12 results on '"Mikhail, Ghada W."'
Search Results
2. Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents
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Baber, Usman, Stefanini, Giulio G, Giustino, Gennaro, Stone, Gregg W, Leon, Martin B, Sartori, Samantha, Aquino, Melissa, Steg, P Gabriel, Windecker, Stephan, Wijns, William, Serruys, Patrick W, Valgimigli, Marco, Morice, Marie-Claude, Camenzind, Edoardo, Weisz, Giora, Smits, Pieter C, Kandzari, David E, Von Birgelen, Clemens, Dangas, George D, Galatius, Soren, Jeger, Raban V, Kimura, Takeshi, Mikhail, Ghada W, Itchhaporia, Dipti, Mehta, Laxmi, Ortega, Rebecca, Kim, Hyo-Soo, Kastrati, Adnan, Chieffo, Alaide, and Mehran, Roxana
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Time Factors ,Coronary Thrombosis ,Myocardial Infarction ,Drug-Eluting Stents ,Coronary Artery Disease ,Middle Aged ,Prosthesis Design ,Risk Assessment ,Diabetes Mellitus, Type 1 ,Percutaneous Coronary Intervention ,Sex Factors ,Treatment Outcome ,Diabetes Mellitus, Type 2 ,Risk Factors ,Cause of Death ,Humans ,Female ,610 Medicine & health ,Aged ,Randomized Controlled Trials as Topic - Abstract
BACKGROUND Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new- versus early-generation DES vary by DM status. METHODS AND RESULTS We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively ( Ptrend
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- 2019
3. Impact of percutaneous revascularization on exercise hemodynamics in patients with stable coronary disease
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Cook, Christopher M., Ahmad, Yousif, Howard, James P., Shun-Shin, Matthew J., Sethi, Amarjit, Clesham, Gerald J., Tang, Kare H., Nijjer, Sukhjinder S., Kelly, Paul A., Davies, John R., Malik, Iqbal S., Kaprielian, Raffi R., Petraco, Ricardo, Mikhail, Ghada W., Al-Janabi, Firas, Karamasis, Grigoris V., Mohdnazri, Shah R., Gamma, Reto A., Al-Lamee, Rasha, Keeble, Thomas R., Mayet, Jamil, Sen, Sayan, Francis, Darrel P., Davies, Justin E., Medical Research Council (MRC), and British Heart Foundation
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surgical procedures, operative ,Cardiovascular System & Hematology ,cardiovascular diseases ,therapeutics ,1102 Cardiorespiratory Medicine and Haematology ,1117 Public Health and Health Services - Abstract
Background: Recently, the therapeutic benefits of percutaneous coronary intervention (PCI) have been challenged in patients with stable coronary artery disease (SCD).\ud \ud Objectives: The authors examined the impact of PCI on exercise responses in the coronary circulation, the microcirculation, and systemic hemodynamics in patients with SCD.\ud \ud Methods: A total of 21 patients (mean age 60.3 ± 8.4 years) with SCD and single-vessel coronary stenosis underwent cardiac catheterization. Pre-PCI, patients exercised on a supine ergometer until rate-limiting angina or exhaustion. Simultaneous trans-stenotic coronary pressure-flow measurements were made throughout exercise. Post-PCI, this process was repeated. Physiological parameters, rate-limiting symptoms, and exercise performance were compared between pre-PCI and post-PCI exercise cycles.\ud \ud Results: PCI reduced ischemia as documented by fractional flow reserve value (pre-PCI 0.59 ± 0.18 to post-PCI 0.91 ± 0.07), instantaneous wave-free ratio value (pre-PCI 0.61 ± 0.27 to post-PCI 0.96 ± 0.05) and coronary flow reserve value (pre-PCI 1.7 ± 0.7 to post-PCI 3.1 ± 1.0; p < 0.001 for all). PCI increased peak-exercise average peak coronary flow velocity (p < 0.0001), coronary perfusion pressure (distal coronary pressure; p < 0.0001), systolic blood pressure (p = 0.01), accelerating wave energy (p < 0.001), and myocardial workload (rate-pressure product; p < 0.01). These changes observed immediately following PCI resulted from the abolition of stenosis resistance (p < 0.0001). PCI was also associated with an immediate improvement in exercise time (+67 s; 95% confidence interval: 31 to 102 s; p < 0.0001) and a reduction in rate-limiting angina symptoms (81% reduction in rate-limiting angina symptoms post-PCI; p < 0.001).\ud \ud Conclusions: In patients with SCD and severe single-vessel stenosis, objective physiological responses to exercise immediately normalize following PCI. This is seen in the coronary circulation, the microcirculation, and systemic hemodynamics.
