BACKGROUND:Patients with diabetes mellitus (DM) represents a challenging subset of population as they experience worse outcomes after percutaneous coronary intervention than patients without diabetes. We evaluated the 2-year efficacy and safety profile of the Abluminus DES+ in patients with diabetes within the population enrolled in the large multicenter en-ABL e-registry.METHODS:Multicenter, prospective, all-comers registry performed in 31 centers in India. We analyze patients according to the diagnosis of DM and insulin dependency (ID or Non-ID): non-DM (1641 patients), NIDDM (721 patients), IDDM (138 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/ target vessel revascularization (TVR) at 2-year. Stent thrombosis (ST) at any time point was also recorded.RESULTS:The MACE rate at 2-year follow-up was 3.0% in the overall population with DM patients showing a higher rate of primary endpoint compared to non-DM (4.4% vs. 2.4%, P=0.025). Rate of cardiac death was actually low and consistent between the 2 groups (1.7% vs. 0.9%, P=0.100). At 2-year follow-up, the rate of ST was 0.9% in DM patients versus 0.5% in non-DM, P=0.213.CONCLUSIONS:At 2-year follow-up, the Abluminus DES+ technology that merges the features of a sirolimus coated balloon with those of a bioresorbable polymer drug eluting stent appears to be safe and effective. This safety/efficacy profile was consistent in patients with or without DM.
Introduction: To evaluate the efficacy/safety profile of the Abluminus DES+ over 2-years follow-up in the "real-world" scenario in diabetics as compared to non-diabetics. Methods: In prospective, all-comers, open-label registry conducted at 31 sites, patients were analyzed for 1 & 2-year outcomes with the primary endpoint defined as 3P-MACE of CV death, target vessel related myocardial infarction (TV-MI), ischemia-driven target lesion revascularization (TLR)/target vessel revascularization (TVR) apart from Stent thrombosis (ST). Results: Of 2500 patients of PCI with 3286 Abluminus-DES+, 1641 (65.64%) were non-diabetics while859 (34.36%) were diabetics. The 3-P MACE for the cohort at 1 & 2 years were 2.9%, and 3.16%; TLR/TVR - 1.4% at both the intervals for 2493 patients at 2 yrs. follow-up. TV-MI & ST were 0.36% and0.56% at 1st and 2nd year respectively. The 3P-MACE was lower in non-diabetics at 1 & 2 years (2.3%vs 4.2%; 2.4% vs 4.7% respectively). For components of MACE, CV mortality (0.9 vs 1.9% at 1 yr ; 1.0vs 2.1% at 2 years) was significant (P < 0.05) while TLR (1.1 vs 1.9% at 1 yr. & 1.1 vs 2.1% at 2 yrs.) and TV-MI (0.9 vs 1.9% at 1 yr. & 1 vs 2.1% at 2 years) were similar for diabetics and non-diabetics so was ST (P > 0.05). Conclusion: Abluminus-DES+ showed excellent 2-year safety and efficacy with low 3-P MACE which was higher in diabetics driven by higher CV death but similar TLR, TV-MI and ST.
Patients with diabetes mellitus (DM) have poorer outcomes after percutaneous coronary intervention than those without diabetes. We evaluate the 2-year safety and efficacy profile of the Abluminus DES+ in patients with diabetes within the population enrolled in the large multicenter en-ABL e-registry
The aim of this registry is to evaluate the clinical performance the Abluminus DES+ (Envision Scientific), Novel Abluminal coated sirolimus eluting stent coated on stent and parts of balloon in a large patient population. Between January 2012 and October 2017, 2372 patients were enrolled
Heart Failure (HF) in chronic setting is an important cardiac cause of morbidity and mortality. HF burden in India is expected to increase because of increasing risk factors especially hypertension and Coronary Artery Disease (CAD). Treatment of HF in India has been as per recommendations from international guidelines. There are no guidelines for management of HF in India. Recently, European Society of Cardiology guidelines on management of HF were released. To understand the new evidence and new recommendations and to apply these in management of HF in India, experts from across the country provided consensus for adaptation of these ESC guideline recommendations in Indian setting. This article provides the consensus opinion from Indian experts on recommendations of ESC guideline for diagnosis and treatment of HF for adaptation in India.
