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1.
Am J Cardiol ; 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31648781

RESUMO

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial.

2.
BMJ Open ; 9(10): e026578, 2019 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-31604782

RESUMO

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.

3.
Am J Cardiol ; 124(8): 1190-1197, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31395298

RESUMO

Characteristics and outcomes of patients with lymphoma undergoing percutaneous coronary intervention (PCI) are unknown. Therefore, we analyzed clinical characteristics and outcomes in patients that underwent PCI and had a concomitant diagnosis of Hodgkin's (HL) or non-Hodgkin's (NHL) lymphoma. We analyzed patients with and without lymphoma diagnosis from the Nationwide Inpatient Sample in the United States who underwent PCI procedure during 2004 to 2014. Multivariable regression analysis was performed to examine the association between lymphoma diagnosis and clinical outcomes post-PCI including short-term complications and in-hospital mortality. A total of 7,119,539 PCI procedures were included in the analysis and 18,052 patients had a diagnosis of lymphoma (0.25%). These patients were likely to experience in-hospital mortality (odds ratio [OR] 1.39, 95% confidence interval [CI] 1.25 to 1.54), stroke or transient ischemic attack (OR 1.75, 95% CI 1.61 to 1.90), and any in-hospital complication (OR 1.31, 95% CI 1.25 to 1.37), following PCI. In the lymphoma subtype-analysis, diagnosis of HL was associated with an increased odds of in-hospital death (OR 1.40, 95% CI 1.24 to 1.56), any in-hospital complication (OR 1.31, 95% CI 1.25 to 1.38), bleeding complications (OR 1.12 95% CI 1.05 to 1.20), and vascular complications (OR 1.13 95% CI 1.06 to 1.20) whereas these odds were not significantly associated with non-Hodgkin's diagnosis. Finally, both types of lymphoma were associated with increased odds of stroke/transient ischemic attack following PCI (OR 1.82, 95% CI 1.67 to 1.99 and OR 1.31, 95% CI 1.05 to 1.63, respectively). In conclusion, while the prevalence of lymphoma in the observed PCI cohort was low, a diagnosis of lymphoma was associated with an adverse prognosis following PCI, primarily in patients with the HL diagnosis.

4.
Am. heart j. ; 214: 134-141, Jul. 2019. ilus, tab
Artigo em Espanhol | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1009228

RESUMO

BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. TRIAL DESIGN: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1year. Patient follow-up is planned for 1, 2, and 6months and 1 and 2years after the procedure. CONCLUSIONS: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1month of DAPT.


Assuntos
Inibidores da Agregação de Plaquetas , Stents , Hemorragia
5.
Am Heart J ; 214: 134-141, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31203158

RESUMO

BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. TRIAL DESIGN: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2, and 6 months and 1 and 2 years after the procedure. CONCLUSIONS: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.

6.
Int J Cardiol ; 290: 7-14, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31133430

RESUMO

BACKGROUND: Clinical predictors of future ischemic events in patients with acute coronary syndrome (ACS) are also risk factors for bleeding, with patients often at high-risk of both outcomes. We aimed to define the clinical outcomes and provision of guideline-recommended care in ACS management for different combinations of ischemic and bleeding risk defined using a combined GRACE and CRUSADE score. METHODS: A retrospective observational analysis of a national ACS database was performed for patients with ACS admitted to three tertiary centres from January 2010 to March 2016. Patients were stratified into 9 groups based on possible CRUSADE-GRACE risk combinations. Multiple logistic regression was used to estimate adjusted odds ratios (ORs [95% CI]) for outcomes (in-hospital net adverse cardiac events (NACE), in-hospital all-cause mortality, 30-day mortality and treatment strategy). RESULTS: A total of 17,701 patients were included in the analysis. We observed a graded risk of mortality and adverse events in the high-risk GRACE strata (Groups 3, 6 and 9). Almost a third of patients with ACS were at a 'dual high-risk' (Group 9, 32%) and were independently associated with higher in-hospital NACE (composite of cardiac mortality, all-cause bleeding and re-infarction): aOR 6.33 [3.55, 11.29], all-cause mortality: aOR 14.17 [5.27, 38.1], all-cause bleeding: aOR 4.82 [1.96, 11.86], and 30-day mortality: aOR 10.79 [5.33, 21.81]. This group was also the least likely to be offered coronary angiography (aOR 0.24 [0.20, 0.29]) and dual anti-platelet therapy (aOR 0.26 [0.20, 0.34]). CONCLUSIONS: One in five patients presenting with an ACS are high ischemic and high bleeding risk, and these patients are more likely to experience poor clinical outcomes and reduced odds of receiving guideline-recommended therapy.

