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Cypher Versus Taxus: Are There Differences? 总被引：3，自引：0，他引：3
Silber S 《Journal of interventional cardiology》2005,18(6):441-446
Today, drug‐eluting stents (DES) are the standard stenting procedure in the USA and in Switzerland. The objective of this analysis is to answer the two questions: what clinically relevant data regarding DES have been published, and is there a clinically relevant difference between the Cypher and the Taxus stents? Twenty‐two randomized, controlled studies with a total of 11,118 patients were identified: 18 randomized studies compared a DES to a bare metal stent of identical design in 8,301 patients, and 4 randomized studies compared the Cypher and the Taxus stents in 2,817 patients. Three studies regarding Paclitaxel‐releasing stents without polymer (1,235 pats) and five studies regarding Paclitaxel released from a polymer (3,513 pats) were analyzed. Sirolimus released from a polymer was investigated in five studies (2,070 pats). Everolimus released from a polymer was investigated in three studies (166 pats), Biolimus A9 released from a polymer in one (120 pats), and Zotarolimus (ABT‐578) released from a polymer in also one (1,197 pats) trial. Thirteen studies chose either a surrogate primary endpoint (angiographic or IVUS) or a clinical endpoint insufficient for a power calculation. A primary clinical endpoint with an adequate sample size for a power calculation was chosen in three trials for the Taxus stent (TAXUS‐IV, TAXUS‐V, TAXUS‐VI; 2,916 patients), in one trial for the Cypher stent (SIRIUS; 1,058 patients), and in one trial for the Endeavor stent (ENDEAVOR‐II; 1,197 patients). In all these trials, the primary clinical endpoint was reached. Of the four studies comparing Cypher stents to Taxus stents, one did not define the primary endpoint (TAXi), two assumed superiority of the Cypher stent (REALITY with a surrogate endpoint and SIRTAX, a single‐center study), and one was designed as a non‐inferiority trial (ISAR‐Diabetes, single‐center study with a surrogate endpoint). Based on the European Society of Cardiology established strict criteria with a clinical primary endpoint as a prerequisite to recommend a DES, only three DES have thus far had proven positive effects on clinical outcome: the Cypher‐stents, Taxus‐stents, and Endeavor‐stents. A trial proving the superiority of one DES over another would require a multicenter study with a clinical primary endpoint at an adequate power. As long as such a trial does not exist, Cypher and Taxus are regarded as being equivalent. 相似文献
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Gianluigi Savarese Nicola Orsini Camilla Hage Ulf Dahlström Ola Vedin Giuseppe M.C. Rosano Lars H. Lund 《Journal of cardiac failure》2018,24(6):365-374
Background
The aim of this study was to characterize N-terminal pro–B-type natriuretic peptide (NT-proBNP) in terms of determinants of levels and of its prognostic and discriminatory role in heart failure with mid-range (HFmrEF) versus preserved (HFpEF) and reduced (HFrEF) ejection fraction.Methods and Results
In 9847 outpatients with HFpEF (n?=?1811; 18%), HFmrEF (n?=?2122; 22%) and HFrEF (n?=?5914; 60%) enrolled in the Swedish Heart Failure Registry, median NT-proBNP levels were 1428, 1540, and 2288?pg/mL, respectively. Many determinants of NT-proBNP differed by ejection fraction, with atrial fibrillation (AF) more important in HFmrEF and HFpEF, diabetes and hypertension in HFmrEF, and age and body mass index in HFrEF and HFmrEF, whereas renal function, New York Heart Association functional class, heart rate, and anemia were similar. Hazard ratios for death and death/HF hospitalization for NT-proBNP above the median ranged from 1.48 to 2.00 and were greatest for HFmrEF and HFpEF. Areas under the receiver operating characteristic curve for death and death/HF hospitalization were greater in HFmrEF than in HFpEF and HFrEF and were reduced by AF in HFpEF and HFmrEF but not in HFrEF.Conclusions
In HFpEF and especially HFmrEF, NT-proBNP was more prognostic and discriminatory, but also more affected by confounders such as AF. These data support the use of NT-proBNP for eligibility, enrichment, and surrogate end points in HFpEF and HFmrEF trials, and suggest that cutoff levels for eligibility should be carefully tailored to comorbidity. 相似文献5.
