Transradial approach to lower extremity interventions

Percutaneous interventions of the coronary and peripheral vessels have historically been performed using a femoral artery approach. There has been increasing recognition of post-procedural bleeding complications and its impact on short- and long-term mortality. Because of its now recognized safety, the transradial approach has recently emerged as a preferred method compared to the transfemoral approach. The limitations associated with the distance from the puncture site to the lesion location are being addressed as new tools are developed for the endovascular treatment of peripheral arterial disease. In this review, we discuss the many facets of the transradial approach to lower extremity endovascular interventions, highlighting its safety and efficacy. Approaches to special populations including individuals with prior surgical bypass, Leriche’s syndrome, and those committed to chronic anticoagulation are also reviewed

Omega-3 fatty acids plus rosuvastatin improves endothelial function in South Asians with dyslipidemia

Catalin Mindrescu1,2,3, Rakesh P Gupta1,3, Eileen V Hermance1, Mary C DeVoe1, Vikas R Soma1, John T Coppola1,2, Cezar S Staniloae1,21Comprehensive Cardiovascular Center, Saint Vincent’s Hospital Manhattan, New York, NY, USA; 2New York Medical College, Valhalla, NY, USA; 3Rakesh P Gupta and Catalin Mindrescu contributed equally to this article.Background: The present study was undertaken to investigate the effect of statins plus omega-3 polyunsaturated fatty acids (PUFAs) on endothelial function and lipid profile in South Asians with dyslipidemia and endothelial dysfunction, a population at high risk for premature coronary artery disease.Methods: Thirty subjects were randomized to rosuvastatin 10 mg and omega-3-PUFAs 4 g or rosuvastatin 10 mg. After 4 weeks, omega-3-PUFAs were removed from the first group and added to subjects in the second group. All subjects underwent baseline, 4-, and 8-week assessment of endothelial function and lipid profile.Results: Compared to baseline, omega-3-PUFAs plus rosuvastatin improved endothelial-dependent vasodilation (EDV: −1.42% to 11.36%, p = 0.001), and endothelial-independent vasodilation (EIV: 3.4% to 17.37%, p = 0.002). These effects were lost when omega-3-PUFAs were removed (EDV: 11.36% to 0.59%, p = 0.003). In the second group, rosuvastatin alone failed to improve both EDV and EIV compared to baseline. However, adding omega-3-PUFAs to rosuvastatin, significantly improved EDV (−0.66% to 14.73%, p = 0.001) and EIV (11.02% to 24.5%, p = 0.001). Addition of omega-3-PUFAs further improved the lipid profile (triglycerides 139 to 91 mg/dl, p = 0.006, low-density lipoprotein cholesterol 116 to 88 mg/dl, p = 0.014).Conclusions: Combined therapy with omega-3-PUFAs and rosuvastatin improves endothelial function in South Asian subjects with dyslipidemia and endothelial dysfunction.Keywords: omega-3 fatty acids, endothelial function, South Asians, dyslipidemia, rosuvastati

Histopathologic changes of the radial artery wall secondary to transradial catheterization

Cezar S Staniloae1, Kanika P Mody1, Kintur Sanghvi1, Catalin Mindrescu1, John T Coppola1, Cristina R Antonescu2, Sanjay Shah3, Tejas Patel31Saint Vincent’s Hospital Manhattan, New York, NY, USA; 2Memorial Sloan-Kettering Cancer Center, New York, NY; 3Total Cardio Vascular Solutions, Ahmedabad, IndiaObjective: The immediate effects of transradial access on the radial artery wall are unknown. In this study we sought to assess the histological changes induced by catheterization on the radial artery.Methods: Thirty-four patients undergoing coronary artery bypass grafting (CABG) had radial arteries harvested to serve as bypass conduits. The proximal and distal ends of the radial artery conduits were sectioned and embedded in paraffin. Both ends of all specimens were evaluated by a blinded pathologist for intimal hyperplasia, medial inflammation, medial calcification, periarterial tissue or fat necrosis, adventitial inflammation, adventitial necrosis, and adventitial neovascularization. Fisher’s exact test was used for statistical analysis.Results: Fifteen previously catheterized radial arteries (TRA group) were compared with 19 noncatheterized arteries (NCA group). The distal ends of the TRA group showed significantly more intimal hyperplasia (73.3% vs 21.1%; p = 0.03), periarterial tissue or fat necrosis (26% vs 0%; p = 0.02), and more adventitial inflammation (33.3% vs 0%; p = 0.01) than the distal ends of the NCA group. The distal ends of the TRA group also showed significantly more intimal hyperplasia (73.3% vs 26.6%; p = 0.03) and adventitial inflammation (33.3% vs 0%; p = 0.01) than the proximal ends of the same arteries. There were no histological differences in the proximal ends of the two groups. Conclusion: Transradial catheterization induces significant histological changes suggestive of radial artery injury limited to the puncture site in the form of intimal hyperplasia, medial inflammation, and tissue necrosis. Both the proximal and distal ends of the radial artery show a spectrum of atherosclerotic changes independent of its use for transradial catheterization. Keywords: radial artery, catheterization, pathology, medial calcifications, intimal hyperplasia, atherosclerosi