7.
Artigo em Inglês | MEDLINE | ID: mdl-30963681

RESUMO

OBJECTIVES: This study aims to examine in-hospital gastrointestinal (GI) bleeding, its predictors and clinical outcomes, including long-term outcomes, in a national cohort of patients undergoing percutaneous coronary intervention (PCI) in England and Wales. BACKGROUND: GI bleeding remains associated with significant morbidity, mortality, and socioeconomic burden. METHODS: We examined the temporal changes in in-hospital GI bleeding in a national cohort of patients undergoing PCI between 2007 and 2014 in England and Wales, its predictors and prognostic consequences. Multivariate analysis was performed to identify independent risk factors between GI bleeding and 30-day mortality. Survival analysis was performed comparing patients with, and without, GI bleeding. RESULTS: There were 480 in-hospital GI bleeds in 549,298 patients (0.09%). Overall, rates of GI bleeding remained stable over time but a significant decline was observed for patients with ST segment elevation myocardial infarction (STEMI). The strongest predictors of bleeding events were STEMI-odds ratio (OR) 7.28 (95% confidence interval [95% CI] 4.82-11.00), glycoprotein IIb/IIIa inhibitor use OR 3.42 (95% CI 2.76-4.24) and use of circulatory support OR 2.65 (95% CI 1.90-3.71). Antiplatelets/coagulants (clopidogrel, prasugrel, and warfarin) were not independently associated with GI bleeding. GI bleeding was independently associated with a significant increase in all-cause 30-day mortality (OR 2.08 [1.52-2.83]). Patients with in-hospital GI bleed who survived to 30-days had increased all-cause mortality risk at 1 year compared to non-bleeders (HR 1.49 [1.07-2.09]). CONCLUSIONS: In-hospital GI bleeding following PCI is rare but is a clinically important event associated with increased 30-day and long-term mortality.

8.
Clin Drug Investig ; 39(6): 495-502, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30972665

RESUMO

Patients with acute coronary syndrome (ACS) require long-term antithrombotic intervention to reduce the risk of further ischemic events; dual antiplatelet therapy with a P2Y12 inhibitor and acetylsalicylic acid (ASA) is the current standard of care. However, pivotal clinical trials report that patients receiving this treatment have a residual risk of approximately 10% for further ischemic events. The development of non-vitamin K antagonist oral anticoagulants (NOACs) has renewed interest in a 'dual pathway' strategy, targeting both the coagulation cascade and platelet component of thrombus formation. In the phase III ATLAS ACS 2 TIMI 51 trial, a 'triple therapy' approach (NOAC plus dual antiplatelet therapy) showed reduced ischemic events with rivaroxaban 2.5 mg twice daily, albeit at an increased risk of bleeding. Two studies have investigated the role of NOACs in combination with a P2Y12 inhibitor, with or without ASA, in reducing bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention; two further studies are underway. Although these trials will help to inform optimal treatment protocols for secondary prevention of ACS, an individualized approach to treatment will be needed, taking account of the high frequency of co-morbid conditions found in this patient population.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Anticoagulantes/uso terapêutico , Inibidores da Agregação de Plaquetas/uso terapêutico , Administração Oral , Aspirina/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Hemorragia/induzido quimicamente , Humanos , Intervenção Coronária Percutânea , Rivaroxabana/uso terapêutico , Prevenção Secundária/métodos
9.
Lancet ; 393(10175): 987-997, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30827782

