bluuebunny/crossref_metadata_2025 huggingface dataset:
Angioscopic findings one year after percutaneous coronary intervention for chronic total occlusion
Authors: Fukuizumi I.F , Tokita Y.T , Mozawa K.M , Sasamoto N.S , Seki T.S , Wakita M.W , Shiomura R.S , Noma S.N , Matsuda J.M , Kubota Y.K , Nakata J.N , Tara S.T , Yamamoto T.Y , Takano H.T , Shimizu W.S
Published: November 2020

Background

Chronic total occlusion (CTO) is thought as a high-risk feature of stent thrombosis, but little is known about the difference in neointimal healing of stents implanted for CTO lesions compared to that of non-CTO lesions.

Methods and results

A total of 62 stents in consecutive 47 patients (69±11 years, 41 male) who underwent follow-up angiography and angioscopy one year after percutaneous coronary intervention (PCI) between March 2016 and July 2019 were evaluated. The examined stents were divided into 3 groups according to the lesion status at previous PCI: CTO group (n=12), stable coronary artery disease without CTO (non-CTO group, n=30) and acute coronary syndrome (ACS group, n=20). The grade of neointimal stent coverage in CTO group was significantly lower than that of non-CTO group (0.5±0.5 vs 1.4±0.9, p=0.001). The frequency of presence of thrombus was significantly higher in CTO group and ACS group compared to non-CTO group (67%, 50%, and 13%, respectively, p=0.001). The yellow grade in CTO group was equivalent (p=1.00) to that in ACS group and was tented to be higher (p=0.051) compared to non-CTO group (1.3±0.8, 1.5±0.6, and 0.8±0.7, respectively).

Conclusion

The present study suggested a delayed healing in stents implanted for CTO lesions. Longer dual-antithrombotic therapy maybe beneficial for these patients.

Funding Acknowledgement

Type of funding source: None
Association between pre-infarction angina and culprit-lesion morphology in patients with ST-segment elevation myocardial infarction: an optical coherence tomography study
Authors: Wang Y , Sheng Z , Li J , Tan Y , Zhou P , Liu C , Zhao X , Zhou J , Chen R , Song L , Zhao H , Yan H
Published: November 2020

Background

Previous studies reported the cardiac protection effect of pre-infarction angina (PIA) in patients with acute myocardial infarction (AMI). However, the association between PIA and culprit plaques characteristics in AMI patients through optical coherence tomography (OCT)assessment remains unclear.

Purpose

We sought to identify culprit-plaque morphology associated with PIA in patients with ST-segment elevation myocardial infarction (STEMI) using OCT.

Methods

A total of 279 STEMI patients who underwent intravascular OCT of culprit-lesion were included. Baseline clinical data and culprit-plaque characteristics were compared between the PIA group the non-PIA group.

Results

Patients with PIA represented 54.8% of the study population (153 patients). No differences were observed in clinical and angiographic data between two groups, except STEMI onset with exertion was significantly less common in PIA group (24.2% versus 40.5%, P=0.004). Patients with PIA exhibited a significantly lower incidence of plaque rupture (40.5% versus 61.9%, P<0.001) and lipid-rich plaques (48.4% versus 69.0%, P=0.001). The thin-cap fibroatheroma (TCFA) prevalence was lower in PIA group, presenting a thicker fibrous cap thickness, although statistically significant differences were not observed (20.3% versus 30.2%, P=0.070; 129.1±92.0μm versus 111.4±78.1μm, P=0.088; respectively). Multivariate logistic regression analysis indicated that PIA was an independent negative predictor for plaque rupture (odds ratio: 0.44, 95% confidence interval: 0.268–0.725, P=0.001).

Conclusion

STEMI patients with PIA showed a significantly lower prevalence of plaque rupture and lipid-rich plaques in culprit-lesion than non-PIA group, implying different mechanisms of STEMI attack.

Flow chart + Bar graphs of OCT findings

Funding Acknowledgement

Type of funding source: Public Institution(s). Main funding source(s): Association between pre-infarction angina and culprit-lesion morphology in patients with ST-segment elevation myocardial infarction: An optical coherence tomography study
The accuracy and interobserver variability in the assessment of coronary atherosclerotic plaques by optical frequency domain imaging: involving five observers with different levels of coronary imaging
Authors: Shibutani H , Fujii K , Kawakami R , Imanaka T , Kawai K , Hashimoto K , Morishita S , Otagaki M , Matsumura K , Tsujimoto S , Hirota S , Shiojima I
Published: November 2020

Background

Whether optical frequency domain imaging (OFDI) images can realize pathological diagnosis of coronary atherosclerotic plaques, and whether its diagnostic accuracy of lesion types varies depending on the personal experience of the clinician caring for coronary intervention have not been elucidated.

Purpose

This study investigated the interobserver variability in characterizing atherosclerotic plaque types by OFDI for multiple OFDI observers with levels of different experience.