This registry aims to evaluate the safety and effectiveness of the sirolimus eluting stent with unique fusion coating (coated on stent and exposed parts of balloon), Abluminus DES+ (Envision Scientific), in all-comers real-world population. This prospective, multi-centre, real world, all-comers
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OBJECTIVES:This study aims to assess the safety and efficacy of a biodegradable polymer-coated Rapamycin-Eluting Stent (Excel) used in conjunction with six-month dual antiplatelet therapy in daily practice.BACKGROUND:The polymeric material of cardiac stents has been reported to adversely affect the safety profile of the drug-eluting stents and is also suspected to cause serious long-term complications. It has been proposed that the biodegradable polymer coatings may reduce such late-stage adverse effects.METHODS:This is a prospective, multi-center registry of 654 patients from across 9 cardiology centers in India, who were enrolled and exclusively treated with Excel stents between February 2008 and May 2010. The recommended antiplatelet regimen included clopidogrel and aspirin for 6 months period, followed by lifelong aspirin therapy.RESULTS:The study population included 46.94% diabetics, 24.31% smokers, 48.93% hypertensives and 14.98% hyperlipidemics. The cumulative rates of major adverse cardiac events were 0.153% at discharge and 1.38% at 12 months. The mean percentage of stenosis was 88.24 ± 9.17% No events occurred between 6 and 12 months.CONCLUSIONS:This multi-center registry study on "real world, all comers" has, thus, showed that EXCEL™ stent which is PLA-coated biodegradable Rapamycin-Eluting Stent exhibited high efficacy and safety profile in treatment of patients undergoing PCI as evidenced by significantly lower rates of MACE and no case of stent thrombosis. There was no event even after DAPT was discontinued after 6 months.
As the developed and developing nations cope up with increasing predisposition to cardiovascular diseases (CVD) by adopting lifestyle changes the burden of coronary artery disease continues to rise globally. The presence of modifiable risk factors, which account for more than 90% of the cardiovascular (CV) risk, cannot always be interpreted as the presence of atherosclerotic heart disease and absence of modifiable risk factors do not guarantee absence of atherosclerotic changes in the arterial tree. Increasing awareness about primordial prevention and primary prevention of CVD is of vital importance in such scenarios. Ultrasonographic measurement of intima media thickness has been reported as a procedure to detect the early stages of atherosclerosis. Carotid intima media thickness (CIMT) testing is a safe, noninvasive and cost effective method to detect early atherosclerotic vascular diseases. This method of CV risk evaluation drew attention worldwide and of Indian physicians because of its feasibility in Indian population. Hence, detection and management of atherosclerosis in asymptomatic individuals will go a long way in preventing atherosclerotic diseases and prolonging survival and improving quality of life.
Cardiovascular disorders are the major cause of morbidity & mortality globally as well in India. In 2008, out of the 57 million deaths globally; around 63% (i.e., nearly 30 million deaths) were due to non-communicable diseases.1 Cardiovascular diseases accounts for nearly half of the deaths due to non-communicable diseases worldwide, thus becoming the leading cause of death due to non-communicable diseases. Approximately, 80% of these deaths have been reported to occur in low and middle-income countries.1 Moreover, out of nine million premature deaths due to non-communicable diseases (viz. age < 60 years); around eight million occurred in low and middle-income countries. With 6.8% and 5.0% of disability-adjusted life-years (DALYs) lost, CAD is the second largest causes of disease burden in population aged 15 years and older globally.1 1.1. Trends of cardiovascular diseases in India Cardiovascular diseases have assumed epidemic proportions in India as well. The Global Burden of Diseases (GBD) study reported the estimated mortality from coronary heart disease (CHD) in India to be 1.6 million in the year 2000 which is estimated to increase to ∼64 million by the year 2015.2 The projected rise in disease burden due to CVD is expected to make it the prime contributor of total mortality and morbidity.2 Reports on CAD in Indians have shown that Asian Indians are at 3–4 times higher risk of CAD than white Americans, 6 times higher than Chinese, and 20 times higher than Japanese.3 Various independent epidemiological studies conducted in North India suggest that the prevalence of CAD has increased from 1% in 1960 to 10.5% in 1998 in the urban population.3 A higher prevalence of CAD, ranging from 11.0% to 14.2%, has been reported from South India.3 Taking into account the size of the Indian population, these prevalence rates indicate that a large number of deaths can be attributed to CAD.3
OBJECTIVE:The e-BioMatrix is a post marketing multicenter registry with an objective to evaluate the 2 year clinical safety and efficacy outcomes in patients treated with BioMatrix™ - Biolimus A9™ (BA9™) drug eluting stents (DES).BACKGROUND:Drug-eluting stents still have late-stage disadvantages that might be attributable to the permanent polymer. BioMatrix a new generation DES containing anti-proliferative drug Biolimus A9™ incorporating a biodegradable abluminal coating that leaves a polymer-free stent after drug release enhancing strut coverage while preventing neointimal hyperplasia.METHODS:This interim analysis consists of a total of 1189 patients with 1418 lesions treated with BioMatrix stent who entered this multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, and 12 months with an extended follow-up of 2 years. Recommended antiplatelet regimen included clopidogrel and aspirin for 12 months.RESULTS:The mean age was 57.6 ± 10.9 years, 81.8% were males, comorbidity index was 1.20 ± 1.33, 68% presented with acute coronary syndrome, 49% had hypertension and 40.8% had diabetes mellitus. One-year clinical follow-up was completed in 987 patients at the time of interim analysis. The incidence of MACE is 0.45 for 1544 person-year follow-up. There were only 03 cases of ST (01 late ST) reported during this time.CONCLUSION:This registry demonstrates excellent one-year clinical safety and efficacy of BioMatrix stents. The 1-year result shows that BioMatrix stent may be a suitable alternative as compared to contemporary DESs which are currently available in the market for simple as well complex disease.
