patients with DCB for ISR had significantly higher rates of arterial hypertension (ISR: 255 [76.1%], DNL: 57 [62.0%], both: 3 [50.0%], other: 20 [69.0%] p value 0.029), hyperlipidaemia (ISR: 228 [68.1%], DNL: 56 [60.9%], both: 2 [33.3%], other: 14 [48.3%], p value 0.041) and previous myocardial infarction (ISR: 231 [69.0%], DNL: 33 [35.9%], both: 2 [33.3%], other: 8 [27.6%], p-value <0.001). When analysing the outcomes, patients with DNL showed lower rates of acute myocardial infarction (8 [8.2%] vs 51 [15.0%]) as well as target lesion (6 [6.1%] vs 56 [16.5%]) and any revascularization (27 [27.6%] vs 122 [35.9%])%]), yet a higher rate of cardiovascular mortality (19 [5.6] vs 9 [9.2%]) during the follow up period compared to patients treated for ISR (Figure 2). Both groups showed a very low rate of target lesion thrombosis within 30 days after PCI (1 [1.0%] vs 1 [0.3%], p-value 0.745). Conclusions The use of DCB in PCIs is increasing, yet as we were able to emphasize with our data, they are primarily used in ISR as well as lesions with a small vessel diameter with favourable outcomes indicated by low event rates. Research should expand beyond small-vessel disease and ISR to assess safety and outcomes of DCB in DNL, larger vessels and bifurcation interventions with one stent to further assess its potential benefits in a wider field of indications.

Comparison of machine learning and traditional methods for prediction of adverse clinical events after percutaneous coronary intervention

Abstract Background Accurate prediction of clinical outcomes following percutaneous coronary intervention (PCI) is essential for mitigating risk and periprocedural planning. Traditional risk models have demonstrated modest predictive value. Machine learning (ML) models offer an alternative risk stratification that may provide improved predictive accuracy. We performed a systematic review and meta-analysis comparing ML models and traditional risk scores for prediction of clinical outcomes after PCI. Methods This study was reported according to PRISMA guidelines. PubMed, EMBASE, Web of Science and Cochrane databases were searched until 1st November, 2023 for studies comparing ML models with traditional statistical methods for event prediction after PCI. The primary outcome was comparative discrimination measured by C-statistics with 95% confidence intervals between ML models and traditional methods in estimating the risk of all-cause mortality, major bleeding and the composite outcome major adverse cardiovascular events (MACE). Results Thirty-four models were included across 13 observational studies (4105916 patients). The summary C-statistic all ML models across all clinical endpoints was 0.81 (95% CI, 0.78-0.85), compared to traditional methods 0.79 (95% CI, 0.74-0.85). The difference in C-statistic was 0.02 (95% CI, 0.002-0.04, p=0.56). Of included studies, only 1 model was externally validated and 10 models were calibrated. Conclusion ML models did not outperform traditional risk scores in the discrimination of all-cause mortality, major bleeding or MACE following PCI. While integration of ML algorithms into electronic healthcare systems may improve periprocedural risk stratification, immediate implementation in the clinical setting remains uncertain. Further research is required to overcome methodological and validation limitations.

Impact of the thin-walled sheath on the distal radial artery occlusion: a randomized trial

Abstract Background Distal transradial access (dTRA) has been increasingly accepted as an alternative to the transradial access (TRA) for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). Although the dTRA has been significantly associated with better patient comfort, shorter haemostasis time, and fewer vascular access-related complications, such as haematoma and proximal radial artery occlusion (pRAO), it has also been associated with an increased risk of distal radial artery occlusion (dRAO). Purpose The aim of the present study was to investigate whether the 6-Fr thin-walled sheath was superior to the conventional radial sheath with respect to the incidence of distal radial artery occlusion (dRAO) at 24 h after CAG and/or PCI via dTRA. Methods A prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr thin-walled sheath or a 6-Fr conventional sheath. The primary endpoint was the incidence of dRAO at 24 h postoperatively, as evaluated by Doppler ultrasound. The second endpoints included the puncture success rate, puncture time, the incidence of pRAO, pain during the sheath placement, and other vascular-associated complications. Results A total of 620 patients were included in the study. The mean age of the patients was 66.6± 9.7 years (median age 69.0 years [interquartile range 60.0- 74.0 years]), and 66.3% were men. The baseline patient and procedural characteristics were similar between the two groups. For the primary endpoint, the incidence of dRAO at 24 h after the procedure was 1.0% (3/314) in the thin-walled sheath group and 3.6% (11/306) in the conventional sheath group (RR= 0.266, 95%CI= 0.075-0.943, P= 0.027) according to the intention-to-treat (ITT) analysis. For secondary endpoints, the incidence of pRAO was 0.3% (1/314) in the thin-walled sheath group and 2.3% (7/306) in the conventional sheath group (P= 0.029). No significant difference was observed between the thin-walled sheath and the conventional sheath groups regarding the puncture success rate (92.4% vs. 92.5%, P= 0.952). The severity of pain experienced during the sheath placement was similar between the two groups (VAS 2 vs. 2 P=0.426). Other secondary endpoints, including procedural outcomes and other puncture-related outcomes and access-related complications, were not significantly different between the two groups. Conclusion A thin-walled sheath can reduce the incidence of early-term dRAO in patients who underwent CAG and/or PCI via the dTRA.The primary endpoint of the trial

