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1.
Am Heart J ; 265: 153-160, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37572785

RESUMEN

BACKGROUND: Over the past few decades, percutaneous coronary intervention (PCI) has undergone significant advancements as a result of the combination of device-based and drug-based therapies. These iterations have led to the development of polymer-free drug-eluting stents. However, there is a scarcity of data regarding their clinical performance. Furthermore, while various risk scores have been proposed to determine the optimal duration of dual antiplatelet therapy (DAPT), none of them have undergone prospective validation within the context of randomized trials. DESIGN: The PARTHENOPE trial is a phase IV, prospective, randomized, multicenter, investigator-initiated, assessor-blind study being conducted at 14 centers in Italy (NCT04135989). It includes 2,107 all-comers patients with minimal exclusion criteria, randomly assigned in a 2-by-2 design to receive either the Cre8 amphilimus-eluting stent or the SYNERGY everolimus-eluting stent, along with either a personalized or standard duration of DAPT. Personalized DAPT duration is determined by the DAPT score, which accounts for both bleeding and ischemic risks. Patients with a DAPT score <2 (indicating higher bleeding than ischemic risk) receive DAPT for 3 or 6 months for chronic or acute coronary syndrome, respectively, while patients with a DAPT score ≥2 (indicating higher ischemic than bleeding risk) receive DAPT for 24 months. Patients in the standard DAPT group receive DAPT for 12 months. The trial aims to establish the noninferiority between stents with respect to a device-oriented composite end point of cardiovascular death, target-vessel myocardial infarction, or clinically-driven target-lesion revascularization at 12 months after PCI. Additionally, the trial aims to demonstrate the superiority of personalized DAPT compared to a standard approach with respect to a net clinical composite of all-cause death, any myocardial infarction, stroke, urgent target-vessel revascularization, or type 2 to 5 bleeding according to the Bleeding Academic Research Consortium criteria at 24-months after PCI. SUMMARY: The PARTHENOPE trial is the largest randomized trial investigating the efficacy and safety of a polymer-free DES with a reservoir technology for drug-release and the first trial evaluating a personalized duration of DAPT based on the DAPT score. The study results will provide novel insights into the optimizing the use of drug-eluting stents and DAPT in patients undergoing PCI.


Asunto(s)
Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents Liberadores de Fármacos/efectos adversos , Intervención Coronaria Percutánea/métodos , Polímeros , Hemorragia/inducido químicamente , Infarto del Miocardio/etiología , Resultado del Tratamiento , Quimioterapia Combinada
2.
Front Cardiovasc Med ; 10: 1326091, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38299080

RESUMEN

Introduction: The use of contemporary drug-eluting stents (DES) has significantly improved outcomes of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, concerns exist regarding the long-term proinflammatory effects of durable polymer coatings used in most DES, potentially leading to long-term adverse events. First-generation polymer-free stent technologies, such as sirolimus- and probucol-eluting stents (PF-SES), have shown an excellent safety and efficacy profile. The aim of this study was to evaluate the safety and efficacy of the new ultrathin Coroflex ISAR NEO PF-SES, in a more-comers PCI population. Methods: The CAESAR (a more-Comers populAtion trEated with an ultrathin struts polimer-free Sirolimus stent: An Italian post-maRketing study) registry is a multicenter, prospective study conducted in Italy, enrolling more-comers CAD patients undergoing PCI with the Coroflex ISAR NEO stent. Patients with left main (LM) disease, cardiogenic shock (CS), or severely reduced left-ventricular ejection fraction (LVEF) were excluded. The primary endpoint was target-lesion revascularization (TLR) at 1 year. Results: A total of 425 patients were enrolled at 13 centers (mean age 66.9 ± 11.6 years, Diabetes mellitus 29%, acute coronary syndrome 67%, chronic total occlusion 9%). Of these, 40.9% had multivessel disease (MVD) and in 3.3% cases, the target lesion was in-stent restenosis (ISR). Clinical device success was reached in 422 (99.6%) cases. At 1 year, only two (0.5%) subjects presented ischemia-driven TLR. The 1-year rates of target vessel revascularization and MACE were 0.5% and 5.1%, respectively. Major bleeding was observed in four (1.0%) patients. Conclusion: In this multicenter, prospective registry, the use of a new ultrathin Coroflex ISAR NEO PF-SES in a more-comers PCI population showed good safety and efficacy at 1 year.

