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3.
Artigo em Inglês | MEDLINE | ID: mdl-31693292

RESUMO

BACKGROUND: Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI. METHODS: We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models. RESULTS: Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement. CONCLUSIONS: Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI.

4.
Circ Cardiovasc Interv ; 12(11): e007982, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31672031

RESUMO

BACKGROUND: Smoking is a potent risk factor for coronary artery disease; however, prior studies describe increased platelet inhibition with clopidogrel among smokers, and some studies report improved outcomes among smokers, a finding described as the smoker's paradox. This study assessed the relationship between platelet reactivity and clinical outcomes after percutaneous coronary interventions among current smokers and nonsmokers. METHODS: ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of patients treated with coronary drug-eluting stents. Platelet reactivity was assessed by the VerifyNow point-of-care assay; high on-treatment platelet reactivity (HPR) was defined as P2Y12 reaction units >208. A propensity-adjusted multivariable analysis was performed to determine the relationship between current smoking, platelet reactivity, and subsequent adverse events. RESULTS: Among 8582 patients, 22.6% were active smokers at the time of their percutaneous coronary intervention procedure. Current smokers were younger and had fewer comorbidities compared with nonsmokers. Current smokers had lower mean P2Y12 reaction units and lower rates of HPR compared with nonsmokers. Current smokers had similar rates of adverse events compared with nonsmokers. HPR was associated with higher rates of adverse events for both smokers and nonsmokers; however, there was evidence of interaction between smoking status and the effect of HPR. Smokers with HPR had significantly higher rates of stent thrombosis. Adverse event rates were highest among current smokers with HPR. CONCLUSIONS: Current smoking was associated with lower P2Y12 reaction units and lower rates of HPR on average; however, the combination of current smoking and HPR was associated with high rates of stent thrombosis. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00638794.

5.
Crit Pathw Cardiol ; 18(4): 167-175, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31725507

RESUMO

Clinical pathways reinforce best practices and help healthcare institutions standardize care delivery. The NewYork-Presbyterian/Columbia University Irving Medical Center has used such a pathway for the management of patients with chest pain and acute coronary syndromes for almost 2 decades. A multidisciplinary panel of stakeholders serially updates the algorithm according to new data and recently published guidelines. Herein, we present the 2019 version of the clinical pathway. We explain the rationale for changes to the algorithm and describe our experience expanding the pathway to all the 8 affiliated institutions within the NewYork Presbyterian healthcare system.

6.
Artigo em Inglês | MEDLINE | ID: mdl-31721430

RESUMO

OBJECTIVES: We sought to compare clinical outcomes after percutaneous coronary intervention (PCI) in patients on versus not on hemodialysis (HD) and examine whether high on-treatment platelet reactivity (HPR) further impacts outcomes among patients on HD. BACKGROUND: Both chronic kidney disease (CKD) and HPR are predictors of major adverse cardiac events (MACE) after PCI. METHODS: Two-year outcomes of patients from the prospective, multicenter ADAPT-DES study (N = 8,582) were analyzed according to HD status at enrollment. All patients underwent platelet function testing with the VerifyNow assay; HPR on clopidogrel was defined as P2Y12 reaction units (PRU) >208. RESULTS: Compared with non-HD patients, patients on HD (n = 85) had significantly higher baseline PRU (median 254 vs. 188, p = .001) and more frequently had HPR (61.7% vs. 42.5%, p < .001). HD was associated with increased 2-year rates of MACE (death, myocardial infarction (MI) or definite stent thrombosis (ST); 23.4% vs. 10.7%, p < .001). HD was also strongly associated with 2-year overall mortality, cardiac death, MI, target vessel revascularization, major bleeding, stroke and ST. Following adjustment for HPR and other covariates, HD was independently associated with overall mortality, MI, ST, and major bleeding at 2 years. The relationship between HD status and 2-year MACE was consistent in patients with and without HPR (Pinteraction = .78). CONCLUSIONS: Nearly two-thirds of patients on HD exhibited HPR on clopidogrel, and both HD and HPR were independently associated with 2-year adverse outcomes after DES implantation. However, the deleterious impact of HD on clinical outcomes was present in both patients with and without HPR.