Coronary stent edge segments as determinant of clinical outcomes: An OCTOBER Trial Substudy

Abstract Background Small lumen dimensions and high plaque burden in stent edge segments are known risk factors for subsequent clinical events after percutaneous coronary intervention (PCI). The evidence using intravascular optical coherence tomography is scarce. Purpose This study aimed to characterize edge segments after PCI and the relation to clinical outcomes in the randomized OCTOBER trial on bifurcation PCI optimized using optical coherence tomography. Methods This is a predefined substudy of the OCTOBER Trial. Edge segments were analysed in detail for degree of stenosis and plaque composition using a dedicated software. Data was planned to be analysed using multi-level cox regression analysis, but descriptive statistics was applied due to very low event rates after OCT-guided PCI. Main endpoints were OCT-detected edge residual stenosis, lipid plaque, calcification, and dissections. Post PCI coronary angiography was analysed for diameter stenosis, edge segment length and minimal lumen diameter. Patients with cardiac events were diagnosed with angiography duringt the two-year follow-up period. Results A total of 597 patients were treated with OCT-guided PCI. Analysable final OCT scans with no additional treatment was available for 505 patients in the main vessel and for the side branch in 289 cases. At deadline for abstract submission 242 scans with 474 edges were analysed and included in preliminary results.Lesions with ≥30% diameter stenosis was found in 20% of proximal edges, 24% of distal edges and 37% of side branch (SB) edges. A plaque burdenOCT ≥180° was found in 74% of proximal edges, 48% of distal edges, and 52% of SB edges. A lipid plaque wafound in 35%, 11% and 14%, dissections in 15%, 6% and 12%, and ≥180° calcium was found in 7%, 4% and 4% of edges respectively. Six patients (1%) of the total OCT-guided population had an edge-related event during the median two-year follow-up. Only two of these 6 patients had post-procedural OCT-scans of the event-related edge, thus 4 of the cases were effectively angiographic guided. Conclusion Only a small fraction of edge segments in the OCTOBER Trial were left with residual edge disease exceeding protocol thresholds. This resulted in historically very low rate of edge related events. No evaluation of a stent edge by OCT in otherwise OCT guided patients appeared to be the main predictor of edge related events. Final results are presented at ESC 2024.