RESUMO

BACKGROUND: Supraflex is a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts. We aimed to compare Supraflex with the standard of care, Xience, an everolimus-eluting stent with a durable polymer coating, regarding clinical outcomes with a randomised trial in an all-comer population. METHODS: We did a prospective, randomised, single-blind, multicentre study (TALENT) across 23 centres in Europe (the Netherlands, Poland, the UK, Spain, Bulgaria, Hungary, and Italy). Eligible participants were aged 18 years or older, had one or more coronary artery stenosis of 50% or greater in a native coronary artery, saphenous venous graft, or arterial bypass conduit, and had a reference vessel diameter of 2·25-4·50 mm. Patients underwent percutaneous coronary intervention in an all-comer manner. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting stent with a biodegradable polymer coating and ultra-thin struts (Supraflex) or an everolimus-eluting stent with a durable polymer coating (Xience). Randomisation was done by local investigators by use of a web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between groups at 12 months after the procedure, assessed in an intention-to-treat population. On assumption of 1-year composite endpoint prevalence of 8·3%, a margin of 4·0% was defined for non-inferiority of the Supraflex group compared with the Xience group. This trial is registered with ClinicalTrials.gov, number NCT02870140. FINDINGS: Between Oct 21, 2016, and July 3, 2017, 1435 patients with 1046 lesions were randomly assigned to Supraflex, of whom 720 received the index procedure, and 715 patients with 1030 lesions were assigned to Xience, all receiving the index procedure. At 12 months, the primary endpoint had occurred in 35 patients (4·9 %) in the Supraflex group and in 37 patients (5·3%) in the Xience group (absolute difference -0·3% [one-sided 95% upper confidence bound 1·6%], pnon-inferiority<0·0001). Definite or probable stent thrombosis prevalence, a safety indicator, was low in both groups and did not differ between them. INTERPRETATION: The Supraflex stent was non-inferior to the Xience stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. Supraflex seems a safe and effective alternative drug-eluting stent to other stents in clinical practice. FUNDING: European Cardiovascular Research Institute.


Assuntos
Aterosclerose/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Determinação de Ponto Final , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Trombose/etiologia
10.
Coron Artery Dis ; 30(3): 159-170, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30676387

RESUMO

OBJECTIVE: This study aims to investigate the temporal trends in utilization of invasive coronary angiography (CA) at different time points and changing profiles of patients undergoing CA following non-ST-elevation acute coronary syndrome (NSTEACS). We also describe the association between time to CA and in-hospital clinical outcomes. PATIENTS AND METHODS: We queried the National Inpatient Sample to identify all admissions with a primary diagnosis of NSTEACS from 2004 to 2014. Patients were stratified into early (day 0, 1), intermediate (day 2) and late strategy (day≥3) according to time to CA. Multivariable logistic regression was used to investigate the association between time to CA and in-hospital mortality, major bleeding, stroke and Major Adverse Cardiac and Cerebrovascular Events. RESULTS: A total of 4 380 827 records were identified with a diagnosis of NSTEACS, out of which 57.5% received CA. The proportion of patients undergoing early CA increased from 65.6 to 72.6%, whereas late CA commensurately declined from 19.6 to 13.5%. Patients receiving early CA were younger (age: 64 vs. 70 years), more likely to be male (63.7 vs. 55.3%) and of Caucasian ethnic background (68.7 vs. 64.7%) compared with late CA group. Similarly, Women, weekend admissions and African Americans remain less likely to receive early CA. In-hospital mortality was lowest in the intermediate group (odds ratio=0.30, 95% confidence interval: 0.28-0.33). CONCLUSION: Use of early CA has increased in the management of NSTEACS; however, there remain significant disparities in utilization of an early invasive approach in women, African Americans, admission day and older patients in the USA.

11.
Sci Rep ; 9(1): 240, 2019 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-30659213

RESUMO

Coronary angiography (CA) is the basis of an invasive management strategy in non-ST elevation acute coronary syndromes (NSTEACS). There are limited contemporary data on national temporal trends in utilization of CA in different patient subgroups. We sought to investigate temporal trends, predictors and clinical outcomes associated with the use of CA in the US. Using the Nationwide Inpatient Sample (NIS) from 2004-2014, we identified all inpatient admissions, age ≥18, with a primary diagnosis of NSTEACS. Descriptive statistics and multivariable logistic regression models were used to investigate temporal trends, predictors and clinical outcomes associated with CA. From a total of 4,380,827 patients, 57.5% received CA during the study period and were more likely to be male, younger and less comorbid as defined per Charlson comorbidity index. The proportion of patients receiving CA increased from 48.5% to 68.5%, however, higher proportional increase was observed in males (53.9% to 69.4% Ptrend < 0.001) and those age ≤60 years (59.0% to 77.9% Ptrend < 0.001). Prior history of CABG (OR 0.33 95%CI 0.35-0.36), previous PCI (OR 0.84 95%CI 0.83-0.86) and previous AMI (OR 0.65 95%CI 0.64-0.67) were inversely related with receipt of CA. Receipt of CA was strongly associated with decreased odds of in-hospital mortality (OR 0.38 95%CI 0.36-0.40). In this national analysis, we observed a temporal increase in utilization of CA albeit slower adoption was noted in older, women and more comorbid patients. The risk-treatment paradox wherein patients who are most likely to benefit were less likely to receive CA persists even in contemporary practice.

