Hypothyroidism in acute coronary syndrome - A prospective Indian study.

BACKGROUND: Evidence suggests that hypothyroidism may be associated with an increased risk of acute coronary syndrome (ACS). The data regarding the influence of hypothyroidism on cardiovascular disease in the Asian population is conflicting. Therefore, we undertook this study to assess the overall prevalence of hypothyroidism in Acute Coronary Syndrome (ACS) patients and determine if there is a relationship between hypothyroidism, both sub-clinical and overt and other significant risk factors of ACS in an Indian population. METHODS: We studied 487 hospitalized patients between March 2018 and February 2021 with a diagnosis of ACS to determine the prevalence of hypothyroidism, both clinical and sub-clinical and their relationship with other known coronary risk factors. Thyroid function Tests - free T3, free T4 and TSH were collected from all the patients within 24 h of their admission to the coronary care unit (CCU) of 2 major hospitals in New Delhi and Imphal (Manipur). RESULTS: Subclinical hypothyroidism was prevalent in 44 (9 %), followed by overt hypothyroidism in 25 (5.2 %). Subclinical hypothyroidism was more common in females, whereas overt hypothyroidism was more common in males. ST Elevation Myocardial Infarction (STEMI) (52 %), followed by Non-ST-Elevation Myocardial Infarction (NSTEMI) (25 %), was the commonest diagnosis at presentation. Patients with overt hypothyroidism showed a higher proportion of increased triglyceride levels. Patients with hypothyroidism had no differences in the prevalence of concomitant diabetes hypertension and other coronary risk factors. CONCLUSIONS: Patients with ACS without known thyroid disorders should be screened for hypothyroidism since it is found frequently. There might be a case to treat their thyroid dysfunction appropriately.

Rationale and design of the TUXEDO-2 India study: Ultra-Thin strUt Supraflex Cruz versus XiencE in a Diabetic pOpulation with multi-vessel disease-2.

BACKGROUND: The role of percutaneous coronary interventions (PCI) in patients with diabetes mellitus and multi-vessel disease has been questioned by the results of the FREEDOM trial, which showed superiority of coronary artery bypass graft(CABG) over first generation drug-eluting stents (DES) including a reduction in mortality. In the light of safer and more efficacious stents and significantly better medical management, those results that date back to 2012 need to be revisited. TUXEDO-2 is a study designed to compare two contemporary stents in Indian diabetic patients with multi-vessel disease. AIMS: The primary objective of the TUXEDO-2 study is to compare the clinical outcomes of PCI with ultra-thin Supraflex Cruz vs Xience when combined with contemporary optimal medical therapy (OMT) in diabetic patients with multi-vessel disease. The secondary objective is to compare clinical outcomes between a pooled cohort from both arms of the study (Supraflex Cruz + Xience; PCI arm) vs CABG based on a performance goal derived from the CABG arm of the FREEDOM trial (historical cohort). The tertiary objective is a randomized comparison of ticagrelor vs prasugrel in addition to aspirin for the composite of ischemic and bleeding events. METHODS: In this prospective, open-label, multi-centre, 2 × 2 factorial, randomized, controlled study, 1,800 patients with diabetes mellitus and multi-vessel disease (inclusion criteria similar to FREEDOM trial) with indication for coronary revascularization will be randomly assigned to Supraflex Cruz or Xience stents and also to ticagrelor- or prasugrel- based antiplatelet strategies. All patients will receive guideline directed OMT and optimal PCI including image- and physiology-guided complete revascularization where feasible. The patients will be followed through five years to assess their clinical status and major clinical events. The primary endpoint is a non-inferiority comparison of target lesion failure at one-year for Supraflex Cruz vs Xience (primary objective) with an expected event rate of 11% and a non-inferiority margin of 4.5%. For PCI vs CABG (secondary objective), the primary endpoint is major adverse cardiac events (MACE), defined as a composite of all cause death, nonfatal myocardial infarction, or stroke at one-year and yearly up to five years, with a performance goal of 21.6%. For ticagrelor vs prasugrel (tertiary objective), the primary endpoint is composite of death, myocardial infarction, stroke, and major bleeding as per the Bleeding Academic Research Consortium (BARC) at one-year with expected event rate of 15% and a non-inferiority margin of 5%. CONCLUSIONS: The TUXEDO-2 study is a contemporary study involving state-of-the-art PCI combined with guideline directed OMT in a complex subset of patients with diabetes mellitus and multi-vessel disease. The trial will answer the question as to whether a biodegradable polymer coated ultra-thin Supraflex Cruz stent is an attractive option for PCI in diabetic patients with multi-vessel disease. It will also help address the question whether the results of FREEDOM trial would have been different in the current era of safer and more efficacious stents and modern medical therapy. In addition, the comparative efficacy and safety of ticagrelor vs prasugrel in addition to aspirin will be evaluated. (CTRI/2019/11/022088).

