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1.
Circ Cardiovasc Interv ; : e013503, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38708609

RESUMO

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI). METHODS: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization). RESULTS: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m2, 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis. CONCLUSIONS: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.

2.
Int J Cardiol ; 398: 131643, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38065329

RESUMO

BACKGROUND: Early studies on transcatheter aortic valve replacement (TAVR) outcomes showed that female sex was associated with better survival. With increased use of new-generation valves, the impact of sex on contemporary TAVR outcomes is less well known. METHODS: Retrospective analysis using institutional National Cardiovascular Data Registry STS/ACC TVT data was performed on all patients undergoing TAVR at Yale New Haven Hospital from July 2012 to August 2019. New-generation valves were Evolut PRO, Evolut R, and SAPIEN 3. Old-generation valves were CoreValve, SAPIEN, and SAPIEN XT. Log-rank test and Kaplan-Meier curves were used to compare sex differences in survival up to 1 year after TAVR. Cox modeling was used to adjust for baseline and procedural characteristic differences. RESULTS: 927 consecutive patients (41.4% women) underwent TAVR. Women were older (82.8 vs 80.6 years old; p < 0.001) with higher STS mortality scores compared with men (7.6% vs 6.4%; p < 0.001) despite lower prevalence of cardiovascular comorbidities including coronary artery disease, peripheral artery disease, and smoking. Most cases used transfemoral access (90.5%) and new-generation devices (72.3%). Women received smaller valves compared with men (20-26 mm: 78.0% vs 32.9%; 29-34 mm: 22.1% vs 67.1%; overall p < 0.0001). There were no statistically significant differences between sexes in both unadjusted and adjusted 1-year mortality. CONCLUSION: Our data show no significant difference in 1-year survival between sexes using primarily new generation valves. Further studies should reassess the impact of sex on TAVR outcomes and whether newer technologies like new valve design and sizes, and CT imaging may have eliminated sex-based disparities.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Masculino , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Desenho de Prótese , Fatores de Risco
3.
J Vasc Surg ; 79(2): 358-365, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37925039

RESUMO

OBJECTIVE: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.


Assuntos
Litotripsia , Doença Arterial Periférica , Calcificação Vascular , Masculino , Humanos , Feminino , Constrição Patológica/etiologia , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Doença Arterial Periférica/etiologia , Litotripsia/efeitos adversos , Litotripsia/métodos
4.
JACC Cardiovasc Interv ; 16(14): 1721-1729, 2023 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-37409991

RESUMO

BACKGROUND: Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). OBJECTIVES: The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. METHODS: We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. RESULTS: From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex. CONCLUSIONS: In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392).


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Acidente Vascular Cerebral , Humanos , Masculino , Feminino , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/complicações , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Resultado do Tratamento , Infarto do Miocárdio/terapia , Infarto do Miocárdio/complicações , Acidente Vascular Cerebral/etiologia , Fatores de Risco
8.
Am J Cardiol ; 118(1): 6-16, 2016 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-27181566

RESUMO

Optimal antithrombotic pharmacotherapy in patients affected by diabetes mellitus (DM) undergoing percutaneous coronary intervention is unclear. We sought to evaluate the safety and efficacy of bivalirudin compared with heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) in patients with DM undergoing percutaneous coronary intervention. We pooled patient-level data from the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events-2, Acute Catheterization and Urgent Intervention Triage strategy, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trials. The primary efficacy end point was the incidence of major adverse cardiac events, defined as the composite of death, myocardial infarction, or unplanned revascularization at 30 days. The primary safety end point was the incidence of 30-day non-coronary artery bypass graft-related major bleeding. All-cause mortality was reported at 30 days and 1 year. Of the 14,737 patients included in the pooled database, 3,641 (24.7%) had DM. Patients with DM had higher rates of 30-day major bleeding and 30-day and 1-year all-cause mortality. There were no differences in 30-day major adverse cardiac events between bivalirudin versus heparin plus GPI in patients with DM (6.9% vs 7.8%; relative risk [RR] 0.89, 95% CI 0.71 to 1.12) or without DM (7.5% vs 6.7%; RR 1.11, 95% CI 0.97 to 1.27; pinteraction = 0.10). Bivalirudin treatment was associated with reduced risk of major bleeding in similar magnitude in patients with DM (4.3% vs 6.6% RR 0.68, 95% CI 0.51 to 0.89) or without DM (3.2% vs 6.1%; RR 0.51, 95% CI 0.43 to 0.61; pinteraction = 0.15). The hemorrhagic benefit of bivalirudin was noted for both access site- and non-access site-related bleeding. Overall, bivalirudin treatment was associated with a significant 1-year mortality benefit (2.7% vs 3.3%; RR 0.82, 95% CI 0.68 to 0.98; p = 0.03), which was consistent between patients with or without DM (pinteraction = 0.30). In conclusion, compared with heparin plus GPI, bivalirudin was associated with similar 30-day antithrombotic efficacy and better 30-day freedom from bleeding and 1-year mortality, irrespective of diabetic status.


