Author(s) Chichareon P.; Modolo R.; Kerkmeijer L.; Kogame N.; Takahashi K. et al.
Source JAMA Cardiology; 2019
Importance: Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI). Objective(s): To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies.

Design, Setting, and Analysis: This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019. Intervention(s): Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy.

Main Outcomes and Measures: The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding. Result(s): Of the 15968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction =.045).

​Conclusions and Relevance: Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years. Trial Registration: ClinicalTrials.gov identifier: NCT01813435.Copyright © 2019 American Medical Association. All rights reserved.

Author(s) Menown I.B.A.; De Silva R.; Mitra R.; Balachandran K.; More R. et al.
Source European Heart Journal; Oct 2019; vol. 40 ; p. 1744
Background: Thin stent struts may be associated with reduced vessel injury and use of biodegradable polymers may further improve long term outcomes. However, data with earlier stents has been inconsistent; thus further studies with newer devices are needed. Purpose(s): To evaluate the efficacy and safety of a new ultra-thin (65um) strut cobalt chromium sirolimus-eluting stent with a hybrid design (closed cell at ends and open cells in middle to reduce edge injury and optimise conformability) in all-comers patients undergoing percutaneous coronary intervention (PCI).

Method(s): We enrolled 752 patients from 14 sites undergoing PCI into a prospective, non-randomised, multi-centre, open-label, observational registry. Inclusion of patients with complex anatomy (long stent lengths, bifurcations and chronic total occlusions) was encouraged. Clinical follow-up was scheduled at 1, 9, 12 and 24 months. The primary endpoint was incidence of major adverse cardiac events (MACE)-cardiac death, non-fatal myocardial infarction (MI), or target vessel revascularization (TVR)-at 9 months.

​Result(s): Mean patient age was 64.7+/-12.2 years, 20.7% had diabetes, 58.8% had dyslipidaemia, 40.4% had multi-vessel disease, 22% had previous PCI, 4.7% had previous coronary-artery bypass graft, and 19.6% had a clinical history of previous MI. Mean lesion length was 25.7+/-17.3 mm. The primary endpoint of cumulative MACE up to 9 months (from 624 patients reaching 9 months follow-up) occurred in 12 patients (1.92%), including 6 (0.96%) cardiac death, 5 (0.80%) MI and 6 (0.96%) clinically indicated TVR. Definite stent thrombosis was reported in 3 patients (0.48%) and probable stent thrombosis in 2 patients (0.32%). Conclusion(s): Use of an ultra-thin strut biodegradable polymer sirolimuseluting stent in all-comers patients undergoing PCI was associated with good clinical efficacy and safety.

Author(s) Garg S.; Chichareon P.; Modolo R.; Tomaniak M.; Onuma Y. et al.
Source European Heart Journal; Oct 2019; vol. 40 ; p. 3108
Objectives: To investigate the impact of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) on clinical outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD) who were enrolled in the Global Leaders Trial. 

Author(s) Franzone A.; Piccolo R.; McFadden E.; Leonardi S.; Ferrario M. et al.
Source Journal of the American College of Cardiology; Nov 2019; vol. 74 (no. 18); p. 2223-2234
Background: The GLOBAL LEADERS (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) study randomly assigned 15,991 patients undergoing percutaneous coronary intervention to 1-month dual antiplatelet therapy (DAPT) followed by 23-month ticagrelor monotherapy or conventional 12-month DAPT followed by 12-month aspirin. Apart from Q-wave myocardial infarction (MI), all study endpoints were analyzed as investigator reported.

Objective(s): This was a pre-specified ancillary study assessing whether experimental therapy is noninferior, and if met, superior, to conventional treatment for the coprimary efficacy endpoint of all-cause death, nonfatal MI, nonfatal stroke, or urgent target vessel revascularization and superior in preventing BARC 3 (Bleeding Academic Research Consortium) or 5 bleeding (coprimary safety endpoint) at 2 years with a 0.025 significance level to preserve nominal 5% alpha error. Method(s): An independent clinical event committee adjudicated investigator-reported and eventually unreported events of 7,585 patients from the 20 top-enrolling participating sites.

