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1.
Am J Cardiol ; 224: 56-64, 2024 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-38729335

RESUMO

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.


Assuntos
Estenose da Valva Aórtica , Ensaios Clínicos Controlados Aleatórios como Assunto , Substituição da Valva Aórtica Transcateter , Humanos , Estenose da Valva Aórtica/cirurgia , Seguimentos , Complicações Pós-Operatórias/epidemiologia , Medição de Risco/métodos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/métodos
2.
J Clin Med ; 13(9)2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38731033

RESUMO

Background: Percutaneous coronary intervention (PCI) is a widely used revascularization strategy for coronary artery disease. The choice between imaging-guided and physiology-guided PCI has been a subject of debate. This meta-analysis aims to systematically compare outcomes between imaging and physiology-guided PCI and management of intermediate coronary lesions (ICLs). Methods: A comprehensive literature search was conducted across major databases for studies published up to December 2023 following PRISMA guidelines. Seven eligible studies comparing imaging-guided and physiology-guided PCI were selected for the final analysis. Relevant outcome measures included major adverse cardiovascular events (MACE), target vessel revascularization (TVR), target vessel failure (TVF), and target lesion revascularization (TLR). Subgroup analysis was performed for ICLs. Results: A total of 5701 patients were included in the meta-analysis. After a mean follow-up of 2.1 years, imaging-guided PCI was associated with lower rates of TVR compared to physiology-guided PCI (OR 0.70, 95% CI 0.52-0.95, p = 0.02); concerning MACE, TVF, and TLR, no differences were found. When the analysis was restricted to studies considering ICLs management, there were no differences between the two techniques. Meta regression analysis did not show any impact of acute coronary syndromes (ACS) presentation on MACE and TVR. Conclusions: The findings suggest that imaging-guided PCI may reduce the need for future revascularization of the target vessel compared to the functional-guided approach, and this result was not influenced by ACS presentation. These results may have important implications for clinical practice, guiding interventional cardiologists in selecting the most appropriate guidance strategy.

3.
J Clin Med ; 12(23)2023 Nov 28.
Artigo em Inglês | MEDLINE | ID: mdl-38068423

RESUMO

BACKGROUND: To provide a comprehensive analysis of the current literature comparing the outcomes of surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic stenosis (BAS), with particular attention to BAV morphology in patients undergoing TAVR. METHODS: Following PRISMA guidelines, all relevant articles with no design restrictions from PubMed, CCTR (Cochrane Controlled Trials Register), and Google Scholar were screened for inclusion. Studies were included if they reported clinical endpoints for SAVR and TAVR or, in BAS treated with TAVR, for type 1 and non-type 1 morphology. Odds ratio and Cohen's D were considered as effect size measurements for qualitative and quantitative variables, respectively. RESULTS: A total of eight studies comparing short-term outcomes between SAVR and TAVR and nine studies with outcomes data between type 1 and non-type 1 BAS treated with TAVR were considered for the final analysis. No statistically significant difference was found for what concerns the rates of death, stroke, and acute kidney injury between SAVR and TAVR. In comparison to patients undergoing SAVR, the incidence of PPI (permanent pacemaker implantation) was greater in the TAVR group (OR 0.35, 95% CI 0.15-0.79, p = 0.01), and the frequency of bleeding events was found to be higher among patients undergoing SAVR (OR 4.3, 95% CI 2.9-6.4, p < 0.001). The probabilities of 30-day mortality, stroke, and any bleeding were not significantly affected by bicuspid valve morphology in TAVR patients. PPI or development of new conduction anomalies was found to be more frequent in type 1 anatomies (OR 0.46, 95% CI 0.30-0.70, p <0.001). Mildly lower post-procedural transprothesic gradients were found in patients with type 1 morphology. CONCLUSIONS: In BAS patients, TAVR has comparable short-term outcomes rates with SAVR, but higher PPI rates and lower incidence of bleeding events. In patients undergoing TAVR, type 1 BAS is associated with lower postoperative transvalvular gradients but higher PPI rates and conduction abnormalities.

