Jayesh Prajapati

Biodegradable-polymer-based, sirolimus-eluting Supralimus ® stent: 6-month angiographic and 30-month clinical follow-up results from the Series I prospective study

AIMS There have been recent concerns regarding the long-term safety of the first generation of drug-eluting stents, which utilised a permanent polymer coating for drug delivery. SERIES I is a prospective, non-randomised, first-in-man open label study with the biodegradable polymer-based Supralimus sirolimus eluting stent (Sahajanand Medical Technologies Pvt. Ltd, India) for the treatment of patients with coronary artery lesions. METHODS AND RESULTS One hundred patients were treated with 126 Supralimus stents (mean lesion length 10.5 +/- 4.3 mm, mean reference vessel diameter 2.66 +/- 0.62 mm). The pre-specified primary endpoint was angiographic binary in-stent restenosis at six months. Secondary endpoints were device-orientated major adverse clinical events (MACE; defined as a composite of cardiac death, nonfatal myocardial infarction [Q-wave and Non-Q wave], or clinically-justified target vessel revascularisation) at 30 days, nine months and 30 months. Angiographic follow-up in a pre-specified subgroup of 60 patients at six months showed binary angiographic restenosis rates of 0% (in-stent) and 1.7% (in-segment). The in-stent late loss was 0.09 +/- 0.37 mm. MACE rates were 0% after one month, 6% at 9-month follow-up and 7% after 30 months follow-up. CONCLUSIONS The biodegradable-polymer-based sirolimus-eluting stent (Supralimus) is effective in inhibiting neointimal hyperplasia.

AGE-Related Differences of Novel Atherosclerotic Risk Factors and Angiographic Profile Among Gujarati Acute Coronary Syndrome Patients

CONTEXT Although numerous risk factors have been established to predict the development of acute coronary syndrome (ACS), the risk factor profile may be different between the younger and older individuals. AIM To analyse the frequency and pattern of atherogenic risk factors and angiographic profiles in age-stratified Gujarati patients with ACS. MATERIALS AND METHODS ACS patients undergoing coronary angiography at U.N. Mehta Institute of Cardiology and Research, Gujarat, India between January 2008 and December 2012 were classified in to two age groups with 40y as cut-off. Patients were assessed for conventional risk factors (diabetes mellitus, dyslipidaemia, hypertension, smoking, obesity), novel risk factors (high sensitivity C-reactive protein, lipoprotein (a), homocysteine), and angiographic profiles.The statistical difference between two age groups was determined by Students t-test for continuous variables and Chi-square or Fishers exact test for categorical variables. RESULTS A total of 200 patients, 100 patients ≤40 y of age and 100 patients >40 y of age, were evaluated. Older patients had higher frequency of hypertension (32 vs. 16%, p=0.008), while family history of coronary artery disease was more common among younger patients (19 vs. 9%, p=0.041). The incidence of diabetes, dyslipidaemia, smoking and tobacco chewing did not vary significantly between the two groups. Total cholesterol and low-density lipoprotein cholesterol levels were significantly higher in the younger group (p<0.05). Lipoprotein (a), homocysteine and high-sensitivity C reactive protein levels were comparable between two age groups. Multi-vessel coronary artery disease was more common among older group. The most commonly affected coronary artery was the left anterior descending artery among younger patients (44%) and the left circumflex artery among older patients (38.1%). CONCLUSION Young patients with ACS had different atherosclerotic risk profile and less extensive coronary artery disease as compared to older counterparts. Emphasis should be given on diagnosis and management of major modifiable risk factors.

Response of blood pressure after percutaneous transluminal renal artery angioplasty and stenting