​Result(s): The 2-year coprimary efficacy endpoint occurred in 271 (7.14%) and in 319 (8.41%) patients in the experimental and conventional groups, respectively (rate ratio [RR]: 0.85; 95% confidence interval [CI]: 0.72 to 0.99), fulfilling noninferiority (p noninferiority <0.001), but not superiority (p superiority = 0.0465). The rates of BARC 3 or 5 bleeding did not differ (RR: 1.00; 95% CI: 0.75 to 1.33; p = 0.986). A time-dependent treatment effect was observed with the experimental strategy being associated with a lower risk of MI (RR: 0.54; 95% CI: 0.33 to 0.88; p interaction = 0.062) and definite stent thrombosis (RR: 0.14; 95% CI: 0.03 to 0.63; p interaction = 0.007) after 1-year post-percutaneous coronary intervention. Conclusion(s): Ticagrelor monotherapy after 1-month DAPT was noninferior, but not superior, to conventional treatment in the prevention of ischemic events, and it did not decrease major bleeding risk as compared with conventional treatment. (GLOBAL LEADERS Adjudication Sub-Study [GLASSY]; NCT03231059).Copyright © 2019 American College of Cardiology Foundation

Author(s) Katsogridakis E.; Perricone V.; Pokusevski G.
Source Interactive Cardiovascular and Thoracic Surgery; 2019; vol. 28 (no. 4); p. 635-637
A best evidence topic in vascular surgery was written according to a structured protocol. The question addressed was whether sartorius muscle flaps (SMF) can be effectively used in the setting of complex groin wounds with exposed prosthetic grafts for graft salvage and limb salvage. The literature review identified 33 articles reporting on the use of SMF for complex vascular wounds. Of these, 7 articles reporting on the use of 539 SMFs were considered the best evidence to answer the clinical question. Indications included surgical site infections with or without wound dehiscence, lymph leaks, graft infection and groin pseudoaneurysms, whereas in 98 of the included 539 cases, the flaps were performed prophylactically. Vacuum-assisted closure systems were used in 25 cases to promote healing. The use of an SMF is associated with low rates of muscle flap and graft complications, whereas outcomes seem to be independent of the presence of occlusive disease in the superficial femoral artery. They can be effectively combined with aggressive debridement strategies and vacuum-assisted closure devices to optimize outcomes. The published literature supports the use of SMF in the management of complex groin wounds following vascular reconstruction and is associated with encouraging flap, limb and graft salvage rates.Copyright © 2018 The Author(s).

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Author(s) Chichareon P.; Modolo R.; Kogame N.; Takahashi K.; Wykrzykowska J. et al.
Source Journal of the American College of Cardiology; Oct 2019; vol. 74 (no. 13)
DOI 10.1016/j.jacc.2019.08.754
Background: Diabetes has been well recognized as a strong predictor of adverse outcomes after percutaneous coronary intervention (PCI), but studies in the era of drug-eluting stents and potent P2Y12 inhibitors have shown conflicting results. We assessed ischemic and bleeding outcomes after contemporary PCI according to diabetic status.

Method(s): We studied 15,957 patients in the GLOBAL LEADERS study with known baseline diabetic status. The primary endpoint was all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5.

Result(s): A quarter of the study cohort had diabetes (4,038 of 15,957), and these patients had a significantly higher risk for the primary endpoint at 2 years compared with those without diabetes (adjusted hazard ratio [HR]: 1.36; 95% confidence interval [CI]: 1.14 to 1.61). The difference was driven by a significantly higher risk for all-cause mortality at 2 years in patients with diabetes (adjusted HR: 1.44; 95% CI: 1.18 to 1.75). The risk for BARC type 3 or 5 bleeding was comparable between the 2 groups (adjusted HR: 1.18; 95% CI: 0.92 to 1.50). The antiplatelet strategy (experimental vs. reference strategy) had no significant effect on the rates of the primary endpoint and secondary safety endpoint at 2 years in patients with and without diabetes.

​Conclusion(s): Patients with diabetes had a higher risk for ischemic events after PCI than those without diabetes, while bleeding risk was comparable. The outcomes of patients with diabetes following PCI were not affected by the 2 different antiplatelet strategies. Categories: CORONARY: Pharmacology/PharmacotherapyCopyright © 2019

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Author(s) Choudhury A.; Garg S.; Smith J.; Sharp A.; Nabais De Araujo S. et al.
Source BMJ Open; 2019; vol. 9 (no. 10)
Objective To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in real world' patient population requiring percutaneous coronary intervention (PCI).