Uncontrolled hypertension in a rural population of Jammu and Kashmir.

AIM: Evaluation of the status of uncontrolled hypertension in diagnosed hypertensives who had been advised drug treatment in the rural areas of 6 districts in Jammu & Kashmir (J&K) and also the risk factors associated with it. METHODS: The study was a cross-sectional observational study conducted between August 2020 to July 2021 in the form of health camps in six government health centres in 6 different rural districts. The camps were focussed on patients with hypertension, diabetes with or without heart disease. The areas included Machil in Kupwara, Khan Sahib in Budgam, Rajpora and Hawal in Pulwama, Rainawari in the Srinagar, Banihal in Ramban, and Jagti in Jammu. Enrolled patients were examined for body weight, blood pressure (BP), random blood sugar and serum lipid profile. The definition of hypertension was as per the eighth Joint National Committee (JNC-8) guidelines. RESULTS: A total of 600 patients (50.1% males) were evaluated. Of these 335 (55%) had history of being diagnosed hypertension and had been recommended drugs for BP control Male: Female ratio 1:0.8.211(63.5%) of these had un controlled blood pressures on measurement. Two or more drugs had been prescribed in 65 (30.8%) patients, 34 (16%) were taking only single drug and 112(53%) were not on any drug. Uncontrolled hypertension was seen more often in age group of 40-60 years (49%), subjects more than 60 years had it in 40%. The comparison of risk factors between patients with diagnosed hypertension with those without it revealed use of tobacco, consumption of salted tea, presence of diabetes, dyslipidaemia as significant factors for the presence of uncontrolled hypertension. CONCLUSION: Uncontrolled hypertension in known patients prescribed drugs is highly prevalent in the rural population of J&K. Steps to mitigate this problem are needed on top priority.

Urinary concentration of endocrine-disrupting phthalates and breast cancer risk in Indian women: A case-control study with a focus on mutations in phthalate-responsive genes.

BACKGROUND: Phthalates are known endocrine-disrupting chemicals used indiscriminately as constituents in consumer products including food processing, and packaging, cosmetics, personal care and household items. Although, few studies have assessed the risk of breast cancer on exposure to phthalates, their association with breast cancer risk in Indian women have not yet been evaluated. METHODS: We conducted a case-control study involving 171 participants. Urinary concentrations of six phthalate dieters; DMP (Dimethyl phthalate), DEP (Diethyl phthalate), DBP (Dibutyl phthalate), BBP (benzyl butyl phthalate), DEHP (Di-2-ethyl-hexyl phthalate), DINOP (Di-n-octyl phthalate) were estimated by GC-MS and geometric means were calculated. Univariate and multivariable logistic regression was performed to assess breast cancer risk on exposure to phthalates. Genes responsive to phthalates were identified through literature search and matched with NGS data, and gene-enrichment analysis was performed. RESULTS: Significant associations were observed between urinary phthalate concentrations and increased risk of breast cancer for di-butyl phthalate (OR=1.5, 95% CI; 1.06, 2.11, p = 0.002) and di-2-ethyl-hexyl phthalate (>median vs ≤ median; OR=2.97, 95% CI; 1.18, 7.47, p = 0.005) in multivariable analyses. We also found several phthalate-responsive gene mutations in paired breast tumor tissues, which include PTPRD (76.19%), AR (42.86%), CYP1A1 (42.86%), CYP19A1 (23.81%), AHRR (19.05%), PIK3CA (19.05%), CYP1B1 (9.52%), RB1 (9.52%) and MMP9 (9.52%). Gene-enrichment analysis revealed that these genes form a major part of ER/PR, PPAR and HIF-1α-TGF-ß signaling cascades involved in breast cancer CONCLUSION: Although the sample size is small, in this first case-control study from India, DBP and DEHP were found to be associated with increased risk of invasive breast cancer and tumor tissues revealed mutations in several phthalate-responsive genes. It is, therefore suggested that human biomonitoring in India and larger studies evaluating the early life genetic and epigenetic alterations on phthalates exposure are required to establish their role in breast carcinogenesis.