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- 2018
4. Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Predicts Hemodynamic Outcome In Humans With Coronary Artery Disease Primary Results of the International Multicenter iFR GRADIENT Registry
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Kikuta, Yuetsu, Cook, Christopher M., Sharp, Andrew S. P., Salinas, Pablo, Kawase, Yoshiaki, Shiono, Yasutsugu, Giavarini, Alessandra, Nakayama, Masafumi, de Rosa, Salvatore, Sen, Sayan, Nijjer, Sukhjinder S., Al-Lamee, Rasha, Petraco, Ricardo, Malik, Iqbal S., Mikhail, Ghada W., Kaprielian, Raffi R., Wijntjens, Gilbert W. M., Mori, Shinsuke, Hagikura, Arata, Mates, Martin, Mizuno, Atsushi, Hellig, Farrel, Lee, Kelvin, Janssens, Luc, Horie, Kazunori, Mohdnazri, Shah, Herrera, Raul, Krackhardt, Florian, Yamawaki, Masahiro, Davies, John, Takebayashi, Hideo, Keeble, Thomas, Haruta, Seiichi, Ribichini, Flavio, Indolfi, Ciro, Mayet, Jamil, Francis, Darrel P., Piek, Jan J., di Mario, Carlo, Escaned, Javier, Matsuo, Hitoshi, Davies, Justin E., Medical Research Council (MRC), ACS - Atherosclerosis & ischemic syndromes, Graduate School, Cardiology, and ACS - Microcirculation
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Science & Technology ,Cardiac & Cardiovascular Systems ,LESIONS ,stenosis ,PRESSURE MEASUREMENT ,1102 Cardiovascular Medicine And Haematology ,physiological lesion assessment ,VALIDATION ,SEVERITY ,MYOCARDIAL-INFARCTION ,Cardiovascular System & Hematology ,FRACTIONAL FLOW RESERVE ,Cardiovascular System & Cardiology ,instantaneous wave-Free Ratio ,SERIAL STENOSES ,Life Sciences & Biomedicine ,INTERVENTION ,coronary artery disease ,INDEX ,RESISTANCE - Abstract
Objectives: The authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings. Background: In tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested. Methods: Angiographically intermediate tandem and/or diffuse lesions were entered into the international, multicenter iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared. Results: Mean age was 67 ± 12 years (81% male). Paired pre- and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93 ± 0.05; observed actual iFR was 0.92 ± 0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4 ± 0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (−0.18 ± 0.05 lesion/vessel; p = 0.0001) and length (−4.4 ± 1.0 mm/vessel; p < 0.0001). Conclusions: In tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback altered revascularization procedural planning in nearly one-third of patients.