Methods National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months-overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE-composite of cardiac death, MI, emergent or repeat revascularisation).

Results At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).

​Conclusions The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.Copyright © 2019 Author(s).

• Available in full text at BMJ open from Europe PubMed Central - Open Access

​Author(s) Takahashi K.; Chichareon P.; Modolo R.; Kogame N.; Tijssen J.G.P. et al.
Source Journal of the American College of Cardiology; Oct 2019; vol. 74 (no. 16); p. 2015-2027
DOI 10.1016/j.jacc.2019.08.997
Background: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. Objective(s): This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI.

Method(s): The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding.

Result(s): Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754).

​Conclusion(s): Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).Copyright © 2019 American College of Cardiology Foundation

Author(s) Chichareon P.; Modolo R.; Kogame N.; Takahashi K.; van Klaveren D. et al.
Source Journal of the American College of Cardiology; Oct 2019; vol. 74 (no. 13)
DOI 10.1016/j.jacc.2019.08.512
Background: The logistic clinical SYNTAX score combined anatomic SYNTAX score and 7 variables to predict 2-year all-cause mortality after percutaneous coronary intervention (PCI). The score was derived from 7 stent trials in which new-generation drug-eluting stent and potent antiplatelet inhibitors were not widely utilized. The original logistic clinical SYNTAX score has been shown to overestimate 2-year all-cause mortality in the GLOBAL LEADERS study. This study aimed to revise and update the logistic clinical SYNTAX score to predict 2-year all-cause mortality after contemporary PCI using the population in the GLOBAL LEADERS study.

Method(s): The authors analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The original model of the logistic clinical SYNTAX score was revised by re-estimating the predictor effects in Cox regression model (revised model). The authors updated the score by combining the original model with additional independent predictors of 2-year mortality identified in the GLOBAL LEADERS study population (updated model). Internal validation with bootstrap method was used to quantify and correct for overfitting and optimism.

Result(s): This study has identified 5 additional independent predictors of 2-year all-cause mortality: hemoglobin level; white blood cell count; chronic obstructive pulmonary disease; prior stroke; and current smoker. The updated model (C-index: 0.78; 95% confidence interval [CI]: 0.76 to 0.80) better discriminated 2-year all-cause mortality than the previous version (C-index: 0.75; 95% CI: 0.73 to 0.77), in an internal validation using bootstrap method. The updated model performed better in differentiating mortality among non-high-risk patients. The calibration of both models was appropriate. Currently the updated model is tested in an external validation cohort of 10,724 patients.

​Conclusion(s): By adding 5 predictors to the logistic clinical SYNTAX score, the score better predicts 2-year all-cause mortality after PCI. The score can be used for risk stratification and prediction in patients undergoing PCI in the contemporary practice. Categories: CORONARY: Stents: Drug-ElutingCopyright © 2019

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Author(s) Anderson S.; Garg S.; Saluja S.; Aghamohammadzadeh R.; Thiru S. et al.
Source Journal of the American College of Cardiology; Oct 2019; vol. 74 (no. 13)
DOI 10.1016/j.jacc.2019.08.990
Background: The impact of socioeconomic class on outcomes of percutaneous coronary intervention (PCI) in populations with access to universal unrestricted health care is limited. Furthermore, prior reports have focused mainly on patients with ST-segment elevation myocardial infarction (STEMI).

Method(s): We performed a retrospective analysis of centrally tracked outcomes from index PCI procedures entered in the British Cardiovascular Intervention Society database between 2007 and 2014 stratified according to quintiles of index of multiple deprivation (IMD; from the least deprived to the most deprived). The analyses were restricted to procedures performed in England. The primary endpoint was 30-day all-cause mortality, with secondary endpoints of mortality at 1 and 5 years. Hazard ratios (HRs) for mortality were determined from multivariate Cox regression models allowing for clustering by hospital.

