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Bivalirudin versus heparin in patients undergoing percutaneous peripheral interventions: A systematic review and meta-analysis

Olmedo, Wilman; Villablanca, Pedro A; Sanina, Cristina; Walker, Jonathan; Weinreich, Michael; Brevik, Jeannine; Avendano, Ricardo; Bravo, Claudio A; Romero, Jorge; Ramakrishna, Harish; Babaev, Anvar; Attubato, Michael; Hernandez-Suarez, D F; Cox-Alomar, P; Pyo, Robert; Krishnan, Prakash; Wiley, Jose
BACKGROUND:Bivalirudin may be an effective alternative anticoagulant to heparin for use in percutaneous peripheral interventions. We aimed to compare the safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing percutaneous peripheral intervention. METHODS:For this meta-analysis and systematic review, we conducted a search in PubMed, Medline, Embase, and Cochrane for all the clinical studies in which bivalirudin was compared to heparin as the procedural anticoagulant in percutaneous peripheral interventions. Outcomes studied included all-cause mortality, all-bleeding, major and minor bleeding, and access site complications. RESULTS:Eleven studies were included in the analysis, totaling 20,137 patients. There was a significant difference favoring bivalirudin over heparin for all-cause mortality (risk ratio 0.58, 95% CI 0.39-0.87), all-bleeding (risk ratio 0.62, 95% CI 0.50-0.78), major bleeding (risk ratio 0.61, 95% CI 0.39-0.96), minor bleeding (risk ratio 0.66, 95% CI 0.47-0.92), and access site complications (risk ratio 0.66, 95% CI 0.51-0.84). There was no significant difference in peri-procedural need for blood transfusions (risk ratio 0.79, 95% CI 0.57-1.08), myocardial infarction (risk ratio 0.87, 95% CI 0.59-1.28), stroke (risk ratio 0.77, 95% CI 0.59-1.01), intracranial bleeding (risk ratio 0.77, 95% CI 0.29-2.02), or amputations (OR 0.75, 95% CI 0.53-1.05). CONCLUSION/CONCLUSIONS:Our meta-analysis suggests that bivalirudin use for percutaneous peripheral interventions is associated with lower all-cause mortality, bleeding, and access site complications as compared to heparin. Further large randomized trials are needed to confirm the current results.
PMID: 30501582
ISSN: 1708-539x
CID: 3520432

Staged Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With ST-Segment-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis

Villablanca, Pedro A; Olmedo, Wilman; Weinreich, Michael; Gupta, Tanush; Mohananey, Divyanshu; Albuquerque, Felipe N; Kassas, Ibrahim; BriceƱo, David; Sanina, Cristina; Brevik, Thomas A; Ong, Emily; Ramakrishna, Harish; Attubato, Michael; Menegus, Mark; Wiley, Jose; Kalra, Ankur
BACKGROUND:Studies have shown that chronic total occlusion (CTO) in a noninfarct-related artery in patients with ST-segment-elevation myocardial infarction is linked to increased mortality. It remains unclear whether staged revascularization of a noninfarct-related artery CTO in patients with ST-segment-elevation myocardial infarction translates to improved outcomes. We performed a meta-analysis to compare outcomes between patients presenting with ST-segment-elevation myocardial infarction with concurrent CTO who underwent percutaneous coronary intervention of noninfarct-related artery CTO versus those who did not. METHOD AND RESULTS/RESULTS:>25. Six studies (n=1253 patients) were included in the analysis. There was a significant difference in major adverse cardiovascular events (OR, 0.54; 95% CI, 0.32-0.91), cardiovascular mortality (OR, 0.43; 95% CI, 0.20-0.95), and heart failure readmissions (OR, 0.57; 95% CI, 0.36-0.89), favoring the patients in the CTO percutaneous coronary intervention group. No significant differences were observed between the 2 groups for all-cause mortality (OR, 0.47; 95% CI, 0.22-1.00), myocardial infarction (OR, 0.78; 95% CI, 0.41-1.46), repeat revascularization (OR, 1.13; 95% CI, 0.56-2.27), and stroke (OR, 0.51; 95% CI, 0.20-1.33). CONCLUSIONS:In this meta-analysis, CTO percutaneous coronary intervention of the noninfarct-related artery in patients presenting with ST-segment-elevation myocardial infarction was associated with a significant reduction in major adverse cardiovascular events, cardiovascular mortality, and heart failure readmissions.
PMCID:6015413
PMID: 29654206
ISSN: 2047-9980
CID: 3037502

Mediastinal Hematoma and Tracheal Compression following Transradial Percutaneous Coronary Intervention

