Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents.

OBJECTIVES: To assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions. MATERIAL AND METHODS: In this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported. RESULTS: A total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported. CONCLUSIONS: Three years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.

Clinical profile and outcome of non-COVID strokes during pandemic and the pre pandemic period: COVID-Stroke Study Group (CSSG) India.

BACKGROUND: As the health systems around the world struggled to meet the challenges of COVID-19 pandemic, care of many non-COVID emergencies was affected. AIMS: The present study examined differences in the diagnosis, evaluation and management of stroke patients during a defined period in the ongoing pandemic in 2020 when compared to a similar epoch in year 2019. METHODS: The COVID stroke study group (CSSG) India, included 18 stroke centres spread across the country. Data was collected prospectively between February and July 2020 and retrospectively for the same period in 2019. Details of demographics, stroke evaluation, treatment, in-hospital and three months outcomes were collected and compared between these two time points. RESULTS: A total of 2549 patients were seen in both study periods; 1237 patients (48.53%) in 2019 and 1312 (51.47%) in 2020. Although the overall number of stroke patients and rates of thrombolysis were comparable, a significant decline was observed in the month of April 2020, during the initial period of the pandemic and lockdown. Endovascular treatment reduced significantly and longer door to needle and CT to needle times were observed in 2020. Although mortality was higher in 2020, proportion of patients with good outcome were similar in both the study periods. CONCLUSIONS: Although stroke admissions and rates of thrombolysis were comparable, some work flow metrics were delayed, endovascular stroke treatment rates declined and mortality was higher during the pandemic study period. Reorganization of stroke treatment pathways during the pandemic has likely improved the stroke care delivery across the globe.

Clinical Features and Outcome of Stroke with COVID-19. COVID-19 Stroke Study Group (CSSG), India.

BACKGROUND AND PURPOSE: Occurrence of stroke has been reported among patients with COVID-19. The present study compares clinical features and outcomes of stroke patients with and without COVID-19. METHODS: The COVID-19 Stroke Study Group (CSSG) is a multicentric study in 18 sites across India to observe and compare the clinical characteristics of patients with stroke admitted during the current pandemic period and a similar epoch in 2019. The present study reports patients of stroke with and without COVID-19 (CoVS and non-CoVS, respectively) seen between February 2020 and July 2020. Demographic, clinical, treatment, and outcome details of patients were collected. RESULTS: The mean age and gender were comparable between the two groups. CoVS patients had higher stroke severity and extent of cerebral involvement on imaging. In-hospital complications and death were higher among CoVS patients (53.06% vs. 17.51%; P < 0.001) and (42.31% vs. 7.6%; P < 0.001), respectively. At 3 months, higher mortality was observed among CoVS patients (67.65% vs. 13.43%; P < 0.001) and good outcome (modified Rankin score [mRS]: 0-2) was seen more often in non-CoVS patients (68.86% vs. 33.33%; P < 0.001). The presence of COVID-19 and baseline stroke severity were independent predictors of mortality. CONCLUSIONS: CoVS is associated with higher severity, poor outcome, and increased mortality. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and baseline stroke severity are independent predictors of mortality.

Safety and performance of everolimus-eluting stents comprising of biodegradable polymers with ultrathin stent platforms.

BACKGROUND: The registry investigated clinical outcomes after 12 months of implantation of ultra-thin strut (60 µm) biodegradable polymer-coated Tetrilimus everolimus-eluting stents (EES; Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in patients with atherosclerotic coronary lesions. Additionally, sub-group analysis was performed to evaluate outcomes of ultra-long (44/48 mm) Tetrilimus EES in patients with long lesions. METHODS: This was an observational, single-center, single-arm and investigator-initiated retrospective registry. In this all-comers registry, patients who underwent implantation of Tetrilimus EES for treatment of coronary artery disease during routine clinical practice between February-2016 and August-2016 at tertiary care center of India were included. Primary endpoint was occurrence of any major adverse cardiac event (MACE) up to 12 months' follow-up. MACE was a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Similar endpoints were observed in sub-group patients. RESULTS: Total 766 stents were implanted to treat 695 lesions in 558 patients. Of treated lesions, 11.4% lesions were type B2 and 78.3% were type C lesions. In sub-group analysis of 143 patients, a total of 155 long coronary lesions were intervened successfully with only one stent been implanted per lesion. At 12 months' follow-up, four (0.7%) cases of cardiac death, eight (1.4%) of MI, and two (0.4%) of TLR were reported, resulting in a 2.5% rate of MACE. The MACE rate was 2.8% in sub-group patients. CONCLUSIONS: Twelve months' clinical data demonstrated favorable safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice and also in patients with ultra-long lesions.