7.
EuroIntervention ; 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31638578

RESUMO

AIMS: The retrograde approach is critical for achieving high success rates in chronic total occlusion (CTO) percutaneous coronary intervention (PCI), but has been associated with higher risk of complications. METHODS AND RESULTS: We compared the technical and procedural outcomes of retrograde (n=1,515) and antegrade-only CTO PCIs (n=2,686) in a contemporary multicenter CTO registry. The mean age of patients undergoing retrograde PCI was 65±10 years and 86% were men, with high prevalence of prior myocardial infarction (51%), prior PCI (71%), and coronary artery bypass graft surgery (45%). The mean J-CTO (3±1 vs 2±1 p<0.001) was higher in retrograde PCIs. The most commonly used collateral channels were septals (65%), epicardials (32%), saphenous venous grafts (14%) and left internal mammary artery grafts (2%). Overall technical (79% vs 91%, p<0.001) and procedural (75% vs 90%, p<0.001) success rates were lower with the retrograde approach, and patients had higher in-hospital major complications rate than antegrade-only PCIs (5.1% vs 0.8%, p<0.001), due to higher mortality (1.1% vs. 0.1%, p<0.001), acute myocardial infarction (1.9% vs 0.2%, p<0.001), repeat-PCI (0.7% vs 0.1%, p=0.001), and pericardiocentesis (1.7% vs 0.3%, p<0.001). CONCLUSIONS: In summary, retrograde approach to CTO PCI is performed in higher complexity lesions and is associated with lower success and higher major complications rates.

8.
Am J Cardiol ; 124(9): 1380-1388, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31477234

RESUMO

Hypertension is associated with vascular and endothelial dysfunction that may result in a greater propensity for reactive platelets to cause thrombosis. We sought to assess whether the risk of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in patients with on-clopidogrel residual high platelet reactivity (HPR) varies in patients with versus without hypertension. Assessment of dual antiplatelet therapy with drug eluting stents (ADAPT-DES) was a prospective, multicenter registry of patients successfully treated with coronary drug-eluting stents (DES). HPR was defined as P2Y12 reaction units (PRU) >208, as assessed by the VerifyNow point-of-care assay. Multivariable Cox proportional hazards regression was used to assess whether the adjusted association between HPR and 2-year risk of MACE (cardiac death, myocardial infarction [MI], or stent thrombosis) was different in patients with versus without hypertension. A total of 6833 of 8582 patients (79.6%) had a history of hypertension. Patients with compared with those without hypertension were older, more likely to have other cardiovascular risk factors, and had higher PRU (190.1 ± 97.3 vs 179.5 ± 94.3; p <0.0001). Patients with hypertension had significantly higher 2-year rates of MACE (7.0% vs 4.4%, p <0.001), all-cause death (4.2% vs 2.5%, p = 0.001), and MI (5.2% vs 3.2%, p <0.001), and had nominally higher rates of stent thrombosis (1.0% vs 0.5%, p = 0.059). A significant interaction was present between hypertension and HPR regarding 2-year MACE risk (adjusted hazard ratio for HPR vs no HPR 1.38, 95% confidence interval 1.14 to 1.68 for patients with hypertension vs 0.81, 95% confidence interval 0.50 to 1.33 for patients without hypertension, p = 0.046). In conclusion, following successful PCI with DES, 2-year MACE rates are increased in patients with both hypertension and residual HPR on clopidogrel. HPR had a greater effect on the risk of adverse events among patients with versus without hypertension.

9.
Am J Cardiol ; 124(9): 1363-1371, 2019 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-31493829

RESUMO

Small vessel diameter and residual platelet reactivity are independent predictors of thrombotic events after percutaneous coronary intervention (PCI). We sought to determine whether an interaction exists between residual platelet reactivity and stent diameter regarding the occurrence of stent thrombosis and other adverse events after PCI. We stratified patients in the prospective ADAPT-DES registry who underwent single-lesion PCI according to if they received a small diameter stent (SDS, defined as a stent with a diameter of 2.25 mm). Patients receiving an SDS were compared with patients receiving a stent ≥2.5 mm using Kaplan-Meier rates and multivariable Cox proportional hazards regression. We defined major adverse cardiac events (MACE) as the composite of cardiac death, myocardial infarction, and stent thrombosis (ST). Among 5,608 patients who underwent single-lesion PCI in ADAPT-DES, 222 (4.0%) patients received an SDS. Patients with an SDS were more likely than patients without an SDS to have 3-vessel disease but received, on average, fewer stents and were less likely to present with a thrombotic lesion. Receiving versus not receiving an SDS was associated with increased risk of ST (adjusted hazard ratio 4.35, 95% confidence interval 1.95 to 9.73, p <0.001) as well as MACE (adjusted hazard ratio 1.75, 95% confidence interval 1.11 to 2.75, p = 0.02). There was no statistical interaction between platelet reactivity and SDS regarding ST (p = 0.12) or MACE (p = 0.51). In conclusion, PCI with small drug-eluting stents is associated with a high risk of thrombotic events, including ST. Further studies should explore whether alternative treatment strategies are appropriate in small vessels.