Smilowitz, Nathaniel R; Saric, Muhamed; Attubato, Michael J; Slater, James N
Vascular complications from transradial percutaneous coronary intervention (PCI) are rare. We report an unusual case of stridor after PCI due to brachiocephalic artery perforation, pseudoaneurysm formation, and development of a large mediastinal hematoma with tracheal compression. Endovascular repair of the brachiocephalic artery was achieved with covered stent placement at the neck of the pseudoaneurysm. This case highlights the importance of careful guide catheter placement from the right radial approach. Ultimately, rapid diagnosis of vascular perforation, appropriate airway management, and prompt endovascular repair of the injured vessel is critical to the successful management of this life-threatening condition.
PMCID:5842741
PMID: 29682356
ISSN: 2090-6404
CID: 3052312

First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter

Price, Matthew J; Saito, Shigeru; Shlofmitz, Richard A; Spriggs, Douglas J; Attubato, Michael; McLaurin, Brent; Popma Almonacid, Alexandra; Brar, Sandeep; Liu, Minglei; Moe, Elizabeth; Mehran, Roxana
OBJECTIVES: The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). BACKGROUND: Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. METHODS: This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions /=2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. RESULTS: A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 +/- 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 +/- 6.3 mm, and the mean RVD was 1.91 +/- 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 +/- 0.48 mm, and the rate of binary restenosis was 12.0%. CONCLUSIONS: In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).
PMID: 28728650
ISSN: 1876-7605
CID: 2640202

Relationship between neutrophil-lymphocyte ratio and severity of lower extremity peripheral artery disease

Teperman, Jacob; Carruthers, David; Guo, Yu; Barnett, Mallory P; Harris, Adam A; Sedlis, Steven P; Pillinger, Michael; Babaev, Anvar; Staniloae, Cezar; Attubato, Michael; Shah, Binita
BACKGROUND: The aim of this study was to determine the association between neutrophil-lymphocyte ratio (NLR) and severity of lower extremity peripheral artery disease (PAD). METHODS: A retrospective chart review identified 928 patients referred for peripheral angiography. NLR was assessed from routine pre-procedural hemograms with automated differentials and available in 733 patients. Outcomes of interest were extent of disease on peripheral angiography and target vessel revascularization. Median follow-up was 10.4months. Odds ratio (OR) [95% confidence intervals] was assessed using a logistic regression model. RESULTS: There was a significant association between elevated NLR and presence of severe multi-level PAD versus isolated suprapopliteal or isolated infrapopliteal disease (OR 1.11 [1.03-1.19], p=0.007). This association remained significant even after adjustment for age (OR 1.09 [1.01-1.17], p=0.02); age, sex, race, and body mass index (OR 1.08 [1.00-1.16], p=0.046); and age, sex, race, body mass index, hypertension, diabetes mellitus, coronary artery disease, and creatinine (OR 1.07 [1.00-1.15], p=0.049). After additional adjustment for clinical presentation, there was a trend towards association between NLR and severe multi-level PAD (OR 1.07 [1.00-1.15], p=0.056), likely limited by sample size. In patients who underwent endovascular intervention (n=523), there was no significant difference in rate of target vessel revascularization across tertiles of NLR (1st tertile 14.8%, 2nd tertile 14.1%, 3rd tertile 20.1%; p=0.32). CONCLUSION: In a contemporary cohort of patients undergoing peripheral angiography with possible endovascular intervention, elevated NLR was independently associated with severe multi-level PAD. Larger studies evaluating the association between this inexpensive biomarker and clinical outcomes are warranted.
PMID: 27865186
ISSN: 1874-1754
CID: 2311112

Bare Metal Stent, Durable Polymer Drug Eluting Stent, or Biodegradable Polymer Drug Eluting Stent in Patients with Diabetes Mellitus - A Mixed Treatment Comparison Analysis of 63,940 Patient-Years of Follow-up from Randomized Trials [Meeting Abstract]

Toklu, Bora; Bangalore, Sripal; Kaul, Upendra; Attubato, Michael; Feit, Frederick; Bhatt, Deepak
ISI:000397332900442
ISSN: 0735-1097
CID: 3589392

The assessment of thrombotic markers utilizing ionic versus non-ionic contrast during coronary angiography and intervention trial

