Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 80
Filtrar
1.
N Engl J Med ; 2019 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-31556978

RESUMO

BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority). CONCLUSIONS: Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).

2.
J Hum Hypertens ; 2019 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-31484988

RESUMO

The present paper reports differences between office blood pressure (BP) measurement (OBPM) and ambulatory blood pressure measurement (ABPM) in a large multi-centre Indian all comers' population visiting primary care physicians. ABPM and OBPM data from 27,472 subjects (aged 51 ± 14 years, males 68.2%, treated 45.5%) were analysed and compared. Patients were classified based on the following hypertension thresholds: systolic BP (SBP) ≥ 140 and/or diastolic BP (DBP) ≥90 mmHg for OBPM, and SBP ≥ 130 and/or DBP ≥ 80 mmHg for 24-h ABPM, and SBP ≥ 120 and/or DBP ≥ 70 mmHg for night-time ABPM and SBP ≥ 135 and/or DBP ≥ 85 mmHg for daytime ABPM, all together. White coat hypertension (WCH) was seen in 12.0% (n = 3304), masked hypertension (MH) in 19.3% (n = 5293) and 55.5% (n = 15,246) had sustained hypertension. Isolated night-time hypertension (INH) was diagnosed in 11.9% (n = 3256). Untreated subjects had MH relatively more often than treated subjects (23.0% vs. 14.8%, p < 0.0001; respectively). Females had higher relative risk (RR) of having WCH than males (RR 1.16 [CI 95, 1.07-1.25], p < 0.0001). Whereas, males had higher RR of MH than females (RR 1.09 [CI 95, 1.02-1.17] p < 0.01). INH subjects had lower average systolic and diastolic dipping percentages (0.7 ± 6.6/ 2.2 ± 7.9 vs. 9.0 ± 7.3/11.9 ± 8.5, p < 0.001) than those without INH. In conclusion, for diagnosis of hypertension there was a contradiction between OBPM and ABPM in approximately one-third of all patients, and a substantial number of patients had INH. Using ABPM in routine hypertension management can lead to a reduction in burden and associated costs for Indian healthcare.

3.
EuroIntervention ; 15(7): 607-614, 2019 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-31147308

RESUMO

AIMS: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). METHODS AND RESULTS: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. CONCLUSIONS: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Vasos Coronários/efeitos dos fármacos , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Everolimo/efeitos adversos , Seguimentos , Humanos , Índia , Intervenção Coronária Percutânea/efeitos adversos , Sirolimo/efeitos adversos , Resultado do Tratamento
4.
Cardiovasc Diabetol ; 18(1): 80, 2019 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-31208414

RESUMO

BACKGROUND: Saroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively. It was granted marketing authorization in India in 2013 for diabetic dyslipidemia. This review was conducted to summarize the effects of Saroglitazar in patients with diabetic dyslipidemia in real world clinical studies conducted after marketing authorization in India. METHODS: In this review, we selected real world clinical studies of Saroglitazar published as manuscripts and abstracts presented at scientific conferences. In all these studies, patients with diabetic dyslipidemia were treated with Saroglitazar 4 mg once daily for at least 12 weeks and different lipid and glycemic parameters were measured at the baseline and end of the study. RESULTS: In 18 selected studies (5 published manuscripts and 13 abstracts), a total of 5824 patients with diabetic dyslipidemia were prescribed Saroglitazar 4 mg for a duration ranging from 12 to 58 weeks. Across all the studies, mean age of patients ranged from 49.6 to 59.1 years and the proportion of female patients ranged from 22% to 42%. Across all the studies, there was a consistent mean reduction in triglyceride levels (~ 45% to 62%), total cholesterol levels (~ 17% to 26%), non-high-density lipoprotein cholesterol levels (~ 21% to 36%), low-density lipoprotein cholesterol levels (~ 11% to 27%), and glycosylated hemoglobin levels (~ 0.7% to 1.6%) with an increase in mean high-density lipoprotein cholesterol levels (up to 9%) from baseline to end of the study. Saroglitazar also improved alanine aminotransferase levels and fatty liver (evaluated by FibroScan™) in non-alcoholic fatty liver disease patients with diabetic dyslipidemia. Body weight remained unchanged and no significant adverse events (AEs) were reported in the studies. CONCLUSION: Saroglitazar effectively improved lipid and glycemic parameters without significant AEs in patients with diabetic dyslipidemia in real-world clinical studies of up to 58 weeks duration.