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- 2018
5. Pre-Angioplasty Instantaneous Wave-Free Ratio Pullback Predicts Hemodynamic Outcome In Humans With Coronary Artery Disease: Primary Results of the International Multicenter iFR GRADIENT Registry
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Kikuta, Yuetsu, Cook, Christopher M, Sharp, Andrew S P, Salinas, Pablo, Kawase, Yoshiaki, Shiono, Yasutsugu, Giavarini, Alessandra, Nakayama, Masafumi, De Rosa, Salvatore, Sen, Sayan, Nijjer, Sukhjinder S, Al-Lamee, Rasha, Petraco, Ricardo, Malik, Iqbal S, Mikhail, Ghada W, Kaprielian, Raffi R, Wijntjens, Gilbert W M, Mori, Shinsuke, Hagikura, Arata, Mates, Martin, Mizuno, Atsushi, Hellig, Farrel, Lee, Kelvin, Janssens, Luc, Horie, Kazunori, Mohdnazri, Shah, Herrera, Raul, Krackhardt, Florian, Yamawaki, Masahiro, Davies, John, Takebayashi, Hideo, Keeble, Thomas, Haruta, Seiichi, Ribichini, Flavio, Indolfi, Ciro, Mayet, Jamil, Francis, Darrel P, Piek, Jan J, Di Mario, Carlo, Escaned, Javier, Matsuo, Hitoshi, and Davies, Justin E
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Male ,Cardiac Catheterization ,Clinical Decision-Making ,stenosis ,Hemodynamics ,Reproducibility of Results ,Hyperemia ,Coronary Artery Disease ,Middle Aged ,Coronary Angiography ,coronary artery disease ,instantaneous wave-Free Ratio ,physiological lesion assessment ,Coronary Vessels ,Percutaneous Coronary Intervention ,Treatment Outcome ,Predictive Value of Tests ,Coronary Circulation ,Humans ,Female ,Prospective Studies ,Registries ,Aged - Abstract
The authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings.In tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested.Angiographically intermediate tandem and/or diffuse lesions were entered into the international, multicenter iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared.Mean age was 67 ± 12 years (81% male). Paired pre- and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93 ± 0.05; observed actual iFR was 0.92 ± 0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4 ± 0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (-0.18 ± 0.05 lesion/vessel; p = 0.0001) and length (-4.4 ± 1.0 mm/vessel; p 0.0001).In tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback altered revascularization procedural planning in nearly one-third of patients.
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- 2017
6. Effect of Increasing Stent Length on 3-Year Clinical Outcomes in Women Undergoing Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents: Patient-Level Pooled Analysis of Randomized Trials From the WIN-DES Initiative
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Chandrasekhar, Jaya, Baber, Usman, Sartori, Samantha, Stefanini, Giulio G, Sarin, Michele, Vogel, Birgit, Farhan, Serdar, Camenzind, Edoardo, Leon, Martin B, Stone, Gregg W, Serruys, Patrick W, Wijns, William, Steg, Philippe G, Weisz, Giora, Chieffo, Alaide, Kastrati, Adnan, Windecker, Stephan, Morice, Marie-Claude, Smits, Pieter C, Von Birgelen, Clemens, Mikhail, Ghada W, Itchhaporia, Dipti, Mehta, Laxmi, Kim, Hyo-Soo, Valgimigli, Marco, Jeger, Raban V, Kimura, Takeshi, Galatius, Søren, Kandzari, David, Dangas, George, and Mehran, Roxana
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Time Factors ,Databases, Factual ,Drug-Eluting Stents ,Coronary Artery Disease ,Middle Aged ,Prosthesis Design ,Risk Assessment ,Percutaneous Coronary Intervention ,Postoperative Complications ,Sex Factors ,Treatment Outcome ,Risk Factors ,Humans ,Female ,cardiovascular diseases ,610 Medicine & health ,Aged ,Randomized Controlled Trials as Topic - Abstract