Result(s): Among 437,024 eligible patients with 1.78 million person-years of observation, 40% of patients had PCI for stable coronary artery disease (CAD), 37.7% with non-STEMI, and 21.6% were treated for STEMI. A total of 52,258 patients (11.9%) died during a median of 3.5 years (interquartile range: 1.8 to 5.5 years) of follow-up. There was a trend toward an increase in crude mortality rates (per 1,000 person-years) with increasing quintile of IMD (from 26.7 per 1,000 in least deprived to 28.5 per 1,000 in the most deprived; p for trend <0.0001. When assessed by indication for PCI, only those undergoing intervention for non-STEMI or unstable angina had increased mortality rates as IMD worsened. In an age-, sex-, and indication for PCI-adjusted Cox regression multivariate analysis, mortality rates at 30 days were 14% greater (HR: 1.14; 95% confidence interval [CI]: 1.06 to 1.24; p < 0.0001) in patients from the most deprived areas compared with those with the least deprived IMD. These findings were similar for mortality at 1 year (HR: 1.09; 95% CI: 1.04 to 1.14) and at 5 years (HR: 1.10; 95% CI: 1.06 to 1.16).

​Conclusion(s): This very large, real-world dataset of patients demonstrates that deprivation is an independent marker of mortality following presentation with non-STEMI, and efforts should be directed at overcoming this. Reassuringly, in the setting of universal health care, deprivation does not influence outcomes from stable or STEMI presentation. Categories: OTHER: Political, International and Societal IssuesCopyright © 2019

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Author(s) Her A.-Y.; Kim Y.H.; Shin E.-S.; Zhou Q.; Saleh A. et al.
Source Clinical Hemorheology and Microcirculation; 2019; vol. 72 (no. 4); p. 353-363
DOI 10.3233/CH-180528
BACKGROUND: Magnetocardiography (MCG) is a non-invasive technique and to characterize the magnetic field, a pseudo-current conversion was used. The role of MCG in detecting left atrial (LA) dysfunction in patients with paroxysmal atrial fibrillation (PAF) is unknown. OBJECTIVE(S): The aim of this study was to evaluate LA function using MCG in patients with PAF and healthy subjects, to identify possible indices to diagnose PAF.

METHOD(S): We enrolled a total of 70 subjects including 26 healthy volunteers (group 1) and 22 marathon runners (group 2) who did not exhibit any cardiac abnormalities, and 22 patients with PAF (group 3) which was documented by electrocardiography (ECG). Spatiotemporal activation graph (STAG) in base-apex and left-right direction was reconstructed. The maximum value of LA pseudo-current under rest and peak exercise were measured between the end of the P wave and beginning of the Q wave.

RESULT(S): LA pseudo-current increase at peak exercise in PAF patients was significantly lower than in healthy volunteers and marathon runners (0.4+/-0.3 pT in group 3 vs. 0.8+/-0.3 pT in group 1 vs. 1.1+/-0.5 pT in group 2, p < 0.001). PAF patients had less pseudo-current increase in STAG at peak exercise than healthy volunteers and marathon runners (46% of 26 PAF patients, 81% of 22 healthy subjects vs. 81% of 22 marathon runners, p = 0.002). Sensitivity, specificity, and the area under the receiver-operator characteristics curve of LA pseudo-current increase at peak exercise for differentiating PAF patients from healthy subjects were 77%, 92%, and 0.896.

​CONCLUSION(S): MCG can provide important non-invasive information for detecting LA dysfunction in PAF patients. Therefore, MCG may help in differentiating PAF patients from healthy subjects.Copyright © 2019-IOS Press and the authors. All rights reserved.

Author(s): Lee M.M.Y.; Petrie M.C.; Rocchiccioli P.; Simpson J.; Jackson C.E.; Corcoran D.S.; Mangion K.; Cialdella P.; Sidik N.P.; McEntegart M.B.; Shaukat A.; Rae A.P.; Hood S.H.M.; Peat E.E.; Oldroyd K.G.; Berry C.; Brown A.; Findlay I.N.; Murphy C.L.; Cormack A.J.; Bukov N.B.; Balachandran K.P.; Ford I.; McConnachie A.; Wu O.; Barry S.J.E.
Source: Circulation. Cardiovascular interventions; Aug 2019; vol. 12 (no. 8)
Publication Date: Aug 2019
Available  at Circulation. Cardiovascular interventions -  from Unpaywall
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Abstract:BACKGROUND: The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. 