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Neil A. Smart Gudrun Dieberg Nicola King 《Journal of the American College of Cardiology》2018,71(9):983-991
Background
When comparing effects of on- versus off-pump coronary artery bypass grafting (CABG), it is important to assess the long-term clinical outcomes. However, most research conducted thus far has concentrated on short-term outcomes and ignored the long-term clinical outcomes, especially the 5-year outcomes of the largest randomized controlled trials.Objectives
The aim of this systematic review and meta-analysis was to investigate the long-term clinical outcomes of on- versus off-pump CABG.Methods
To identify potential studies systematic searches were carried out using various databases. The search strategy included the key concepts of cardiopulmonary bypass AND off-pump AND long term OR 5-year outcomes. This was followed by a meta-analysis investigating mortality, incidence of myocardial infarction, incidence of angina, need for revascularization, and incidence of stroke.Results
Six studies totaling 8,145 participants were analyzed. In the on-pump group mortality was 12.3%, compared with 13.9% in the off-pump group. The odds ratio (OR) for this comparison was 1.16 (95% confidence interval [CI]: 1.02 to 1.32; p = 0.03; 13.9% vs. 12.3%). In contrast, there were no differences in the incidence of myocardial infarction (OR: 1.06: 95% CI: 0.91 to 1.25; p = 0.45; 8.4% vs. 7.9%), incidence of angina (OR: 1.09; 95% CI: 0.75 to 1.57; p = 0.65; 2.3% vs. 2.1%), need for revascularization (OR: 1.15; 95% CI: 0.95 to 1.40; p = 0.16; 5.9% vs. 5.1%), and the incidence of stroke (OR: 0.78; 95% CI: 0.56 to 1.10; p = 0.16; 2.2% vs. 2.8%).Conclusions
Statistically, on-pump CABG appeared to offer superior long-term survival, although the clinical significance of this may be more uncertain. 相似文献8.
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J. C. Yugar-Toledo V. Brunelli J. F. Vilela-Martin A. Fattori H. Moreno 《Current hypertension reports》2018,20(3):26
Purpose of Review
Resistant hypertension (RHTN) is a condition in which besides the antihypertensive therapy using at least three different drugs (including a diuretics), brachial blood pressure does not reach the target (e.g., 140/90 mmHg).Recent Findings
Despite the diversity of clinical presentations, we divide RHTN in two major groups according to blood pressure and number of drugs taken: controlled (C-RHTN) and uncontrolled (UC-RHTN) resistant hypertension, with refractory hypertension (RfHTN) included in the latter subgroup.Both C-RHTN and UC-RHTN are heterogenic and complex syndromes. To better approach this matter, the some pathophysiological mechanisms (increased volemia, hyperactivity, plasma cortisol, adipocitokines, and other pro-inflammatory factors), have a pivotal clinical role.Some features (African ethnic, obesity, age >?60, LV hypertrophy, and vascular stiffness) increase the risk of refractoriness as well as worst prognosis. Based on increased target organ damage, cardiovascular risk and events will be addressed in this review.Summary
Our conclusion is that although both C-RHTN and UC-RHTN are extreme phenotypes of hard-to-control BP, some mechanisms of the disease and clinical expressions are distinct. According to these differences, “UC-RHTN and C-RHTN are not in the same bag.”14.