OBJECTIVES The aim of this study was to examine whether stent length per patient and stent length per lesion are negative markers for 3-year outcomes in women following percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES). BACKGROUND In the era of advanced stent technologies, whether stent length remains a correlate of adverse outcomes is unclear. METHODS Women treated with new-generation DES in 14 randomized trials from the WIN-DES (Women in Innovation and Drug-Eluting Stents) pooled database were evaluated. Total stent length per patient, which was available in 5,403 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 24 mm; quartile 3, 24 to 36 mm; quartile 4, ≥36 mm), and stent length per lesion, which was available in 5,232 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 20 mm; quartile 3, 20 to 27 mm; quartile 4, ≥27 mm) were analyzed in quartiles. The primary endpoint was 3-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, or target lesion revascularization. RESULTS In the per-patient analysis, a stepwise increase was observed with increasing stent length in the adjusted risk for 3-year MACE (p for trend
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- 2017
7. Correlates and Impact of Coronary Artery Calcifications in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents From the Women in Innovation and Drug-Eluting Stents (WIN-DES) Collaboration
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Chieffo, Alaide, Von Birgelen, Clemens, Steg, P Gabriel, Kim, Hyo-Soo, Stone, Gregg W, Aquino, Melissa, Dangas, George D, Leon, Martin B, Mehran, Roxana, Mehta, Laxmi, Sartori, Samantha, Kandzari, David, Kastrati, Adnan, Serruys, Patrick W, Mastoris, Ioannis, Valgimigli, Marco, Jeger, Raban V, Baber, Usman, Mikhail, Ghada W, Wijns, William, Windecker, Stephan, Galatius, Soren, Kimura, Takeshi, Ortega, Rebecca, Morice, Marie-Claude, Weisz, Giora, Stefanini, Giulio, Smits, Pieter C, Itchhaporia, Dipti, Giustino, Gennaro, Camenzind, Edoardo, Cardiology, Health Technology & Services Research, and Faculty of Behavioural, Management and Social Sciences
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Time Factors ,Myocardial Infarction ,Coronary Artery Disease ,Kaplan-Meier Estimate ,Coronary Angiography ,Prosthesis Design ,Risk Assessment ,Severity of Illness Index ,Percutaneous Coronary Intervention ,Sex Factors ,Risk Factors ,Odds Ratio ,Humans ,cardiovascular diseases ,610 Medicine & health ,Vascular Calcification ,Aged ,Proportional Hazards Models ,Randomized Controlled Trials as Topic ,Aged, 80 and over ,Evidence-Based Medicine ,Coronary Thrombosis ,Drug-Eluting Stents ,Middle Aged ,n/a OA procedure ,Logistic Models ,Treatment Outcome ,Female - Abstract
Objectives: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES). Background: The clinical correlates and the prognostic significance of CAC in women undergoing percutaneous coronary intervention with DES remain unclear. Methods: Patient-level data from female participants in 26 randomized trials of DES were pooled. Study population was categorized according to the presence of moderate or severe versus mild or no target lesion CAC, assessed through coronary angiography. Co–primary endpoints of interest were the composite of death, myocardial infarction (MI), or target lesion revascularization and death, MI, or stent thrombosis at 3-year follow-up. Results: Among 11,557 women included in the pooled dataset, CAC status was available in 6,371 women. Of these, 1,622 (25.5%) had moderate or severe CAC. In fully adjusted models, independent correlates of CAC were age, hypertension, hypercholesterolemia, smoking, previous coronary artery bypass graft surgery, and worse left ventricular and renal function. At 3 years, women with CAC were at higher risk for death, MI, or target lesion revascularization (18.2% vs. 13.1%; adjusted hazard ratio: 1.56; 95% confidence interval: 1.33 to 1.84; p < 0.0001) and death, MI, or stent thrombosis (12.7% vs. 8.6%; adjusted hazard ratio: 1.48; 95% confidence interval: 1.21 to 1.80; p = 0.0001). The adverse effect of CAC on ischemic outcomes appeared to be consistent across clinical and angiographic subsets of women, including new-generation DES. Conclusions: Women undergoing PCI of calcified lesions tend to have worse clinical profile and remain at increased ischemic risk, irrespective of new-generation DES.