Methods

Three-hundred-thirty-three histological cross-sections from 21 autopsy hearts were co-registered with the corresponding OFDI images. Histological cross-sections were classified into the following 7 lesion types according to the modified AHA atherosclerosis classification by a single experienced pathologist blinded for OCT findings: adaptive intimal thickening (AIT), intimal xanthoma (IX), pathological intimal thickening (PIT), fibrous cap atheroma (FA), fibrocalcific plaque (FC), calcified nodule (CN), and healed erosion/rupture (HER). The five OFDI observers, unaware of the histological diagnosis, provided a single diagnosis for each corresponding OFDI image. The OFDI observer 1 was an expert interventional cardiologist with sufficient experience in OFDI imaging, followed by the OFDI observer 2, 3, and 4 as middle career interventional cardiologists who had completed training ten, seven, and four years. The OFDI observer 5 was a young career interventional cardiologist. The diagnostic accuracy of lesion types for each OFDI observer was determined taking histology as a gold standard.

Results

On histological analysis, 13% of histological cross-sections were diagnosed as AIT, 5% as IX, 23% as PIT, 25% as FA, 27% as FC, 2% as CN, and 5% as HER. The overall agreement between OFDI diagnosis and histopathologic diagnosis for OFDI observer 1 to 5 was 77%, 62%, 61%, 56%, and 46% (k values of 0.71, 0.54, 0.54, 0.45, and 0.33), respectively. Although the performance for characterizing AIT and FC was excellent and comparable among all OFDI observers, the sensitivity and positive predictive value for characterizing IX, PIT and FA varied depending on the OFDI observers' years of experience (Table). The main causes of false-positive or -negative diagnosis of FA were IX and PIT for all OFDI observers.

Conclusion

The diagnostic accuracy of atherosclerotic tissue properties from OFDI images correlated with the observers' years of experience, subspecialty training in coronary imaging, which suggests that the interpretation of OFDI images requires expertise and can be challenging to a less experienced reader.

Table 1

Funding Acknowledgement

Type of funding source: None
Coronary plaque characteristics associated with reduced thrombolysis in myocardial infarction flow in st-segment elevation myocardial infarction patients with plaque erosion
Authors: Wang J , Dai J , Fang C , Yu B
Published: November 2020

Background

It has been reported that the lumen factors of the culprit lesions are related to Thrombolysis in Myocardial Infarction (TIMI) flow grade in ST-Segment–Elevation Myocardial Infarction (STEMI) patients, but the factors of reduced TIMI flow in plaque erosion have not been studied.

Methods

329 STEMI patients with plaque erosion who underwent pre-intervention optical coherence tomography after thrombectomy were included and divided into 2 groups according to preprocedural TIMI flow grade [TIMI 0–1 (n=219) and TIMI 2–3 (n=110)].

Results

The patients with older age (55.7±11.1yrs vs. 51.8±10.6yrs, P=0.003) and diabetes patients (18.3% vs. 8.2%, P=0.015) had poorer TIMI flow, and the patients with reduced TIMI flow grade have lower initial cTnI (1.2ng/mL vs. 2.1ng/mL, P=0.023). The lesion in the LAD had better blood flow than the lesion in RCA (P=0.003), and the patients in TIMI 0–1 grade had more lipid plaques (53.9% vs. 41.8%, P=0.039), more macrophage (59.8% vs. 41.8%, P=0.002), and more calcification (34.2% vs. 21.8%, P=0.020). There was no statistically significant difference in the descriptive indicators of lipid or lumen between the two groups. And In a multivariate logistic regression model, the independent correlation factors of reduced TIMI flow grade in erosion patients were age, diabetes mellitus, lesion vessel, and macrophage.

Conclusions

In STEMI patients with plaque erosion non-lumen factors greatly affect flow, which suggests that systemic treatment is as important as local treatment for plaque erosion.

Flow Chart

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): National Natural Science Foundation of China (81827806, 81801861), National Key R&D Program of China (2016YFC1301100)
Real-world clinical impact of external elastic lamina-based stent sizing criteria using optical coherence tomography
Authors: Okamoto N , Shutta R , Yanagawa K , Matsuhiro Y , Nakamura H , Yasumoto K , Tsuda M , Tanaka A , Matsunaga Y , Yano M , Yamato M , Egami Y , Tanouchi J , Nishino M
Published: November 2020

Introduction

ILUMIEN III trial has reported that non-inferiority of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) to intravascular ultrasound-guided PCI for postprocedural minimum stent area. In the trial, external elastic lamina (EEL)-based stent sizing criteria was introduced, however OCT has limitations including incomplete visualization of EEL in severale lesions.

Purpose

The aim of the study is to investigate real-world clinical impact of EEL-based stent sizing criteria.

Methods

The study included consecutive patients who underwent OCT-guided percutaneous coronary intervention (PCI) for de novo lesions in our institution between September 2016 and April 2018. EEL visibility, mean EEL diameter, mean lumen diameter and plaque morphology were assessed at proximal and distal references. The plaque morphology at references was categorized according to its most prevalent component as follows: normal, fibrous plaque, lipid plaque, and calcified plaque. Both references were divided into 3 groups according to visibility of EEL.

Results

Among 205 lesions, 31 lesions had artifacts at references (16 proximal and 17 distal references). EEL visibility was summarized in a table. Out of 174 lesions with both analyzable references, 111 lesions (63.8%) had >180-degree EEL visibility at both references. Proportion of plaque morphology were significantly different among 3 groups at proximal and distal references as shown in a figure.

Conclusions

EEL-based stent sizing criteria was usable for 63.8% of all the lesions. Vessel size and plaque morphology were significantly associated with EEL visibility.