Markers of coagulation and early coronary stent thrombosis

Abstract Background Acute stent thrombosis is a rare but deleterious event after percutaneous coronary intervention (PCI). Hemostatic factors such as D-Dimer, fibrinogen, and platelet count have emerged as potential indicators of increased thrombotic risk. However, data regarding the association with early stent thrombosis (ST) is sparse. Purpose The aim of this study was to investigate whether markers of coagulation are associated with increased risk of early (< 30 days after PCI) ST. Methods Within a prospective single-center registry, we retrospectively analyzed the association between pre-procedural platelet count, plasma levels of fibrinogen and D-Dimer with the occurrence of early ST within 30 days after PCI. Results We included 10,714 consecutive patients who underwent percutaneous coronary intervention (PCI) with implantation of drug-eluting stents (DES). Pre-procedural measurements of platelet count, fibrinogen and D-Dimer was available in 6,337, 6,155 and 956 patients, respectively. The number of definite early ST within 30 days was 58 (0.92 %). Pre-procedural platelet count (p<0.05) and plasma levels of fibrinogen (p<0.05) were significantly higher in patients with early ST as compared to patients without ST. Whereas D-Dimer was not associated with early ST, patients in the fifth quintile of platelet count had a significant increased risk for early ST (HR 2.43; 95% CI 1.43 - 4.14; p=0.001) as compared to patients in the lower four quintiles and patients in the fifth quintile of fibrinogen had a significant increased risk for early ST (HR 1.86; 95% CI 1.07 – 3.26; p<0.05) as compared to patients in the lower four quintiles. These associations were independent of clinical risk factors, the presence of acute coronary syndromes and the number of stents. Conclusions Pre-procedural platelet count and plasma levels of fibrinogen are associated with the risk of early ST in patients after implantation of DES. Device-level risk factors like stent-type or size and procedure-level risk factors like peri-interventional medication and complications during stent apposition are associated with ST. Platelet count and plasma levels of fibrinogen may be additional patient-level risk factors that have to be taken in account in the development of future personalized strategies to prevent these rare but deleterious complications.

Favorable impact of FFRCT on myocardial revascularization outcomes: results from an observational real-world registry

Abstract Background Based on excellent clinical outcomes data, coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFRCT) is endorsed by guidelines to diagnose obstructive coronary artery disease (OCAD)(1). Dedicated outcome analyses in revascularized patients are essential to assess the additional value of FFRCT in revascularization. Purpose To assess the impact of FFRCT use on the postprocedural myocardial injury (PMI) and long-term outcomes of patients with OCAD undergoing myocardial revascularization. Methods Patients with suspected OCAD on CCTA (at least one stenosis of >50% in any vessel) were included from a 2013-2021 tertiary hospital registry. Propensity score adjusted Cox- regression and logistic regression analysis were used to assess the impact of FFRCT on the outcomes of OCAD patients post-revascularization. PMI was defined as cardiac troponin (cTn)>5 times the 99th percentile URL for percutaneous coronary intervention (PCI) and cTn>10 times the 99th percentile URL for coronary artery bypass graft (CABG) (2). Major adverse cardiovascular events (MACE) comprised all – cause mortality, acute myocardial infarction (AMI), stroke, hospitalization for heart failure (HHF) and new revascularization. Results From a registry of 7541 patients, suspected CCTA - derived OCAD was reported in 1601 cases. 559 OCAD patients were revascularized: 386(69.05%) by PCI, 166(29.7%) by CABG and 7(1.25%) by PCI and CABG. FFRCT was performed in 252(45.1%) patients. During a follow-up of 4.4±2.2 years, MACE occurred in 137(24.5%) patients: 43(7.7%) died, 21(3.8%) patients were hospitalized for AMI, 14(2.5%) patients had a stroke, 12 (2.1%) patients had HHF and 77(13.8%) patients had a new revascularization. Survival analysis indicated significant differences in MACE and all-cause mortality–rates between FFRCT use and no FFRCT use (log- rank p = 0.033 and 0.004, Fig 1). Multivariable propensity–adjusted Cox–regression analysis showed a non–significant trend towards reduced MACE risk by using FFRCT (HR 0.736, 95% CI 0.513-1.055, P=0.095) and a significant reduction in all-cause mortality risk (HR 0.476, 95% CI 0.230–0.985, P=0.046). Sub-analysis in the PCI and CABG groups showed no significant association between FFRCT and MACE. Among the 477 patients with available cTn values, 203 (42.5%) had PMI. In the CABG group, FFRCT use correlated with low PMI incidence (5.3% vs. 15.6%, p=0.044). However, multivariable Cox regression analysis revealed no significant association between FFRCT use and PMI(Fig 2). Conclusion This observational designed study reveals for the first time that FFRCT reduces post-myocardial revascularization MACE, primarily driven by reduced all-cause mortality. No clear reduction of PMI was observed suggesting that FFRCT value extends beyond procedural enhancements. Although derived from a large real-world registry, these promising observations need to be confirmed by randomized studies.Figure 1Figure 2

Clopidogrel versus aspirin monotherapy for secondary prevention after percutaneous coronary intervention - a nationwide population-based study