12.
Circ Cardiovasc Interv ; 11(11): e006824, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30571201

RESUMO

Background There are limited data on outcomes of patients with previous coronary artery bypass graft (CABG) presenting with non-ST-segment-elevation myocardial infarction undergoing percutaneous coronary intervention (PCI). We compare clinical characteristics and outcomes in non-ST-segment-elevation myocardial infarction patients undergoing PCI with or without prior CABG surgery in a national cohort. Methods and Results We identified 205 039 patients with non-ST-segment-elevation myocardial infarction who underwent PCI between 2007 and 2014 in the British Cardiovascular Intervention Society database. Clinical, demographic, procedural, and outcome data were analyzed by dividing into 3 groups: group 1, PCI in native coronary arteries and no prior CABG (n=186 670); group 2, PCI in native arteries with prior CABG (n=8825); group 3, PCI in grafts (n=9544). Patients in group 2 and 3 were older and had more comorbidities and higher mortality at 30 days (group 2, 2.6% and group 3, 1.9%) and 1 year (group 2, 8.29% and group 3, 7.08%) as compared with group 1 (1.7% and 4.87%). After multivariable analysis, no significant difference in outcomes was observed in 30-days mortality (odds ratio; group 2=0.87 [CI, 0.69-1.80; P=0.20], group 3=0.91 [CI, 0.71-1.17; P=0.46]), in-hospital major adverse cardiovascular event (odds ratio: group 2=1.08 [CI, 0.88-1.34; P=0.45], group 3=0.97 [CI=0.77-1.23; P=0.82]), and in-hospital stroke (odds ratio: group 2=1.37 [CI, 0.71-2.69; P=0.35], group 3=1.13 [CI, 0.55-2.34; P=0.73]; group 1=reference). Conclusions Patients with prior CABG are presenting with non-ST-segment-elevation myocardial infarction and treated with PCI had more comorbid illnesses, but once these differences were adjusted for, prior CABG did not independently confer additional risk of mortality and major adverse cardiovascular event.


Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea , Idoso , Comorbidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Doença da Artéria Coronariana/mortalidade , Bases de Dados Factuais , Inglaterra , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Recidiva , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , País de Gales
13.
Artigo em Inglês | MEDLINE | ID: mdl-30409759

RESUMO

OBJECTIVES: The aims of the present study were to investigate the applicability of quantitative flow ratio (QFR) in patients with 3-vessel disease and to demonstrate the impact of functional SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score derived from QFR (fSSQFR) on clinical outcomes. BACKGROUND: The applicability of QFR in patients with 3-vessel disease and the feasibility of fSSQFR have not yet been investigated. METHODS: All lesions interrogated using instantaneous wave-free ratio and/or fractional flow reserve in the SYNTAX II trial were retrospectively screened and analyzed for QFR. The diagnostic performance of QFR was investigated using hybrid wire-derived pressure assessment (instantaneous wave-free ratio and fractional flow reserve), used in the trial as a reference. Patients with analyzable QFR in 3 vessels were stratified according to fSSQFR to evaluate its clinical prognostic value on the basis of 2-year patient-oriented composite endpoint. RESULTS: QFRs were analyzable in 71.0% of lesions (836 lesions). The diagnostic performance of QFR to predict binary wire-based ischemia was substantial (area under the curve 0.81, accuracy 73.8%), with a positive predictive value of 85.9%. Independent predictors of diagnostic discordance were lesions in side branches, involvement of bifurcation or trifurcation, and small vessel. According to the 2-year patient-oriented composite endpoint, fSSQFR reclassified 26.1% of the patients (36 of 138) in the high- to intermediate-risk group into the low-risk group appropriately (net reclassification improvement 0.32, p < 0.001). The area under the curve for fSSQFR to predict the 2-year patient-oriented composite endpoint was higher than that of the classic anatomic SYNTAX score (0.68 vs 0.56, p = 0.002). CONCLUSIONS: QFR demonstrated substantial applicability in patients with 3-vessel disease. The fSSQFR has the potential to further refine prognostic risk estimation compared with the classic anatomic SYNTAX score.

