Clinical outcomes of ultrathin strut biodegradable polymer-coated everolimus-eluting stent in patients with coronary artery disease.

BACKGROUND: Evermine 50™ (Meril Life Sciences Pvt. Ltd., India) everolimus-eluting stent system (EES) is a novel ultrathin strut (50 µm) cobalt-chromium coronary drug-eluting stent (DES) platform with biodegradable polymer coating. The Evermine 50 EES-KLES study aimed to evaluate the Evermine 50 EES in terms of 24-month clinical safety and performance in patients with coronary artery disease (CAD). METHODS: This retrospective study consisted of 171 patients (258 lesions) implanted with Evermine 50 EES for managing CAD. We analyzed the major adverse cardiac events (MACE) incidence, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (ID-TLR) at 6-, 12-, and 24-month follow-up. RESULTS: A total of 171 patients were included with a mean age of 57.85 ± 10.05 years, of which, 139 (81.29%) were men, 69 (40.35%) were hypertensive, and 70 (40.94%) were diabetic. The incidence of MACE was 1 (0.58%), 3 (1.81%), and 4 (2.42%) at 6-, 12-, and 24-month follow-up, respectively. There were three cases (1.82%) of cardiac death and one case (0.61%) of ID-TLR up to 24 months. None of the patients was presented with definite or probable stent thrombosis (ST). CONCLUSION: This study demonstrated that implantation of ultrathin strut Evermine 50 EES resulted in a low rate of incidence of MACE, indicating a favourable clinical safety and performance profile of Evermine 50 EES in patients with CAD [Clinical Trials Registry-India (CTRI) Number: CTRI/2017/09/009939)].

Clinical Outcomes of Novel Long-Tapered Sirolimus-Eluting Coronary Stent System in Real-World Patients With Long Diffused De Novo Coronary Lesions.

BACKGROUND: When coronary lesions involve segments > 48 mm, the only treatment possibility is stent overlapping which is associated with higher neointimal proliferation that lead to more restenosis. Furthermore, tapering of coronary arteries is a major challenge observed with long diffuse coronary lesions. This study attempted to assess the safety and performance of world's first commercialised long-tapered (60 mm) sirolimus-eluting coronary stent (SES) system for the treatment of long diffused de novo coronary lesions in real world scenario. METHODS: This was a retrospective, non-randomised, multicentre study which included 362 consecutive patients implanted with long-tapered BioMime™ Morph SES system for the treatment of long diffused de novo coronary lesions. Safety endpoint was major adverse cardiac events (MACE), which was defined as composite of cardiac death, myocardial infarction (MI) and ischemic-driven target lesion revascularization (ID-TLR), at 12-month follow-up. RESULTS: Out of 362 patients included, 170 (47.0%) were diabetic and 159 (43.9%) were hypertensive. The mean age of all patients was 61.09 ± 9.04 years. A total of 625 lesions were identified; out of which 402 lesions were intervened successfully using BioMime Morph. The cumulative incidence of MACE was 7 (2.0%) at 12-month follow-up which included four (1.1%) cardiac deaths, one (0.3%) case of MI and two (0.6%) ID-TLR. Acute stent thrombosis was reported in one (0.3%) patient. CONCLUSIONS: The present study confirms the safety and performance of BioMime Morph, and hence, can be considered as a treatment of choice for long diffused tapered de novo coronary lesions in routine clinical practice.

Pharmacokinetic Study of Sirolimus-Eluting BioResorbable Vascular Scaffold System for Treatment of De Novo Native Coronary Lesions: A Sub-Study of MeRes-1 Trial.

BACKGROUND: MeRes100™ (Meril Life Sciences Pvt. Ltd., Vapi, India) is a novel sirolimus-eluting bioresorbable vascular scaffold (BRS). The purpose of this sub-study of MeRes-1 trial is to evaluate the systemic release of sirolimus from MeRes100 BRS implanted for the treatment of de novo native coronary artery lesions. METHODS: The MeRes-1 is a prospective, multicenter, first-in-human trial of sirolimus-eluting MeRes100 BRS. The pharmacokinetic sub-study was conducted at two Indian sites in 10 patients who were implanted with the MeRes100 BRS loaded with sirolimus at a dose of 1.25 µg/mm2. Venous blood samples were collected at pre-dose and 12-time points after implantation of the scaffold. Sirolimus concentration was successively analyzed using ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry method. RESULTS: A total of 12 scaffolds were implanted in 10 patients. Non-compartmental analysis demonstrated time to reach peak concentration of sirolimus between 0.5 h to 3 h after scaffold implantation. The peak concentration (Cmax) was deduced to be 7.47 ± 2.61 ng/mL, AUC was 436.45 ± 171.24 h·ng/mL, and the t½ was observed at 98.59 ± 33.58 h. The clearance was 0.66 ± 0.16 L/h and lower limit of quantification was detectable at 14.1 days. CONCLUSIONS: The MeRes-1 pharmacokinetic sub-study confirmed that MeRes100 BRS is safe and tolerable at limited systemic exposure of sirolimus.