Abstract Background After percutaneous coronary intervention (PCI), patients are maintained on single antiplatelet therapy (SAPT) for secondary cardiovascular prevention after completing the guideline-recommended duration of DAPT for a period of time. We sought to compare the efficacy and safety of clopidogrel versus aspirin monotherapy for secondary prevention in patients who undergoing PCI in a population-based cohort study using the database from the National Health Insurance Service (NHIS) in Korea. Methods Of those who underwent PCI from 2009 to 2020, 133,343 patients were selected for analysis. (aspirin 65,802 patients, clopidogrel 67,653 patients). To balance between aspirin and clopidogrel users for the comparison of efficacy and safety, we applied the inverse probability of treatment weighting (IPTW) of propensity score method. The primary effectiveness outcome was major cardiovascular events (MACEs) as the composite of cardiovascular death, myocardial infarction (MI) or stroke. The primary safety outcome was any bleeding. We divided the short DAPT user (< 6 months of DAPT in patients with CCS or < 12 months of DAPT in patients with ACS) and long DAPT user (≥ 6 months of DAPT in patients with CCS or ≥ 12 months of DAPT in patients with ACS) by DAPT duration. Results After IPTW matching, overall the mean age of participants was 63.8±16.3 and the median SAPT duration was 3.3 (1.3 – 6.2). During period, the overall primary effectiveness outcome occurred in 4.1% in aspirin group and 2.8% in clopidogrel group (hazard ratio [HR], 0.684; 95% CI, 0.656 – 0.712; p-value <0.0001) (Figure 1-A). the overall primary safety outcome occurred in 2.4% in aspirin group and 2.1% in clopidogrel group (HR, 0.945; 95% CI, 0.899 – 0.994; p-value, 0.0287) (Figure 1-B). In short DAPT group, clopidogrel reduced the risk of MACE (HR, 0.761; 95% CI, 0.715 – 0.811; p-value, <0.0001) but did not reduce the risk of bleeding (HR, 0.973; 95% CI, 0.893 – 1.056; p-value, 0.5067) comaped with aspirin. However, in the long DAPT group, clopdiogrel reduced both MACE (HR, 0.633; 95% CI, 0.600 – 0.669; p-value <0.0001) and bleeding risk (HR, 0.931; 95% CI, 0.873 – 0.992; p-value, 0.028) compared with aspirin. (Figure 2) Conclusion Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after PCI reduced the risk of MACEs and bleeding. As shown in randomized controlled trials, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future clinical adverse events in real-world bid database.

Drug-coated balloon for de-novo coronary artery lesions exceeding 2.5 mm in diameter: optical coherence tomography analysis and clinical follow-up

Abstract Objective To investigate the precise changes in the lumen and lesions, and clinical outcomes after DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT. Methods This is a prospective study including 53 consecutive patients with 55 de-novo coronary lesions, who underwent DCB angioplasty-only between January 2021 and April 2022. Quantitative coronary angiography (QCA) and OCT were performed before percutaneous coronary interventions (PCI), immediately after PCI, and at 6-9 months follow-up after PCI. Target lesion failure (TLF) was the primary endpoint of the present study. Multivariate logistic regression analysis was performed to identify the predictors or risks for late lumen enlargement (LLE). Results A total of 52 patients were successfully treated with DCB. The median follow-up was 7 months, and the incidence of TLF was 7.5%. After the DCB procedure, 43 patients had their scheduled angiographic and OCT examination. QCA demonstrated that the late lumen loss was -0.79 ± 0.28 mm. OCT demonstrated LLE in 79.1% and dissection healing in 65.1% of lesions. After multivariable logistic analysis, type B dissection (odds ratio [OR] 2.92, 95% confidence interval [CI] 1.34-7.41, p = 0.037) was found to be a predictor of LLE, but lipid plaque (OR 0.09, 95% CI 0.01-0.63, p = 0.015) was a risk of LLE. Conclusions This is the first and largest prospective study to assess the outcomes of DCB treatment for de-novo coronary lesions exceeding 2.5 mm in diameter and the detection of significant vessel enlargement and dissection healing guide by OCT. DCB could be a novel, safe and effective treatment for de-novo coronary lesions exceeding 2.5 mm in diameter through a detailed analysis of OCT.Representative coronary angiography (CAGRepresentative optical coherence tomogra

The comparison of short-term dual antiplatelet therapy versus standard dual antiplatelet therapy in elderly patients with coronary artery disease who underwent percutaneous coronary intervention