5.
Artigo em Inglês | MEDLINE | ID: mdl-31036397

RESUMO

BACKGROUND: Patients with diabetes and those with chronic kidney disease (CKD) are at increased risk of cardiovascular events. Everolimus eluting stents (EES) have been shown to be superior to paclitaxel eluting stents (PES) in patients with diabetes. However, it is not known if EES is as beneficial in diabetic patients with CKD compared with those without CKD. METHODS AND RESULTS: Patients enrolled in the TUXEDO-India trial, which is a clinical trial of patients with diabetes and coronary artery disease (CAD) randomly assigned to EES vs. thin-strut PES (Taxus Element), with data on baseline renal function were selected. CKD was defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 using the Cockcroft-Gault formula. Primary outcome was target vessel failure (TVF-defined as cardiac death, TV myocardial infarction (MI) or ischemia driven TV revascularization) at 1 year. Various secondary outcomes including stent thrombosis were evaluated. Among the 1821 patients with diabetes included in this analysis, 344 (19%) had CKD. In a propensity score adjusted analysis, patients with CKD had a significant increase in MACE (HR = 2.02; 95% CI 1.17-3.50; P = 0.01); death/MI/TVR (HR = 1.99; 95% CI 1.18-3.34; P = 0.009); death/MI (HR = 2.31; 95% CI 1.30-4.08; P = 0.004); cardiac death/MI (HR = 2.40; 95% CI 1.31-4.42; P = 0.005); death (HR = 2.88; 95% CI 1.35-6.13; P = 0.006) driven by an increase in cardiac death (HR = 3.33; 95% CI 1.42-7.83; P = 0.006) when compared with those without CKD. However, stent related events (TV-MI, TVR, TLR and stent thrombosis) were not different between CKD and non CKD groups. A significant interaction between CKD status and stent type (EES vs. PES) was noted for the outcomes of TVF (Pinteraction = 0.046), MACE (Pinteraction = 0.02), cardiac death or MI (Pinteraction = 0.05), non-target vessel related MI (Pinteraction = 0.04), non-Q-wave MI (Pinteraction = 0.03) and deaths/MI/TVR (Pinteraction = 0.04) such that EES was superior to PES in the non-CKD cohort but not in the CKD cohort. CONCLUSIONS: In subjects with diabetes, CKD is an independent predictor of adverse cardiovascular outcomes including increased risk of death driven largely by non-stent related events. While EES was superior to PES in patients without CKD, this was not the case in those with CKD (Clinical Trials Registry-India number, CTRI/2011/06/001830).