Proportion of plaque morphology

Funding Acknowledgement

Type of funding source: None
Ex Vivo assessment of competent strut coverage after coronary stenting by optical coherence tomography
Authors: Bhoite R , Jinnouchi H , Otsuka F , Sato Y , Sakamoto A , Kolodgie F , Virmani R , Finn A
Published: November 2020

Background

In many studies, struts coverage is defined as >0 mm of tissue overlying the stent struts by optical coherence tomography (OCT). However, this definition has never been validated using histology as the “gold standard”. The present study sought to assess the appropriate cut-off value of neointimal thickness of stent strut coverage by OCT using histology.

Methods

OCT imaging was performed on 39 human coronary arteries with stents from 25 patients at autopsy. A total of 165 cross-sectional images from 46 stents were co-registered with histology. The optimal cut-off value of strut coverage by OCT was determined. Strut coverage by histology was defined as endothelial cells with at least underlying two layers of smooth muscle cells. Considering the resolution of OCT is 10–20 μm, 3 different cut-off values (i.e. at ≥20, ≥40, and ≥60 μm) were assessed.

Results

A total of 2235 struts were evaluated by histology. Eventually, 1216 struts which were well-matched struts were analyzed in this study. By histology, uncovered struts were observed in 160 struts and covered struts were observed in 1056 struts. The broadly used definition of OCT-coverage which does not consider neointimal thickness yielded a poor specificity of 37.5% and high sensitivity 100%. Of 3 cut-off values, the cut-off value of >40 μm was more accurate as compared to >20 and >60 mm [sensitivity (99.3%), specificity (91.0%), positive predictive value (98.6%), and negative predictive value (95.6%)]

Conclusion

The most accurate cut-off value was ≥40 μm neointimal thickness by OCT in order to identify stent strut coverage validated by histology.

Funding Acknowledgement

Type of funding source: None
Discordance predictor between fractional flow reserve and resting full-cycle ratio in clinical characteristics
Authors: Ohashi H , Takashima H , Ando H , Suzuki A , Sakurai S , Nakano Y , Sawada H , Fujimoto M , Suzuki W , Waseda K , Amano T
Published: November 2020

Introduction

Fractional flow reserve (FFR) is a gold standard method to evaluate functional lesion severity in daily clinical practice. Recently, the resting full-cycle ratio (RFR) which was newly developed resting indices was launched. Unlike other resting indices evaluated in diastolic phase, RFR is evaluated during entire cardiac phase. Previous studies showed discordance predictors between FFR and instantaneous wave-free ratio. However, it is previously unreported what predictor cause discordant outcome between FFR and RFR.

Purpose

The purpose of this study was to evaluate clinical predictors of discordance between FFR and RFR.

Methods

A total of 156 patients with 220 lesions were prospectively enrolled in this study. RFR was evaluated before inducing hyperemia. FFR was measured after intravenous adenosine triphosphate administration (180 mcg/kg/min). According to FFR and RFR values, the patients and lesions were classified into 4 groups: Concordant negative (Group-1 [n=114]: FFR >0.80, RFR >0.89); negative FFR and positive RFR (Group-2 [n=18]: FFR >0.80, RFR ≤0.89); positive FFR and negative RFR (Group-3 [n=25]: FFR ≤0.80, RFR >0.89); Concordant positive (Group-4 [n=63]: FFR ≤0.80, RFR ≤0.89). Among them, discordance predictors with clinical characteristics between RFR and FFR were compared using by two separate logistic regression analyses. (Group-1 vs. Group-2, Group-3 vs. Group-4, respectively). Age, sex and those predictors with a p value ≤0.10 were included in a multivariate regression analysis using by forward stepwise selection to identify independent predictors of discordance.

Results

On multiple regression analysis, hemodialysis (HD) (OR:6.072 [1.090–33.836]), peripheral artery disease (PAD) (OR:9.053 [1.776–46.162]) and left anterior descending artery (LAD) (OR:9.264 [2.092–41.031]) were significantly associated with positive RFR among negative FFR groups (Groupe 2 discordance). Conversely, diabetes mellitus (DM) (OR:0.212 [0.062–0.721]) and Hb (OR:1.480 [1.102–1.987]) were significantly associated with negative RFR among positive FFR groups (Groupe 3 discordance)

Conclusions

Since the clinical characteristics with HD, PAD, LAD, DM and Hb may influence concordant with FFR during RFR evaluation, it should be considered when interpreting RFR.

Distribution and independent predictors

Funding Acknowledgement

Type of funding source: None
Predictors of fractional flow reserve/instantaneous wave-free ratio discordance documented during functional coronary stenosis assessment: impact of tailored diagnostic cut-offs on long-term outcomes
Authors: De Filippo O , Gallone G , D'Ascenzo F , Peirone A , Castelli C , Leone A.M , Mancone M , Cerrato E , Niccoli G , Rognoni A , Varbella F , Omede P , Conrotto F , Escaned J , De Ferrari G.M
Published: November 2020

Background

Patient- and lesion-related factors may influence concordance between instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR), potentially affecting safety of revascularization deferral.

Methods

Consecutive patients with at least an intermediate coronary stenosis evaluated by both iFR and FFR were retrospectively enrolled. Revascularization was at physician's discretion. The agreement between IFR and FFR at their diagnostic cut-offs (FFR 0.80, iFR 0.89) according to patient- and lesion-level characteristics was assessed. Multivariate analyses were carried to identify the independent predictors of discordance. Tailored iFR cut-offs according to predictors of discordance best matching an FFR of 0.80 were identified by receiver-operating characteristic (ROC) curves. The impact of reclassification according to tailored iFR cut-offs on major cardiovascular events (MACE: cardiovascular death, myocardial infarction or target lesion revascularization) among deferred lesions was investigated.