Assuntos
Antitrombinas/uso terapêutico , Complicações do Diabetes/complicações , Infarto do Miocárdio/terapia , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea , Idoso , Estudos de Casos e Controles , Complicações do Diabetes/mortalidade , Feminino , Heparina/uso terapêutico , Hirudinas , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Proteínas Recombinantes/uso terapêutico , Resultado do Tratamento
9.
Am J Cardiol ; 117(2): 186-91, 2016 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-26704028

RESUMO

Women have higher bleeding complication and mortality rates after percutaneous coronary interventions (PCI). The contribution of female gender to bleeding and mortality is poorly understood. We evaluated the effect of gender and bleeding on outcomes of patients treated with bivalirudin during PCI by performing a patient-level pooled analysis of 3 randomized controlled trials (the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events, Acute Catheterization and Urgent Intervention Triage strategY, and Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) comparing bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor (GPI) treatment in patients undergoing PCI. Of 14,784 patients, 7,413 patients received bivalirudin (1,870 women) and 7,371 patients received heparin + GPI (1,910 women). Women had significantly higher 30-day non-coronary artery bypass grafting (CABG)-related major bleeding rates (7.6% vs 3.8%, p <0.0001). After multivariate adjustment, female gender increased the hazard of major bleeding by 80% (hazard ratio 1.80, 95% confidence interval 1.52 to 2.11, p <0.001). Furthermore, women had a higher 1-year mortality rate (3.7% vs 2.7%, p = 0.002) than men; 30-day major bleeding was the strongest independent predictor of 1-year mortality in women (hazard ratio 2.48, 95% confidence interval 1.57 to 3.91, p = 0.001). Bivalirudin therapy in women reduced 30-day non-CABG-related major bleeding (5.6% vs 9.7%, p <0.0001) and 1-year mortality (2.9% vs 4.4%, p = 0.02) compared to standard therapy. In conclusion, in this cohort of patients treated for acute coronary syndrome and ST-segment elevation myocardial infarction, women have a near 2-fold increase in bleeding complications compared to men after PCI. Bleeding complications rather than gender is the strongest independent predictor of 1-year mortality in patients undergoing PCI. Furthermore, we observed a more pronounced clinical benefit in women treated with bivalirudin including a 44% reduction in major bleeding and a significant reduction in mortality rates at 1 year.


Assuntos
Hemorragia/induzido quimicamente , Hirudinas/administração & dosagem , Infarto do Miocárdio/terapia , Fragmentos de Peptídeos/administração & dosagem , Intervenção Coronária Percutânea/métodos , Idoso , Antitrombinas/administração & dosagem , Antitrombinas/efeitos adversos , Argentina/epidemiologia , Eletrocardiografia , Feminino , Seguimentos , Hemorragia/mortalidade , Hirudinas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Fragmentos de Peptídeos/efeitos adversos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Reino Unido/epidemiologia , Estados Unidos/epidemiologia
11.
EuroIntervention ; 11(1): 75-84, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25868876