4.
Minerva Cardiol Angiol ; 71(1): 77-82, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33944532

RESUMO

BACKGROUND: Chronic pre-procedural and acute post-procedural myocardial injury are frequently observed in patients with aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The aim of our study was to investigate the prognostic role of high sensitivity cardiac troponins (hs-cTns) elevation before and after TAVI. METHODS: 106 patients with severe aortic stenosis who underwent TAVI were enrolled. High sensitivity cardiac troponin T (hs-cTnT) was measured before and after TAVI (6, 24, 48, 72 hours). Post-procedural myocardial damage was defined as a 15-fold rise in hs-cTnT upper reference limit (URL) after TAVI. The clinical endpoints were all cause death, cardiovascular death and re-hospitalization at 24 months follow-up. RESULTS: Before TAVI, hs-cTnT median value was 0.03 µg/L (2.3±2.1 fold over URL). After TAVI procedure, myocardial damage (MD), as defined by VARC-2 criteria, was observed in 40 patients (38%) (MD group). In our population, logarithmically transformed hs-cTnTs were independently associated with all-cause mortality at 24 months F/U (pre-TAVI hs-cTnT: Hazard ratio [HR] 2.2, 95% confidence interval [CI]: 1.1 to 4.4, P=0.027). No significant differences were observed between the MD and non-MD groups for the three endpoints of all cause death (p log rank: 0.15), cardiovascular death (p log rank: 0.86) and re-hospitalization (p log rank: 0.87). CONCLUSIONS: Only baseline hs-cTnT levels correlated with outcomes at 24 months of follow-up. Chronic pre-procedural myocardial injury significantly affects prognosis after TAVI.


Assuntos
Estenose da Valva Aórtica , Traumatismos Cardíacos , Substituição da Valva Aórtica Transcateter , Humanos , Prognóstico , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Biomarcadores , Fatores de Risco , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Troponina T , Traumatismos Cardíacos/etiologia , Traumatismos Cardíacos/complicações
6.
J Clin Med ; 9(7)2020 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-32635532

RESUMO

INTRODUCTION: Despite a successful percutaneous coronary intervention (PCI), several studies reported that the recurrence of angina after revascularization, even complete, is a particularly frequent occurrence in the first year after PCI. METHODS: The aim was to evaluate the efficacy of treatment with ranolazine in addition to conventional anti-ischemic therapy in patients who underwent coronary angiography for persistent/recurrent angina after PCI and residual ischemia only due to small branches not suitable for further revascularization. Forty-nine consecutive patients were included in our registry, adding the ranolazine (375 mg b.i.d) to optimal medical therapy (OMT). The Exercise ECG Test (EET) was performed in all patients before to start the therapy (baseline BL) and at 30 days (T1) after enrollment. RESULTS: The average duration of the exercise was increased after the therapy with ranolazine comparing to baseline (RG 9'1'' ± 2' versus BL 8'10'' ± 2', p = 0.01). Seven (14.3%) patients after receiving ranolazine had not crossed the threshold of six minutes (75 watts) compared to 20 (40.8%) of BL (p = 0.0003). Stress angina appeared more frequently at BL than at 30 days (T1 4.1% versus BL 16.3%, p = 0.04) as well as exercise-induced arrhythmias (BL 30.6% versus T1 14.3%, p = 0.05). CONCLUSIONS: The addition of ranolazine to standard anti-ischemic therapy showed a significant improvement in EET results after one month of therapy, including reduced exercise angina, increased exercise tolerance, and reduced exercise arrhythmias.

8.
Int J Cardiol ; 245: 69-76, 2017 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-28874301

RESUMO

OBJECTIVES: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BACKGROUND: The PF-AES has shown promising preliminary results in patients with DM. METHODS: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). RESULTS: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005). CONCLUSIONS: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.


Assuntos
Implantes Absorvíveis/normas , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/cirurgia , Stents Farmacológicos/normas , Polímeros , Sirolimo/análogos & derivados , Idoso , Anti-Inflamatórios/administração & dosagem , Estudos de Coortes , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/normas , Sistema de Registros , Sirolimo/administração & dosagem
9.
Circulation ; 136(6): 602-604, 2017 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-28784829
10.
Int J Cardiol ; 231: 54-60, 2017 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-28104306

RESUMO

BACKGROUND: To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS: 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS: The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.