Results

299 coronary stenosis (diameter stenosis 54±14%, FFR 0.84 [0.78–0.89], iFR 0.91 [0.87–0.95], left main/left anterior descending [LM/LAD] vessel 67.6%) of 260 patients were studied, and 46.5% were revascularized. Discordance rate was 23.4% (10.7% iFR-negative discordant, 12.7% iFR-positive discordant). Independent predictors of discordance were LM/LAD disease, multivessel disease, non-ST-elevation myocardial infarction presentation, smoking, reduced glomerular filtration rate and hypertension. Lesion reclassification with tailored iFR-cut-offs based on patient-level predictors carried no prognostic value among deferred lesions. Reclassification according to lesion location, which was entirely driven by LM/LAD lesions (iFR-cut-offs: 0.93 for LM/LAD, 0.89 for non-LM/LAD), identified increased MACE among lesions deferred based on a negative FFR, between patients with a positive as compared to a negative iFR (19.4% vs. 6.1%, p=0.044), while the same association was not observed with the conventional 0.89 iFR cut-off (15.0% vs 8.6%, p=0.303).

Conclusion

Tailored vessel-based iFR cut-offs carry prognostic value among FFR negative lesions, suggesting that iFR may more safely defer revascularization of LM/LAD lesions than FFR and that a single iFR cut-off might be clinically unsatisfactory.

Funding Acknowledgement

Type of funding source: None
Evaluation of traditional and non-traditional risk factors as predictive values for a positive acetylcholine provocation test in patients with ischemia and no obstructive coronary artery disease
Authors: Beijderwellen E , Feenstra R.G.T , Beijk M.A.M , Wittekoek M.E , Stegehuis V.E , Piek J.J
Published: November 2020

Background

Coronary vasomotor function disorders, such as microvascular angina (MVA) and vasospastic angina (VSA) can be diagnosed in three quarters of all patients with signs and symptoms of ischemia and no obstructive coronary artery disease (INOCA). Intracoronary acetylcholine provocation testing (Ach-test) is considered the gold standard for the assessment of VSA and MVA. Our aim is to identify the correlation between a positive Ach-test identifying an abnormal coronary vasomotor response and predictive traditional and non-traditional risk factors in patients with INOCA.

Methods

In this single centre retrospective cohort study, data from all patients who were referred for an Ach-test between 2002 and 2019 was collected. All patients underwent an invasive test with assessment of the vasomotor responses by intracoronary acetylcholine and assessment of coronary microvascular dysfunction (CMD) by measuring the coronary flow reserve (CFR). VSA and MVA were diagnosed on the basis of the criteria as proposed by the Coronary Vasomotor Disorders International Study Group (COVADIS). The predictive risk factors were analyzed by means of logistic regression.

Results

A total of 134 patients were included, median age was 57 years and 85.1% were female. The Ach-test revealed VSA in 95 patients (70.9%), MVA in 13 patients (9.7%) and a negative Ach-test in 26 patients (19.4%). A multivariable logistic regression model showed smoking as an independent variable for a positive Ach-test (OR of 3.0 with 95% CI 1.1–8.2; p=0.031) and as an independent predictor for VSA (OR of 2.9 95% CI 1.1–7.9 p=0.039). In addition we showed that migraine (OR of 6.7 95% CI 1.4–32.9 p=0.019) is an independent predictor for MVA and MVA has a strong association with female patients who have a history of recurrent miscarriages (p=0.015).

Conclusion

MVA and VSA are associated with different risk factors which support a different underlying pathophysiology. Smoking is an independent predictor for a positive Ach-test and an independent predictor for VSA. In addition, we showed that migraine is an independent predictor for MVA and MVA has a strong association with female patients who have a history of miscarriages. MVA and VSA require a different treatment strategy and because there are no clear predictive values for a positive Ach-test, it is important to support identification with an Ach-test.

Funding Acknowledgement

Type of funding source: None
PCI complexity and cardiovascular risk in relation to high bleeding risk among patients receiving drug-eluting Stents: insight from China Fuwai PCI registry
Authors: Wang H.Y , Gao R.L , Xu B , Kirtane A , Dou K
Published: November 2020

Background

The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score.

Methods

Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion requiring a rotablator system. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding.

Results

The median duration of follow-up was 30 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P<0.001), compared with non-complex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or <8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279).

Conclusions

Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures.

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences;National Natural Science Foundation of China
Suppression of gastric acid secretion decreased cardiovascular events independent of severe bleeding events in patients after percutaneous coronary intervention – sub-analysis from multicenter registry
Authors: Kamishima K , Jujo K , Tanaka H , Hata T , Ota Y , Oka T , Koganei H , Kobayashi H , Mori F , Sakamoto T , Yamaguchi J , Hagiwara N
Published: November 2020

Background

Suppression of gastric acid secretion by proton-pump inhibitor (PPI) or potassium-competitive acid blocker (P-CAB) has recently been developed as a standard strategy for preventing gastrointestinal bleeding for patients receiving antiplatelet therapy after percutaneous coronary intervention (PCI). However, there has been limited evidences on the association between PPI/P-CAB administration and adverse cardiovascular events in patients undergoing PCI.