RESUMO

AIMS: This study aimed to evaluate the safety and performance of the TriGuard™ Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs to deflect emboli away from the cerebral circulation, in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The prospective, multicentre DEFLECT I study (NCT01448421) enrolled 37 consecutive subjects undergoing TAVR with the TriGuard EDD. Subjects underwent clinical and cognitive follow-up to 30 days; cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed pre-procedure and at 4±2 days post procedure. The device performed as intended with successful cerebral coverage in 80% (28/35) of cases. The primary safety endpoint (in-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgery) occurred in 8.1% of subjects (VARC-defined two life-threatening bleeds and one vascular complication). The presence of new cerebral ischaemic lesions on post-procedure DW-MRI (n=28) was similar to historical controls (82% vs. 76%, p=NS). However, an exploratory analysis found that per-patient total lesion volume was 34% lower than reported historical data (0.2 vs. 0.3 cm3), and 89% lower in patients with complete (n=17) versus incomplete (n=10) cerebral vessel coverage (0.05 vs. 0.45 cm3, p=0.016). CONCLUSIONS: Use of the first-generation TriGuard EDD during TAVR is safe, and device performance was successful in 80% of cases during the highest embolic-risk portions of the TAVR procedure. The potential of the TriGuard EDD to reduce total cerebral ischaemic burden merits further randomised investigation.


Assuntos
Estenose da Valva Aórtica/terapia , Valva Aórtica , Cateterismo Cardíaco/instrumentação , Dispositivos de Proteção Embólica , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Embolia Intracraniana/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Ligas , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Isquemia Encefálica/etiologia , Isquemia Encefálica/prevenção & controle , Brasil , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/mortalidade , Cognição , Transtornos Cognitivos/etiologia , Transtornos Cognitivos/prevenção & controle , Imagem de Difusão por Ressonância Magnética , Europa (Continente) , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Embolia Intracraniana/diagnóstico , Embolia Intracraniana/etiologia , Embolia Intracraniana/mortalidade , Masculino , Valor Preditivo dos Testes , Estudos Prospectivos , Desenho de Prótese , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Transcraniana
12.
Eur J Clin Invest ; 45(3): 333-45, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25615282

RESUMO

BACKGROUND: Despite advancements from balloon angioplasty to drug-eluting stents, primary patency rates after endovascular revascularization of peripheral artery disease have remained inferior compared to surgery. Endovascular revascularization has been limited by restenosis and mechanical stent failure. Thus, there is increased research into other nonstent-based local drug delivery modalities, which can provide an active drug to inhibit restenosis focally and avoid the risk of systemic adverse effects. METHODS: This review will summarize the unique properties of paclitaxel and studies on paclitaxel local delivery for the treatment of peripheral artery disease. A MEDLINE search for relevant peer-reviewed scientific literature published in English was conducted. Search terms included but were not limited to paclitaxel pharmacodynamics, paclitaxel local drug delivery, and drug eluting balloons, with a focus on the use of paclitaxel in the context of coronary and peripheral vascular disease. RESULTS: The primary search produced 182 results of which 51 papers were relevant. Of the 51 relevant papers, 27 were original research papers and 24 were either review papers, commentary or opinion papers. CONCLUSIONS: Paclitaxel has several chemical properties, which make it ideal for local drug delivery including its hydrophobicity, ability to concentrate into the arterial intima layer and prolonged effect on cells even after brief exposure periods. Local delivery of paclitaxel via injection catheters, balloon catheters and coated balloons has shown encouraging results in terms of efficacy and safety in small-scale animal and clinical studies. Additional preclinical and clinical studies are needed to determine the long-term efficacy and safety of these treatments in humans.


Assuntos
Paclitaxel/administração & dosagem , Doença Arterial Periférica/tratamento farmacológico , Moduladores de Tubulina/administração & dosagem , Angioplastia com Balão/métodos , Ensaios Clínicos como Assunto , Avaliação Pré-Clínica de Medicamentos , Stents Farmacológicos , Glicerol/administração & dosagem , Glicerol/análogos & derivados , Humanos , Infusões Intravenosas , Iohexol/administração & dosagem , Iohexol/análogos & derivados , Nanopartículas/administração & dosagem , Paclitaxel/farmacocinética , Paclitaxel/farmacologia , Veículos Farmacêuticos/administração & dosagem , Moduladores de Tubulina/farmacocinética , Moduladores de Tubulina/farmacologia
13.
JACC Cardiovasc Interv ; 8(15): 1966-1974, 2015 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-26738667