Assuntos
Síndrome Coronariana Aguda/cirurgia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Oclusão de Enxerto Vascular/prevenção & controle , Revascularização Miocárdica/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Polímeros , Síndrome Coronariana Aguda/tratamento farmacológico , Idoso , Reestenose Coronária/epidemiologia , Feminino , Seguimentos , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Incidência , Itália/epidemiologia , Masculino , Sistema de Registros , Estudos Retrospectivos , Espanha/epidemiologia , Fatores de Tempo
12.
G Ital Cardiol (Rome) ; 17(10 Suppl 1): 12S-21, 2016 Oct.
Artigo em Italiano | MEDLINE | ID: mdl-27729664

RESUMO

Erectile dysfunction (ED) is defined as the inability to get and maintain a sufficient erection to ensure an acceptable sexual activity for the subject and the partner. Although ED does not represent per se a serious disease, it carries a notable and severe influence on quality of life, with significant implications on familiar and social relationship; DE may cause depression, shame, impairment of personal esteem and relational problems. Among many possible etiologies of ED, atherosclerotic disease of penile arteries represents one of the most frequent causes, so it should always be looked for in patients with multiple risk factors for cardiovascular disease or an established coronary or peripheral artery disease. Up to 75% of patients with ED have a stenosis of the iliac-pudendus-penile artery system, deputy to perfusion of male genital organ. Recently the potential treatment of this pathologic condition by percutaneous approach has emerged with valid angiographic results and with a significant improvement in symptoms and quality of life. This review focuses on the normal anatomy and physiology of erection, the pathophysiology of ED, the common points between ED and ischemic cardiomyopathy and, lastly, the new chance of endovascular intervention for ED, to give our cardiologist colleagues the opportunity to screen and adequately treat patients with vascular ED.


Assuntos
Angioplastia , Disfunção Erétil , Doença Arterial Periférica , Stents , Angioplastia/métodos , Disfunção Erétil/epidemiologia , Disfunção Erétil/etiologia , Disfunção Erétil/terapia , Europa (Continente)/epidemiologia , Medicina Baseada em Evidências , Saúde Global/estatística & dados numéricos , Humanos , Incidência , Masculino , Doença Arterial Periférica/complicações , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/terapia , Qualidade de Vida , Fatores de Risco , Resultado do Tratamento
13.
Int J Cardiol ; 214: 113-20, 2016 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-27060269

RESUMO

BACKGROUND: Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. METHODS: 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. RESULTS: 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. CONCLUSIONS: The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/tratamento farmacológico , Diabetes Mellitus/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
14.
Case Rep Cardiol ; 2014: 932595, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25328715

RESUMO

A 51-year-old male patient presented to the emergency room with an anterior ST-elevation myocardial infarction. After a loading dose of both ticagrelor and aspirin, the patient underwent primary-PCI on the left anterior descending coronary artery with stent implantation. After successful revascularization, medical therapy included beta-blockers, statins, and angiotensin II receptor antagonists. Two days later, ivabradine was also administered in order to reduce heart rate at target, but the patient developed a severe symptomatic bradycardia and sinus arrest, even requiring administration of both atropine and adrenaline. Ivabradine and ticagrelor have been then suspended and this latter changed with prasugrel. Any other similar event was not reported during the following days. This clinical case raised concerns about the safety of the combination of beta-blockers and ivabradine in patients treated with ticagrelor, particularly during the acute phase of an acute coronary syndrome. These two latter drugs, in particular, might interact with the same receptor. In fact, ivabradine directly modulates the If-channel which is also modulated by the cyclic adenosine monophosphate levels. These latter have been shown to increase after ticagrelor assumption via inhibition of adenosine uptake by erythrocytes. Further studies are warrant to better clarify the safety of this association.

15.
J Nephrol ; 25(6): 1098-107, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22383347

RESUMO

BACKGROUND: Contrast-induced acute kidney injury (CI-AKI) represents an important cause of hospital-acquired AKI. The aim of this study was to evaluate the incidence of CI-AKI after coronary angiography (CA) or percutaneous coronary intervention (PCI) and the role of patient-/procedure-related risk factors. METHODS: For 11 months, patients undergoing CA or PCI were prospectively evaluated for CI-AKI, and factors possibly affecting CI-AKI were analyzed. Statistical analysis was completed using Student's t-test, chi-square or Fisher exact test, and multivariate logistic regression. RESULTS: Among 585 consecutive patients, incidence of CI-AKI was 5.1% (n=30) and renal replacement therapy was required in 10% of those (n=3). Incidence of CI-AKI was higher in patients with anemia or chronic kidney disease (CKD) associated with diabetes. Basal hemoglobin was significantly lower in CI-AKI patients while Mehran score, contrast medium (CM) volume, contrast ratio (CM volume / maximum contrast dose) and ratio glomerular filtration rate (CM volume / GFR) were significantly higher. Multivariate analysis selected a higher contrast ratio as a factor independently associated with a higher risk of CI-AKI which otherwise appeared to be lower with increasing basal hemoglobin. CONCLUSIONS: The incidence of CI-AKI after CA or PCI was higher in patients with CKD associated with diabetes. Lower levels of basal hemoglobin appeared to be related to a higher risk of CI-AKI, and contrast media volume, especially if exceeding the dose adjusted for renal function, was a strong modifiable risk factor for CI-AKI.