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- 2016
8. Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents A Patient-Level Pooled Analysis of Randomized Controlled Trials
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Baber, Usman, Giustino, Gennaro, Sartori, Samantha, Aquino, Melissa, Stefanini, Giulio G., Steg, Gabriel, Windecker, Stephan, Leon, Martin B., Wijns, William, Serruys, Patrick W., Valgimigli, Marco, Stone, Gregg W., Dangas, George D., Morice, Marie-Claude, Camenzind, Edoardo, Weisz, Giora, Smits, Pieter C., Kandzari, David E., von Birgelen, Clemens, Mastoris, Ioannis, Galatius, Soren, Jeger, Raban V., Kimura, Takeshi, Mikhail, Ghada W., Itchhaporia, Dipti, Mehta, Laxmi, Ortega, Rebecca, Kim, Hyo-Soo, Kastrati, Adnan, Chieffo, Alaide, Mehran, Roxana, Cardiology, Health Technology & Services Research, and Faculty of Behavioural, Management and Social Sciences
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Time Factors ,Outcomes ,Comorbidity ,Coronary Artery Disease ,Kaplan-Meier Estimate ,Kidney ,Prosthesis Design ,Risk Assessment ,Percutaneous Coronary Intervention ,Risk Factors ,Chronic kidney disease ,Humans ,Women ,Renal Insufficiency, Chronic ,610 Medicine & health ,Aged ,Randomized Controlled Trials as Topic ,Drug-eluting stents (DES) ,Aged, 80 and over ,Drug-Eluting Stents ,Middle Aged ,n/a OA procedure ,Treatment Outcome ,Creatinine ,Multivariate Analysis ,Women's Health ,Female ,Biomarkers ,Glomerular Filtration Rate - Abstract
OBJECTIVES This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD). BACKGROUND The prevalence and effect of CKD in women undergoing PCI with DES is unclear. METHODS We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl)
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- 2016
9. Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents A Patient-Level Pooled Analysis of Randomized Controlled Trials
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Baber, Usman, Giustino, Gennaro, Sartori, Samantha, Aquino, Melissa, Stefanini, Giulio G., Steg, P. Gabriel, Windecker, Stephan, Leon, Martin B., Wijns, William, Serruys, Patrick W., Valgimigli, Marco, Stone, Gregg W., Dangas, George D., Morice, Marie-Claude, Camenzind, Edoardo, Weisz, Giora, Smits, Pieter C., Kandzari, David, Von Birgelen, Clemens, Mastoris, Ioannis, Galatius, Soren, Jeger, Raban V., Kimura, Takeshi, Mikhail, Ghada W., Itchhaporia, Dipti, Mehta, Laxmi, Ortega, Rebecca, Kim, Hyo-Soo, Kastrati, Adnan, Chieffo, Alaide, and Mehran, Roxana
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drug-eluting stents ,women ,outcomes ,chronic kidney disease - Abstract
ObjectivesThis study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD).BackgroundThe prevalence and effect of CKD in women undergoing PCI with DES is unclear.MethodsWe pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl)
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10. Influence of Sex on Long-Term Outcomes After Percutaneous Coronary Intervention With the Paclitaxel-Eluting Coronary Stent Results of the 'TAXUS Woman' Analysis
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Mikhail, Ghada W., Gerber, Robert T., Cox, David A., Ellis, Stephen G., Lasala, John M., Ormiston, John A., Stone, Gregg W., Turco, Mark A., Joshi, Anita A., Baim, Donald S., and Colombo, Antonio
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sex ,revascularization ,coronary disease ,drug-eluting stent(s) - Abstract
ObjectivesWe conducted the “TAXUS Woman” analysis to assess the influence of sex on long-term outcomes after percutaneous coronary intervention using paclitaxel-eluting stents (PES) in a broad spectrum of patients.BackgroundPrevious studies indicate that the sex gap suggesting worse outcomes in women has narrowed. However, limited data are available on long-term sex-based outcomes with drug-eluting stents despite their extensive use in current practice.MethodsWe analyzed 2,271 PES-treated patients (women = 665), from 5 randomized trials and 7,492 PES-treated patients (women = 2,449) from 2 “real-world” registries. The trial and registry datasets were stratified by sex to compare long-term outcomes. Additionally, the outcomes in PES-treated women were compared with bare-metal stent–treated women (n = 395) in the randomized trials.ResultsIn the randomized trials, PES-treated women had a lower target lesion revascularization (TLR) rate (11.5% vs. 22.6%, p < 0.001) than bare-metal stent–treated women, with no significant sex-based differences in death, myocardial infarction, stent thrombosis, or TLR through 5 years. In both the trials and the registries, although women had more adverse baseline characteristics including advanced age, hypertension, and diabetes, they had similar outcomes to men. In expanded-use patients, however, women showed significantly higher rates of death and TLR, although only the higher TLR rate was confirmed by multivariate analysis.ConclusionsThis study of nearly 10,000 patients including more than 3,000 women demonstrates that despite their higher-risk profile, women have comparable benefits to men from percutaneous coronary intervention with PES except for a slightly higher revascularization rate in the high-risk cohort.