6.
Indian Heart J ; 71(1): 25-31, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31000179

RESUMO

BACKGROUND: Acute coronary syndrome (ACS) is associated with emergency hospitalizations, and there are limited real-world data on clinical outcomes in post-ACS Asian patients. This article presents data on the Indian subgroup from the Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia (EPICOR-Asia) study. METHODS: EPICOR included patients with ACS [ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)]. The study had two phases: acute phase and follow-up phase. The primary objective was to describe short- and long-term antithrombotic management patterns. RESULTS: EPICOR-India enrolled 2468 patients (STEMI-1482; NSTEMI-562; and UA-424). Cardiovascular risk factors were present in 1362 (55.2%) patients. Prehospital care was received by 879 (35.6%) patients, and the median time from the symptom onset to the first medical attention was 3 h (0.08, 100.33). The most common drug regimen prescribed during the acute phase was ≥2 antiplatelet agents + anticoagulants with no glycoprotein IIb/IIIa inhibitors and at discharge were aspirin + clopidogrel. About 78.8% of patients were discharged on dual antiplatelet therapy (DAPT) and 16%, on single antiplatelet therapy (SAPT). At 23 months after discharge, 55.6% were on DAPT, while 16.4% were on SAPT. Postdischarge outcomes at 2 years included death in 165 (6.7%) patients, composite events of death, myocardial infarction (MI), or ischemic stroke in 182 (7.4%) patients, and bleeding events in seven (0.3%) patients. CONCLUSION: This study showed a gap between international recommendations and implementation for managing ACS in Indian patients. Most of the patients prefer to undergo invasive management instead of non-invasive therapy. At the end of the 2-year follow-up, more than half of the population was receiving DAPT, with most patients on receiving a combination of aspirin and clopidogrel. The mortality along with composite events of death, MI, or ischemic stroke was highest for patients with NSTEMI.


Assuntos
Síndrome Coronariana Aguda/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Hospitalização/tendências , Pacientes Internados , Medição de Risco/métodos , Terapia Trombolítica/métodos , Síndrome Coronariana Aguda/epidemiologia , Eletrocardiografia , Feminino , Seguimentos , Humanos , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Estudos Prospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
7.
Lancet ; 393(10175): 987-997, 2019 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-30827782

RESUMO

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


Assuntos
Aterosclerose/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Sirolimo/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Determinação de Ponto Final , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Trombose/etiologia
8.
EuroIntervention ; 2018 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-30066672

RESUMO

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

9.
Eur J Prev Cardiol ; 25(10): 1087-1094, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29771156

RESUMO

Background Little is known about the achievement of low density lipoprotein cholesterol (LDL-C) targets in patients at cardiovascular risk receiving stable lipid-lowering therapy (LLT) in countries outside Western Europe. Methods This cross-sectional observational study was conducted in 452 centres (August 2015-August 2016) in 18 countries in Eastern Europe, Asia, Africa, the Middle East and Latin America. Patients ( n = 9049) treated for ≥3 months with any LLT and in whom an LDL-C measurement on stable LLT was available within the previous 12 months were included. Results The mean±SD age was 60.2 ± 11.7 years, 55.0% of patients were men and the mean ± SD LDL-C value on LLT was 2.6 ± 1.3 mmol/L (101.0 ± 49.2 mg/dL). At enrolment, 97.9% of patients were receiving a statin (25.3% on high intensity treatment). Only 32.1% of the very high risk patients versus 51.9% of the high risk and 55.7% of the moderate risk patients achieved their LDL-C goals. On multivariable analysis, factors independently associated with not achieving LDL-C goals were no (versus lower dose) statin therapy, a higher (versus lower) dose of statin, statin intolerance, overweight and obesity, female sex, neurocognitive disorders, level of cardiovascular risk, LDL-C value unknown at diagnosis, high blood pressure and current smoking. Diabetes was associated with a lower risk of not achieving LDL-C goals. Conclusions These observational data suggest that the achievement of LDL-C goals is suboptimal in selected countries outside Western Europe. Efforts are needed to improve the management of patients using combination therapy and/or more intensive LLTs.