3.
J Pers Med ; 11(4)2021 Apr 08.
Artículo en Inglés | MEDLINE | ID: mdl-33917902

RESUMEN

Globally, at the time of writing (20 March 2021), 121.759.109 confirmed COVID-19 cases have been reported to the WHO, including 2.690.731 deaths. Globally, on 18 March 2021, a total of 364.184.603 vaccine doses have been administered. In Italy, 3.306.711 confirmed COVID-19 cases with 103.855 deaths have been reported to WHO. In Italy, on 9 March 2021, a total of 6.634.450 vaccine doses have been administered. On 15 March 2021, Italian Medicines Agency (AIFA) decided to temporarily suspend the use of the AstraZeneca COVID-19 vaccine throughout the country as a precaution, pending the rulings of the European Medicines Agency (EMA). This decision was taken in line with similar measures adopted by other European countries due to the death of vaccinated people. On 18 March 2021, EMA's safety committee concluded its preliminary review about thromboembolic events in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting, confirming the benefits of the vaccine continue to outweigh the risk of side effects, however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets with or without bleeding, including rare cases of cerebral venous thrombosis (CVT). We report the case of a 54-year-old woman who developed disseminated intravascular coagulation (DIC) with multi-district thrombosis 12 days after the AstraZeneca COVID-19 vaccine administration. A brain computed tomography (CT) scan showed multiple subacute intra-axial hemorrhages in atypical locations, including the right frontal and the temporal lobes. A plain old balloon angioplasty (POBA) of the right coronary artery was performed, without stent implantation, with restoration of distal flow, but with persistence of extensive thrombosis of the vessel. A successive thorax angio-CT added the findings of multiple contrast filling defects with multi-vessel involvement: at the level of the left upper lobe segmental branches, of left interlobar artery, of the right middle lobe segmental branches and of the right interlobar artery. A brain magnetic resonance imaging (MRI) in the same day showed the presence of an acute basilar thrombosis associated with the superior sagittal sinus thrombosis. An abdomen angio-CT showed filling defects at the level of left portal branch and at the level of right suprahepatic vein. Bilaterally, it was adrenal hemorrhage and blood in the pelvis. An evaluation of coagulation factors did not show genetic alterations so as the nasopharyngeal swab ruled out a COVID-19 infection. The patient died after 5 days of hospitalization in intensive care.

6.
Echocardiography ; 36(4): 803-805, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30726561

RESUMEN

A young patient affected by a lung neoplasm, presented at emergency department with cardiac tamponade, underwent pericardiocentesis with a prompt restoration of hemodynamic stability. An hour later, the patient presented again signs of tamponade, without evidence of fluids in the drainage that was left in pericardial space. The echocardiography revealed an intrapericardial thrombus compressing the right chambers. An emergency pericardiotomy was performed and a large thrombus was removed from the pericardial space; cardiac walls were intact. Echocardiography played a pivotal role for the identification of a pericardial thrombus as a complication of pericardiocentesis.


Asunto(s)
Taponamiento Cardíaco/terapia , Ecocardiografía/métodos , Pericardiocentesis/efectos adversos , Pericardio/diagnóstico por imagen , Trombosis/diagnóstico por imagen , Adulto , Humanos , Masculino , Pericardio/cirugía , Recurrencia , Trombosis/etiología , Trombosis/cirugía
7.
Catheter Cardiovasc Interv ; 93(1): E63-E70, 2019 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-30144332