10.
JACC Cardiovasc Interv ; 12(18): 1768-1777, 2019 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-31473238

RESUMO

OBJECTIVES: This study sought to evaluate the outcomes and factors associated with aborted procedures among patients undergoing elective transcatheter aortic valve replacement (TAVR). BACKGROUND: Elective TAVR procedures can be aborted because of device limitations or aborted for other reasons, including patient and procedural factors. Little is known about 30-day outcomes and factors associated with aborted procedures and procedures aborted because of device limitations (ADs). METHODS: Patients undergoing elective TAVR procedures from 2011 to 2017 in the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were examined. The incidence of aborted procedures, both ADs and procedures aborted for other reasons (AOs), was examined. Rates of 30-day all-cause death or stroke and a composite of vascular complications and bleeding events were compared between patients with and those without aborted procedures and between patients with ADs and those with AOs. Multivariate modeling identified factors associated with aborted procedures and ADs. RESULTS: Among 106,169 patients who underwent TAVR between 2011 and 2017, procedures were aborted in 1,150 (1.1%) (581 ADs and 569 AOs). Patients with aborted procedures were more likely female with peripheral artery disease and more often treated at lower volume centers compared with those with nonaborted procedures (p < 0.01 for all). The incidence of aborted procedures and ADs decreased over the study period (p < 0.01). The adjusted rates of 30-day death and stroke were greater for aborted versus nonaborted procedures (odds ratio: 5.02; 95% confidence interval: 4.13 to 6.11). Peripheral artery disease, alternative access, and low institutional TAVR volume were factors associated with aborted procedures and ADs (p < 0.05 for all). CONCLUSIONS: The incidence of aborted procedures is declining, but peripheral artery disease and low institutional TAVR volume remain associated with aborted procedures. A thorough pre-procedural assessment and referral of challenging cases to high-volume centers may be strategies to minimize aborted procedures.

11.
JACC Cardiovasc Interv ; 12(18): 1751-1764, 2019 Sep 23.
Artigo em Inglês | MEDLINE | ID: mdl-31537276

RESUMO

OBJECTIVES: The aim of this study was to evaluate the incidence and outcomes of surgical bailout during transcatheter aortic valve replacement (TAVR). BACKGROUND: The incidence and outcomes of unplanned conversion to open heart surgery, or "surgical bailout," during TAVR are not well characterized. METHODS: Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry was analyzed with respect to whether surgical bailout was performed during the index TAVR procedure. A Cox proportional hazards models was used to evaluate 1-year mortality and major adverse cardiovascular events. RESULTS: Between November 2011 and September 2015, a total of 47,546 patients underwent TAVR. Surgical bailout during TAVR was performed in 1.17% of the cases (n = 558); the most frequent indications were valve dislodgement (22%), ventricular rupture (19.9%), and aortic valve annular rupture (14.2%). The incidence of surgical bailout significantly decreased over time (first tertile 1.25%, second tertile 1.43%, third tertile 1.04%; p = 0.0088). The 30-day and 1-year incidence of major adverse cardiovascular events (54.6% vs. 7.4% [p < 0.0001] and 63.92% vs. 20.29% [p < 0.0001]) and all-cause mortality (50.00% vs. 4.98% [p < 0.0001] and 59.79% vs. 17.06% [p < 0.0001]) were significantly higher in those who underwent bailout. Independent predictors of surgical bailout included female sex, hemoglobin, left ventricular ejection fraction, nonelective cases, and nonfemoral access. Body surface area was the only independent predictor of survival after surgical bailout. CONCLUSIONS: In a large, nationally representative registry, the need for surgical bailout in patients undergoing TAVR is low, and its incidence has decreased over time. However, surgical bailout after TAVR is associated with poor outcomes, including 50% mortality at 30 days.