Abstract Introduction Elderly patients are likely to have more underlying risk factors for bleeding and the bleeding risk increases with age although dual anti-platelet therapy (DAPT) is mandatory for patients who underwent percutaneous coronary intervention (PCI) for prevention of ischemic events. Therefore, elderly patients aged 75 or older are included as minor criteria for high bleeding risk, as defined by the Academic Research Consortium for High Bleeding Risk criteria. However, only limited data have been investigated of optimal duration of DAPT for patients aged 75 or older. Purpose The aim of this study is to evaluate optimal DAPT duration for elderly patients aged 75 and older. Methods We selected 1,571 patients aged 75 and older with coronary artery disease (CAD) from the pooled database among the 5 randomized controlled trials related to DAPT duration after PCI. DAPT was consisted of clopidogrel or ticagrelor in addition to aspirin. Short-term DAPT duration was defined as 1 to 3months, and standard DAPT duration was defined as 6 to 12months after PCI. Primary outcomes were net clinical adverse outcomes (NACE), composite of major cardiovascular and cerebrovascular adverse outcomes (MACCE) and TIMI major bleeding at 1 year. The inversed probability of treatment weighting (IPTW) analysis was performed to minimize selection bias effects of pooled database. Results The NACE was not significantly different between the short-term DAPT group (3.9%) and standard DAPT group (7.6%) (HR: 0.69, 95% CI: 0.46-1.04; p=0.076) (Figure A). Moreover, MACCE was not different in both groups. However, the significant reduction of bleeding risk was observed in short-term DAPT group (1.4%) than standard DAPT group (3.4%) (hazard ratio (HR): 0.40, 95% confidential interval (CI): 0.19-0.83; p=0.015) (Figure B). These results were consistent after multivariable Cox regression analysis and IPTW analysis. Conclusions Short-term DAPT duration (1 to 3months) was found to be superior to standard DAPT duration (6 to 12months) in terms of bleeding outcomes without the increased ischemic outcomes in patients aged 75 or older with CAD who underwent PCI.

Complete revascularisation versus culprit lesion only PCI in patients with non-ST-elevation myocardial infarction and multivessel disease.

Abstract Background The incidence of non-ST-elevation myocardial infarction (NSTEMI) is escalating, with patients diagnosed with multivessel disease (MVD) facing more adverse clinical outcomes. Yet, optimal treatment strategies for NSTEMI patients with MVD remain uncertain. Objectives This study aimed to assess the clinical outcome of NSTEMI patients with MVD who underwent complete revascularization compared to those treated with the culprit lesion only. Methods Between 2014 and 2017, patients presenting with NSTEMI and MVD undergoing successful percutaneous coronary intervention (PCI) were retrospectively included. MVD was defined as patients having more than one lesion considered angiographically significant, exhibiting at least 50% stenosis of the vessel diameter on visual estimation, or having a Coronary Angiography-Derived Fractional Flow Reserve (caFFR) measurement of 0.80 or less. The main exclusion criteria were single vessel disease, and previous coronary-artery bypass grafting surgery. The primary endpoint of this study was major adverse cardiac events (MACE) at 3 years, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven revascularization. Results A total of 358 patients were included (mean age: 67.34±12.77; male: 70.1%), 155 and 203 patients were stratified into complete revascularisation group and culprit-lesion-only PCI group respectively. During 3-year follow-up, the culprit-lesion-only PCI group exhibited a significantly elevated risk of MACE compared to the complete revascularization group (17.7% vs 7.74%; hazard ratio [HR] 2.412, 95% confidence interval [CI] 1.255 - 4.636, P = 0.008). The increase 3-year MACE rate was mainly driven by the higher rate of ischaemia-driven revascularization in the culprit-lesion-only PCI group (11.3% vs 3.23%, HR 3.637, 95% CI 1.383 - 9.566, P = 0.009). Conclusion In NSTEMI patients with MVD, complete revascularization was superior to culprit-lesion-only PCI in mitigating the risk of future MACE at 3 years, which is predominantly attributed by a reduced incidence of repeat revascularisations.