Purpose

We aimed to evaluate the prognostic impact of the prescription of PPI/P-CAB on clinical outcomes in patients after PCI.

Methods

This study is a subanalysis from the TWINCRE registry that is a multicentral prospective cohort including patients who underwent PCI at 12 hospitals in Japan between 2017 and 2019. Among registered patients, we ultimately evaluated 1,428 patients who were followed-up. They were divided into two groups by the prescriptions of PPI or P-CAB at discharge for the index PCI; the PPI/P-CAB group (n=1,023), and the Non-PPI/P-CAB group (n=407). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) including death, acute coronary syndrome, stent thrombosis, hospitalization due to heart failure and ischemic stroke. Secondary endpoints was major bleeding events defined BARC3, 4 and 5.

Results

The average age of the study population was 70.3 years and 80.3% were male. Baseline clinical profiles were comparable between the groups, except that the PPI/P-CAB group included significantly higher rate of patients who had history of prior PCI (28.4% vs 18.7%, P=0.02). Additionally, there was no significant difference in the duration of dual antiplatelet therapy between the PPI/P-CAB group and Non-PPI/P-CAB group (average duration; 287±8 vs. 285±8 days, P=0.66). Overall, MACCE was developed in 132 patients (9.3%), and bleeding event was observed in 24 patients (1.7%) during 574 days of median follow-up period. Kaplan-Meier analysis showed that patients in the PPI/P-CAB group had a significantly lower rate of MACCE than those in the Non-PPI/P-CAB group (Log-rank test, p=0.0003, Figure 1A). Multivariate Cox regression analysis revealed that the prescription of PPI/P-CAB still was independently associated with the primary endpoint (hazard ratio 0.532, 95% confidence interval 0.369–0.766, p=0.0007), even after the adjustment by diverse covariates. Whereas, there was no significant difference in the bleeding event (p=0.64, Figure 1B).

Conclusion

PPI or P-CAB therapy was associated with better clinical outcomes after PCI, independent of the incidences of severe bleeding events.

Figure 1

Funding Acknowledgement

Type of funding source: None
Comparative Effectiveness of CABG versus PCI in Patients with Ischemic Heart Disease: insights from SWEDEHEART Registry
Authors: Redfors B , Volz S , Angeras O , Ioanes D , Odenstedt J , Haraldsson I , Dworeck C , Myredal A , Hirlekar G , Ramunddal T , Petursson P , Bollano E , Dellgren G , Jeppsson A , Omerovic E
Published: November 2020

Background

Several studies have compared CABG to PCI as revascularization treatment in patients with ischemic heart disease (IHD). However, it remains unclear which revascularization strategy carries survival benefits in the long-term.

Methods

We used data from the SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry for all hospital admissions at 13 cardiac care centers within Västra Götaland County in Sweden (∼20% of all SWEDEHEART data). The database contains >1000 clinical variables documenting the entire process of acute coronary hospital care. All patients hospitalized for stable angina or NSTE-ACS during the period 2000–2018 were included in the analysis. We used a propensity score-adjusted Cox proportional-hazards regression with hospitals as random-effect variables. We adjusted for patients' demographics, socio-economic status, traditional risk factors, comorbidities, the severity of coronary artery disease, left ventricular function, calendar year and medication at discharge. For sensitivity analysis, we used the instrumental variable estimator for the Cox proportional-hazards model (with treating hospital as a treatment-preference instrument) to simultaneously deal with the problems of unmeasured confounding and censoring of the outcome. The primary outcome was all-cause mortality.

Results

In total, 11,896 patients were included in the study. Of these, 3,129 (26.3%) were women. 20.4% had diabetes and 10.4% had a previous myocardial infarction. The mean age was 66.7±10.7, and 42.9% were >70 years old. 61.5% had three-vessel and/or left main disease. Median follow-up time was 5.7 years (range 1 day-18.2 years). Revascularization therapy after coronary angiography was PCI in 9449 (79.4%) and CABG in 2,447 (20.6%) patients. CABG patients were more likely to have diabetes, left main/multivessel disease and heart failure. The number of revascularized patients with PCI increased by 6.4% per calendar year (P<0.001). There were 2,481 (20.9%) deaths. CABG was associated with a lower risk of death compared to PCI (HR 0.81; 95% CI 0.69–0.95; P=0.011. We found no evidence for treatment heterogeneity between the revascularization strategy and age, gender, diabetes, heart failure and indication for revascularization (all P-interaction >0.05). Results from the sensitivity analysis support the conclusions from the primary model.

Conclusions

In hospitalized patients due to IHD, revascularization with CABG was associated with superior long-term survival compared to PCI.

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): Heart and Lung Foundation, ALF Västra Götaland, Swedish Scientific Council
Safety and efficacy of the treatment of in-stent restenosis and de novo complex lesions with the novel paclitaxel-coated scoring balloon (Angiosculpt X)
Authors: Agip Fustamante D.P , Ortiz Cruces S , Camacho Freire S , Gutierrez Barrios A , Gomez Menchero A , Canadas Pruano D , Roa Garrido J , Calle Perez G , Cardenal Piris R , Diaz Fernandez J
Published: November 2020

Background

The AngioSculpt X (Spectranetics) is a novel paclitaxel-coated scoring balloon with encouraging preliminary data for the treatment of in-stent restenosis or de novo complex lesions.