SEX-BASED DIFFERENCES IN OUTCOMES AFTER TRANSCATHETER REPAIR OF MITRAL REGURGITATION WITH THE MITRALCLIP SYSTEM

Background: Females have a higher rate of adverse events after coronary intervention. Outcomes after transcatheter mitral valve repair (TMVr) intervention by sex remain incompletely elucidated. Methods: Patients (n=5295) who underwent TMVr for mitral regurgitation with the MitraClip system in the STS/ACC TVT registry were evaluated. Linked administrative claims from the Centers for Medicare & Medicaid Services were used to evaluate 1-year clinical outcomes. The adjusted associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 2,523 (47.6%) female and 2,772 (52.4%) male patients underwent TMVr. Compared with male patients, female patients were older with lower prevalence of multivessel coronary artery disease, coronary revascularization, and diabetes, but a higher rate of New York Heart Class III-IV functional capacity and home oxygen use (p \u3c0.001 for all). Female patients had a lower glomerular filtration rate, smaller left ventricular cavity but higher ejection fraction, and higher rate of mitral stenosis with more mitral leaflet calcification when compared to male patients. Females were more likely to have only one clip implanted (p \u3c0.001) and lower adjusted odds of MVARC procedural success (aOR 0.78, CI 0.67-0.90) or residual mitral gradient \u3c5 mmHg (aOR 0.54, CI 0.46-0.63) when compared with males. The composite outcome of in-hospital all-cause mortality, stroke, or major bleeding did not significantly differ in females compared with males (adjusted odd ratio [aOR] 1.00, CI 0.82-1.21). At 1-year follow up, female sex was associated with lower all-cause mortality (aHR 0.82, CI 0.69-0.96). However, the 1-year adjusted risk of stroke and any bleeding did not significantly differ by sex. Conclusion: Although females undergoing TMVr had lower odds of procedural success, adjusted 1-year all-cause mortality were lower in females compared with males. Further studies to determine how to further optimize transcatheter management of mitral valve disease by sex are warranted

Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI) : a phase 3, placebo-controlled, randomised trial

Background: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3·3 years (IQR 2·8–3·8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7·3%] of 5558 vs 480 [8·6%] of 5596; HR 0·85 [95% CI 0·74–0·97], p=0·013). The same effect was not observed in patients without PCI (p=0·76, p interaction=0·16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3·1%] with ticagrelor vs 183 (3·3%) with placebo; HR 0·96 [95% CI 0·78–1·18], p=0·68), as well as all-cause death (282 [5·1%] vs 323 [5·8%]; 0·88 [0·75–1·03], p=0·11). TIMI major bleeding occurred in 111 (2·0%) of 5536 patients receiving ticagrelor and 62 (1·1%) of 5564 patients receiving placebo (HR 2·03 [95% CI 1·48–2·76], p<0·0001), and fatal bleeding in 6 (0·1%) of 5536 patients with ticagrelor and 6 (0·1%) of 5564 with placebo (1·13 [0·36–3·50], p=0·83). Intracranial haemorrhage occurred in 33 (0·6%) and 31 (0·6%) patients (1·21 [0·74–1·97], p=0·45). Ticagrelor improved net clinical benefit: 519/5558 (9·3%) versus 617/5596 (11·0%), HR=0·85, 95% CI 0·75–0·95, p=0·005, in contrast to patients without PCI where it did not, p interaction=0·012. Benefit was present irrespective of time from most recent PCI. Interpretation: In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk

Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes

BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo