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Resistant in-stent restenosis in the drug eluting stent era
Theodoropoulos, Kleanthis; Mennuni, Marco G; Dangas, George D; Meelu, Omar A; Bansilal, Sameer; Baber, Usman; Sartori, Samantha; Kovacic, Jason C; Moreno, Pedro R; Sharma, Samin K; Mehran, Roxana; Kini, Annapoorna S
BACKGROUND:In the drug eluting stent (DES) era, repeat in-stent restenosis (ISR) of the same coronary lesion, despite percutaneous coronary intervention (PCI), is a rare but challenging problem that has not been reported. We aim to describe what we propose as the occurrence of "resistant"-ISR (R-ISR) in the DES era, including angiographic patterns and outcomes. METHODS:We defined R-ISR as the recurrence of an ISR episode after successful treatment of the same lesion. We identified 276 consecutive patients with 291 lesions who had R-ISR between May 2003 and June 2012. Quantitative coronary angiography (QCA) was performed for the first and second ISR episodes. Outcomes at one year, including death, myocardial infarction (MI), and target lesion failure (TLF), were analyzed. RESULTS:Patients with R-ISR had a high frequency of diabetes (62%), chronic kidney disease (39%), bifurcation lesions (51%), and moderate to severe calcified lesions (52%). The most common pattern of R-ISR was focal (77%). R-ISR lesions were treated with DES implantation (55%) or balloon-only strategy (45%). The mortality rate and TLF at 2-years were 9.3% and 51% respectively. The overall 2-year TLF rate did not vary with the originally implanted stent, angiographic pattern (focal versus diffuse), or revascularization strategy. CONCLUSIONS:R-ISR appears to consist predominantly of focal lesions and occurs in patients at high clinical and angiographic risk, conceivably owing to their unique diabetic and coronary calcification profile. Clinical outcomes are suboptimal irrespective of angiographic pattern or treatment strategy, indicating the recalcitrant nature of the disease, and need for aggressive treatment of cardiovascular risk factors and novel interventional approaches. © 2016 Wiley Periodicals, Inc.
PMID: 27184223
ISSN: 1522-726x
CID: 2980432
Balancing the Risk of Bleeding and Stroke in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the AVIATOR Registry)
Mennuni, Marco G; Halperin, Jonathan L; Bansilal, Sameer; Schoos, Mikkel M; Theodoropoulos, Kleanthis N; Meelu, Omar A; Sartori, Samantha; Giacoppo, Daniele; Bernelli, Chiara; Moreno, Pedro R; Krishnan, Prakash; Baber, Usman; Lucarelli, Carla; Dangas, George D; Sharma, Samin K; Kini, Annapoorna S; Tamburino, Corrado; Chieffo, Alaide; Colombo, Antonio; Presbitero, Patrizia; Mehran, Roxana
Patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) are at elevated risk for bleeding and thromboembolic ischemic events. Currently, guidelines on antithrombotic treatment for these patients are based on weak consensus. We describe patterns and determinants of antithrombotic prescriptions in this population. The Antithrombotic Strategy Variability in Atrial Fibrillation and Obstructive Coronary Disease Revascularized with PCI Registry was an international observational study of 859 consecutive patients with AF who underwent PCI from 2009 to 2011. Patients were stratified by treatment at discharge with either dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) or triple therapy (TT; warfarin plus DAPT). Bleeding and thromboembolism risks were assessed by the HAS-BLED and CHADS2 scores, respectively, and predictors of TT prescription at discharge were identified. Major adverse cardiovascular events and clinically relevant bleeding (Bleeding Academic Research Consortium score >/=2) at 1-year follow-up were compared across antithrombotic regimens. Compared with patients on DAPT (n = 488; 57%), those given TT (n = 371; 43%) were older, with higher CHADS2 scores, lower left ventricular ejection fraction, and more often had permanent AF, single-vessel coronary artery disease, and bare-metal stents. In multivariate analysis, increasing thromboembolic risk (CHADS2) was associated with a higher rate of TT prescription at discharge (intermediate vs low CHADS2: odds ratio 2.2, 95% confidence interval [CI] 2.0 to 3.3, p <0.01; high vs low CHADS2: odds ratio 1.6, 95% CI 2.6 to 4.3, p <0.01 for TT). However, there was no significant association between bleeding risk and TT prescription in the overall cohort or within each CHADS2 risk stratum. The rates of major adverse cardiovascular events were similar for patients discharged on TT or DAPT (20% vs 17%, adjusted hazard ratio 0.8, 95% CI 0.5 to 1.1, p = 0.19), whereas the rate of Bleeding Academic Research Consortium >/=2 bleeding was higher in patients discharged on TT (11.5% vs 6.4%, adjusted hazard ratio 1.8, 95% CI 1.1 to 2.9, p = 0.02). In conclusion, the choice of the intensity of antithrombotic therapy correlated more closely with the risk of ischemic rather than bleeding events in this cohort of patients with AF who underwent PCI.