RESUMO

OBJECTIVES: This study sought to investigate the effect of treatment delay on microvascular reperfusion in ST-segment elevation myocardial infarction (STEMI) patients from the large, multicenter, prospective HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial. BACKGROUND: Despite restoration of epicardial blood flow during primary percutaneous coronary intervention (PCI), one-third of patients do not obtain myocardial perfusion due to impairment in the microvascular circulation. METHODS: We examined the effect of symptom onset-to-balloon time (SBT) and door-to-balloon time (DBT) on myocardial reperfusion during primary PCI in STEMI, utilizing resolution of ST-segment elevation (STR) and the myocardial blush grade (MBG). The primary analysis was the relationships between SBT ≤2, >2 to 4, and >4 h and DBT ≤1, >1 to 1.5, >1.5 to 2, and >2 h with MBG and STR. Clinical risk was assessed using a modified version of the Thrombolysis In Myocardial Infarction risk score for STEMI. RESULTS: In 2,056 patients, absent microvascular perfusion (MBG 0/1) and STR (STR <30%) after primary PCI was significantly more common in patients with longer SBT, in patients with both low and high clinical risk profiles. By multivariable analysis, SBT (p < 0.0001), anterior infarction (p < 0.0001), reference vessel diameter (p = 0.005), lesion minimum lumen diameter (p < 0.0001), hyperlipidemia (p = 0.03), and current smoking (p = 0.001) were independent predictors of MBG 0/1, whereas SBT (p = 0.007), anterior infarction (p < 0.0001), and history of renal insufficiency (p = 0.0002) were independent predictors of absent STR. DBT (p < 0.0001) was an independent predictor of MBG 0/1. MBG 0/1 and STR<30% identified patients with increased 3-year mortality. CONCLUSIONS: The present study suggests that delay in mechanical reperfusion therapy during STEMI is associated with greater injury to the microcirculation.


Assuntos
Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/instrumentação , Stents , Tempo para o Tratamento , Idoso , Idoso de 80 Anos ou mais , Circulação Coronária , Stents Farmacológicos , Feminino , Humanos , Masculino , Metais , Microcirculação , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Imagem de Perfusão do Miocárdio , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
14.
EuroIntervention ; 10(12): 1383-90, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24801119

RESUMO

AIMS: To compare the efficacy and safety of the MiStent absorbable polymer sirolimus-eluting stent (APSES) with a zotarolimus-eluting stent (ZES). METHODS AND RESULTS: The trial was a 2:1 randomisation at 26 sites of 184 patients implanted with an APSES (n=123) versus a ZES (n=61). Following stent implantation, all patients underwent quantitative coronary angiography at baseline and at nine months of follow-up, while a select subgroup also underwent optical coherence tomography (OCT). The primary efficacy hypothesis was superiority of in-stent late lumen loss (LLL) of APSES compared to ZES. At nine months, the primary endpoint was met, with a mean in-stent LLL of 0.27±0.46 mm in 103 APSES patients versus 0.58±0.41 mm in 52 ZES patients (p<0.001). The proportion of uncovered stent struts by OCT at nine months was very low in both groups. The mean neointimal thickness of covered struts (p=0.002) and percent net volume obstruction (p≤0.003) were significantly lower in the APSES than in the ZES group. Major adverse cardiac event and stent thrombosis rates were low and comparable between groups. CONCLUSIONS: The DESSOLVE II trial demonstrated superiority in the primary efficacy endpoint of nine-month mean LLL for APSES compared to ZES. Strut coverage by OCT was high with both stents and the clinical safety endpoints including stent thrombosis were equally low in both groups. ClinicalTrials.gov Identifier: NCT01294748.


Assuntos
Implantes Absorvíveis , Antibióticos Antineoplásicos/uso terapêutico , Reestenose Coronária/patologia , Estenose Coronária/terapia , Stents Farmacológicos , Neointima/patologia , Intervenção Coronária Percutânea/métodos , Sirolimo/análogos & derivados , Sirolimo/uso terapêutico , Idoso , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/diagnóstico por imagem , Polímeros , Método Simples-Cego , Tomografia de Coerência Óptica , Resultado do Tratamento
15.
Rev. urug. cardiol ; 29(3): 380-390, dic. 2014. graf, tab
Artigo em Espanhol | LILACS-Express | LILACS | ID: lil-754325

RESUMO

La placa coronaria inestable es la causa de base más común de síndromes coronarios agudos (SCA) y se puede manifestar como angina inestable, infarto sin elevación del segmento ST (SCASEST), e infarto con elevación del segmento ST (IAMCEST), pero también se puede manifestar como paro cardíaco súbito debido a taquiarritmias inducidas por isquemia. La mortalidad de los SCA ha disminuido significativamente en el curso de los últimos años, especialmente la debida a las manifestaciones más extremas de SCA, IAMCEST, y paro cardíaco. Es probable que esta tendencia continúe gracias a avances terapéuticos recientes, entre los que se incluyen nuevos agentes antiplaquetarios tales como prasugrel, ticagrelor y cangrelor.