10.
J Invasive Cardiol ; 30(1): 10-17, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28915510

RESUMO

BACKGROUND: Most drug-eluting stent (DES) trials have excluded patients with chronic kidney disease (CKD). The efficacy of DES implantation in patients with CKD is therefore not known. OBJECTIVES: To evaluate the outcomes with DES vs bare-metal stent (BMS) implantation in patients with CKD. METHODS AND RESULTS: MEDLINE, EMBASE, and CENTRAL were searched for studies including at least 100 patients with CKD (estimated glomerular filtration rate ≤60 mL/min/1.73 m² or on dialysis) treated with DES or BMS and followed for at least 1 month and reporting outcomes of all-cause mortality, cardiovascular (CV) mortality, myocardial infarction (MI), target-vessel revascularization (TVR), and stent thrombosis (ST). Thirty-one studies (5 randomized) with 91,817 participants (49,081 DES and 42,736 BMS) fulfilled the inclusion criteria. DES was associated with lower all-cause mortality (relative risk [RR], 0.77; 95% confidence interval [CI], 0.71-0.84), CV mortality (RR, 0.51; 95% CI, 0.38-0.70), MI (RR, 0.90; 95% CI, 0.86-0.95), TVR (RR, 0.61; 95% CI, 0.47-0.80), and numerically lower ST (RR, 0.75; 95% CI, 0.55-1.01) when compared with BMS. Analysis by study type (RCTs vs non-RCTs) showed similar results for most outcomes (Pinteraction>.05) except all-cause mortality, where there was no difference between DES vs BMS in RCTs (Pinteraction=.04). The effects were greater with 2nd-generation DES vs BMS (for example, ST: RR, 0.38; 95% CI, 0.20-0.72). CONCLUSIONS: In patients with CKD, the available evidence, largely from observational studies, suggests significantly fewer events with DES vs BMS with even a lower ST rate with 2nd-generation DES. These findings should be tested in large, randomized trials.


Assuntos
Doença da Artéria Coronariana , Reestenose Coronária , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Insuficiência Renal Crônica/complicações , Stents , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/epidemiologia , Reestenose Coronária/etiologia , Reestenose Coronária/mortalidade , Humanos , Estudos Observacionais como Assunto , Avaliação de Processos e Resultados (Cuidados de Saúde) , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos
11.
Indian Heart J ; 70 Suppl 3: S377-S383, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30595293

RESUMO

BACKGROUND: Heart failure (HF) is a common health problem in South Asia, and its incidence and prevalence are projected to rise. Cardiac resynchronization therapy (CRT) has been shown to improve mortality, reduce hospitalizations, and improve symptoms in selected patients with HF. The South Asian Systolic Heart Failure Registry (SASHFR) was designed to be a large and comprehensive registry of Indian HF patients with the purpose of enhancing the quality of care and clinical outcomes of HF patients by promoting the adoption of evidence-based, guideline-recommended therapies, in particular CRT. METHODS: Overall, 471 patients on optimized medical therapy and meeting CRT implantation guidelines were followed up in 12 Indian hospitals. During the 2-year follow-up period, clinical response in terms of clinical composite score, overall performance and changes in HF performance metrics, mortality and hospitalizations rates were evaluated. RESULTS: Of 471 patients, 116 (24.6%) accepted to be implanted with a CRT device, while 355 (75.4%) refused, financial constraints being the main reason for refusing a CRT device. The study met its primary outcome, as the number of patients associated with an improvement in clinical composite score at 24 months was significantly higher (69.1%) in the CRT group than in the no-CRT group (44.7%) [odds ratio = 2 (95% confidence interval 1.25-3.20), p = 0.004]. Also, changes in HF metrics, mortality and hospitalizations rates indicated a more favorable response among patients who underwent CRT. CONCLUSIONS: The results from the SASHFR registry show a clear superiority of CRT over optimal pharmacological therapy in terms of improvement in clinical conditions among HF patients. The low rate of CRT acceptance, in patients indicated to this therapy, highlights the need for new health-care policies to improve awareness about HF disease and its therapies and possibly to enhance financial coverage of indicated therapies.


Assuntos
Terapia de Ressincronização Cardíaca/métodos , Insuficiência Cardíaca/terapia , Sistema de Registros , Volume Sistólico/fisiologia , Feminino , Seguimentos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Estudos Prospectivos , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento
12.
Indian Heart J ; 70 Suppl 3: S280-S284, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30595275