RESUMEN

OBJECTIVES: To evaluate the safety and the feasibility of balloon aortic valvuloplasty (BAV) procedure made by trained operators in centers not performing transcatheter aortic valve implantation (TAVI). BACKGROUND: BAV is a valuable therapeutic tool for patients with symptomatic severe aortic valve stenosis (AS) at prohibitive risk for TAVI or surgery. METHODS: Consecutive high-risk AS patients underwent BAV in five non-TAVI centers, where BAV operators had completed a 6-month training period in high-volume TAVI centers (Group A). All clinical, echocardiographic, and procedural data were prospectively collected and compared with data of patients treated in TAVI center (Group B). RESULTS: Between June 2016 and June 2017, 55 patients (83.9 ± 7.0 years) were enrolled: 25 in Group A and 30 in Group B. After BAV, a substantial reduction of the peak-to-peak aortic valve gradient was obtained in both groups (-35.3 ± 15.2 vs -28.8 ± 13.9 mmHg, P =0.25). No major bleeding or vascular complications occurred. In-hospital death was observed in three patients of Group A and two patients of Group B (P =0.493). The mean follow-up time was 303 ± 188 days; no patients were lost. The 1-year survival free from overall death (Group A 75.8% vs Group B 68.8%; P =0.682) and heart failure rehospitalization (Group A 73.0% vs Group B 66.8%; P =0.687) was similar in the two groups. At multivariable analysis, low left ventricular (LV) ejection fraction (HR: 0.943; P = 0.011) and cardiogenic shock (HR: 5.128; P = 0.002) at admission were independent predictors of mortality. CONCLUSIONS: BAV is a safe and effective procedure that can be performed by trained operators in centers not performing TAVI.


Asunto(s)
Estenosis de la Válvula Aórtica/terapia , Valvuloplastia con Balón , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Valvuloplastia con Balón/efectos adversos , Valvuloplastia con Balón/mortalidad , Estudios de Factibilidad , Femenino , Mortalidad Hospitalaria , Humanos , Italia , Masculino , Estudios Prospectivos , Recuperación de la Función , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
8.
J Thromb Thrombolysis ; 46(4): 559-569, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-29943351

RESUMEN

Dual antiplatelet therapy (DAPT) is a cornerstone of treatment for patients with acute coronary syndromes (ACS). Mounting evidences have opened the debate about the optimal DAPT duration. Considering the ACS-pathophysiology, the most recent guidelines recommend DAPT in all ACS patients for at least 12 months unless there are contraindications such as excessive risk of bleeding. Thus, it can be considered acceptable earlier discontinuation if the risk of morbidity from bleeding outweighs the anticipated benefit. On the other hand, several studies have clearly indicated that a significant burden of platelet related-events, such as stroke and new ACS might occur after this period, suggesting that potential benefits might derive by prolonging DAPT beyond 12 months (Long DAPT). Indeed, although current guidelines give some indications about patients eligible for Long DAPT, they do not embrace several real-life clinical scenarios. Thus, in such scenarios, how to decide whether a patient is eligible for Long DAPT or not might be still challenging for clinicians. This position paper presents and discusses various "real-life" clinical scenarios in ACS patients, in order to propose several possible recommendations to overcome guidelines potential limitations.


Asunto(s)
Síndrome Coronario Agudo/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Síndrome Coronario Agudo/complicaciones , Hemorragia/inducido químicamente , Humanos , Cuidados a Largo Plazo , Inhibidores de Agregación Plaquetaria/efectos adversos , Guías de Práctica Clínica como Asunto , Recurrencia , Prevención Secundaria , Accidente Cerebrovascular/prevención & control , Resultado del Tratamiento
9.
Angiology ; 68(7): 598-607, 2017 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-28660806

RESUMEN

The incidence of ST-segment elevation myocardial infarction (STEMI) has significantly decreased. Conversely, the rate of non-STEMI (NSTEMI) has increased. Patients with NSTEMI have lower short-term mortality compared to patients with STEMI, whereas at long-term follow-up, the mortality becomes comparable. This might be due to the differences in baseline characteristics, including older age and a greater prevalence of comorbidities in the NSTEMI population. Although antithrombotic strategies used in patients with NSTEMI have been well studied in clinical trials and updated guidelines are available, patterns of use and outcomes in clinical practice are less well described. Thus, a panel of Italian cardiology experts assembled under the auspices of the "Campania NSTEMI Study Group" for comprehensive discussion and consensus development to provide practical recommendations, for both clinical and interventional cardiologists, regarding optimal management of antithrombotic therapy in patients with NSTEMI. This position article presents and discusses various clinical scenarios in patients with NSTEMI or unstable angina, including special subsets (eg, patients aged ≥85 years, patients with chronic renal disease or previous cerebrovascular events, and patients requiring triple therapy or long-term antithrombotic therapy), with the panel recommendations being provided for each scenario.