Assuntos
Injúria Renal Aguda/induzido quimicamente , Injúria Renal Aguda/epidemiologia , Meios de Contraste/efeitos adversos , Angiografia Coronária/efeitos adversos , Radiografia Intervencionista/efeitos adversos , Injúria Renal Aguda/sangue , Injúria Renal Aguda/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Distribuição de Qui-Quadrado , Comorbidade , Nefropatias Diabéticas/epidemiologia , Feminino , Hemoglobinas/análise , Humanos , Incidência , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Intervenção Coronária Percutânea , Estudos Prospectivos , Insuficiência Renal Crônica/epidemiologia , Terapia de Substituição Renal , Fatores de Risco , Cidade de Roma/epidemiologia , Fatores de Tempo , Adulto Jovem
16.
J Cardiovasc Med (Hagerstown) ; 11(7): 529-35, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-19918189

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction. Adjunctive therapy with platelet glycoprotein (GP) IIb/IIIa inhibitor can result in increased vessel patency and improved outcomes in ST-elevation myocardial infarction patients undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes. METHODS: IC-Clearly is a randomized, open-label, multicenter trial, with the purpose of evaluating the effectiveness of an intracoronary bolus dose of abciximab delivered using the ClearWay RX catheter vs. an intravenous bolus of abciximab for ST-elevation myocardial infarction with angiographically visible thrombus (thrombus grade >or=2). A total of 150 patients will be randomized 1: 1 to treatment of the culprit artery with intracoronary abciximab (75 patients) or intravenous abciximab (75 patients) in addition to a maintenance infusion regimen of abciximab administered intravenously for 12 h after PCI. The number of patients included in this study is based on the estimation of sample size needed to identify a statistically significant difference in the primary endpoints between the two groups. The primary endpoint chosen to evaluate this hypothesis is infarct size assessed by cardiac magnetic resonance. Clinical outcomes will be assessed for each patient through hospital discharge and at 30-day follow-up. CONCLUSION: The purpose of this study is to evaluate whether an intracoronary bolus of abciximab delivered with the ClearWay RX catheter prior to the 12 h post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo and improved myocardial perfusion when compared with an intravenous bolus of abciximab on top of the 12 h post-PCI intravenous infusion regimen of abciximab as per standard practice. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed by cardiac magnetic resonance.


Assuntos
Angioplastia Coronária com Balão , Anticorpos Monoclonais/administração & dosagem , Trombose Coronária/terapia , Fragmentos Fab das Imunoglobulinas/administração & dosagem , Infarto do Miocárdio/terapia , Inibidores da Agregação Plaquetária/administração & dosagem , Projetos de Pesquisa , Abciximab , Cateterismo Cardíaco , Angiografia Coronária , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/tratamento farmacológico , Eletrocardiografia , Humanos , Infusões Intravenosas , Injeções Intravenosas , Itália , Imageamento por Ressonância Magnética , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/tratamento farmacológico , Miocárdio/patologia , Tamanho da Amostra , Fatores de Tempo , Resultado do Tratamento
17.
J Cardiovasc Med (Hagerstown) ; 10(6): 469-73, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19318976