RESUMO

OBJECTIVE: The aim of the present study was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus sirolimus-eluting stent (S-SES) [Sahajanand Medical Technologies Pvt. Ltd., Surat, India] in real-world patients with coronary artery disease. METHODS: This observational, retrospective study was carried out in all 346 consecutive enrolled patients who underwent percutaneous coronary intervention (PCI) with the S-SES, between April 2008 and December 2009, at a single center. We analyzed major adverse cardiac events (MACE) [a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR)] as primary outcomes at seven-year follow-up. RESULTS: Out of 346 patients, seven-year follow-up was obtained in 327 (94.5%) patients and hence results were analyzed for 327 patients. At seven-year, MACE occurred in 41 (12.5%) patients, consisting of 23 (7.0%) cardiac deaths, 14 (4.3%) TLR, and 4 (1.2%) TVR. The incidence of late stent thrombosis was observed in 3 (0.9%) patients. At follow-up of seven-year, the cumulative event-free survival was found to be 84.7% by Kaplan-Meier method. CONCLUSIONS: The present study demonstrated satisfactory and sustained seven-year clinical outcomes as evidenced by the low rates of MACE and ST for the biodegradable polymer coated S-SES.


Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Polímeros , Sirolimo/farmacologia , Feminino , Seguimentos , Humanos , Imunossupressores/farmacologia , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
13.
Indian Heart J ; 70 Suppl 3: S36-S42, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30595290

RESUMO

OBJECTIVE: Present paper describes trends in prevalence and control of cardiovascular risk factors and clinical outcomes at 5-years for CLARIFY Indian cohort compared with rest of the world (ROW). METHOD: CLARIFY is an international, prospective-observational, longitudinal cohort study in stable coronary artery disease outpatients. The 5-year data of both cohorts were compared, and evaluated. RESULTS: In Indian cohort, the angina prevalence declined significantly. There are few favorable changes in the pattern of receiving guideline-recommended therapy over 5 years, and the Indian cohort exhibited significantly lower adverse clinical outcomes than ROW. CONCLUSION: The 5-year trend of CLARIFY India registry indicate varying trends in prevalence and control of cardiovascular risk factors, the need for approaches to improve control of all modifiable risk factors, and increase in long-term use of essential primary and secondary prevention medications in clinical practice as emphasized in the latest Indian guidelines for management of stable CAD.


Assuntos
Doença da Artéria Coronariana/epidemiologia , Pacientes Ambulatoriais , Sistema de Registros , Medição de Risco , Prevenção Secundária/métodos , Idoso , Doença da Artéria Coronariana/prevenção & controle , Feminino , Seguimentos , Humanos , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Fatores de Risco , Fatores de Tempo
14.
EuroIntervention ; 13(10): 1194-1201, 2017 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-28741578

RESUMO

AIMS: The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. METHODS AND RESULTS: One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). CONCLUSIONS: In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.


Assuntos
Doença da Artéria Coronariana/terapia , Complicações do Diabetes , Stents Farmacológicos , Everolimo/uso terapêutico , Paclitaxel/uso terapêutico , Idoso , Fármacos Cardiovasculares/uso terapêutico , Diabetes Mellitus , Feminino , Humanos , Imunossupressores/uso terapêutico , Índia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Sirolimo/uso terapêutico , Resultado do Tratamento
16.
EuroIntervention ; 13(4): 415-423, 2017 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-28504218

RESUMO

AIMS: The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. METHODS AND RESULTS: The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%. CONCLUSIONS: The MeRes-1 trial demonstrated the safety and effectiveness of MeRes100 BRS. The favourable clinical outcomes and effective vascular responses have provided the basis for further studies in a larger patient population. The MeRes-1 trial is registered at the Clinical Trials Registry-India.


Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Poliésteres/uso terapêutico , Sirolimo/uso terapêutico , Idoso , Vasos Coronários/diagnóstico por imagem , Everolimo/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento
18.
Stem Cells Int ; 2017: 4137626, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28194186

RESUMO

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.

19.
EuroIntervention ; 13(4): 415-423, 2017.
Artigo em Inglês | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: ses-36707

RESUMO

AIMS: The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. METHODS AND RESULTS: The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%...(AU)


Assuntos
Técnicas In Vitro , Humanos , Sirolimo , Doença da Artéria Coronariana
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA