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1.
Am J Cardiol ; 2019 Aug 07.
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.

2.
Am J Cardiol ; 2019 Aug 13.
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.

3.
Circ Cardiovasc Interv ; 12(9): e008007, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31495220

RESUMO

BACKGROUND: The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS: The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS: A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (Pinteraction=0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (Pinteraction=0.03). CONCLUSIONS: In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.

4.
J Invasive Cardiol ; 31(7): E211-E219, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31257216

RESUMO

High-quality invasive pulmonary angiography is invaluable for the evaluation of chronic pulmonary thromboembolic disease. Optimization of multiple technical factors enables optimal angiography, crucial for identifying both high-grade pulmonary thromboembolic disease warranting surgical resection, and surgically inaccessible disease for interventional and/or targeted medical therapy. Appropriate strategies to address the pitfalls encountered during angiography are highlighted. This manuscript provides detailed guidance in performing hemodynamic assessment and invasive pulmonary angiography for the evaluation of chronic thromboembolic pulmonary disease.

5.
EuroIntervention ; 15(6): e531-e538, 2019 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-31186220

RESUMO

AIMS: The impact of an occluded right coronary artery (RCA) in patients with left main coronary artery disease (LMCAD) undergoing revascularisation is unknown. We compared outcomes for patients with LMCAD randomised to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of an occluded RCA in the EXCEL trial. METHODS AND RESULTS: The EXCEL trial randomised 1,905 patients with LMCAD and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus CABG. Patients were categorised according to whether they had an occluded RCA at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at three years. Among 1,753 patients with a dominant RCA by core laboratory analysis, the RCA was occluded in 130 (7.4%) at baseline. PCI was attempted in 34 of 65 patients with an occluded RCA (52.3%) and was successful in 27 (79.4% of those attempted; 41.5% of all RCAs recanalised). The RCA was bypassed in 42 of 65 patients with an occluded RCA (64.6%; p=0.0008 versus PCI). The three-year absolute and relative rates of the primary endpoint were similar between PCI and CABG, in patients with or without an occluded RCA (pinteraction=0.92). CONCLUSIONS: In the EXCEL trial, the presence of an occluded RCA at baseline did not confer a worse three-year prognosis in patients undergoing revascularisation for LMCAD and did not affect the relative outcomes of PCI versus CABG in this high-risk patient cohort.


Assuntos
Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Oclusão de Enxerto Vascular , Intervenção Coronária Percutânea/métodos , Acidente Vascular Cerebral/epidemiologia , Humanos , Prognóstico , Fatores de Tempo , Resultado do Tratamento
6.
EuroIntervention ; 2019 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-31062694

RESUMO

AIMS: Pulmonary arterial hypertension is a devastating disease characterized by pulmonary vascular remodelling and right heart failure. Radio-frequency pulmonary artery denervation (PDN) improves pulmonary hemodynamics in pre-clinical and early clinical studies, however denervation depth is limited. High-frequency non-focused ultrasound can deliver energy to the vessel adventitia, sparing the intima and media. We therefore investigated the feasibility, safety and efficacy of ultrasound PDN. METHODS AND RESULTS: Histological examination demonstrated that innervation of human pulmonary arteries are predominantly sympathetic (71%), with >40% of nerves at a depth of >4mm. Finite element analysis of ultrasound energy distribution and ex-vivo studies demonstrated generation of temperatures >47ºC to a depth of 10mm. In domestic swine PDN reduced mean pulmonary artery pressure induced by thromboxane A2 in comparison to sham. No adverse events were observed to 95-days. Histological examination identified structural and immunohistological alterations of nerves in PDN treated animals, with sparing of the intima and media and reduced tyrosine hydroxylase staining 95-days post-procedure indicating persistent alteration of the structure of sympathetic nerves. CONCLUSIONS: Ultrasound PDN is safe and effective in the pre-clinical setting, with energy delivery to a depth that will permit targeting sympathetic nerves in humans.

7.
Coron Artery Dis ; 30(5): 346-351, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31094895

RESUMO

OBJECTIVE: We sought to describe a technique for ultra-low-contrast angiography (ULCA) in patients with advanced chronic kidney disease (CKD) and previous coronary artery bypass surgery (CABG). BACKGROUND: Patients with advanced CKD and previous CABG are at high risk of developing contrast-induced nephropathy (CIN) because of the additional contrast often required to identify bypass grafts. Apart from hydration, reduced contrast administration is the only established method to minimize the risk of CIN. PATIENTS AND METHODS: Ten patients underwent ULCA, whereby an intracoronary injection of saline and coronary guidewires were used instead of test injections of contrast for engagement of bypass grafts with catheters. Estimated glomerular filtration rate (eGFR) before and 30 days following angiography were recorded as was the need for renal replacement therapy 1 year after the procedure. RESULTS: All patients completed a diagnostic angiogram without complications. The median volume of contrast delivered was 13.5 ml (interquartile range: 10.5-17.8). The median eGFR was 18.3 ml/min/1.73 m (interquartile range: 16.5-28.2). There was no statistically significant difference in eGFR before the procedure and 30 days after the procedure (P=0.79). No patient required dialysis 30 days after the procedure. Two patients required initiation of dialysis at 1 year after the procedure. CONCLUSION: In patients with advanced CKD and previous CABG, ULCA may be performed with high procedural success and without complications, minimizing the risk of CIN in these high-risk patients.