Purpose

To assess the safety and efficacy of real-world patients with in-stent restenosis (ISR) or de novo complex lesions (vessels <2.5 mm, calcified lesions, bifurcation lesions...) treated with the novel paclitaxel-coated scoring balloon.

Methods

A “real-world”, prospective registry from two centers was performed including consecutive patients presenting with ISR or de novo complex lesions and treated with AngioSculpt X. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, stent thrombosis, nonfatal myocardial infarction, target lesion revascularization (TLR) and target vessel revascularization (TVR).

Results

Overall, 87 real-world patients and 93 lesions (73% male, 68±10 years, 46% smoker, 83% hypertensive, 62% diabetic, 71% hyperlipidemic, 35% LVEF <60% impairment) were enrolled in the study. Clinical presentation was stable angina in 19%, unstable angina in 33%, NSTEMI in 29% and STEMI in 5%. Radial access account 84%. The median fluoroscopy time was 17 (IQ range 10,0 - 37.5) min. De novo complex lesions were treated in 35% (n=32) while ISR in 63% (n=57), (Prior BMS 19%; Sirolimus DES 9%; Everolimus DES 26%; Biolimus/Anfilimus DES 20%; Zotarolimus DES 26%) with a median time to ISR of 3.6 (IQ range 1.1 - 10.7) years. Total stent length was 28±18 mm, with an overlap spot affected in 18%, and 27% had >1 treatment for ISR. The most frequent artery treated was left anterior descending (41%) followed by left circumflex (35%) and right coronary artery (17%).

Quantitative coronary angiography reference diameter of lesions was 2.7±0.5 mm and length 9.0±4.8 mm, with a % stenosis of 75±20. Predilatation/postdilatation was performed in 60/24% respectively. Device diameter was 2.9±0.4 mm and length 13.6±3.9 mm, deployed at 16±3 atmospheres, with an inflation time of 33±16 seconds. The balloon/artery ratio was 0.99±0.03. Crossover was decided on 18 cases (19%) due to remaining intimal flap, but the success rate (residual stenosis <30%) was 100%. Intracoronary imaging technique was performed in 12% (OCT=7, IVUS=4). At 7±6 month follow-up, there were 10 MACE (cardiac death=1, nonfatal myocardial infarction =4, TLR=4 and TVR=1).

Conclusions

Paclitaxel-coated scoring balloon offers a safe and valuable treatment option for ISR and de novo complex lesions.

Funding Acknowledgement

Type of funding source: Public hospital(s). Main funding source(s): Juan Ramόn Jiménez University Hospital
5-year outcomes in patients with acute coronary syndrome treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents
Authors: Iglesias J.F , Heg D , Roffi M , Tueller D , Muller O , Moarof I , Cook S , Weilenmann D , Kaiser C , Valgimigli M , Juni P , Windecker S , Pilgrim T
Published: November 2020

Background

Newest generation drug-eluting stents (DES) combining ultrathin cobalt chromium platforms with biodegradable polymers may reduce target lesion failure (TLF) as compared to second generation DES among patients with acute coronary syndrome (ACS). While previous studies indicated a potential benefit within the first two years after percutaneous coronary intervention (PCI), it remains uncertain whether the clinical benefit persists after complete degradation of the polymer coating.

Purpose

To compare the long-term effects of ultrathin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) versus thin-strut durable polymer everolimus-eluting stents (DP-EES) for PCI in patients with ACS.

Methods

We performed a subgroup analysis of ACS patients included into the BIOSCIENCE trial (NCT01443104), a randomized trial comparing BP-SES with DP-EES. The primary endpoint of the present post-hoc analysis was TLF, a composite of cardiac death, target vessel myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR), at 5 years.

Results

Among 2,119 patients enrolled between March 2012 and May 2013, 1,131 (53%) presented with ACS (ST-segment elevation myocardial infarction, 36%). Compared to patients with stable CAD, ACS patients were younger, had a lower baseline cardiac risk profile, including a lower prevalence of hypertension, hypercholesterolaemia, diabetes mellitus, and peripheral artery disease, and had a greater incidence of previous revascularization procedures. At 5 years, TLF occurred similarly in 89 patients (cumulative incidence, 16.9%) treated with BP-SES and 85 patients (16.0%) treated with DP-EES (RR 1.04; 95% CI 0.78–1.41; p=0.78) in patients with ACS, and in 109 patients (24.1%) treated with BP-SES and 104 patients (21.8%) treated with DP-EES (RR 1.11; 95% CI 0.85–1.45; p=0.46) in stable CAD patients (p for interaction=0.77) (Figure 1, Panel A). Cumulative incidences of cardiac death (8% vs. 7%; p=0.66), target vessel MI (5.2% vs. 5.8%; p=0.66), clinically indicated TLR (8.9% vs. 8.3%; p=0.63) (Figure 1, Panel B-D), and definite thrombosis (1.4% vs. 1.0%; p=0.57) at 5 years were similar among ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES. Overall, there was no interaction between clinical presentation and treatment effect of BP-SES versus DP-EES.