Serial evaluation of vascular responses after implantation of everolimus-eluting coronary stent by optical coherence tomography.

AIM: To evaluate healing response at strut-level and cross-section level after implanting an ultra-thin strut, everolimus-eluting stent with biodegradable polymer (Tetrilimus) using optical coherence tomography (OCT) at 3 and 6 months. METHODS: This was prospective, multi-centre, single-arm, and investigator-initiated study performed at seven Indian sites between January, 2017 and September, 2018. OCT evaluations were performed in 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at 3 months for first 16 patients and at 6 months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts. RESULTS: Sixty one Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data was available for 12 patients and 30 patients at 3 and 6 months, respectively. At 3 months, rapid early healing was indicated by 95.48% covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At 6 months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to 3 months. 99.77% of struts per lesion were covered at 6 months. There was a very symmetrical healing as shown by very low eccentricity index. There was no difference in vascular healing between stents with small to moderate size vessels (≤3.00 mm) and large size vessels (>3.00 mm). CONCLUSION: Present study demonstrated nearly complete endothelization and low NIH accumulation at 3 and 6 months following implantation of ultra-thin strut everolimus-eluting biodegradable polymer-coated Tetrilimus stent. Moreover, though being an ultra-thin strut stent, there was no difference in vascular healing and eccentricity after implantation of the Tetrilimus stents with smaller and larger diameters.

Prognostic implications of thyroid hormone alterations in acute coronary syndrome-A systematic review.

There is considerable association of thyroid function and the cardiovascular system during various acute systemic illnesses. It is well established that the normal thyroid homeostasis is known to alter in disease states including the acute coronary syndromes (ACS). Abnormal thyroid hormonal status has been shown to be related to worse outcomes and prognosis. This review focuses on the relationship of alterations in thyroid function and its influence on the pathophysiological mechanisms and cardiovascular hemodynamics in ACS and based upon the literature, summarises all the existing evidence to this date on this subject. The data largely points out that low levels of triiodothyronine (T3) levels seen in ACS might be useful in prognosticating the outcomes of ACS.

Blood pressure and heart rate related to sex in untreated subjects: the India ABPM study.

Women are underrepresented in groups of patients seeking hypertension care in India. The present paper reports trends in office and ambulatory blood pressure measurement (OBPM, ABPM) and 24-h heart rate (HR) with sex in 14,977 subjects untreated for hypertension (aged 47.3 ± 13.9 years, males 69.4%) visiting primary care physicians. Results showed that, for systolic blood pressure (SBP), females had lower daytime ABPM (131 ± 16 vs. 133 ± 14 mm Hg, P < .001) but higher nighttime ABPM (122 ± 18 vs. 121 ± 16 mm Hg, P < .001) than males. Females had higher HR than men at daytime (80 ± 11 vs 79 ± 11.5 bpm) and nighttime (71 ± 11 vs 69 ± 11), respectively (all P < .001). Dipping percentages for SBP (7.4 ± 7.3 vs 9.3 ± 7.4%), DBP (10.1 ± 8.6 vs. 12.3 ± 8.9%), and HR (10.7 ± 7.9 vs. 12.8 ± 9.2%) were lower (P < .001) for females than for males, respectively. Females more often had isolated nighttime hypertension as compared to males (14.9%, n = 684% vs 10.6%, n = 1105; P < .001). BP patterns and HR showed clear differences in sex, particularly at nighttime. As females were more often affected by non-dipping and elevated nighttime SBP and HR than males, they should receive ABPM, at least, as frequently as men to document higher risk necessitating treatment.