Asunto(s)
Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio sin Elevación del ST/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Resultado del Tratamiento , Anciano , Anciano de 80 o más Años , Consenso , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria , Humanos , Masculino , Sistema de Registros , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico
11.
Eur Heart J Cardiovasc Pharmacother ; 1(3): 168-78, 2015 07.
Artículo en Inglés | MEDLINE | ID: mdl-27533991

RESUMEN

AIMS: Patients with acute coronary syndromes (ACSs) who are managed without coronary revascularization represent a mixed and understudied population that seems to receive suboptimal pharmacological treatment. METHODS AND RESULTS: We assessed patterns of antithrombotic therapies employed during the hospitalization and in-hospital clinical events of medically managed patients with ACS enrolled in the prospective, multicentre, nationwide EYESHOT (EmploYEd antithrombotic therapies in patients with acute coronary Syndromes HOspitalized in iTalian cardiac care units) registry. Among the 2585 consecutive ACS patients enrolled in EYESHOT, 783 (30.3%) did not receive any revascularization during hospital admission. Of these, 478 (61.0%) underwent coronary angiography (CA), whereas 305 (39.0%) did not. The median GRACE and CRUSADE risk scores were significantly higher among patients who did not undergo CA compared with those who did (180 vs. 145, P < 0.0001 and 50 vs. 33, P < 0.0001, respectively). Antithrombotic therapies employed during hospitalization significantly differ between patients who received CA and those who did not with unfractioned heparin and novel P2Y12 inhibitors more frequently used in the first group, and low-molecular-weight heparins and clopidogrel in the latter group. During the index hospitalization, patients who did not receive CA presented a higher incidence of ischaemic cerebrovascular events and of mortality compared with those who underwent CA (1.6 vs. 0.2%, P = 0.04 and 7.9 vs. 2.7%, P = 0.0009, respectively). CONCLUSION: Almost one-third of ACS patients are managed without revascularization during the index hospitalization. In this population, a lower use of recommended antiplatelet therapy and worse clinical outcome were observed in those who did not undergo CA when compared with those who did. CLINICAL TRIAL REGISTRATION: Unique identifier: NCT02015624, http://www.clinicaltrials.gov.


Asunto(s)
Síndrome Coronario Agudo/tratamiento farmacológico , Fibrinolíticos/uso terapéutico , Guías de Práctica Clínica como Asunto , Terapia Trombolítica/métodos , Síndrome Coronario Agudo/mortalidad , Anciano , Unidades de Cuidados Coronarios/estadística & datos numéricos , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Italia/epidemiología , Tiempo de Internación/tendencias , Masculino , Revascularización Miocárdica , Estudios Retrospectivos , Tasa de Supervivencia/tendencias
12.
Circ Arrhythm Electrophysiol ; 6(3): 538-45, 2013 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-23592833

RESUMEN

BACKGROUND: Current recommendations require a QRS duration of ≥120 ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure (HF) of ischemic origin, current indications for defibrillator implantation, and QRS <120 ms may benefit from CRT in the presence of marked mechanical dyssynchrony. METHODS AND RESULTS: Patients with intraventricular dyssynchrony on echocardiography were randomly assigned to CRT or dual-chamber defibrillator implantation (CRT defibrillator and dual-chamber implantable cardioverter-defibrillator arm, respectively). The primary end point was the HF clinical composite response, which scores patients as improved, unchanged, or worsened. The secondary end point was the cumulative survival from HF hospitalization and HF death. An additional secondary end point was the composite of HF hospitalization, HF death, and spontaneous ventricular fibrillation. Twenty-three of 56 patients with CRT defibrillator showed an improvement in their clinical composite response at 1 year, compared with 9 of 55 patients with dual-chamber implantable cardioverter-defibrillator (41% versus 16%; P=0.004). After a median follow-up of 16 months, the CRT defibrillator arm showed a nonsignificant higher survival from HF hospitalization and HF death (P=0.077), and a significantly higher survival from the combined end point of HF hospitalization, HF death, and spontaneous ventricular fibrillation (P=0.028). CONCLUSIONS: In this comparison of CRT defibrillator and dual-chamber implantable cardioverter-defibrillator, CRT improved clinical status in some patients with ischemic cardiomyopathy, mild-to-moderate symptoms, narrow QRS duration, and mechanical dyssynchrony on echocardiography. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT01577446.