AIM To evaluate the short and intermediate term outcome of percutaneous transluminal renal artery angioplasty (PTRA) and stenting particularly on blood pressure (BP) control and renal function and to evaluate predictors of poor BP response after successful PTRA and stenting. METHODS We conducted a prospective analysis of all patients who underwent PTRA and stenting in our institute between August 2010 to September 2012. A total number of 86 patients were underwent PTRA and renal stenting. Selective angiography was done to confirm at least 70% angiographic stenosis. The predilatation done except few cases with critical stenosis, direct stenting was done in the rest of cases. All patients received aspirin 325 mg orally, and clopidogrel 300 mg orally within 24 h before the procedure. Heparin was used as the procedural anticoagulant agent. Optimal results with TIMI-III flow obtained in all cases. Following stent placement, aspirin 150 mg orally once daily was continued for a minimum of 12 mo and clopidogrel 75 mg orally once daily for at least 4 wk. The clinical, radiological, electrocardiography, echocardiography and treatment data of all patients were recorded. The BP measurement, serum creatinine and glomerular filtration rate (GFR) were recorded before the procedure and 1 and 6 mo after PTRA. RESULTS A total of 86 patients were included in the study. The mean age of study population was 55.87 ± 11.85 years old and 67 (77.9%) of patients were male. There was a significant reduction in both systolic and diastolic BP at 1 mo after the procedure: 170.15 ± 20.10 mmHg vs 146.60 ± 17.32 mmHg and 98.38 ± 10.55 mmHg vs 89.88 ± 9.22 mmHg respectively (P = 0.0000). The reduction in BP was constant throughout the follow-up period and was evident 6 mo after the procedure: 144.23 ± 18.19 and 88.26 ± 9.79 mmHg respectively (P = 0.0000). However, no improvement in renal function was observed at any time during the follow-up period. After multivariate analysis, we found male sex, low GFR (< 60 mL/min) and higher baseline mean BP as a poor predictors of successful outcome on BP response after PTRA and stenting. CONCLUSION The PTRA and stenting can be considered as an effective therapeutic intervention for improving BP control with minimal effect on renal function. The male sex, higher baseline BP and low GFR are associated with poor BP response after successful PTRA and stenting.

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.

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Objectives To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up. Interventions Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures The primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months. Results At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm. Conclusions The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Clinical Outcomes from Unselected “Real-World” Patients with Long Coronary Lesion Receiving 40 mm Biodegradable Polymer Coated Sirolimus-Eluting Stent

Background. Long lesions being implanted with drug-eluting stents (DES) are associated with relatively high restenosis rates and higher incidences of adverse events. Objectives. We aimed to examine the safety and efficacy of the long (40 mm) biodegradable polymer coated Indolimus sirolimus-eluting stent (SES) in real-world patients with long coronary lesions. Methods. This study was observational, nonrandomized, retrospective, and carried out in real-world patients. A total of 258 patients were enrolled for the treatment of long coronary lesions, with 40 mm Indolimus. The primary endpoints in the study were incidence of major adverse cardiac events (MACE), a miscellany of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) or target vessel revascularization (TVR), and stent thrombosis (ST) up to 6-month follow-up. Results. The study population included higher proportion of males (74.4%) and average age was 53.2 ± 11.0 years. A total of 278 lesions were intervened successfully with 280 stents. The observed MACE at 6-month follow-up was 2.0%, which included 0.8% cardiac death and 1.2% MI. There were no TLR or TVR and ST observed during 6-month follow-up. Conclusions. The long (40 mm) Indolimus stent demonstrated low MACE rate and was proven to be safe and effective treatment for long lesions in “real-world” patients.

Diagnostic accuracy of serum cystatin C for early recognition of contrast induced nephropathy in Western Indians undergoing cardiac catheterization

Aims We aimed to compare the diagnostic efficacy of serum cystatin C (sCyC) for contrast induced nephropathy (CIN) in Western Indians undergoing cardiac catheterization. We also aimed to propose a clinically applicable cut-off of sCyC for early identification of CIN in this ethnic group. Methods In this prospective study, 253 patients undergoing coronary angiography and/or percutaneous coronary intervention were enrolled. The demographic and risk factor details, levels of sCr at baseline, 24 and 48 h after the procedure, whereas baseline and 24 h levels of sCyC were noted. Increase of 0.5 mg/dl or ≥25% from baseline sCr was used to define CIN. Optimum cut off of sCyC for CIN diagnosis was obtained using Receiver Operating Characteristic (ROC) curve analysis. Results After 48 h of contrast media (CM) exposure, the incidence of CIN was 12.25% (31 patients) according to sCr definition, where only 3.9% (10 patients) had sCr rise in 24 h. Overall significant (p < 0.0001) rise in mean levels of sCr (48 h) and sCyC (24 h) was observed in CIN patients. However, the mean sCr rise at 24 h was non-significant. The optimum cut off of sCyC for diagnosing CIN was found to be a rise of ≥10% from baseline (AUC – 0.901; sensitivity – 100%, specificity – 77.89%). According to sCyC, 94 (37.15%) patients had CIN. Conclusion We may conclude that a rise of ≥10% in sCyC at 24 h could be used as a reliable marker for identification of CIN in western Indians undergoing cardiac catheterization.