Clinical Outcomes of World's Thinnest (50 µmr) Strut Biodegradable Polymer Coated Everolimus-Eluting Coronary Stent System in Real-World Patients.

BACKGROUND: The thinnest strut platform is revolutionary improvement into the field of percutaneous coronary intervention. The aim of this study was to assess the safety and performance of world's thinnest (50 µm) strut biodegradable polymer coated Evermine 50™ everolimus-eluting coronary stent system (EES) in real-world patients with coronary artery disease. METHODS: This was a prospective, single-arm, single-center, post-marketing study in real-world patients. A total of 251 patients with de novo coronary artery lesion (lengths < 44 mm) and/or in-stent restenosis were enrolled and implanted with at least one Evermine 50 EES. The safety endpoint was major adverse cardiac events (MACE), composite of cardiac death, myocardial infarction (MI) attributed to the target vessel and clinically-driven target lesion revascularization (CD-TLR), at 6-month follow-up. RESULTS: Out of 251 patients enrolled (mean age: 58.20 ± 9.92 years and 193 males), 48.6% and 45.4% patients were diabetic and hypertensive, respectively. A total of 343 lesions were intervened successfully with Evermine 50 out of 474 identified lesions (1.89 lesions per patients). Average stent length and diameter were 23.50 ± 12.21 mm and 2.83 ± 0.23 mm, respectively. At 6-month follow-up, the incidence of MACE was two (0.8%) in the form of one (0.4%) cardiac death and one (0.4%) CD-TLR. In addition, there was no definite or probable stent thrombosis reported up to 6-month follow-up. CONCLUSIONS: In the present study, lower rate of MACE was demonstrated, which reaffirms favourable clinical safety and performance of world's thinnest (50 µm) strut Evermine 50 EES in real-world patients with coronary artery disease.

Basic Concepts and Clinical Outcomes of Drug-Eluting Balloons for Treatment of Coronary Artery Disease: An Overview.

The technology of percutaneous coronary intervention for atherosclerotic coronary artery disease has evolved considerably since its inception. Though Drug-Eluting Stent (DES) reduces the rate of restenosis, long-term safety outcomes and persistent restenosis in complex lesion subset remain area of concern. Recently, Drug-Eluting Balloon (DEB) represents a novel treatment strategy for atherosclerotic coronary artery disease. DEB demonstrated its added value in preclinical studies. Inspired by these results, several clinical trials particularly in complex lesion subsets have been started to explore the value of this novel treatment strategy in a broader range of lesions. This review would summarise material compositions and different characteristics and clinical outcomes of currently available DEB.

A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.

INTRODUCTION: The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. AIM: To assess the performance of EXIMO™ (Meril Diagnostics Pvt. Ltd., Vapi, Gujarat, India) BGMS as per International Organization for Standardization (ISO) 15197:2013 section 8 user performance criteria. MATERIALS AND METHODS: This was a non-randomized and post-marketing study conducted at a tertiary care centre of India. A total of 1005 patients with diabetes themselves performed fingertip blood glucose measurement using EXIMO™ BGMS. Immediately after capillary blood glucose measurement using the blood glucose monitoring system, venous blood sample from each patient was obtained by a trained technician which was assessed by reference laboratory method- Cobas Integra 400 plus (Roche Instrument Centre, Rotkreuz, Switzerland). All the blood glucose measurements assessed by EXIMO™ were compared with laboratory results. Performance of the system was assessed as per ISO 15197:2013 criteria using Bland-Altman plot, Parkes-Consensus Error Grid (CEG) and Surveillance Error Grid analyses (SEG). RESULTS: A total of 1005 patients participated in the study. Average age of the patients was 44.93±14.65 years. Evaluation of capillary fingertip blood glucose measurements demonstrated that 95.82% measurements fulfilled ISO 15197:2013 section 8 user performance criteria. All the results lie within clinically non-critical zones; Zone A (99.47%; n=1000) and Zone B (0.53%; n=05) of the CEG analysis. As per SEG analysis, majority of the results fell within "no-risk" zone (risk score 0 to 0.5; 90.42%). CONCLUSION: The result of the study confirmed that intended users are able to obtain accurate glucose measurements when operating EXIMO™ BGMS, given only the instructions and training materials routinely provided with the system, in clinical practice.

Small-for-gestational-age versus appropriate-for-gestational-age: Comparison of cord blood lipid profile & insulin levels in term newborns (SAGA-ACT study).