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11. A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study
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Ghada W. Mikhail, Raffaele Piccolo, Dik Heg, Josepa Mauri Ferre, Peter Jüni, Serge Zaugg, Stephan Windecker, Maria Grazia Modena, Anna Franzone, Marie-Claude Morice, Liliana Grinfeld, Ruth H. Strasser, Franzone, Anna, Zaugg, Serge, Piccolo, Raffaele, Modena, Maria Grazia, Mikhail, Ghada W., Ferré, Josepa Mauri, Strasser, Ruth, Grinfeld, Liliana, Heg, Dik, Jüni, Peter, Windecker, Stephan, and Morice, Marie-Claude
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Cardiovascular Procedures ,medicine.medical_treatment ,Myocardial Infarction ,lcsh:Medicine ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Cardiovascular Medicine ,Pathology and Laboratory Medicine ,Vascular Medicine ,0302 clinical medicine ,Restenosis ,Drug-Eluting Stent ,Medicine and Health Sciences ,Coronary Heart Disease ,030212 general & internal medicine ,610 Medicine & health ,lcsh:Science ,Aged, 80 and over ,Stenosis ,Multidisciplinary ,Drug-Eluting Stents ,Hematology ,Middle Aged ,Everolimu ,Treatment Outcome ,Cardiovascular Diseases ,Cardiology ,360 Social problems & social services ,Aged ,Cardiovascular Agents ,Everolimus ,Humans ,Percutaneous Coronary Intervention ,Biochemistry, Genetics and Molecular Biology (all) ,Agricultural and Biological Sciences (all) ,Human ,Research Article ,medicine.medical_specialty ,Coronary Stenting ,Surgical and Invasive Medical Procedures ,03 medical and health sciences ,Signs and Symptoms ,Diagnostic Medicine ,Internal medicine ,Multicenter trial ,Cypher stent ,medicine ,Blood Coagulation ,Coagulation Disorders ,business.industry ,Revascularization ,lcsh:R ,Stent ,Percutaneous coronary intervention ,Thrombosis ,medicine.disease ,Surgery ,Cardiovascular Agent ,Cardiovascular agent ,Conventional PCI ,Stent Implantation ,Lesions ,lcsh:Q ,business - Abstract
BACKGROUND The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner. OBJECTIVES The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI). METHODS A total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR). RESULTS At 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036). CONCLUSIONS Among women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months. TRIAL REGISTRATION ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/.
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- 2017
12. Advances in percutaneous interventional therapies: The tricuspid valve
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Francesco Giannini, Antonio Colombo, Antonio Mangieri, Akihito Tanaka, Azeem Latib, Richard J. Jabbour, Ghada Mikhail, Jabbour, Richard J., Giannini, Francesco, Tanaka, Akihito, Mangieri, Antonio, Mikhail, Ghada W., Latib, Azeem, and Colombo, Antonio
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medicine.medical_specialty ,Percutaneous ,Heart disease ,Regurgitation (circulation) ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,medicine ,Humans ,030212 general & internal medicine ,Surgical treatment ,tricuspid regurgitation ,Heart Valve Prosthesis Implantation ,Tricuspid valve ,business.industry ,Treatment options ,medicine.disease ,Tricuspid Valve Insufficiency ,Surgical risk ,Surgery ,functional ,percutaneou ,Treatment Outcome ,medicine.anatomical_structure ,Latency stage ,Molecular Medicine ,Tricuspid Valve ,business ,Cardiology and Cardiovascular Medicine - Abstract
Tricuspid regurgitation (TR) is a prevalent valve condition, with an estimated 1.6 million people in the USA living with moderate or greater severity. Functional TR, which predominantly develops due to left-sided heart disease, is the predominant condition affecting the tricuspid valve in the Western world and severe TR is associated with substantial morbidity and mortality. In part, due to a prolonged latency period with insidious symptoms, patients are often referred for surgery at advanced stages, with associated increased or prohibitive surgical risk. In addition, surgical treatment can result in high rates of recurrence. Therefore, there is an unmet need for percutaneous therapies that may provide a relatively low-risk treatment option. There are several devices with early human feasibility data available that will be reviewed in this article.
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- 2017
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