Author(s): Balata H.; Blandin Knight S.; Barber P.; Evison M.; Booton R.; Crosbie P.A.J.; Colligan D.; Taylor S.; Tonge J.; Waplington S.; Crosbie E.J.; Duerden R.; Greaves M.; Sawyer R.; Sharman A.; Smith E.; Elton P.; Howells J.; Irion K.; Karunaratne D.; Kirwan M.; Slevin K.; Macnab A.; Miller C.; Mellor S.; Newton T.; Novasio J.; Taylor B.; Walsham A.; Whittaker J.
Source: Lung Cancer; Oct 2018; vol. 124 ; p. 148-153
Publication Date: Oct 2018
Publication Type(s): Article
Abstract:Background: Cardiovascular disease (CVD) is a major cause of morbidity and mortality in populations eligible for lung cancer screening. The aim of this study was to determine whether a brief CV risk assessment, delivered as part of a targeted community-based lung cancer screening programme, was effective in identifying individuals at high risk who might benefit from primary prevention.

Methods: The Manchester Lung Screening Pilot consisted of annual low dose CT (LDCT) over 2 screening rounds, targeted at individuals in deprived areas at high risk of lung cancer (age 55-74 and 6-year risk >=1.51%, using PLCOM2012 risk model). All participants of the second screening round were eligible to take part in the study. Ten-year CV risk was estimated using QRISK2 in participants without CVD and compared to age (+/-5 years) and sex matched Health Survey for England (HSE) controls; high risk was defined as QRISK2 score >=10%. Coronary artery calcification (CAC) was assessed on LDCT scans and compared to QRISK2 score.

​Results: Seventy-seven percent (n=920/1,194) of screening attendees were included in the analysis; mean age 65.6 +/- 5.4 and 50.4% female. QRISK2 and lung cancer risk (PLCOM2012) scores were correlated (r = 0.26, p < 0.001). Median QRISK2 score was 21.1% (IQR 14.9-29.6) in those without established CVD (77.6%, n = 714/920), double that of HSE controls (10.3%, IQR 6.6-16.2; n = 714) (p < 0.001). QRISK2 score was significantly higher in those with CAC (p < 0.001). Screening attendees were 10-fold more likely to be classified high risk (OR 10.2 [95% CI 7.3-14.0]). One third (33.7%, n = 310/920) of all study participants were high risk but not receiving statin therapy for primary CVD prevention.

Discussion: Opportunistic CVD risk assessment within a targeted lung cancer screening programme is feasible and is likely to identify a very large number of individuals suitable for primary prevention.Copyright © 2018 Elsevier B.V.
Database: EMBASE

​Author(s): Her A.-Y.; Kim Y.H.; Shin E.-S.; Garg S.
Source: Coronary Artery Disease; Aug 2018; vol. 29 (no. 5); p. 403-408
Publication Date: Aug 2018
Publication Type(s): Article
Abstract:Objectives Periprocedural myocardial infarction (PMI) is reported to be associated with adverse long-term clinical outcomes. This study compared the rates of PMI following treatment of de novo coronary lesions using either a paclitaxel-coated balloon (PCB) or a newer-generation drug-eluting stent (DES). 

​Author(s): Her A.-Y.; Shin E.-S.; Lee J.M.; Garg S.; Doh J.-H.; Nam C.-W.; Koo B.-K.
Source: International Journal of Cardiovascular Imaging; Apr 2018 ; p. 1-9
Publication Date: Apr 2018
Publication Type(s): Article In Press
Abstract:There is limited data on the efficacy of paclitaxel-coated balloon (PCB) compared to stents for de novo coronary lesions. The purpose of this study was to compare the efficacy of PCB treatment with stent implantation for de novo coronary lesions after successful plain old balloon angioplasty (POBA) guided by fractional flow reserve (FFR). In 200 patients scheduled for elective percutaneous coronary intervention (PCI) for de novo lesions, FFR was measured after POBA (POBA-FFR). If POBA-FFR was >= 0.75, patients were treated with PCB (PCB group, n = 78) or stent (Stent group, n = 73). If POBA-FFR was < 0.75, stent was implanted as planned (Reference group, n = 42). The primary endpoint was late lumen loss at 9 months and the secondary endpoint was adverse cardiac events (cardiac death, myocardial infarction, target lesion thrombosis, or repeat revascularization) at 12 months follow-up. There was no between-group differences in the POBA-FFR (0.87 +/- 0.05 in PCB, 0.89 +/- 0.06 in stent, p = 0.101). At 9 months, late lumen loss was significantly lower in the PCB group compared to the Stent group (0.05 +/- 0.33 vs. 0.59 +/- 0.76 mm, p < 0.001). Adverse cardiac events were not different between the PCB, Stent and Reference groups (2.6, 5.5, and 9.5% respectively; p = 0.430 for PCB vs. Stent group; p = 0.229 for the reference vs. both other groups). PCB treatment guided by POBA-FFR showed excellent 9 months angiographic and functional results, as well as comparable 12 months clinical outcomes, compared with stent implantation for de novo coronary lesions.Copyright © 2018 Springer Science+Business Media B.V., part of Springer Nature
Database: EMBASE