Impact of ultra-long sirolimus-eluting stents on coronary artery lesions: one-year results of real-world FLEX-LONG Study.

BACKGROUND: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions. METHODS: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome. RESULTS: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free. CONCLUSIONS: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

Predicting falls in multiple sclerosis: Do electrophysiological measures have a better predictive accuracy compared to clinical measures?

BACKGROUND: The risk of falls in people with Multiple Sclerosis (MS) is much greater than that of the general population due to impaired coordination, gait, sensation, muscle tone, strength, and cognition. These MS related falls hamper the day to day living of these individuals and are one of the prime factors aggravating the disease related morbidity. The fear of falling itself may make these individuals more dependent and hinder their professional and leisurely activities. Hence, the significance of identifying individuals who are at risk of falling and instituting preventive counter-measures cannot be overemphasized. Various simple clinical tests and questionnaires have been recommended for this purpose, but are far from ideal. OBJECTIVE: The objective was to find accurate measures to predict a future fall in MS patients. We also aimed to enquire about the prevalence of falls in MS population and its clinical profile which included detailed history about the past falls, Expanded disability status scale (EDSS) scores, Timed 25 foot walk (T25FW) scores, Activities specific balance confidence (ABC) scores, Falls efficacy scale international (FESI) scores, Multiple Sclerosis Walking Scale 12 (MSWS12) questionnaire. DESIGN/METHODS: This was a prospective cohort study conducted at the Institute of Neurology, Chennai from January 2015 to August 2017. MS patients of any subtype attending Neurology OPD satisfying revised 2010 McDonald criteria were recruited. 134 subjects with MS consented to participate in this study and 113 of them who met the criteria were included. Baseline history was obtained about the number of falls in the previous year. EDSS, T25FW, ABC, FESI, and MSWS12 scores were obtained at the baseline. VEMP and SEP tests were done and the baseline P13/N23 cVEMP latencies, N10 oVEMP latency, and P37 lower limb SEP latency were obtained. These subjects were followed up for one year and were enquired if they had fallen during that period and the number of falls was recorded. Logistic regression models were used to compute the area under receiver operating characteristic curve (AUC) for each variable tested. Pearson correlation coefficients were calculated for each variable with the number of future falls. RESULTS: Among the 113 patients, 72% (n = 81) had one or more falls during follow-up. Among all variables tested P13 cervical VEMP latency had the highest predictive accuracy (AUC = 0.820) followed by N10 ocular VEMP latency (AUC = 0.794) and P37 SEP latency (AUC = 0.732). P13 latency also had the highest correlation coefficient (R = 0.689, R2 = 0.475) with the number of future falls. CONCLUSION: P13, N10 and P37 latencies were the most accurate in predicting a future fall when compared to clinical measures.

Balloon Angioplasty for Intracranial Atherosclerotic Disease: A Multicenter Study.