14.
Interv Cardiol ; 13(3): 135-136, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30443270

RESUMO

Current guidelines recommend percutaneous coronary intervention (PCI) in patients with ongoing stable angina symptoms despite optimal medical therapy (OMT), although trials have shown no reduction in death or myocardial infarction. The recently published ORBITA trial compared OMT + PCI with OMT + 'placebo' PCI in patients with angina and single-vessel coronary artery disease (CAD), and found no significant difference in treadmill exercise time between the two groups after six weeks. The trial concluded that invasive procedures can be assessed with placebo control while numerous editorials interpreted the trial as showing that PCI has no role in the management of stable angina. However, the highly selected patient population, low ischaemic burden and level of symptoms and high proportion of non-flow-limiting stenoses on invasive physiological testing mean that, while ground-breaking in terms of its methodology, ORBITA does not add to the current evidence base supporting ischaemia-guided revascularisation if symptoms are not controlled on medical therapy alone.

15.
Artigo em Inglês | MEDLINE | ID: mdl-30341836

RESUMO

OBJECTIVES: The goal of this analysis was to evaluate the final 5-year safety and effectiveness of the PROMUS Element platinum-chromium everolimus-eluting stent in unselected patients treated in routine clinical practice. BACKGROUND: The prospective, open-label PROMUS Element™ European Post-Approval Surveillance Study (PE-PROVE) enrolled 1,010 "real-world" patients who received the PROMUS Element stent. Adverse event rates were low at 1-year, and the incidence of stent thrombosis was 0.6%. METHODS: The primary endpoint was target vessel failure (TVF; overall and PE stent-related), a composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target vessel revascularization (TVR) at 1-year post-implantation. Five-year clinical outcomes were evaluated in overall as well as high-risk patient subgroups. RESULTS: The overall 5-year TVF rate was 14.9%, with 7.0% being related to the study stent. Cardiac death, MI and TVR related to the study stent occurred in 0.5%, 3.2%, and 5.7%, respectively. Stent thrombosis through 5-year follow-up was 1.0%. The rates of overall and study stent related TVF were numerically higher in patients with medically treated diabetes, long lesions (≥28 mm), and small diameter vessels (≤2.5 mm) compared to the overall study population. Additionally, favorable stent thrombosis rates through 5 years were reported for the PROMUS Element stent in these high-risk subgroups. CONCLUSIONS: The final 5-year data from the PE-PROVE study demonstrate favorable outcomes and low rates of adverse events with the PE stent when used in "real-world" patients with coronary artery disease.

16.
EuroIntervention ; 2018 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-30066672

RESUMO

AIMS: To compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population. METHODS AND RESULTS: This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centers in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint Target Lesion Failure (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization) of the SUPRAFLEX group to the XIENCE group at 12 months post-procedure. Secondary endpoints include the Patient Oriented Composite Endpoint, Target Vessel Failure, Mortality, Myocardial Infarction, Revascularization and Stent thrombosis rates (ARC classification). CONCLUSIONS: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard care (XIENCE - EES) in patients with atherosclerotic lesions. This will provide us valuable information on the impact of this thin-strut device in an all-comers population.

17.
Interv Cardiol ; 13(2): 87-92, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29928314

RESUMO

Anticoagulation in conjunction with antiplatelet therapy is central to the management of acute coronary syndromes (ACS). When used effectively it is associated with a reduction in recurrent ischaemic events including myocardial infarction and stent thrombosis as well as a reduction in death. Effective ischaemic risk reduction whilst balancing bleeding risk remains a clinical challenge. This article reviews the current available evidence for anticoagulation in ACS and recommendations from the European Society of Cardiology.