16.
Rev. urug. cardiol ; 29(3): 391-404, dic. 2014. ilus, graf
Artigo em Espanhol | LILACS-Express | LILACS | ID: lil-754326

RESUMO

Resumen Las recientes innovaciones en el área de la cardiología intervencionista han ampliado drásticamente las opciones terapéuticas aplicables a los pacientes portadores de afecciones cardíacas. La cardiología intervencionista ya no queda limitada al tratamiento de las coronariopatías, sino que permite también tratar valvulopatías, prevenir accidentes cerebrovasculares, hipertensión, etcétera. Una de las principales opciones nuevas es el tratamiento percutáneo de la estenosis de válvula aórtica (implantación de la válvula aórtica transcatéter o percutánea); la valvulopatía aórtica es un problema bastante común en pacientes añosos, muchos de los cuales presentan un alto riesgo quirúrgico. De igual manera, la insuficiencia mitral a menudo se asocia con comorbilidades que determinan un alto riesgo quirúrgico. MitraClip es una promisoria alternativa percutánea que sustituiría la reparación o el reemplazo valvular quirúrgico. Otros procedimientos analizados en esta revisión son el cierre percutáneo de la orejuela de la aurícula izquierda como terapia no farmacológica para evitar accidentes cerebrovasculares y la denervación renal para la hipertensión resistente. Esta revisión explica los principios básicos de estos procedimientos, la evidencia clínica más importante, y también aporta datos clínicos recientes adicionales sobre cada uno de ellos.

17.
J Am Coll Cardiol ; 64(12): 1189-97, 2014 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-25236509

RESUMO

BACKGROUND: The prospective, randomized FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial found coronary artery bypass graft surgery (CABG) was associated with better clinical outcomes than percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease, managed with or without insulin. OBJECTIVES: In this subgroup analysis of the FREEDOM trial, we examined the association of long-term clinical outcomes after revascularization in patients with insulin-treated diabetes mellitus (ITDM) compared with patients not treated with insulin. METHODS: A total of 1,850 FREEDOM subjects had an index revascularization procedure performed: 956 underwent PCI with drug-eluting stents (DES), and 894 underwent CABG. A total of 602 patients (32.5%) had ITDM (PCI/DES n = 325, 34%; CABG n = 277, 31%). Subjects were classified according to ITDM versus non-ITDM, with comparison of PCI/DES versus CABG for each group. Interaction analyses were performed for treatment by diabetes mellitus (DM) status alone and for treatment by DM status by coronary lesion complexity. Analyses were performed for the primary outcome composite of death/stroke/myocardial infarction (MI) using all available follow-up data. RESULTS: The overall 5-year event rate of death/stroke/MI was significantly higher in ITDM versus non-ITDM patients (28.7% vs. 19.5%, p < 0.001), which persisted even after adjustment for multiple baseline factors, angiographic complexity, and revascularization treatment group (death/stroke/MI hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.06 to 1.73, p = 0.014). With respect to the primary composite endpoint, CABG was superior to PCI/DES in both DM types and the magnitude of treatment effect was similar (interaction p = 0.40) for ITDM (PCI vs. CABG HR: 1.21; 95% CI: 0.87 to 1.69) and non-ITDM patients (PCI vs. CABG HR: 1.46; 95% CI 1.10 to 1.94), even after adjusting for the angiographic SYNTAX score level. Based on 5-year event rates, the number needed to treat with CABG versus PCI to prevent 1 event is 12.7 in ITDM and 13.2 in non-ITDM. CONCLUSIONS: In patients with diabetes and multivessel coronary artery disease, the rate of major adverse cardiovascular events (death, MI, or stroke) is higher in patients treated with insulin than in those not treated with insulin. Furthermore, we did not detect a significant difference in the magnitude of PCI versus CABG treatment effect for patients treated with insulin and those not treated with insulin. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).