8.
Am Heart J ; 213: 105-111, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31132582

RESUMO

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

9.
J Am Coll Cardiol ; 73(15): 1877-1886, 2019 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-30999989

RESUMO

BACKGROUND: Although results of percutaneous coronary intervention (PCI) have been steadily improving, whether surgical outcomes have improved over time is not fully elucidated. OBJECTIVES: This study sought to compare the current outcomes of patients undergoing coronary artery bypass grafting (CABG) with prior surgical results, in the context of randomized trials including the left main (LM) coronary artery stem. METHODS: The authors performed a propensity-matched analysis of patients randomized to CABG in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) (enrollment period 2005 to 2007) and EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) (enrollment period 2010 to 2014) trials. All patients had left main (LM) disease with or without multivessel disease. Adjustment was based on 15 clinical and angiographic variables, including anatomic SYNTAX score, with a 2:1 ratio for the EXCEL and SYNTAX trials, collectively analyzing 909 subjects (n = 580 and n = 329, respectively). The primary endpoint was the composite of all-cause death, myocardial infarction (MI), stroke, or ischemia-driven revascularization at 3 years. RESULTS: Baseline characteristics, anatomic SYNTAX score, number and types of grafts, and duration of hospitalization for the procedures were similar in both groups. CABG procedures in the EXCEL compared with the SYNTAX trial were more often off-pump (29.6% vs. 15.4%; p < 0.001), and guideline-directed medical therapies were used more frequently in the EXCEL surgical cohort. The primary endpoint occurred in 14.0% and 20.9% (p = 0.008) of patients in the EXCEL and SYNTAX trials, respectively. With the exception of MI (4.1% vs. 3.7%), all nonhierarchical events tended to contribute to the improved outcomes in the more recent trial: all-cause death (5.5% vs. 8.5%), stroke (3.1% vs. 5.1%), and ischemia-driven revascularization (7.1% vs. 9.4%) in the EXCEL and SYNTAX trials, respectively. CONCLUSIONS: Over a 5- to 7-year period, significant improvement in event-free survival after surgical revascularization for LM disease at 3 years was noted between the SYNTAX and EXCEL trials, consistent with improving results with cardiac surgery over time. (Synergy Between PCI With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972; Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

10.
J Am Coll Cardiol ; 73(13): 1616-1628, 2019 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-30947913

RESUMO

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

11.
Eur Heart J ; 40(24): 1930-1941, 2019 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-30919909

RESUMO

AIMS: The prognostic implications of periprocedural myocardial infarction (PMI) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) remain controversial. We examined the 3-year rates of mortality among patients with and without PMI undergoing left main coronary artery intervention randomized to PCI with everolimus-eluting stents vs. CABG in the large-scale, multicentre, prospective, randomized EXCEL trial. METHODS AND RESULTS: By protocol, PMI was defined using an identical threshold for PCI and CABG [creatinine kinase-MB (CK-MB) elevation >10× the upper reference limit (URL) within 72 h post-procedure, or >5× URL with new Q-waves, angiographic vessel occlusion, or loss of myocardium on imaging]. Cox proportional hazards modelling was performed controlling for age, sex, hypertension, diabetes mellitus, left ventricular ejection fraction, SYNTAX score, and chronic obstructive pulmonary disease (COPD). A total of 1858 patients were treated as assigned by randomization. Periprocedural MI occurred in 34/935 (3.6%) of patients in the PCI group and 56/923 (6.1%) of patients in the CABG group [odds ratio 0.61, 95% confidence interval (CI) 0.40-0.93; P = 0.02]. Periprocedural MI was associated with SYNTAX score, COPD, cross-clamp duration and total procedure duration, and not using antegrade cardioplegia. By multivariable analysis, PMI was associated with cardiovascular death and all-cause death at 3 years [adjusted hazard ratio (HR) 2.63, 95% CI 1.19-5.81; P = 0.02 and adjusted HR 2.28, 95% CI 1.22-4.29; P = 0.01, respectively]. The effect of PMI was consistent for PCI and CABG for cardiovascular death (Pinteraction = 0.56) and all-cause death (Pinteraction = 0.59). Peak post-procedure CK-MB ≥10× URL strongly predicted mortality, whereas lesser degrees of myonecrosis were not associated with prognosis. CONCLUSION: In the EXCEL trial, PMI was more common after CABG than PCI, and was strongly associated with increased 3-year mortality after controlling for potential confounders. Only extensive myonecrosis (CK-MB ≥10× URL) was prognostically important.