AIM: To evaluate the role and efficacy of the balloon angioplasty in intracranial atherosclerotic disease (ICAD) in patients who presented with acute stroke due to vessel occlusion and in patients with symptomatic disease despite optimum medical management. METHODS: From 2013 to 2016, a total of 39 patients (24 males and 15 females with a mean age of 64.5 years) underwent balloon angioplasty over a period of 2 years and 8 months in three different institutions in India. Maverick balloon catheter (Boston scientific) is used in all the patients. MRI brain with MR angiogram was done in all the patients prior to intervention. Twenty-three patients who had underlying severe ICAD presented with acute stroke due to vessel occlusion. Sixteen patients presented with symptomatic ICAD with recurrent ischemic attack due to the progressing underlying disease despite optimum medical management. Technical success, peri-procedural events, and clinical outcomes were documented for all the patients. RESULTS: Technical success (residual stenosis < 50%) was achieved in 37 cases. Extra cranial carotid stenting was required in 2 patients. In patients with acute stroke presentation (NIHSS score median of 16.5), adjuvant intravenous and intra-arterial tissue plasminogen activator were given in 8 and 3 patients, respectively, and mechanical thrombectomy (MT) with solitaire was used in 15 patients. Patients who underwent MT in acute stroke without ICAD were not included in the study. Reocclusion occurred in one patient who developed disabling stroke and one patient died of intra-cerebral hemorrhage. Thus, the mortality of this study is 2%. Clinical outcome was assessed based on mRS. One-month, three-month, and six-month follow-up was available in >90% of the patients. MR angiogram on follow-up of nine months was done in 26 patients, and none of them had restenosis. CONCLUSION: Balloon angioplasty is a safe option and can be effectively used in patients of ICAD with acceptable risks and promising outcomes.

Local Intrasinus Thrombolysis for Cerebral Venous Sinus Thrombosis.

BACKGROUND: Cerebral venous strokes due to cerebral venous sinus thrombosis (CVST) have varied presentation and clinical outcome. Despite aggressive medical treatment with optimal anticoagulation, some patients develop progressive neurologic deterioration causing significant morbidity and mortality. The aim of the present series is to analyze the safety and efficacy of in situ thrombolysis in patients with cerebral venous sinus thrombosis in severe clinical grade and refractory to conventional medical management. MATERIALS AND METHODS: Twenty-nine patients with cerebral venous thrombosis who received in situ thrombolysis during a 3-year period (April 2013 to April 2016) were included in the study. Tissue plasminogen activator (tpa) was used in all the patients. The lytic agent was infused into the sinus via the micro catheter. Data regarding demographic, clinical, and radiologic features were analyzed in all the patients. RESULTS: Recanalization of the affected sinuses was achieved in all the cases. Twenty-four patients had good outcome (mRs 0 or1) and three patients had mild deficits (mRs 2). One patient had moderate disability (mRs 3). One patient succumbed due to increased hematoma causing midline shift and transtentorial herniation. At 3 months follow-up, 26 patients were asymptomatic and two patients had minor symptoms. CONCLUSION: Local intrasinus thrombolysis (LIST) is safe and effective method in patients with poor clinical grade and the present study highlights the benefit of thrombolysis, particularly in patients unresponsive to anticoagulation. The improved efficacy of this therapy depends on early recognition of worsening symptoms and timely intervention.

Higher mortality in patients with right hemispheric intracerebral haemorrhage: INTERACT1 and 2.

BACKGROUND AND PURPOSE: Controversy exists over the prognostic significance of the affected hemisphere in stroke. We aimed to determine the relationship between laterality of acute intracerebral haemorrhage (ICH) and poor clinical outcomes. METHODS: A subsidiary analysis of the INTERACT Pilot and INTERACT2 studies--randomised controlled trials of patients with spontaneous acute ICH with elevated systolic blood pressure (BP), randomly assigned to intensive (target systolic BP <140 mm Hg) or guideline-based (<180 mm Hg) BP management. Outcomes were the combined and separate end points of death and major disability (modified Rankin scale (mRS) scores of 3-6, 6 and 3-5, respectively) at 90 days. RESULTS: A total of 2708 patients had supratentorial/hemispheric ICH and information on mRS at 90 days. Patients with right hemispheric ICH (1327, 49%) had a higher risk of death at 90 days compared to those with left hemispheric ICH after adjustment for potential confounding variables (OR, 1.77 (95% CI 1.33 to 2.37)). There were no differences between patients with right and left hemispheric ICH regarding the combined end point of death or major disability or major disability in the multivariable-adjusted models (1.07 (0.89 to 1.29) and 0.85 (0.72 to 1.01), respectively). CONCLUSIONS: Right hemispheric lesion was associated with increased risk of death in patients with acute ICH. The laterality of the ICH does not appear to affect the level of disability in survivors. TRIAL REGISTRATION NUMBER: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00226096 and NCT00716079.