Asunto(s)
Estimulación Cardíaca Artificial/métodos , Cardiomiopatías/terapia , Desfibriladores Implantables , Insuficiencia Cardíaca/terapia , Taquicardia Ventricular/terapia , Terapia de Resincronización Cardíaca/métodos , Cardiomiopatías/diagnóstico , Cardiomiopatías/mortalidad , Ecocardiografía Doppler , Electrocardiografía/métodos , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Isquemia Miocárdica/diagnóstico por imagen , Isquemia Miocárdica/mortalidad , Isquemia Miocárdica/terapia , Estudios Prospectivos , Medición de Riesgo , Estadísticas no Paramétricas , Tasa de Supervivencia , Taquicardia Ventricular/diagnóstico , Resultado del Tratamiento , Disfunción Ventricular Izquierda/diagnóstico por imagen , Disfunción Ventricular Izquierda/mortalidad , Disfunción Ventricular Izquierda/terapia
13.
J Renin Angiotensin Aldosterone Syst ; 13(4): 496-503, 2012 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-22546623

RESUMEN

INTRODUCTION: Atrial remodelling, leading to atrial fibrillation (AF), is mediated by the renin-angiotensin-aldosterone system. METHODS: Mild hypertensive outpatients (systolic/diastolic blood pressure 140-159/90-99 mmHg) in sinus rhythm who had experienced ≥ 1 electrocardiogram (ECG)-documented AF episode in the previous six months received randomly telmisartan 80 mg/day or carvedilol 25 mg/day. Blood pressure and 24-hour ECG were monitored monthly for one year; patients were asked to report symptomatic AF episodes and to undergo an ECG as early as possible. RESULTS: One hundred and thirty-two patients completed the study (telmisartan, n=70; carvedilol, n=62). Significantly fewer AF episodes were reported with telmisartan versus carvedilol (14.3% vs. 37.1%; p<0.003). Left atrial diameter, assessed by echocardiography, was similar with telmisartan and carvedilol (3.4±2.3 cm vs. 3.6±2.4 cm). At study end, both regimes significantly reduced mean left ventricular mass index, but the reduction obtained with telmisartan was significantly greater than with carvedilol (117.8±10.7 vs. 124.7±14.5; p<0.0001). Mean blood pressure values were not significantly different between the groups (telmisartan 154/97 to 123/75 mmHg; p<0.001; carvedilol 153/94 to 125/78 mmHg; p<0.001). CONCLUSIONS: Telmisartan was significantly more effective than carvedilol in preventing recurrent AF episodes in hypertensive AF patients, despite a similar lowering of blood pressure.


Asunto(s)
Antihipertensivos/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/prevención & control , Bencimidazoles/uso terapéutico , Benzoatos/uso terapéutico , Carbazoles/uso terapéutico , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Propanolaminas/uso terapéutico , Adulto , Anciano , Antihipertensivos/farmacología , Fibrilación Atrial/etiología , Fibrilación Atrial/patología , Bencimidazoles/farmacología , Benzoatos/farmacología , Carbazoles/farmacología , Carvedilol , Femenino , Ventrículos Cardíacos/efectos de los fármacos , Ventrículos Cardíacos/patología , Humanos , Hipertensión/patología , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Tamaño de los Órganos/efectos de los fármacos , Propanolaminas/farmacología , Recurrencia , Telmisartán
14.
Heart Rhythm ; 7(11): 1600-5, 2010 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-20691283