Diagnostic Accuracy of Computed Tomography Angiography as Compared to Conventional Angiography in Patients Undergoing Noncoronary Cardiac Surgery.

Objective: To compare the diagnostic accuracy of multi-slice computed tomography (MSCT) angiography with conventional angiography in patients undergoing major noncoronary cardiac surgeries. Materials and Methods: We studied fifty major noncoronary cardiac surgery patients scheduled for invasive coronary angiography, 29 (58%) female and 21 (42%) male. Inclusion criteria of the study were age of the patients ≥40 years, having low or intermediate probability of coronary artery disease (CAD), left ventricular ejection fraction (LVEF) >35%, and patient giving informed consent for undergoing MSCT and conventional coronary angiography. The patients with LVEF <35%, high pretest probability of CAD, and hemodynamically unstable were excluded from the study. Results: The diagnostic accuracy of CT coronary angiography was evaluated regarding true positive, true negative values. The overall sensitivity and specificity of CT angiography technique was 100% (95% confidence interval [CI]: 39.76%–100%) and 91.30% (95% CI: 79.21%–97.58%). The positive (50%; 95% CI: 15.70%–84.30%) and negative predictive values (100%; 95% CI: 91.59%–100%) of CT angiography were also fairly high in these patients. Conclusion: Our study suggests that this non-invasive technique may improve perioperative risk stratification in patients undegoing non-cardiac surgery.

Clinical performance of biodegradable polymer coated Sirolimus-eluting stent in multivessel disease: Results from MULTIDES study

Context: The role of percutaneous coronary intervention in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. Aim: The aim of this study was to examine the incidence of clinical outcomes after utilization of Indolimus, biodegradable polymer coated sirolimus-eluting stent (SES), in multivessel coronary stenting in an unselected patient population. Settings and Design: From April-2012 to June-2014, patients with multivessel (≥2 vessels) disease were examined in the retrospective, nonrandomized, observational, multicenter MULTIDES study. Materials and Methods: A total of 151 patients, exclusively treated with Indolimus SES in multivessel, were included in the study. The study was conducted in accordance with the Declaration of Helsinki and country-specific regulatory requirements. All patients signed informed consent form. Statistical Analysis Used: Continuous variables are presented as mean ± standard deviation and categorical variables as counts and percentages. All data were analyzed using Statistical Package for Social Sciences program. Results: The mean age was 53.7 ± 10.7 years; male gender represented 108 (71.5%) patients. A total of 314 Indolimus stents were implanted. Clinical follow-up was performed at 30-day, at 6-month, and at 9-month. The primary endpoint, major adverse cardiac events (MACEs) at 9-month follow-up, occurred in 5 (3.3%) patients, consisting of 1 (0.7%) cardiac death, 2 (1.3%) myocardial infarction, 2 (1.3%) target lesion revascularization, 0 (0%) target vessel revascularization, and 0 (0%) stent thrombosis. Conclusion: The present study describes that Indolimus implantation is safe and effective treatment in multivessel CAD, showing low rates of MACEs during 9-month follow-up.

Study of Effectiveness and Safety of Percutaneous Balloon Mitral Valvulotomy for Treatment of Pregnant Patients with Severe Mitral Stenosis.

INTRODUCTION In pregnant women mitral stenosis is the commonest cardiac valvular lesion. When it is present in majorly severe condition it leads to maternal and fetal morbidity and mortality. In mitral stenosis pregnancy can lead to development of heart failure. AIM To evaluate the safety and efficacy of balloon mitral valvulotomy (BMV) in pregnant females with severe mitral stenosis. MATERIALS AND METHODS A total of 30 pregnant patients who underwent BMV were included in the study from July 2011 to November 2013. Clinical follow-up during pregnancy was done every 3 months until delivery and after delivery. The mean follow up time after BMV was 6.72±0.56 months. RESULTS From the 30 pregnant females 14 (46.67%) and 16 (53.3%) patients underwent BMV during the third and second trimester of pregnancy respectively. The mean mitral valve area was 0.85+0.16 cm(2) before BMV that increased to 1.60+0.27 cm(2) (p<0.0001) immediately after BMV. Peak and mean diastolic gradients had decreased significantly within 48 hours after the procedure (p<0.001) but remained very much unchanged at 6.72 month period of follow-up. Two patients had an increase in mitral regurgitation by 2 grades. CONCLUSION During pregnancy BMV technique is safe and effective in patients with severe mitral stenosis. This results in marked symptomatic relief along with long term maternal and fetal outcomes.