Comparison of clinical outcomes in diabetic and non-diabetic patients undergoing coronary bifurcation stenting

Abstract Background Diabetes mellitus (DM) is a well-known risk factor for cardiovascular diseases, including coronary artery diseases (CAD). Due to poor post-intervention outcomes, bypass surgery is often recommended in preference to percutaneous coronary intervention (PCI) in DM patients with complex scenarios, such as bifurcation lesions. Methods In this retrospective, multicentre, observational, real-world registry of 2,648 patients with coronary bifurcation lesions undergoing PCI with 2nd-generation drug-eluting stents (DES), the effect of DM on cardiovascular outcomes was analysed. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, and stroke, at 5 years. The adjusted outcomes were compared using 1:1 propensity score (PS) matching. Results Overall, DM patients were more likely to be older, female, and have hypertension or chronic kidney disease. In the PS-matched cohort, the cumulative incidence of the primary outcome was numerically higher in the DM group, but without statistical significance (7.9% vs. 5.5%, log-rank p=0.276). Secondary outcomes including all-cause mortality (5.5% vs. 3.9%, log-rank p=0.090) and cardiac mortality (3.2% vs. 1.8%, log-rank p=0.060) were also comparable between the two groups. Conclusion For patients with coronary bifurcation lesions undergoing contemporary PCI, the outcomes were comparable for DM and non-DM patients. Bifurcation PCI can thus be successfully performed in diabetic patients with 2nd-generation DES.

C-reactive protein after discharge and infarct size in patients with ST segment elevation myocardial infarction

Abstract Background C-reactive protein (CRP) peaks at 2 days in patients with ST-segment elevation myocardial infarction (STEMI) after percutaneous coronary intervention (PCI) and can predict final infarct size. It is, however, unknown whether CRP level after discharge, indicative of prolonged inflammation, plays a prognostic role in myocardial damage. Purpose To investigate the prevalence of high CRP level within 3 months after discharge in patients with STEMI and its association with myocardial damage. Methods In the current study, all patients were identified through the xx database and treated with timely PCI at xx hospital from 2011 to 2014. Blood samples were retrieved within 3 months after discharge. High CRP level was defined as CRP >=3 mg/L. Only patients with a cardiac magnetic resonance (CMR) at baseline or follow-up were recruited. The primary outcome was final infarct size. Multiple regression was performed to adjust for potential confounders using any baseline variable with P<0.10 for the difference between groups. Results Of the 1603 patients from xx, 273 patients had CRP measured following discharge and at least one CMR measured. Of them, 200 (73.3%) had high CRP level after discharge. There was no difference in period from PCI to CRP testing between patients with high CRP and those with low CRP [11 days, interquartile range (IQR) (4, 40) vs. 21 days, IQR (4, 42), P=0.31]. Patients with high CRP level showed larger final infarct size [12.5% left ventricle (LV) vs. 7.0% LV, P <0.001] and larger acute infarct size [15.2% LV vs. 10.6% LV, p=0.004] compared with those with low CRP level. Patients with high CRP level also had lower final myocardial salvage index (MSI) (0.67 vs. 0.75, P=0.003) and lower acute MSI (0.47 vs. 0.61, P=0.006). The results persisted after adjusting for potential confounders in multiple regression. Conclusions A large proportion of patients with STEMI undergoing PCI persisted high CRP within 3 months after discharge. High CRP level after discharge was associated with larger acute and final infarct size as well as lower acute and final MSI level.

Implementation of prasugrel and prognostic outcomes after percutaneous coronary intervention for myocardial infarction: a nationwide observational study