Conclusion

In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term clinical outcomes between ACS patients treated with ultrathin-strut BP-SES or thin-strut DP-EES at five years.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Unrestricted research grant to the institution from Biotronik AG, Switzerland
Provisional versus 2-stent strategies for coronary bifurcations: is a bird in the hand worth two in the bush?
Authors: Sousa J.P , Puga L , Ribeiro J , Lopes J , Saleiro C , Gomes R , Campos D , Lourenco C , Goncalves L
Published: November 2020

Background

Among all subsets of coronary artery lesions, bifurcations stand out due to high incidence, demanding percutaneous interventions (PCIs) and poor outcomes. Amid the different PCI strategies, the provisional (PS) approach is generally recommended over 2-stent (TS) techniques, but this paradigm has been challenged.

Purpose

To compare PS with TS for PCI of coronary bifurcation lesions, concerning procedural aspects and both immediate and long-term patient outcomes.

Methods

Retrospective study encompassing patients consecutively referred to a tertiary interventional cardiology unit for coronary angiography, who were found to have at least 1 native bifurcation lesion. According to operator experience and angiographic features, patients were managed with PS or/(and) TS. Procedural aspects regarding radiological variables, angiographic success and immediate complications were reviewed, as were in-hospital outcomes. Besides, clinical follow-up, by clinic appointment or telephone calling, was performed targeting stent failure, target vessel revascularization (TVR), acute coronary syndromes (ACS), heart failure and mortality.

Results

From January 2010 to June 2017, 404 patients with 433 bifurcation lesions were included. Median age was 70 (62–77) years and 25.3% were female. Median follow-up was 2 (1–3) years. Chronic angina was the dominant PCI context (61.3%) with 9.7% presenting with ST-segment elevation myocardial infarction (MI). Medina class 1,1,1 was documented in 54.1% and 64.9% of lesions were hailed as true bifurcations. 303 patients underwent PS, whereas 67 were managed with TS, with TAP (43.3%) and mini-crush (34.3%) as the leading techniques. True bifurcations were more frequently approached with TS (p<0.001), whereas PCI context did not influence procedure selection. Fluoroscopy time (p<0.001), radiation dose (p=0.003) and contrast volume (p=0.009) were higher in the TS subgroup. OCT guidance (p=0.039) was also more common with TS. Angiographic success was uniformly high (95.1% for PS and 97% for TS), while procedural complications, including iatrogenic coronary dissections (7.4%, mostly minor) and slow-reflow (3.5%), were homogenously low. Acute kidney injury and type 4a MI occurred in 14.5% and 32.3%, respectively, also with no difference between groups. As for long-term outcomes, stent failure, encompassing both stent thrombosis (1 event) and restenosis (4.2%), occurred more often with TS (p=0.046), with ACS events (9.5%) following the same trend (p=0.08). In turn, rates of TVR (12.5%), heart failure hospitalization (6.2%) and mortality, regardless of its cardiovascular nature, were similar.

Conclusion

PS outperforms TS during follow-up, particularly due to lower stent failure odds. Thus, this study further supports the concept of PS as the standard approach for coronary bifurcation lesions.

Funding Acknowledgement

Type of funding source: None
Complete versus culprit-only percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndrome: a meta-analysis
Authors: Sakurai R
Published: November 2020

Background

The clinical benefit of complete or culprit-only percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) still remains controversial.

Purpose

The purpose of this study was to investigate the clinical outcomes of complete or culprit-only PCI in patients with unstable angina and/or non-ST-segment elevation myocardial infarction.

Methods

PubMed, the Cochrane Library, and Web of Science were queried to conduct a meta-analysis. The same terms or relevant studies were also queried on the website of the U.S. National Institute of Health and relevant reviews. The primary endpoint was the incidence of major adverse cardiac events (MACE: the composite of all-cause mortality, myocardial infarction, or coronary revascularisation) during follow-up period, and the secondary endpoints were the incidences of each component of MACE. When multiple follow-up results were reported in the same study, the latest results were abstracted. Pooled estimates were calculated using a random-effects model.

Results

Nine studies (60345 patients) were included in this meta-analysis. The risk of all-cause mortality (odds ratio (OR): 0.79, 95% confidence interval (CI): 0.64–0.98, p=0.03) or coronary revascularisation (OR: 0.71, 95% CI: 0.50–1.00, p=0.05) were lower in the complete PCI group than in the culprit-only PCI group, whereas the risk of MACE (OR: 0.98, 95% CI: 0.65–1.49, p=0.94) or myocardial infarction (OR: 0.77, 95% CI: 0.54–1.08, p=0.13) was similar between the 2 groups.

Conclusions

In this meta-analysis, complete PCI is associated with a lower risk of all-cause mortality or coronary revascularisation, and a similar risk of MACE or myocardial infarction compared with culprit-only PCI in patients with NSTE-ACS.

Funding Acknowledgement

Type of funding source: None
Japanese multicenter registry evaluating the antegrade dissection reentry with cardiac computed tomography for chronic coronary total occlusion
Authors: Habara M , Tsuchikane E , Shimizu K , Kawasaki T
Published: November 2020

Objective

This study was performed to evaluate the efficacy of cardiac computed tomography (CT) for antegrade dissection re-entry (ADR) technique in chronic total occlusion (CTO) percutaneous coronary intervention (PCI).