BACKGROUND & OBJECTIVES: The genesis of atherosclerotic lesions, a major cardiovascular risk factor starts in the early stage of life. If the premature development of cardiovascular risk factors can be anticipated during childhood, cardiovascular events can be prevented effectively by taking appropriate measures. This study was carried out to assess the role of in utero malnutrition in cardiovascular disease development by comparing cord blood lipid profiles and serum insulin levels between small-for-gestational-age (SGA) and appropriate-for-gestational-age (AGA) term newborns. METHODS: Consecutive full-term infants who were born between June 20 and August 19, 2013, at the Obstetric Unit of a Hospital at Secunderabad, India, were enrolled in this study. Participating newborns were divided into SGA group (n = 51; test group) and AGA group (n = 52; control group) based on their gestational age and body weight. Cord blood lipid profile and insulin levels were compared between these two groups. RESULTS: As compared to the newborns in AGA group, SGA group of newborns had significantly (P<0.01) higher levels of cholesterol, triglyceride and low-density lipoprotein. No difference was observed between the groups for high-density lipoprotein and insulin levels. Mild and moderate anaemia was observed among mothers of both groups, while severe anaemia was seen in mothers of SGA group only. INTERPRETATION & CONCLUSIONS: SGA newborns exhibited elevated lipid profiles as compared to AGA newborns. Hence, SGA newborns should be closely monitored for cardiovascular morbidities during childhood, adolescence and early adult life.

A case of type†I†variant Kounis syndrome with Samter-Beer triad.

Kounis syndrome is defined as the coexistence of acute coronary syndromes with situations associated with allergy or hypersensitivity, as well as anaphylactic or anaphylactoid reactions, to a variety of medical conditions, environmental and medication exposures. We report a case of Kounis-Zavras syndrome type I variant in the setting of aspirin-induced asthma, or the Samter-Beer triad of asthma, nasal polyps and aspirin allergy. When there is a young individual with no predisposing factors of atherosclerosis and apparent coronary lesion, with or without electrocardiography and biochemical markers of infarction, the possibility of Kounis syndrome should be kept in mind.

In vivo assessment of stent recoil of biodegradable polymer-coated cobalt-chromium sirolimus-eluting coronary stent system.

INTRODUCTION: Immediate and acute stent recoil has been observed following balloon deflation in normal and diseased coronary arteries, and the degree varies by stent design. METHODS: A total of 19 patients, who underwent elective stent implantation for single de novo native coronary artery lesions, were enrolled: all patients treated with the biodegradable polymer-coated sirolimus-eluting cobalt-chromium coronary stent system (Supralimus-Core(®)). The immediate, acute and cumulative stent recoil was assessed by quantitative coronary angiography. The cumulative stent recoil was measured at 24 h of stent implantation. RESULTS: The absolute late loss due to recoil was found 0.08 ± 0.19 mm for Immediate Stent Recoil (ISR), 0.05 ± 0.21 mm for Acute Stent Recoil (ASR) and 0.11 ± 0.25 mm for Cumulative Stent Recoil (CSR) respectively. CONCLUSIONS: In vivo acute stent recoil of the Supralimus-Core(®) has higher radial strength compared to other available standard drug-eluting stents.

A first-in-man study of sirolimus-eluting, biodegradable polymer coated cobalt chromium stent in real life patients.

INTRODUCTION: Despite considerable benefits associated with current drug-eluting stents, continued attention to the safety, efficacy, and deliverability of available drug-eluting stent has led to the development of newer stent. METHODS: This study was a single-centre, prospective, non-randomized, first-in-man study which included clinical follow-up data was collected at 1, 8 and 12 months after the procedure. The study included 105 patients with de novo native coronary artery lesions including multi-vessel disease treated with Supralimus-Core® stent. Repeat angiography was performed 8 months post-stent implantation. RESULTS: At quantitative coronary angiography 8-month luminal late loss was 0.39 ± 0.33 mm in-stent and 0.33 ± 0.35 mm in-segment. The incidence of any major adverse cardiac event at 30 days, 8 months and 12 months was 1 (1%), 6 (6%) and 7 (7%) respectively. CONCLUSION: This study demonstrates that the Supralimus-Core® SES is a safe and effective treatment for patients with obstructive coronary artery disease. ClinicalTrials.gov ID: NCT00811616.

Systemic exposure of sirolimus after coronary stent implantation in patients with de novo coronary lesions: Supralimus-Core® pharmacokinetic study.

OBJECTIVES: This study was conducted to assess the systemic drug release and distribution of sirolimus-eluting coronary stents. METHODS: Twenty patients with coronary artery disease (CAD) were treated with 1, 2, or 3 a newly designed metallic stents. Blood samples were drawn at 14 time points to determine the pharmacokinetic of sirolimus. Whole blood concentrations of sirolimus were determined by using a sensitive validated high-performance liquid chromatography mass spectrometry/mass spectrometry method. RESULTS: Minimal measurable blood levels were detectable at 7 days. Across all dose levels, individual T(max) values ranged from 1.00 hour and 12.00 hours; individual C(max) ranged from 0.73 ng/mL and 4.13 ng/mL. CONCLUSION: This study confirms the limited exposure of the systemic circulation of the eluted drug with the use of the Supralimus-Core® Sirolimus-Eluting Coronary Stent System (Sahajanand Medical Technologies Pvt. Ltd., Surat, India). In this study, sirolimus concentration in systemic circulation is to be safe, well-tolerated and short-lived.