Abstract Background Prasugrel has shown superior efficacy and similar safety compared to ticagrelor for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) in a randomised setting. Since 2020, prasugrel has been recommended over ticagrelor in our country. It remains unknown if these recommendations have been implemented, and if the findings from the randomised trial can be expanded to an all-comer population. Purpose To assess the implementation of prasugrel and compare effectiveness and safety between prasugrel and ticagrelor in PCI-treated, all-comer patients with myocardial infarction (MI). Methods From January 1st, 2019, to December 31st, 2021 patients with MI treated with PCI were identified by use of nationwide health registries. We included patients who were alive and claimed a prescription of prasugrel or ticagrelor within 7 days from discharge. Incidence rates per 100 person-years (IRs) 6 months from discharge were calculated for a composite outcome of all-cause mortality, recurrent MI (>28 days after index MI), and stroke (MACE), all-cause mortality alone, ischaemic events (a composite of recurrent MI and stroke) and bleeding leading to hospitalisation. We illustrated a Kaplan Meier curve with log-rank test and a cumulative incidence curve with Gray’s test and performed Cox models to assess adjusted comparative differences of the outcomes between prasugrel and ticagrelor after adjusting for age, sex, relevant comorbidities, and calendar year. Results We identified 14,365 PCI-treated patients with MI, of whom 13,887 (96.7%) were alive 7 days from discharge. After excluding patients who did not collect a P2Y12 inhibitor (n=1097 [7.9%]) or collected clopidogrel within 7 days from discharge (n=2696 [21.1%]), the final study population counted 10,094 patients of whom 2045 (20.3%) patients collected prasugrel and 8049 (79.7%) ticagrelor. Figure 1 shows the temporal use of P2Y12 inhibitors. The mean age was 64.4 (±11.7) years and 23.9% were female. Patients with prasugrel were less often ≥75 years old (16.3% vs. 23.2%), female (22.1% vs. 24.3%), and had fewer comorbidities (hypertension, hypercholesterolemia, diabetes, stroke or transient ischaemic attack, bleeding, and prior PCI) than ticagrelor-treated patients. Figure 2 illustrates IRs of the outcomes and Kaplan Meier and cumulative incidence curves. Prasugrel treatment was associated with reduced risk of MACE (HR 0.67 [95% CI 0.47-0.95]) and ischaemic events (HR 0.68 [0.47-0.97]) compared with ticagrelor after adjustment, and there were no differences in all-cause mortality or bleeding (Figure 2). Conclusion Prasugrel use increased from 1% to 44% from 2019 to 2021, but most all-comer patients with MI were treated with ticagrelor after PCI. Prasugrel showed lower risk of MACE and ischaemic events without excess in bleeding 6 months post-discharge compared to ticagrelor, consistent with the findings of a previous randomised trial.Temporal use of potent P2Y12 inhibitorsSix-months outcomes of potent P2Y12i

Intravascular imaging-guided percutaneous coronary intervention according to lesion complexity

Abstract Background Recent trials have shown intravascular imaging (IVI)-guided percutaneous coronary intervention (PCI) has prognostic benefit compared with angiograph-guided PCI in complex coronary artery lesions. However, it is unclear whether this benefit is affected by overall complexity of target lesions in each patient. Objectives To investigate an impact of the number of complex lesion features on the benefit of IVI-guided PCI. Methods A total of 4,611 patients with complex coronary artery lesions from the RENOVATE-COMPLEX-PCI trial (n=1,639) and the institutional registry of a medical center (n=2,972) were classified according to the number of complex lesion features found in each patient. The primary outcome was a target vessel failure (TVF) at 3 years, a composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization. Results The best cut-off number of complex lesion features for the risk of TVF was 3 and patients with ≥3 complex lesion features had higher risk of TVF than those with <3 complex lesion features (11.0% vs. 7.2%; HR 1.59, 95% CI 1.28-1.96, P<0.001). IVI-guided PCI significantly reduced the risk of TVF compared to angiography-guided PCI in both groups (≥3 complex lesion features: 7.4% vs. 14.4%, HR 0.49; 95% CI 0.35-0.69, P<0.001; <3 complex lesion features: 5.7% vs. 8.1%; HR 0.72, 95% CI 0.53-0.98, P=0.039). The benefit of IVI-guided PCI tended to increase as the number of complex lesion features increased (absolute risk reduction for TVF: -0.012 vs. -0.027 vs. -0.055 vs. -0.077, respectively, for the number of complex lesion features 1 vs. 2 vs. 3 vs. ≥4, interaction P=0.048). Conclusion In patients with complex coronary artery lesions, IVI-guided PCI reduced the risk of TVF regardless of overall complexity of the target lesions in each patient. The prognostic benefit of IVI-guided PCI tended to increase as patients had more complex lesion features.Clinical Outcomes

Economic evaluation of fractional flow reserve-guided versus intravascular ultrasound-guided percutaneous coronary intervention