Coronary heart disease (CHD) is the leading cause of death in the United States. CHD risk differs between genders, with coronary events lagging behind ten years for women in comparison to men. Low-density lipoprotein cholesterol lowering with statin therapy is a major target for cardiovascular risk reduction. The benefit of statin therapy has been well established in men, for both primary and secondary prevention. However, the same has not been shown for women. While studies have demonstrated benefit in women for secondary prevention, their role in primary prevention of cardiovascular disease remains controversial. Data released over the past several years regarding statin efficacy and safety in men and women has been inconsistent, given that these studies had small sample sizes with numerous study limitations. A recent large scale meta-analysis of both primary and secondary statin prevention trials with sex-specific outcomes demonstrated a similar benefit in both men and women. Statins demonstrated a decrease in cardiovascular events and all-cause mortality in both sexes. In regards to statin safety, additional trials investigating the difference in adverse events of statins in men versus women, particularly new onset of diabetes, myalgias, and liver dysfunction, are warranted. Increased awareness and monitoring of female patients for myalgias and hyperglycemia should be considered as a precaution. Overall, women need to be better represented in prospective clinical trials powered to evaluate gender-specific differences in statin safety and efficacy in the management of cardiovascular disease. 相似文献
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Purpose of Review
The choice of optimum transplant in a patient with type 1 diabetes mellitus (T1DM) and chronic kidney disease stage V (CKD V) is not clear. The purpose of this review was to investigate this in more detail—in particular the choice between a simultaneous pancreas-kidney transplantation (SPKT) and living donor kidney transplantation (LDKT), including recent evidence, to aid clinicians and their patients in making an informed choice in their care.Recent Findings
Analyses of large databases have recently shown SPKT to have better survival rates than a LDKT in the long-term, despite an early increase in morbidity and mortality in SPKT recipients. This survival advantage has only been shown in those SPKT recipients with a functioning pancreas and not those who had early pancreas graft loss.Summary
The choice of SPKT or LDKT should not be based on patient and graft survival outcomes alone. Individual patient circumstances, preferences, and comorbidities, among other factors should form an important part of the decision-making process. In general, an SPKT should be considered in those patients not on dialysis and LDKT in those nearing or already on dialysis.16.
Wouter Ouwerkerk Aeilko H. Zwinderman Leong L. Ng Biniyam Demissei Hans L. Hillege Faiez Zannad Dirk J. van Veldhuisen Nilesh J. Samani Piotr Ponikowski Marco Metra Jozine M. ter Maaten Chim C. Lang Pim van der Harst Gerasimos Filippatos Kenneth Dickstein John G. Cleland Stefan D. Anker Adriaan A. Voors 《Journal of the American College of Cardiology》2018,71(4):386-398
Background
Heart failure guidelines recommend up-titration of angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blockers (ARBs), beta-blockers, and mineralocorticoid receptor antagonists (MRAs) to doses used in randomized clinical trials, but these recommended doses are often not reached. Up-titration may, however, not be necessary in all patients.Objectives
This study sought to establish the role of blood biomarkers to determine which patients should or should not be up-titrated.Methods
Clinical outcomes of 2,516 patients with worsening heart failure from the BIOSTAT-CHF (BIOlogy Study to Tailored Treatment in Chronic Heart Failure) were compared between 3 theoretical treatment scenarios: scenario A, in which all patients are up-titrated to >50% of recommended doses; scenario B, in which patients are up-titrated according to a biomarker-based treatment selection model; and scenario C, in which no patient is up-titrated to >50% of recommended doses. The study conducted multivariable Cox regression using 161 biomarkers and their interaction with treatment, weighted for treatment-indication bias to estimate the expected number of deaths or heart failure hospitalizations at 24 months for all 3 scenarios.Results
Estimated death or hospitalization rates in 1,802 patients with available (bio)markers were 16%, 16%, and 26%, respectively, in the ACE inhibitor/ARB up-titration scenarios A, B, and C. Similar rates for beta-blocker and MRA up-titration scenarios A, B, and C were 23%, 19%, and 24%, and 12%, 11%, and 24%, respectively. If up-titration was successful in all patients, an estimated 9.8, 1.3, and 12.3 events per 100 treated patients could be prevented at 24 months by ACE inhibitor/ARB, beta-blocker, and MRA therapy, respectively. Similar numbers were 9.9, 4.7, and 13.1 if up-titration treatment decision was based on a biomarker-based treatment selection model.Conclusions
Up-titrating patients with heart failure based on biomarker values might have resulted in fewer deaths or hospitalizations compared with a hypothetical scenario in which all patients were successfully up-titrated. 相似文献17.