RESUMEN

BACKGROUND: Cardiac resynchronization therapy (CRT) is effective in selected patients with heart failure (HF). Nevertheless, the nonresponder rate remains high. The low-dose dobutamine stress-echo (DSE) test detects the presence of left ventricular (LV) contractile reserve (LVCR) in HF patients of any etiology and may be useful in predicting response to resynchronization. OBJECTIVE: The purpose of this study was to present the results of the LODO-CRT trial, which evaluated whether LVCR presence at baseline increases the chances of response to CRT. METHODS: LODO-CRT is a multicenter prospective study that enrolled CRT candidates according to guidelines. LVCR presence was defined as an LV ejection fraction increase >5 units during DSE test. CRT response is assessed at 6-month follow-up as an LV end-systolic volume reduction ≥10%. RESULTS: Two hundred seventy-one patients were enrolled. The DSE test was feasible without complications in 99% of patients. Nine patients died from noncardiac disease, and 31 presented inadequate data. Two hundred thirty-one patients were included in the analysis. Mean patient age was 67 ± 10 years; 95% were in New York Heart Association class III, and 42% had HF of ischemic etiology. Mean QRS and LV ejection fraction were 147 ± 25 ms and 27% ± 6%, respectively. LVCR presence was found in 185 subjects (80%). At follow-up, 170 (74%) patients responded to CRT, 145/185 in the group with LVCR (78%) and 25/46 (54%) in the group without LVCR. Difference in responder proportion to CRT was 24% (P <.001). Reported test sensitivity is 85%. CONCLUSION: The DSE test in CRT candidates is safe and feasible. LVCR presence at baseline increases the chances of response to CRT.


Asunto(s)
Terapia de Resincronización Cardíaca , Ventrículos Cardíacos/diagnóstico por imagen , Ventrículos Cardíacos/fisiopatología , Contracción Miocárdica , Anciano , Ecocardiografía de Estrés , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sensibilidad y Especificidad
15.
J Cardiovasc Med (Hagerstown) ; 11(4): 299-309, 2010 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-20090550

RESUMEN

BACKGROUND: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. CONCLUSION: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.


Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Inmunosupresores/administración & dosificación , Proyectos de Investigación , Sirolimus/análogos & derivados , Angiografía , Implantación de Prótesis Vascular , Protocolos Clínicos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Análisis Costo-Beneficio , Everolimus , Humanos , Revascularización Miocárdica , Estudios Prospectivos , Sirolimus/administración & dosificación
16.
Catheter Cardiovasc Interv ; 75(5): 715-21, 2010 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-19937780

RESUMEN

OBJECTIVE: To report, for the first time, angiographic and ECG results as well as in-hospital and 1-month clinical follow-up, after MGuard net protective stent (Inspire-MD, Tel-Aviv, Israel-MGS) implantation in consecutive, not randomized, STEMI patients undergoing primary or rescue PCI. BACKGROUND: Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI), in ST-elevation myocardial infarction (STEMI) setting. METHODS: One-hundred consecutive patients underwent PCI, with MGS deployment for STEMI, in five different high-volume PCI centres. Sixteen patients presented cardiogenic shock at admission. RESULTS: All patients underwent successful procedures: mean TIMI flow grade and mean corrected TIMI frame count-cTFC(n)-improved from baseline values to 2.85 +/- 0.40 and to 17.20 +/- 10.51, respectively, with a mean difference in cTFC(n) between baseline and postprocedure of 46.88 +/- 31.86. High-myocardial blush grade (90% MBG 3; 10% MBG 2) was also achieved in all patients. Sixty minutes post-PCI, a high rate (90%) of complete (>or=70%) ST-segment resolution was achieved. At in-hospital follow-up, seven deaths occurred: noteworthy, 5 of 16 patients with cardiogenic shock at admission died. After hospital discharge, no Major Adverse Cardiac Events have been reported up to 30-day follow-up. CONCLUSIONS: MGS might represent a safe and feasible option for PCI in STEMI patients, providing high perfusional and ECG improvement. Further randomized trials comparing this strategy with the conventional one are needed in the near future to assess the impact on clinical practice of this strategy.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Infarto del Miocardio/terapia , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Angiografía Coronaria , Circulación Coronaria , Bases de Datos como Asunto , Electrocardiografía , Estudios de Factibilidad , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Infarto del Miocardio/fisiopatología , Imagen de Perfusión Miocárdica , Alta del Paciente , Estudios Prospectivos , Diseño de Prótesis , Factores de Tiempo , Resultado del Tratamiento
17.
Pacing Clin Electrophysiol ; 32 Suppl 1: S173-6, 2009 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19250087

RESUMEN

BACKGROUND: Much information is available regarding the possible negative effects of long-term right ventricular (RV) apical pacing, which may cause worsening of heart failure. However, very limited data are available regarding the effects of RV pacing in patients with a previous myocardial infarction (MI). METHODS AND RESULTS: We screened 115 consecutive post-MI patients and matched a group of 29 pacemaker (PM) recipients with a group of 49 unpaced patients, for age, left ventricular (LV) ejection fraction, and site of MI. During a median follow-up of 54 months, echocardiograms showed a decrease in LV ejection fraction in the paced group, from 51 +/- 10 to 39 +/- 11 (P < 0.01), and a minimal change in the unpaced group, from 57 +/- 8 to 56 +/- 7 (P = 0.98). Similar change was observed in systolic and diastolic diameters and volumes. CONCLUSIONS: The study showed that, in post-MI patients, RV apical pacing was associated with a worsening of LV function, suggesting that, among MI survivors, the need for a PM is a marker of worse outcome.