Abstract Background The randomized, controlled FLAVOUR trial demonstrated that the clinical outcomes of the fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) strategy were non-inferior to the intracoronary ultrasound (IVUS)-guided PCI strategy. Purpose This study aimed to compare the difference in economic implications and health-related quality of life between the two strategies. Methods A total of 890 patients with intermediate stenosis in 9 sites in China from the FLAVOUR trial were included. Direct medical costs were calculated using a combination of resource-based and event-based methods. Health utility was defined as quality-adjusted life years and assessed based on the 19-item Seattle Angina Questionnaire. The primary analysis was a cost-utility analysis. Probabilistic sensitivity, one-way sensitivity, and subgroup analyses were performed. Results At two years, the average total cost per patient was Chinese yuan (CNY) 36,287±19,531 in the IVUS-guided group and CNY 29,237±19,239 in the FFR-guided group (ΔIVUS-FFR=CNY 7,050, p<0.001). The difference was driven primarily by the cost of initial admission (ΔIVUS-FFR=CNY 6,284, p<0.001). Quality-adjusted life years gained showed no significant differences between the two groups (FFR vs. IVUS: 1.639±0.086 years vs. 1.638±0.128 years, p=0.872). The probabilistic sensitivity and one-way sensitivity analyses revealed robust results. The subgroup analysis found that the cost reductions attributed to FFR guidance decreased in several subgroups, including patients with diabetes and those with high anatomical complexity. Conclusions In patients with intermediate stenosis, FFR-guided PCI is associated with significant cost savings compared with IVUS-guided PCI at two years and shows no differences in health-related quality of life outcomes.Central Illustration

Clinical outcomes following debulking atherectomy of calcified left main coronary lesions: a high-volume centre experience

Abstract Introduction Plaque modifying-debulking (PMD) devices are the most effective initial strategy for percutaneous coronary intervention (PCI) of severely calcified lesions including left main coronary artery (LMCA). There is limited data comparing the short and long clinical outcomes of these devices in LMCA lesions. Methods A retrospective analysis of patients with fibrocalcified LMCA lesions treated with PCI with adjunctive PMD devices at a large centre between 2008 and 2021. The primary study endpoint was long-term mortality at documented longest follow-up. Secondary endpoints included procedural complications and inhospital clinical outcome. Results A total of 302 patients with fibrocalcified LMCA lesions treated with rotational atherectomy (RA; n=240), intracoronary lithotripsy (ICL; n=30) or excimer laser coronary atherectomy (ELCA; n=32) were included. Approximately 55% of all patients presented with acute coronary syndromes. Technical success was achieved in 98.7% of patients and procedural success was achieved in 95.4% of patients. At a median follow-up of 42 [19-62] months, there was no difference in mortality between the 3 PMD modalities (RA 54/240 [23.4%] vs. ICL 1/30 [3.3%] vs. ELCA 5/32 [15.6%], P=0.128). Likewise, in-hospital clinical outcomes were similar. However, procedural complications were significantly higher in the ELCA group. Conclusions In patients with fibrocalcified LMCA lesions treated with PCI, adjunctive PMD devices appear safe with survival excceding 80% at long-term follow-up. Our study suggests that ELCA use may be associated with higher procedural risks however this did not increase in-hospital clinical outcomes or long-term mortality risk.

The coronary angiography-derived index of microcirculatory resistance predicts perioperative myocardial injury in stable coronary artery disease patients undergoing PCI

Abstract Background Coronary microvascular dysfunction (CMD) assessed by the index of microcirculatory resistance (IMR) is associated with perioperative myocardial injury(PMI).The angiography-derived index of microcirculatory resistance (caIMR) is a novel and accurate alternative of IMR. Objective This study aims to evaluate the predictive value of caIMR on PMI in stable coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). Methods Consecutive stable CAD patients undergoing elective PCI of a single lesion were recruited. caIMR were measured before and after revascularization.Total creatine kinase-MB (CK-MB) and high sensitivity Troponin T (hsTnT) levels were measured before and within 24 hours after PCI. Results A total of 65 patients were enrolled, twenty-six patients fulfilled the diagnostic criteria of PMI. Post-PCI caIMR values in the PMI group were significantly higher than those in the control group (27.02±3.70 vs. 15.91±3.43U, P<0.001). Pearson correlation analysis demonstrated that increased post-PCI caIMR values have a significant positive correlation with peak hsTnT (r = 0.803, P<0.001) and peak CK-MB (r = 0.512, P= 0.001). Multivariate logistic regression analysis showed the post-PCI caIMR was independent predictors of PMI(OR,1.731;95% CI:1.348-2.023; P<0.001).The ROC analysis suggested that the best cutoff value of post-PCI caIMR was 25.17U to diagnose PMI(AUC=0.951, sensitivity 88.5%, specificity 97.1%%). Conclusions The post-PCI caIMR can accurately predict PMI in stable CAD patients receiving elective PCI, supporting its use in clinical practice.