Author(s): Her A.-Y.; Kim Y.H.; Cho K.-I.; Garg S.; Shin E.-S.
Source: Yonsei Medical Journal; 2017; vol. 58 (no. 5); p. 954-958
Publication Date: 2017
Publication Type(s): Article
PubMedID: 28792138
Available  at Yonsei Medical Journal -  from EBSCO (MEDLINE Complete)
Available  at Yonsei Medical Journal -  from Europe PubMed Central - Open Access
Available  at Yonsei Medical Journal -  from nih.gov
Abstract:Purpose: There are no sufficient data on the correlation between inter-arm blood pressure (BP) difference and coronary atherosclerosis found using coronary artery calcium score (CACS). We aimed to investigate if the increased difference in inter-arm BP is independently associated with severity of CACS. Materials and Methods: Patients who had >=3 cardiovascular risk factors or an intermediate Framingham Risk Score (FRS; >=10) were enrolled. Inter-arm BP difference was defined as the absolute difference in BP in both arms. Quantitative CACS was measured by using coronary computed tomography angiography with the scoring system. Results: A total of 261 patients were included in this study. Age (r=0.256, p<0.001), serum creatinine (r=0.139, p=0.030), mean of right arm systolic BP (SBP; r=0.172, p=0.005), mean of left arm SBP (r=0.190, p=0.002), inter-arm SBP difference (r=0.152, p=0.014), and the FRS (r=0.278, p<0.001) showed significant correlation with CACS. The increased inter-arm SBP difference (>=6 mm Hg) was significantly associated with CACS >=300 [odds ratio (OR) 2.17, 95% confidence interval (CI) 1.12-4.22; p=0.022]. In multivariable analysis, the inter-arm SBP difference >=6 mm Hg was also significantly associated with CACS >=300 after adjusting for clinical risk factors (OR 2.34, 95 % CI 1.06-5.19; p=0.036). Conclusion: An increased inter-arm SBP difference (>=6 mm Hg) is associated with coronary atherosclerotic disease burden using CACS, and provides additional information for predicting severe coronary calcification, compared to models based on traditional risk factors. Copyright © Yonsei University College of Medicine 2017.
Database: EMBASE

Author(s): Her A.-Y.; Kim Y.H.; Cho K.-I.; Singh G.B.; Shin E.-S.; Garg S.; Koo B.-K.

Source: Yonsei Medical Journal; Jan 2017; vol. 58 (no. 1); p. 99-104

Publication Date: Jan 2017

Publication Type(s): Journal: Article

Available in full text at Yonsei Medical Journal 


Abstract:Purpose: This study compared the impact of paclitaxel-coated balloons (PCB) or drug eluting stents (DES) on peri-procedural myocardial infarction (PMI) on de novo coronary lesion in stable patients. Materials and Methods: In this observational study, we compared the incidence of PMI amongst patients with single vessel de novo coronary lesions who underwent treatment with a PCB or DES. Propensity score-matching analysis was used to assemble a cohort of patients with similar baseline characteristics. PMI was classified as myocardial infarction occurring within 48 hours after percutaneous coronary intervention with a threshold of 5 x the 99th percentile upper reference limit of normal for creatine kinase-myocardial band (CK-MB) or troponin T (TnT). Results: One hundred four patients (52 receiving PCB and 52 receiving DES) were enrolled in this study. The peak mean values of CK-MB and TnT were significantly higher in the DES group. There was a significantly higher rate of PMI in the DES group (23.1% vs. 1.9%, p=0.002). Total occlusion of the side-branch occurred in two patients treated with DES, while no patients treated with PCB. In multivariable analysis, DES was the only independent predictor of PMI compared with PCB (odds ratio 42.85, 95% confidence interval: 3.44-533.87, p=0.004). Conclusion: Treatment with a PCB on de novo coronary lesion might be associated with a significant reduction in the risk of PMI compared to DES. Copyright © Yonsei University College of Medicine 2017.
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Database: EMBASE