Assuntos
Ponte de Artéria Coronária/tendências , Diabetes Mellitus/tratamento farmacológico , Diabetes Mellitus/cirurgia , Insulina/uso terapêutico , Intervenção Coronária Percutânea/tendências , Idoso , Ponte de Artéria Coronária/mortalidade , Diabetes Mellitus/mortalidade , Feminino , Seguimentos , Humanos , Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
18.
Acta Cardiol ; 69(4): 435-45, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25181919

RESUMO

Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of them.

19.
Turk Kardiyol Dern Ars ; 42(2): 203-15, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24643156

RESUMO

Recent innovations in interventional cardiology have dramatically expanded the therapeutic options for patients with cardiac conditions. Interventional cardiology is no longer limited to the treatment of coronary artery disease but allows also treatment of valvular disease, stroke prevention, hypertension, etc. One of the most important new treatment options is the percutaneous treatment for aortic valve stenosis (transcatheter aortic valve implantation), since aortic valve disease is a rather common problem in elderly patients, with many of them at high risk for surgery. Similarly, mitral regurgitation is often associated with comorbidities which make surgery high risk. The MitraClip is a promising percutaneous alternative to surgical valve repair or replacement. Other procedures discussed in this review are the percutaneous left atrial appendage closure as a non-pharmacologic therapy to prevent strokes, and renal denervation for resistant hypertension. This review explains the basic principles of these procedures, the most important clinical evidence, and also provides additional recent clinical data on each of these them.


Assuntos
Estenose da Valva Aórtica/cirurgia , Apêndice Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/instrumentação , Procedimentos Cirúrgicos Cardíacos/métodos , Insuficiência da Valva Mitral/cirurgia , Humanos
20.
JACC Cardiovasc Interv ; 7(4): 372-9, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24630881

RESUMO

OBJECTIVES: This study sought to evaluate the short- and long-term outcomes for smokers with non-ST-segment elevation acute coronary syndromes (NSTE-ACS). BACKGROUND: Smoking has been associated with the "paradox" of reduced mortality after acute myocardial infarction (MI). This is thought to be due to favorable baseline characteristics and less diffuse coronary artery disease (CAD) among smokers. METHODS: In the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 13,819 patients (29.1% smokers) with moderate- to high-risk NSTE-ACS underwent angiography and, if indicated, revascularization. RESULTS: Smokers were significantly younger and had fewer comorbidities than nonsmokers. Incidence of death and MI were comparable at 30 days, although smokers had significantly reduced risks of 30-day major bleeding (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.67 to 0.96; p = 0.016) and 1-year mortality (HR: 0.797, 95% CI: 0.65 to 0.97; p = 0.027). After correction for baseline and clinical differences, smoking was no longer predictive of major bleeding (odds ratio: 1.06, 95% CI: 0.86 to 1.32; p = 0.56) and was associated with higher 1-year mortality (HR: 1.37, 95% CI: 1.07 to 1.7; p = 0.013). This pattern of reversed risk after multivariable correction held true for those smokers requiring percutaneous coronary intervention. Core laboratory angiographic analysis showed that smokers and nonsmokers were comparable in terms of the extent of CAD, Thrombolysis In Myocardial Infarction flow, myocardial blush, and the presence of thrombi. CONCLUSIONS: In contrast to the paradox previously described in ST-segment elevation MI, our analysis finds smoking to be an independent predictor of higher 1-year mortality in patients presenting with NSTE-ACS, and our angiographic study demonstrates CAD in smokers that is comparable to that in nonsmokers but evident ∼1 decade earlier. (Acute Catheterization and Urgent Intervention Triage Strategy [ACUITY]; NCT00093158).


Assuntos
Síndrome Coronariana Aguda/etiologia , Doença da Artéria Coronariana/etiologia , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea , Fumar/efeitos adversos , Triagem , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/terapia , Idoso , Distribuição de Qui-Quadrado , Comorbidade , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/terapia , Feminino , Hemorragia/etiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/terapia , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fumar/mortalidade , Fatores de Tempo , Resultado do Tratamento
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