18.
Catheter Cardiovasc Interv ; 92(6): E393-E402, 2018 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-29726633

RESUMO

OBJECTIVES: To study the relationship between diabetes mellitus (DM) and left ventricular (LV) function on outcomes following percutaneous coronary intervention (PCI). BACKGROUND: DM is a growing public health challenge worldwide and a significant risk factor for cardiovascular disease and heart failure. METHODS: All PCI procedures performed between 2006 and 2013 with LV function and diabetic status recorded in the BCIS-NICOR database were included. Demographic, procedural, and clinical outcomes data were collected. Multivariable logistic regression was used to provide adjusted estimates of clinical outcome by LV function and DM, including DM sub-type. RESULTS: Of 260,726 patients, DM was present in 52,160 (20%); moderate LV systolic dysfunction (LVSD) was present in 51,266 (20%), and severe LVSD in 18,148 (7%). Worsening LVSD in diabetic patients was associated with poorer prognosis following PCI; moderate LVSD odds ratio (OR) 2.03 (95% CI 1.72-2.38) and severe LVSD OR 4.17 (95% CI 3.52-4.93). There was a higher crude and adjusted mortality rate for patients with DM across all grades of LVSD. However, the relative effect of DM appeared attenuated in the severe LVSD group compared with moderate or good LV function, particularly evident in patients with insulin requiring DM (good LV OR 2.09 [95% CI 1.66-2.65]; moderate LVSD OR 1.56 [95% CI 1.26-1.93], poor LV OR 1.40 [95% CI 1.13-1.74]). CONCLUSIONS: DM was associated with increased 30-day mortality for all grades of LV function. The prognostic impact of DM was strongest in patients with normal LV function and less evident in patients with severe LV systolic dysfunction.

19.
J Am Coll Cardiol ; 71(16): 1781-1796, 2018 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-29673469

RESUMO

Thyroid hormone (TH) receptors are present in the myocardium and vascular tissue, and minor alterations in TH concentration can affect cardiovascular (CV) physiology. The potential mechanisms that link CV disease with thyroid dysfunction are endothelial dysfunction, changes in blood pressure, myocardial systolic and diastolic dysfunction, and dyslipidemia. In addition, cardiac disease itself may lead to alterations in TH concentrations (notably, low triiodothyronine syndrome) that are associated with higher morbidity and mortality. Experimental data and small clinical trials have suggested a beneficial role of TH in ameliorating CV disease. The aim of this review is to provide clinicians dealing with CV conditions with an overview of the current knowledge of TH perturbations in CV disease.

20.
JACC Cardiovasc Interv ; 11(5): 482-492, 2018 Mar 12.
Artigo em Inglês | MEDLINE | ID: mdl-29519382

RESUMO

OBJECTIVES: Using the British Cardiovascular Intervention Society percutaneous coronary intervention (PCI) database, access site choice and outcomes of patients undergoing PCI with previous coronary artery bypass grafting (CABG) were studied. BACKGROUND: Given the influence of access site on outcomes, use of radial access in PCI-CABG warrants further investigation. METHODS: Data were analyzed from 58,870 PCI-CABG procedures performed between 2005 and 2014. Multivariate logistic regression was used to identify predictors of access site choice and its association with outcomes. RESULTS: The number of PCI-CABG cases and the percentage of total PCI increased significantly during the study period. Femoral artery (FA) utilization fell from 90.8% in 2005 to 57.6% in 2014 (p < 0.001), with no differences in the rate of change of left versus right radial use. In contemporary study years (2012 to 2014), female sex, acute coronary syndrome presentation, chronic total occlusion intervention, and lower operator volume were independently associated with FA access. Length of stay was shortened in the radial cohort. Unadjusted outcomes including an access site complication (1.10% vs. 0.30%; p < 0.001), blood transfusion (0.20% vs. 0.04%; p < 0.001), major bleeding (1.30% vs. 0.40%; p < 0.001), and in-hospital death (1.10% vs. 0.60%; p = 0.001) were more likely to occur with FA access compared with radial access. After adjustment, although arterial complications, transfusion, and major bleeding remained more common with FA use, short- and longer-term mortality and major adverse cardiac event rates were similar. CONCLUSIONS: In contemporary practice, FA access remains predominant during PCI-CABG with case complexity associated with it use. FA use was associated with longer length of stay, and higher rates of vascular complications, major bleeding, and transfusion.

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