Background

Although PCI of CTO is a rapidly evolving field, procedure success rate remains suboptimal. Recently, ADR with Stingray device for CTO-PCI has also evolved to one of the pillar technique of the hybrid algorithm. Although the success rate of the device could be improved, it also remains not always high especially as first crossing strategy.

Methods

Forty eight patients with total occlusion suitable for revascularization evaluated by baseline coronary angiography and cardiac CT were enrolled in this study from April 2017 to April 2019 from 30 enrolled centers. The primary observation was procedural success. Furthermore, all puncture point with Stingray were analyzed by cardiac CT. In each point, 1) plaques on the isolated myocardial side at distal puncture site (+1 point), 2) any plaques excluded above definition at distal puncture site (+2 points), 3) calcification on both 1 and 2 at distal puncture site (+1 point) were analyzed and calculated the score (Score 0–3) (Figure 1).

Results

Overall procedure success rate was 95.8% (46/48) and antegrade success rate was 91.3% (42/46). Sixteen cases were succeeded with single guidewire escalation and 32 cases were attempted ADR with Stingray system. Within them, 25 cases were succeeded and 7 cases were observed puncture failure. And 3cases were succeeded with IVUS guide and 2 cases were with retrograde appTechnical success rate with stingray was 78.1% (25/32). Cardiac CT was analyzed 60 puncture sites in 32 cases which were attempted ADR with stingray system (1.88 sites/case). CT score at ADR success point was significantly smaller compare to that at ADR failure point (0.68±1.09 vs 1.77±1.09, p<0.0001).

Conclusions

Pre procedure Cardiac CT and CT score might be useful for ADR technique in CTO PCI not only for case selection but also for puncture site selection.

Figure 1

Funding Acknowledgement

Type of funding source: None
Invasive- versus computed tomography-angiography for the evaluation of coronary artery disease among elderly patients undergoing transcatheter aortic valve implantation
Authors: Berkovitch A , Finkelstein A , Barbash I.M , Fefer P , Maor E , Banai S , Brodov Y , Goitein O , Aviram G , Halkin A , Guetta V , Steinvil A , Segev A
Published: November 2020

Background

Coronary artery disease (CAD) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend that percutaneous coronary intervention (PCI) of >70% proximal coronary lesions prior to TAVI. The aim of the current study was to evaluate two approaches to CAD diagnosis pre-TAVI.

Methods

We investigated 2,027 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural CAD assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results (N=831) or mandatory invasive angiography (IA) (N=1,196). Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented.

Results

Mean age of the study population was 86±4, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (32% vs. 17%, p<0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were significantly lower among the IA group (0.1% vs. 1.5%, p=0.001). However, multivariate binary logistic regression analysis adjusted for age, gender and cardiovascular risk factors failed to show association between centers strategy and peri-procedural MI. Periprocedural bleeding rates were similar between the groups (3.5% vs. 2.9%, p=0.477). Thirty day, and 1-year mortality crude rates were similar between the groups (2.5% vs. 3.4%, p=0.25, and 10.2% vs. 12.0%, p=0.19). Multivariate cox regression adjusted for age, gender and cardiovascular risk factors did not find association between CAD clearance strategy and outcome.

Conclusions

In elderly patients, CTA driven approach for CAD evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome.

Funding Acknowledgement

Type of funding source: None
Transcatheter aortic valve implantation with the LOTUS Edge system: early European experience
Authors: Armario X , Rosseel L , Banning A , Khogali S.S , Blackman D.J , Abdel-Wahab M.S , Tchetche D , Hildick-Smith D , Van Mieghem N.M , Spence M.S , Frerker C , Nickenig G , Pilgrim T , Sondergaard L , Mylotte D
Published: November 2020

Aims

To evaluate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the recently commercialised LOTUS EdgeTM system.

Methods and results

We performed a multicentre, single-arm, retrospective registry to generate early information on patients undergoing TAVI with the LOTUS EdgeTM system following its commercial release in July 2019. Novel features of this second-generation device include increased flexibility of the delivery catheter, enhanced visualisation of the locking mechanism and the depth guard technology to reduce left ventricular outflow tract interaction and, potentially, reduce the risk of permanent pacemaker (PPM) implantation. All endpoints were defined according to the VARC-2 definitions and were reported by the treating site.

A total of 286 consecutive patients from 18 participating centres were included. The mean age and STS score were 81.2±6.9 years and 5.2±5.4%, respectively. Most procedures were performed under local anaesthesia (97.2%) via transfemoral access (98.6%).

Successful vascular access, valve delivery and deployment and system retrieval were achieved in 97.6% of cases. 30-day rates of all-cause mortality (2.1%, N=6) and stroke (3.5%, N=10) were acceptable. Disabling, life-threatening or major bleeding occurred in 3.8% and major vascular complications in 2.1%. The incidence of new PPM implantation was 27.1% among all patients and 32.2% among pacemaker-naive patients. After TAVI, the mean transvalvular pressure gradient was 11.9±5.6 mmHg and the mean aortic valve area was 1.9±0.9 cm2. The rate of moderate paravalvular leak was 2.1% with no cases of severe paravalvular leak.

Conclusions

Early experience with the LOTUS EdgeTM system demonstrated acceptable 30-day clinical outcomes with impressively low rates of paravalvular leak. The requirement for new PPM remained high in this early experience. Further study is required to understand if improving operator experience with the device can reduce PPM rates.

Funding Acknowledgement

Type of funding source: None