Mohammad Abdelghani Nader Mankerious Abdelhakim Allali Martin Landt Jatinderjit Kaur Dmitriy S. Sulimov Constanze Merten Susanne Sachse Julinda Mehilli Franz-Josef Neumann Christian Frerker Thomas Kurz Mohamed El-Mawardy Gert Richardt Mohamed Abdel-Wahab 《JACC: Cardiovascular Interventions》2018,11(24):2507-2518
Objectives
The aim of this study was to compare self-expanding and balloon-expandable transcatheter heart valves (THVs) in large versus small aortic valve annuli.Background
The degree of THV oversizing varies according to annular size, and this can modify the hemodynamic performance of self-expanding and balloon-expandable THVs.Methods
Patients undergoing transcatheter aortic valve replacement in the randomized CHOICE (Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve vs Edwards SAPIEN XT) trial (CoreValve [CV], n = 120; SAPIEN XT [SXT], n = 121) and the nonrandomized CHOICE-Extend registry (Evolut R [ER], n = 100; SAPIEN 3 [S3], n = 334) were compared for THV performance by echocardiography (in all patients) and by cardiac magnetic resonance imaging (MRI) regurgitant fraction (RF) (in a subgroup of patients). Patients were stratified according to aortic valve annular mean diameter into those with large (>23 mm) or small (≤23 mm) annuli.Results
THV percentage oversizing was 19.1 ± 6.4% with the CV, 11.4 ± 7.0% with the SXT, 18.8 ± 4.8% with the ER, and 3.7 ± 5.5% with the S3. Transvalvular mean pressure gradient was lower with the CV and ER than with the SXT and S3 in both the large and small annulus groups. In the randomized CHOICE trial, moderate to severe prosthetic valve regurgitation (PVR) was more with the CV than the SXT in large annuli (15.1% vs. 0.0%; p = 0.002; MRI RF: 10.5 ± 10.2% vs. 4.4 ± 4.5%; p = 0.036) but not in small annuli (0.0% vs. 5.7%; p = 0.50; MRI RF: 4.0 ± 4.1% vs. 4.0 ± 3.4%; p = 0.98). In the CHOICE-Extend registry, moderate to severe PVR occurred in 2 patients, and any PVR was not significantly different between the ER and the S3 in large (41.7% vs. 32.5%; p = 0.24) or small (47.1% vs. 43.8%; p = 0.84) annuli. MRI RF was not different in large annuli (5.0 ± 3.8% vs. 5.0 ± 6.1%; p = 0.99) but was significantly lower with the ER than the S3 in small annuli (2.9 ± 2.3% vs. 4.8 ± 3.7%; p = 0.023). On multivariate analysis, transcatheter aortic valve replacement with the ER in small annuli was associated with a lower rate of prosthesis-patient mismatch than with the S3, with no increased risk for PVR.Conclusions
Older-generation balloon-expandable THVs were associated with less PVR than self-expanding THVs in patients with large but not small annuli. The next-generation self-expanding THV has improved sealing in patients with large annuli and may have potential advantages in patients with small annuli. 相似文献18.
David B. Reuben MD Thomas M. Gill MD Alan Stevens PhD Jeff Williamson MD Elena Volpi MD PhD Maya Lichtenstein MD Lee A. Jennings MD MSHS Zaldy Tan MD Leslie Evertson DNP RN GNP-BC David Bass PhD Lisa Weitzman MSSA LISW-S ASW-G C-ASWCM Martie Carnie Nancy Wilson MA MSW Katy Araujo MPH Peter Charpentier MPH Can Meng MS MPH Erich J. Greene PhD James Dziura PhD Jodi Liu PhD MSPH MSE BSE Erin Unger Mia Yang MD Katherine Currie BSPH MAT Kristin M. Lenoir MPH Aval-NaʼRee S. Green MD Sitara Abraham MPH Ashley Vernon MPH Rafael Samper-Ternent MD PhD Mukaila Raji MD MSc Roxana M. Hirst MS Rebecca Galloway PT PhD Glen R. Finney MD Ilene Ladd MS Alanna Kulchak Rahm PhD MS CGC Pamela Borek MSN RN-C Peter Peduzzi PhD 《Journal of the American Geriatrics Society》2020,68(11):2492-2499
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Seoyoung C. Kim Tuhina Neogi Eun Ha Kang Jun Liu Rishi J. Desai MaryAnn Zhang Daniel H. Solomon 《Journal of the American College of Cardiology》2018,71(9):994-1004