12.
EuroIntervention ; 2019 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-31403461

RESUMO

AIMS: To use optical coherence tomography (OCT) to predict newly implanted stent expansion for treatment of in-stent restenosis (ISR). METHODS AND RESULTS: With OCT-guidance, 143 ISR lesions were treated with a new stent. Stent underexpansion was defined as minimum stent area (MSA) <4.5mm 2 and MSA/average of reference lumen area <70%. New stent underexpansion was found in 33 lesions (23%), had a smaller old stent MSA (4.13 [3.32-4.62] versus 5.18 [4.01-6.38] mm 2 , p=0.001), and had a higher prevalence of multiple old stent layers (51.5% versus 10.9%, p<0.001) and neointimal or peri-stent calcium (69.7% versus 37.3%, p=0.001) compared to those without new stent underexpansion. Old stent underexpansion, multiple layers of old stent, maximum calcium angle >180°, and maximum calcium thickness >0.5mm were independently associated with new stent underexpansion. Patients with new stent underexpansion had a higher prevalence of major adverse cardiac events (35.5% vs 14.3%, p=0.009) mainly driven by a higher rate of myocardial infarction and target vessel revascularization at 2 years. CONCLUSIONS: When re-stenting an ISR lesion, old stent underexpansion, the amount of neointimal or peri-stent calcium, and multiple old stent strut layers are important determinants of new stent underexpansion that is then associated with adverse long-term outcomes.

13.
Am J Cardiol ; 124(6): 912-919, 2019 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-31375245

RESUMO

Fragmented care following elective surgery has been associated with poor outcomes. The association between fragmented care and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. We examined patients who underwent TAVI from 2011 to 2015 at 374 sites in the STS/ACC TVT Registry, linked to Center for Medicare and Medicaid Services claims data. Fragmented care was defined as at least one readmission to a site other than the implanting TAVI center within 90 days after discharge, whereas continuous care was defined as readmission to the same implanting center. We compared adjusted 1-year outcomes, including stroke, bleeding, heart failure, mortality, and all-cause readmission in patients who received fragmented versus continuous care. Among 8,927 patients who received a TAVI between 2011 and 2015, 27.4% were readmitted within 90 days of discharge. Most patients received fragmented care (57.0%). Compared with the continuous care group, the fragmented care group was more likely to have severe chronic lung disease, cerebrovascular disease, and heart failure. States that had lower TAVI volume per Center for Medicare and Medicaid Services population had greater fragmentation. Patients living > 30 minutes from their TAVI center had an increased risk of fragmented care 1.07 (confidence interval [CI] 1.06 to 1.09, p < 0.001). After adjustment for comorbidities and procedural complications, fragmented care was associated with increased 1-year mortality (hazards ratio 1.18, CI 1.04 to 1.35, p = 0.010) and all-cause readmission (hazards ratio 1.08, CI 1.00 to 1.16, p = 0.051. In conclusion, fragmented readmission following TAVI is common, and is associated with increased 1-year mortality and readmission. Efforts to improve coordination of care may improve these outcomes and optimize long-term benefits yielded from TAVI.

14.
Int J Cardiol ; 2019 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-31301862

RESUMO

BACKGROUND: During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated. METHODS: We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry. RESULTS: Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65 ±â€¯10 vs. 64 ±â€¯10 years, p = 0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p < 0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p < 0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p = 0.33) and procedural (85% vs. 85%, p = 0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p = 0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p < 0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p < 0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p < 0.01). CONCLUSIONS: Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

15.
Artigo em Inglês | MEDLINE | ID: mdl-31301219

RESUMO

OBJECTIVES: To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES). BACKGROUND: The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation. METHODS: The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring. RESULTS: A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004). CONCLUSIONS: Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.