Self-blood pressure measurement as compared to office blood pressure measurement in a large Indian population; the India Heart Study.

OBJECTIVE: India Heart Study (IHS) is aimed at investigating the agreement between office blood pressure measurement (OBPM) and self (S)BPM in a hypertension-naive population. METHODS: A total of 18 918 individuals (aged 42.6 ±â€Š11.7 years, 62.7% men), visiting 1237 primary care physicians across India, underwent OBPM. They performed SBPM for a period of 1 week using a validated oscillometric BP monitor that was preprogrammed to adhere to a guideline-based SBPM-schedule and blinded to the results. Thereafter, individuals underwent a second OBPM. Available laboratory results were obtained. Thresholds for elevated OBPM and SBPM were 140/90 and 135/85 mmHg, respectively. RESULTS: On the basis of first-visit OBPM and SBPM, there were 5787 (30.6%) individuals with normotension; 5208 (27.5%) with hypertension; 4485 (23.7%) with white-coat hypertension (WCH) and 3438 (18.2%) with masked hypertension. Thus, a diagnosis contradiction between SBPM and first-visit OBPM was seen in 9870 (41.9%) individuals. On the basis of second-visit OBPM, the normotension, hypertension, WCH and masked hypertension prevalence values were 7875 (41.6%); 4857 (25.7%); 2397 (12.7%) and 3789 (20.0%). There was poor agreement (kappa value 0.37) between OBPM of visit 1 and 2 with a diagnosis difference in 6027 (31.8%) individuals. The majority of masked hypertension and WCH individuals had BP values close to thresholds. CONCLUSION: There was a poor agreement between OBPM of visit1 and visit 2. Likewise, the agreement between OBPM at both visits and SBPM was poor. SBPM being considered to have a better correlation with patient prognosis should be the preferred method for diagnosing hypertension.

Usefulness of ambulatory blood pressure measurement for hypertension management in India: the India ABPM study.

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.

Blood pressure related to age: The India ABPM study.

The present paper reports trends in office blood pressure (BP) measurement (OBPM) and ambulatory blood pressure measurement (ABPM) with age in a large multi-center 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 analyzed and compared. Individual differences between OBPM and ABPM patterns were compared for patients according to 10-year age categories. Results showed that systolic (S) BP values started to increase with age from the age of 40, BP variability (SD) increased from the age of 30 years. Diastolic (D) BP values started to decrease from the age of 50 years. Mean OBPM values were higher than daytime ABPM values (all P < .001) in all age-groups. The prevalence of white coat hypertension (WCH) and masked hypertension (MH) was based on OBPM and daytime, 24-hour, and nighttime average BPs together. WCH decreased with age from 15.1% and 12.4% in treated and untreated subjects at the youngest age to 7.2% and 6.9% in the oldest age, respectively. MH prevalence was higher for untreated than for treated subjects but remained similar for all age-groups (range of 18.6%-21.3%). The prevalence of reverse dippers increased with age from the youngest to oldest group with 7.3%-34.2% (P < .001 for trend). Dippers prevalence decreased from 42.5% to 17.9% from the youngest to oldest age-groups, respectively (P < .001 for trend). These findings confirm that BP patterns show clear differences in trends with age, particularly regarding nighttime BP.

Everolimus Eluting Stents in Patients with Diabetes Mellitus and Chronic Kidney Disease: Insights from the TUXEDO Trial.

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).

Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

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.

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

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.

Percutaneous Coronary Intervention in Patients With Insulin-Treated and Non-Insulin-Treated Diabetes Mellitus: Secondary Analysis of the TUXEDO Trial.