Asunto(s)
Estimulación Cardíaca Artificial/métodos , Ventrículos Cardíacos , Infarto del Miocardio/complicaciones , Infarto del Miocardio/prevención & control , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/prevención & control , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Sobrevivientes , Resultado del Tratamiento
19.
Am Heart J ; 156(4): 656-61, 2008 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18926147

RESUMEN

BACKGROUND: Although cardiac resynchronization therapy (CRT) has a well-demonstrated therapeutic effect in selected patients with advanced heart failure on optimized drug therapy, nonresponder rate remains high. The LODO-CRT is designed to improve patient selection for CRT. Design and rationale of this study are presented herein. METHODS: LODO-CRT is a multicenter prospective study, started in late 2006, that enrolls patients with conventional indications for CRT (symptomatic stable New York Heart Association class III-IV on optimized drug therapy, QRS > or =120 milliseconds, left ventricular [LV] dilatation, LV ejection fraction < or =35%). This study is designed to assess the predictive value of LV contractile reserve (LVCR), determined through dobutamine stress echocardiography (defined as an LV ejection fraction increase >5 units), in predicting CRT response during follow-up. Assessment of CRT effects will follow 2 sequential phases: in phase 1, CRT response end point is defined as LV end-systolic volume reduction > or =10% at 6 months; in phase 2, both LV end-systolic volume reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 (with 95% confidence, 80% power, alpha < or = .05). Enrollment should be complete by the end of 2008. CONCLUSIONS: The LODO-CRT trial is testing the hypothesis that LVCR assessment, using low-dose dobutamine stress echocardiography test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.


Asunto(s)
Estimulación Cardíaca Artificial , Ecocardiografía de Estrés , Selección de Paciente , Humanos , Estudios Multicéntricos como Asunto , Evaluación de Resultado en la Atención de Salud , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Proyectos de Investigación , Disfunción Ventricular Izquierda , Remodelación Ventricular
20.
G Ital Cardiol (Rome) ; 9(6): 421-4, 2008 Jun.
Artículo en Italiano | MEDLINE | ID: mdl-18681393

RESUMEN

Anomalous origin of the circumflex coronary artery from the right sinus of Valsalva is the most common coronary anomaly. This anomaly is thought to be of little clinical significance without the presence of severe narrowing of the vessel. A 43-year-old woman was referred to our institution for evaluation of atypical chest pain and equivocal results of the exercise stress test. We decided to perform multislice computed tomography coronary angiography before any other invasive studies. The scan was performed with a 16-row scanner (Aquilion 16 CFX, Toshiba Medical Systems, Tokyo, Japan) after intravenous administration of non-ionic contrast material. Scans revealed that the circumflex coronary artery originated from the right sinus of Valsalva; the initial course was retro-aortic until it reached its target in the atrioventricular groove; peripheral distribution of the circumflex coronary artery was then normal. The anomalous vessel presented a significant stenosis in its proximal tract. Coronary angiography confirmed that the origin of the circumflex coronary artery was from the right aortic sinus and the significant stenosis of the proximal portion of this vessel. This case confirms the full capability and accuracy of multislice computed tomography with the aid of post-processing techniques in the identification and evaluation of the ectopic origin of the left circumflex coronary artery from the right sinus of Valsalva, displaying accurately the origin, size, course, and relationship of the anomalous vessel with respect to surrounding structures.


Asunto(s)
Anomalías Múltiples/diagnóstico por imagen , Angiografía Coronaria , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Seno Aórtico/anomalías , Seno Aórtico/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Adulto , Femenino , Humanos , Tomografía Computarizada por Rayos X/métodos
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