PMID: 25956624
ISSN: 1879-1913
CID: 1569762
Gender-specific outcomes after balloon aortic valvuloplasty: Inhospital and long-term outcomes
Christodoulidis, Georgios; Yu, Jennifer; Kini, Annapoorna; Dangas, George D; Baber, Usman; Melissa, Aquino; Sartori, Samantha; Theodoropoulos, Kleanthis; Bhat, Arjun; Kovacic, Jason; Moreno, Pedro; Krishnan, Prakash; Mehran, Roxana; Sharma, Samin
BACKGROUND: Increasing numbers of balloon aortic valvuloplasty (BAV) are performed in the management of symptomatic aortic stenosis as bridge and therapeutic challenge in the work-up for transcatheter aortic valve replacement. However, the significance of gender in outcomes following BAV remains controversial. METHODS: We retrospectively reviewed 664 consecutive patients who underwent BAV from January 2005 to December 2012. Patients were stratified according to gender. Clinical and procedural characteristics as well as in-hospital outcomes and 1-year mortality were collected. Cumulative survival curves for women and men were constructed using the Kaplan-Meier method and were compared by the log-rank test. Cox regression analysis was performed to identify the independent effect of sex on 1-year mortality. RESULTS: Of the 664 patients, 333 (52%) were women. Women had lower body surface area, tended to be frailer and were less likely to have history of coronary artery disease. Women were more likely to present with heart failure whereas men presented more commonly with chest pain. In hospital death was significantly higher in women compared to men, mainly driven by the difference in cardiac death (8.1% vs 3.9%, P = .02 and 6.3% vs 2.6%, P = .02 respectively). One-year mortality rates were similar in women and men (25.4% vs 29.4%, P = .42) and after multivariate analysis gender had no association with 1-year mortality (HR = 0.9, P = .65). CONCLUSIONS: Significant differences exist in baseline characteristics and presentation between genders. Although in hospital mortality after BAV was significantly higher in women, 1-year mortality was similar between women and men.
PMID: 26093880
ISSN: 1097-6744
CID: 1641332
Comparison of Provisional 1-Stent and 2-Stent Strategies in Diabetic Patients With True Bifurcation Lesions: The EES Bifurcation Study
Meelu, Omar A; Tomey, Matthew I; Sartori, Samantha; Kherada, Nisharahmed; Mennuni, Marco G; Theodoropoulos, Kleanthis N; Sayeneni, Swapna; Baber, Usman; Pyo, Robert T; Kovacic, Jason C; Moreno, Pedro; Krishnan, Prakash; Mehran, Roxana; Dangas, George D; Kini, Annapoorna S; Sharma, Samin K
BACKGROUND: Percutaneous coronary intervention (PCI) of true bifurcation lesions (Medina classification 1, 1, 1; 1, 0, 1; or 0, 1, 1) is challenging and may involve either a 1-stent strategy with provisional side branch stenting, or a 2-stent strategy. Diabetes mellitus is associated with greater atherosclerotic burden and higher incidence of bifurcation lesions, and unfavorable outcomes after PCI. It is unknown whether use of newer everolimus-eluting stent (EES) implantation impacts relative outcomes of 1-stent and 2-stent strategies in patients with diabetes. METHODS: We performed a retrospective analysis of consecutive patients with diabetes mellitus and complex true bifurcation lesions (side branch diameter >2.0 mm) who underwent PCI with EES between February 2010 and December 2011. We grouped subjects based on initial treatment to a 1-stent (n = 81) or 2-stent (n = 54) strategy, and compared baseline characteristics, quantitative coronary angiography, and 1-year major adverse cardiovascular event (MACE) rates, defined as death, myocardial infarction, target lesion revascularization (TLR), or target vessel revascularization (TVR). RESULTS: Baseline characteristics were well matched. A 2-stent strategy was associated with larger side-branch reference vessel diameter at baseline and post PCI. In-hospital events included 1 periprocedural myocardial infarction in each group and no deaths. At 1 year, there was no significant difference between 1-stent and 2-stent strategies in TVR rates (6.2% vs 3.7%; P=.53), TLR (both 3.7%; P>.99), or MACE (7.4% vs 3.7%; P=.37). CONCLUSION: In this series of diabetic patients undergoing complex bifurcation PCI using EES implantation, there was no difference between 1-stent and 2-stent strategies with respect to ischemic events at 1 year.
PMID: 25480989
ISSN: 1042-3931
CID: 1371342
Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)
Dangas, George D; Serruys, Patrick W; Kereiakes, Dean J; Hermiller, James; Rizvi, Ali; Newman, William; Sudhir, Krishnankutty; Smith, Robert S Jr; Cao, Sherry; Theodoropoulos, Kleanthis; Cutlip, Donald E; Lansky, Alexandra J; Stone, Gregg W
OBJECTIVES: This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes. BACKGROUND: Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up. METHODS: We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis. RESULTS: At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other). CONCLUSIONS: In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.
PMID: 24050859
ISSN: 1876-7605
CID: 749312
Pregnancy-Induced Disorders Identify High-Risk Women who Benefit from Cardiovascular Screening: Results from the Women's Heart Health Initiative, an OB/GYN Screening Pilot Program [Meeting Abstract]
Yu, Jennifer; Johnson, Jerri A.; Theodoropoulos, Kleanthis; Mungee, Sudhir; Couri, Michele A.; Malasky, Beth; Wild, Robert A.; Dobies, David; Badin, Auroa; Vadde, Raj; Sartori, Samantha; Sergie, Ziad; Baber, Usman; Mehran, Roxana
ISI:000208885008394
ISSN: 0009-7322
CID: 3853592