Background. Atherosclerotic cardiovascular disease (ASCVD) is a common complication of diabetes mellitus and impaired fasting glucose (IFG). We hypothesized that the relation of fasting glucose levels to ASCVD is linear, with the prevalence of clinical ASCVD beginning to increase even among individuals currently categorized as normoglycemic. Methods. Patient charts were retrospectively reviewed from our Dyslipidemic Preventive Cardiology Clinic. We evaluated the prevalence of ASCVD relative to fasting glucose levels in a cross-section of patients at high risk for ASCVD. Results. In 558 dyslipidemic patients, ASCVD prevalence increased with increasing fasting glucose levels. A significantly higher prevalence of ASCVD was observed among patients with fasting glucose levels between 90 and 99 mg/dL versus lower levels. As glucose levels increased from 90 to 125 mg/dL, the prevalence of ASCVD continued to rise in parallel. Logistic regression analysis with forward likelihood ratio stepwise selection indicated that individuals with fasting blood glucose of 90-99 mg/dL were 2.6 times more likely to have ASCVD than those with lower levels of fasting blood glucose. Conclusion. Our findings suggest that the current cutoff for impaired fasting glucose of 100 mg/dL may be somewhat conservative and that a level above 90 mg/dL may be more appropriate as an ASCVD risk factor, particularly in patients with a lipid disorder.
![Figure][1] [![Graphic][3] ][3][![Graphic][4] ][4] A transthoracic echocardiogram detected an atrial myxoma (T) in the left atrium (LA) of a 39-year-old woman with a tumor plop heart sound (A and E) . Onset of systole (A, left) , midsystole (A, middle) , and isovolumic
Background: National guidelines have been set to achieve door-to-balloon time (D2B) is less than 90 minutes to improve outcomes for patients with STEMI. The purpose of this study is to see if a more aggressive approach utilizing prehospital ECGs could improve reperfusion times. Methods: The EMS personnel obtained a 12-lead ECG during initial assessment in the field from patients with chest pain. The ECG was immediately transmitted to the ER physician by cellular link to a computer receiving station. The ER physician reviewed the ECG digital tracing. The cardiac catheterization laboratory (CCL) team was activated from the patients' homes. Patients were transported from the field directly to the CCL by EMS bypassing the emergency department. Results: The mean D2B for patients with initial ECG in hospital in all three hospitals combined was 90.5 minutes, compared to 60.2 minutes in patients with prehospital ECG. (P < 0.0001). When analyzing the mean D2B in regards to times of presentation, we found a significant reduction in mean 13213 in patients presenting during working hours (75 minutes) compared with those presenting during off hours (98 minutes) in the control group. However, with the use of prehospital ECGs, there was a significant reduction in D2B regardless of what time the patient arrived in the ER. Conclusions: Utilizing the prehospital ECG as a tool to bypass ER triage significantly decreases D2B times in patients with STEMI. This technology has the potential to substantially expedite reperfusion therapy in patients with STEMI. (C) 2009 Wiley-Liss, Inc.
Spontaneous ST-segment resolution (STR) after acute ST-elevation myocardial infarction is associated with favorable outcomes. Effect on STR of newer, more powerful antiplatelet and antithrombotic agents is unclear. The aim of this study was to identify independent clinical and angiographic predictors of STR in patients with ST-elevation acute myocardial infarction before percutaneous coronary intervention. We studied 206 patients admitted with ST-elevation acute myocardial infarction, of whom 37 (18%) had STR. There were 12 deaths (5.8%) that occurred in the group without spontaneous STR. Patients with spontaneous STR were younger (55 vs 61 years old, p = 0.02), had shorter duration of symptoms (117 vs 212 minutes, p < 0.0001), had preserved ejection fraction (55% vs 40%, p < 0.0001) had shorter hospital stays, and had lower in-hospital arrhythmias or death. Independent predictors of STR, identified by stepwise logistic regression analysis, were early clopidogrel administration (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.00 to 4.40, p = 0.045), single-vessel disease (OR 2.85, 95% CI 1.22 to 6.70, p = 0.02), chest pain duration (OR 0.98, 95% CI 0.98 to 0.99, p < 0.0001), collaterals (OR 4.3, 95% CI 1.7 to 10.8, p = 0.002), circumflex as a culprit vessel (OR 4.74, 95% CI 1.5 to 14.95, p = 0.008), and coronary thrombus noted on angiography (OR 5.76, 95% CI 1.63 to 20.4, p = 0.006). In conclusion, early clopidogrel administration is associated with, and likely causal for, STR. Patients with thrombus, collateral flow, and circumflex culprit vessel are more likely to have STR. In addition, our study confirms previous findings that patients with STR have preserved left ventricular function and better hospital outcomes compared with those with out STR. (c) 2006 Elsevier Inc. All rights reserved.