IMPORTANCE: Prior studies have shown that patients with insulin-treated diabetes mellitus (ITDM) have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent. OBJECTIVES: To assess the outcomes of patients with ITDM vs non-ITDM who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status. DESIGN, SETTING, AND PARTICIPANTS: A prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. MAIN OUTCOMES AND MEASURES: The primary end point was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention. RESULTS: Among the 1830 patients (1377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 [5.6%] vs 36 [3.3%]; P = .02), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]; P = .009), death (26 [3.5%] vs 18 [1.7%]; P = .01), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]; P = .03). However, in a propensity score-adjusted analysis to account for baseline differences between the 2 groups, the differences in outcomes were no longer significant. In patients with ITDM, everolimus-eluting stents reduced the rate of target vessel failure (13 of 382 [3.4%] vs 29 of 365 [7.9%]; P = .007), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]; P = .01), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]; P = .01), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3.0%]; P = .009), target lesion revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001), and target vessel revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001) when compared with paclitaxel-eluting stents. The results largely trended in the same direction in patients with non-ITDM (P > .05 for the interaction). CONCLUSIONS AND RELEVANCE: Patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment. Everolimus-eluting stents reduced the rate of cardiovascular events, including stent thrombosis, when compared with paclitaxel-eluting stents in patients with ITDM. TRIAL REGISTRATION: ctri.nic.in Identifier: CTRI/2011/06/001830.

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes.

BACKGROUND: The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents. METHODS: We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up. RESULTS: At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002). CONCLUSIONS: In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Comparison of anti-thrombotic strategies using Bivalirudin, Heparin plus Glycoprotein IIb/IIIa inhibitors and Unfractionated Heparin Monotherapy for patients undergoing percutaneous coronary intervention - A single centre observational study.

AIMS: The study was planned to compare Anti-thrombotic strategies for patients undergoing PCI in a real world population with an emphasis on occurrence of major bleeding, composite ischemic end points and economic outcomes. METHODS: The present study is a single center, prospective, observational study in consecutive patients undergoing PCI at Fortis Escorts Heart Institute (FEHI) and describes Authors' experience with three different Anti-Thrombotic Strategies in a real world population. Patients were consecutively enrolled in the study and the choice of Anti-thrombotic strategy was left to individual operator(s) based on their own clinical judgment and patient's affordability. No specific inclusion/exclusion criteria were specified on the choice of Anti-Thrombotic Strategy. RESULTS: A total 1453 patients were consecutively enrolled into the study and were followed telephonically after 30 days. 252 patients were treated with Bivalirudin (Angiomax) during PCI (17.3%), 430 (29.6%) patients were treated with Heparin plus GPI & remaining 771 (53.1%) were treated with Heparin monotherapy. Incidence of major bleeding was lowest in patients treated with Bivalirudin (1.59%) when compared to Heparin plus GPI (3.49%) and Heparin monotherapy (5.97%), p = 0.005 Bivalirudin vs. Heparin Monotherapy, and p = 0.145, Bivalirudin vs. Heparin + GPI. No bleeding was observed in STEMI patients treated with Bivalirudin compared to 7.4% in patients treated with GPI and 14.3% in patients treated with UFH. Similarly non-access site bleeding was lowest in patients treated with Bivalirudin. Only 4 patients (1.6%) treated with Bivalirudin required Blood transfusion compared to 25 in Heparin plus GPI (5.8%) and 38 (5%) in Heparin Monotherapy arm. In Composite Ischemic end-points, no "All-cause Mortality" was observed in Bivalirudin group compared to 2.8% in Heparin plus GPI. Early stent thrombosis was seen in 1 patient with Heparin plus GPI and none with Heparin monotherapy and Bivalirudin group. None of the patients underwent TLR (target lesion revascularization) and TVR (target vessel revascularization) within 30 days post procedure other than one early stent thrombosis reported with Heparin plus GPI. Cost of blood product transfusion was lower with Bivalirudin as compared to Heparin plus GP IIb/IIIa arm (p = 0.01) and with Heparin alone (p = 0.001). Due to lower complications including blood transfusions and reduced hospital stay in Bivalirudin group, these benefits outweigh the incremental cost due to higher acquisition cost of the drug. CONCLUSION: Bivalirudin use during PCI is associated with a distinct advantage of having lower access site and non-access site bleeding without compromising on the efficacy. We observed a reduction in blood transfusions, hospital stay and mortality for patients treated with Bivalirudin compared with Heparin plus GPI or Heparin Monotherapy. Bivalirudin can be safely adopted into our Institutional protocol for the treatment of high risk PCI such as STEMI, ACS, and Complex elective PCI.