16.
J Invasive Cardiol ; 31(7): E220-E225, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31257217

RESUMO

BACKGROUND: Left main coronary artery (LMCA) chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. METHODS: We reviewed 4436 CTO-PCIs performed in 4340 patients between 2012 and 2018 at 25 sites. LMCA-CTO-PCI was performed in 20 cases (0.45%). We examined the clinical and angiographic characteristics and procedural outcomes of these cases. RESULTS: Mean patient age was 68 ± 11 years and 65% were men. Most patients (85%) had undergone prior coronary artery bypass graft surgery and had a protected left main. Mean J-CTO score was 2.7 ± 1.3, mean PROGRESS-CTO score was 1.3 ± 1.1, and mean PROGRESS-CTO Complications score was 3.8 ± 1.9. Antegrade-wire escalation was the most common successful crossing strategy (50%), followed by retrograde crossing (30%) and antegrade dissection/re-entry (10%). Technical and procedural success rates were both 85%. One patient with failed LMCA-CTO-PCI had periprocedural myocardial infarction. Median procedure time was 178 minutes (interquartile range [IQR], 123-250 minutes), median contrast volume was 190 mL (IQR, 133-339 mL), and patient air kerma radiation dose was 2.6 Gray (IQR, 1.3-3.9 Gray). CONCLUSIONS: LMCA-CTO-PCI is infrequent, is performed mostly in patients with prior coronary artery bypass graft surgery, and is associated with good procedural outcomes.

17.
Mayo Clin Proc ; 94(8): 1488-1498, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31279542

RESUMO

OBJECTIVE: To explore the burden and clinical correlates of valvular heart disease in Hispanics/Latinos in the United States. PATIENTS AND METHODS: A total of 1818 individuals from the population-based study of Latinos/Hispanics from 4 US metropolitan areas (Bronx, New York; Chicago, Illinois; San Diego, California; and Miami, Florida) underwent a comprehensive clinical and echocardiographic examination from October 1, 2011, through June 24, 2014. Logistic regression analysis was used to examine the associations of clinical and sociodemographic variables with valvular lesions. RESULTS: The mean age was 55.2±0.2 years; 57.4% were female. The prevalence of any valvular heart disease (AVHD) was 3.1%, with no considerable differences across sex, and a higher prevalence with increasing age. The proportion of US-born vs foreign-born individuals was similar in those with vs without AVHD (P=.31). The weighted prevalence of AVHD was highest in Central Americans (8.4%) and lowest in Mexicans (1.2%). Regurgitant lesions of moderate or greater severity were present in 2.4% of the population and stenotic lesions of moderate or greater severity in 0.2%. Compared with those without AVHD, individuals with AVHD were more likely to have health insurance coverage (59.6% vs 79.2%; P=.007) but similar income (P=.06) and educational status (P=.46). Univariate regression models revealed that regurgitant lesions were associated with lower body mass index whereas stenotic lesions were associated with higher body mass index. CONCLUSION: Our data provide the first population-based estimates of the prevalence of valvular heart disease in Hispanic/Latinos. Valvular heart disease is fairly common in the Hispanic/Latino population and may constitute an important public health problem.

19.
Am. heart j. ; 214: 134-141, Jul. 2019. ilus, tab
Artigo em Espanhol | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1009228

RESUMO

BACKGROUND AND RATIONALE: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown. TRIAL DESIGN: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1year. Patient follow-up is planned for 1, 2, and 6months and 1 and 2years after the procedure. CONCLUSIONS: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1month of DAPT.


Assuntos
Inibidores da Agregação de Plaquetas , Stents , Hemorragia
20.
JAMA ; 321(23): 2306-2315, 2019 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-31211345

RESUMO

Importance: Reducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR). Objective: This study evaluated the trends of stroke occurring within 30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk. Design, Setting, and Participants: Retrospective cohort study including 101 430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017. Exposures: TAVR. Main Outcomes and Measures: The rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively. Results: Among 101 430 patients included in the study (median age, 83 years [interquartile range {IQR}, 76-87 years]; 47 797 women [47.1%]; and 85 147 patients [83.9%] treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99 140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio [HR], 6.1 [95% CI, 5.4-6.8]; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83). Conclusions and Relevance: Between 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.


Assuntos
Estenose da Valva Aórtica/cirurgia , Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Prognóstico , Pontuação de Propensão , Modelos de Riscos Proporcionais , Sistema de Registros , Estudos Retrospectivos , Acidente Vascular Cerebral/epidemiologia , Estados Unidos/epidemiologia
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