Shah, Binita; Berger, Jeffrey S; Allen, Nicole; Guo, Yu; Sedlis, Steven P; Xu, Jinfeng; Perez, Adriana; Attubato, Michael; Slater, James; Feit, Frederick
OBJECTIVE: To determine how two different types of iodinated contrast media (CM), low-osmolar ionic dimer ioxaglate (Hexabrix) and iso-osmolar non-ionic dimer iodixanol (Visipaque), affect multiple indices of hemostasis. BACKGROUND: In vitro models demonstrate differential effects of ionic and non-ionic CM on markers of hemostasis. METHODS: This blinded endpoint trial randomized 100 patients to ioxaglate or iodixanol. The primary endpoint was change in endogenous thrombin potential (ETP) following diagnostic angiography. Secondary endpoints included change in markers of fibrinolysis [tissue plasminogen activator (tPA) and plasminogen activator inhibitor 1 (PAI-1)] and platelet aggregation following diagnostic angiography and percutaneous coronary intervention (PCI) with bivalirudin. Data are presented as median [interquartile range]. RESULTS: ETP significantly decreased after diagnostic angiography in both ioxaglate (baseline 1810 nM*minute [1540-2089] to post-angiography 649 nM*minute [314-1347], p < 0.001) and iodixanol groups (baseline 1682 nM*minute [1534-2147] to post-angiography 681 nM*minute [229-1237], p < 0.001), but the decrease was not different between CM (p = 0.70). There was a significant increase in ETP during PCI (n = 45), despite the use of bivalirudin, suggesting a prothrombotic effect of PCI (post-angiography 764 nM*minute [286-1283] to post-PCI 1081 nM*minute [668-1552], p = 0.02). There were no significant differential effects on tPA, PAI-1, and markers of platelet activity. CONCLUSION: There were no significant differential effects between ioxaglate and iodixanol. Both CM led to significant reductions in thrombin generation and no significant effects on fibrinolytic activity or platelet activity, thereby contributing to a favorable antithrombotic milieu. (c) 2015 Wiley Periodicals, Inc.
PMCID:4947456
PMID: 26773574
ISSN: 1522-726x
CID: 1912822

Treatment of Angio-Seal-Related Femoral Artery Occlusion Using Directional Atherectomy-Primary Results and Midterm Follow-Up

Babaev, Anvar; Gokhale, Rohit; Zavlunova, Susanna; Attubato, Michael
OBJECTIVE: We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. BACKGROUND: Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. METHODS: We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 +/- 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. CONCLUSION: The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes.
PMID: 27852881
ISSN: 1938-9116
CID: 2431172

Effect of Left Versus Right Radial Artery Approach for Coronary Angiography on Radiation Parameters in Patients With Predictors of Transradial Access Failure

Shah, Binita; Burdowski, Joseph; Guo, Yu; Velez de Villa, Bryan; Huynh, Andrew; Farid, Meena; Maini, Mansi; Serrano-Gomez, Claudia; Staniloae, Cezar; Feit, Frederick; Attubato, Michael J; Slater, James; Coppola, John
Left transradial approach (TRA) for coronary angiography is associated with lower radiation parameters than right TRA in an all-comers population. The aim of this study was to determine the effects of left versus right TRA on radiation parameters in patients with predictors of TRA failure. Patients with predictors of TRA failure (>/=3 of 4 following criteria: age >/=70 years, female gender, height
PMCID:4976048
PMID: 27328954
ISSN: 1879-1913
CID: 2159122

Relationship between neutrophil-lymphocyte ratio and severity of lower extremity peripheral artery disease in patients undergoing peripheral angiography [Meeting Abstract]

Teperman, J; Barnett, M P; Carruthers, D; Pillinger, M; Sedlis, S P; Babaev, A; Attubato, M; Staniloae, C S; Shah, B
Background: Unlike for coronary artery disease, the association between neutrophil-lymphocyte ratio (NLR) and peripheral artery disease (PAD) has not been well established. The aim of this study was to determine the association between neutrophil-lymphocyte ratio and the severity of lower extremity peripheral artery disease. Methods: A retrospective chart review analysis identified 928 patients referred for peripheral angiography at a tertiary care center between December 2012 and June 2015. NLR was assessed from routine pre-procedural hemograms with automated differentials and available in 733 (79%) patients. Outcomes of interest included extent of disease on peripheral angiography and target vessel revascularization. Median follow-up was 10.4 months. Odds ratio (OR) [95% confidence intervals] was assessed using a logistic regression model. Results: There was a significant association between elevated NLR and the presence of severe multi-level PAD versus isolated suprapopliteal or isolated infrapopliteal disease (OR 1.42 [1.18-1.70], p=<0.001). This association between NLR and severe multi-level PAD remained significant even after adjustment for age (OR 1.31 [1.09-1.58], p=0.004); age, sex, race, and body mass index (OR 1.27 [1.05-1.5], p=0.015); and age, sex, race, body mass index, hypertension, diabetes, coronary artery disease, and creatinine (OR 1.25 [1.03-1.53], p=0.024). In patients who underwent endovascular intervention (n=523), there was no significant difference in the rate of target vessel revascularization on follow-up across tertiles of NLR (1st tertile 14.8%, 2nd tertile 14.1%, 3rd tertile 20.1%; p= 0.32). Conclusion: In a contemporary cohort of patients undergoing peripheral angiography with possible endovascular intervention, elevated NLR was independently associated with severe multi-level PAD
EMBASE:72281982
ISSN: 1522-726x
CID: 2151582