RESUMO

OBJECTIVE: To evaluate the long-term outcomes after different modalities of treatment of drug-eluting stent (DES) in-stent restenosis (ISR) in a 'real world' setting. METHODS: Actually, few and conflicting data are available about the management of in-stent restenosis (ISR) after DES implantation. In our 'real world' registry 1082 consecutive patients who received a DES implantation were included. At 9-month angiographic follow-up, 93 patients presented a DES ISR that was treated with 'homo-DES' (HMD) (N = 27), 'hetero-DES' (HTD) (N = 19) and conventional balloon angioplasty (POBA) (N = 47). We evaluated the clinical outcomes in terms of major adverse cardiac event (MACE) (death, myocardial infarction and target vessel revascularization) at 18 months. RESULTS: There was no difference for clinical and angiographic characteristics between the three groups, except for the presence of silent ischaemia as clinical presentation (7.7 HMD vs. 2.2% POBA; P = 0.0001). No late stent thrombosis was found. At 18-month clinical follow-up patients treated with HMD, HTD and POBA presented a rate of MACE of 10.2, 0 and 8.7%, respectively (P = NS). Kaplan-Meier survival probability showed that HTD and POBA treatment tended to have more favourable outcomes at 18 months than the HMD treatment. CONCLUSION: In our registry, POBA seems to be as effective as other DES implantations in cases of DES ISR, especially in cases of focal type (Mehran classification IA, IC), in terms of long-term outcomes.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Reestenose Coronária/terapia , Stents Farmacológicos , Idoso , Angioplastia Coronária com Balão/mortalidade , Angiografia Coronária , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/etiologia , Reestenose Coronária/mortalidade , Quimioterapia Combinada , Feminino , Humanos , Itália/epidemiologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Isquemia Miocárdica/etiologia , Isquemia Miocárdica/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Sistema de Registros , Medição de Risco , Fatores de Tempo , Resultado do Tratamento
19.
Catheter Cardiovasc Interv ; 71(1): 84-91, 2008 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-17985382

RESUMO

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) may cause thrombus dislodgment leading to microvascular function impairment, which is a negative independent predictor of myocardial function recovery. Compared with conventional stenting, pretreatment with aspiration thrombectomy during primary PCI significantly improves coronary epicardial flow and myocardial tissue perfusion parameters. We sought to evaluate the angiographic findings of two different manual aspiration thrombectomy devices (Diver-Invatec (DI) and Export-Medtronic (EM)) in STEMI patients undergoing primary angioplasty. METHODS: We randomized 103 STEMI patients referred to our hospital to undergo primary PCI (<12 hr from symptoms onset) to DI (n = 52) and EM (n = 51) devices. The primary angiographic composite end-points were the rates of post-thrombectomy thrombus score (TS) < or =2, TIMI flow grade > or =2, and post-stenting myocardial blush grade (MBG) > or =2 in the two groups. RESULTS: Baseline, clinical, and angiographic preprocedural findings did not differ between the two groups. After aspiration thrombectomy, a TS < or = 2 was more frequently present in EM group (92.3 vs. 69.3%, P = 0.0052). Also the rate of post-thrombectomy TIMI > or = 2 (69.3 vs. 92.2%, P = 0.0052) and post-stenting MBG > or =2 (88.2 vs. 69.3%, P = 0.029) were significantly higher in EM group. No significative differences were observed in terms of clinical events at 1 and 12 months. CONCLUSIONS: In this single-center, prospective, randomized study, a EM use before stenting in STEMI patients seems to remove more thrombotic burden compared with DI, providing a greater post-thrombectomy epicardial flow and a better post-stenting microvascular perfusion.


Assuntos
Angioplastia Coronária com Balão , Circulação Coronária , Trombose Coronária/cirurgia , Infarto do Miocárdio/terapia , Trombectomia , Idoso , Angiografia Coronária , Feminino , Humanos , Masculino , Microcirculação , Pessoa de Meia-Idade , Análise Multivariada , Estudos Prospectivos , Stents , Trombectomia/instrumentação , Resultado do Tratamento
20.
J Cardiovasc Med (Hagerstown) ; 8(8): 625-8, 2007 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-17667035

RESUMO

Drug-eluting stents (DES) present a slightly higher incidence of stent thrombosis compared to bare metal stents and some cases of DES thrombosis are described in the literature. Therefore, there is consensus in recommending treatment with clopidogrel for at least 6 months in addition to life-long aspirin administration. We describe a case of very late paclitaxel-eluting stent thrombosis despite 21 months of clopidogrel treatment, which occurred just 2 weeks after its withdrawal, causing an acute coronary syndrome that was promptly resolved with an urgent invasive strategy. In our experience, paclitaxel-eluting stent thrombosis can occur several months after stent implantation despite prolonged clopidogrel treatment.


Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/administração & dosagem , Trombose Coronária/etiologia , Isquemia Miocárdica/etiologia , Paclitaxel/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Stents , Ticlopidina/análogos & derivados , Doença Aguda , Angioplastia Coronária com Balão/instrumentação , Clopidogrel , Angiografia Coronária , Trombose Coronária/complicações , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico por imagem , Guias de Prática Clínica como Assunto , Desenho de Prótese , Síndrome , Ticlopidina/uso terapêutico , Fatores de Tempo , Resultado do Tratamento
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