12.
Am J Cardiol ; 123(9): 1399-1405, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30771861

RESUMO

Greater optimism regarding recovery from chronic illness is associated with improved quality of life and clinical outcomes. We performed a post-hoc analysis on the association between optimism and outcomes in Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention (RIVER-PCI), a randomized trial in patients with chronic angina pectoris who had incomplete revascularization following percutaneous coronary intervention. At baseline, patients answered how much they agreed with the phrase, "I am optimistic about my future and returning to a normal lifestyle." We evaluated the association between baseline optimism and time to ischemia-driven hospitalization or revascularization using a Cox model, and the association between baseline optimism and change in frequency of angina pectoris using a mixed measures model. Of 2,389 patients, 782 (33.2%) were very optimistic ("strongly agree"), 1,000 (42.4%) were optimistic ("agree"), 451 (19.1%) were neutral ("undecided"), and 123 (5.2%) were not optimistic ("disagree" or "strongly disagree"). Very optimistic patients had a lower prevalence of co-morbidities and less severe angina at baseline than less optimistic patients. The rate of ischemia-driven revascularization or hospitalization was higher in neutral and not optimistic patients compared with very optimistic patients; this finding persisted after adjustment for co-morbidities and baseline angina frequency (hazard ratio 1.42, 95% confidence interval 1.14 to 1.77 for neutral vs very optimistic; hazard ratio 1.38, 95% confidence interval 0.98 to 1.94 for not optimistic vs very optimistic). Neutral and not optimistic patients also had less improvement in angina than very optimistic patients. In conclusion, in patients with angina, those with more self-reported optimism had better health status outcomes. Whether structured interventions targeting optimism improve outcomes in these patients warrants further study.

13.
Am Heart J ; 210: 49-57, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30738244

RESUMO

BACKGROUND: The prognostic impact of high-sensitivity C-reactive protein (CRP) levels in patients with left main coronary artery disease (LMCAD) treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) is unknown. We sought to determine the effect of elevated baseline CRP levels on the 3-year outcomes after LMCAD revascularization and to examine whether CRP influenced the relative outcomes of PCI versus CABG. METHODS: In the EXCEL trial, patients with LMCAD and Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) scores ≤32 were randomized to PCI versus CABG. The primary composite outcome of death, myocardial infarction (MI), or stroke was analyzed according to baseline CRP levels. RESULTS: Among 999 patients with available CRP levels, median CRP was 3.10 mg/L (interquartile range 1.12-6.40 mg/L). The rate of the primary composite end point of death, MI, or stroke at 3 years steadily increased with greater baseline CRP levels. The adjusted relationship between the 3-year composite rate of death, MI, or stroke and baseline CRP modeled as a continuous log-transformed variable demonstrated steadily increasing event rates with greater CRP levels (adjusted hazard ratio, 1.26, 95% CI 1.10-1.44, P = .0008). Similarly, patients with CRP ≥10 mg/L had a 3-fold higher risk of the 3-year primary end point compared to patients with lower CRP levels (adjusted hazard ratio 2.92, 95% CI 1.88-4.54, P < .0001). The association between an elevated CRP level and the adjusted 3-year risk of the primary composite end point did not differ according to revascularization strategy (Pinteraction = .75). CONCLUSIONS: In patients with LMCAD undergoing revascularization, elevated baseline CRP levels were strongly associated with subsequent death, MI, and stroke at 3 years, irrespective of the mode of revascularization. Further studies are warranted to determine whether anti-inflammatory therapies may improve the prognosis of high-risk patients with LMCAD following revascularization.

14.
Eur J Cardiothorac Surg ; 55(6): 1144-1151, 2019 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-30596978

RESUMO

OBJECTIVES: Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores. METHODS: Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG. RESULTS: COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P < 0.0001), death (17.1% vs 7.5%, P = 0.0005) and myocardial infarction (18.3% vs 7.3%, P < 0.0001), but not stroke (3.3% vs 2.9%, P = 0.84). There were no statistically significant interactions in the relative risks of PCI versus CABG for the primary composite end point in patients with and without COPD at 30 days [hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.12-1.21 vs HR 0.55, 95% CI 0.29-1.06; Pinteraction = 0.61] or at 3 years (HR 0.85, 95% CI 0.46-1.56 vs HR 1.28, 95% CI 0.84-1.94; Pinteraction = 0.27). CONCLUSIONS: In the EXCEL trial, COPD was independently associated with poor prognosis after left main coronary artery disease revascularization. The relative risks of PCI versus CABG at 30 days and 3 years were consistent in patients with and without COPD. CLINICAL TRIAL REGISTRATION NUMBER: http://www.clinicaltrials.gov; NCT01205776.

15.
JACC Cardiovasc Imaging ; 12(1): 172-184, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30621989

RESUMO

Clinical management of patients with only moderate aortic stenosis (AS) but symptoms of heart failure with a reduced left ventricular ejection fraction (HFrEF) is challenging. Current guidelines recommend clinical surveillance with multimodality imaging; aortic valve replacement (AVR) is deferred until the stenosis becomes severe. Given the known benefits of afterload reduction in management of patients with HFrEF, it has been hypothesized that AVR may be beneficial in patients with only moderate AS who present with HFrEF. In this article, we first review the current approach for management of patients with moderate AS and HFrEF based on close clinical and imaging surveillance with AVR delayed until AS is severe. We then discuss the case for transcatheter AVR (TAVR) earlier in the disease course, when AS is moderate, based on stress echocardiographic data. We conclude with a detailed summary of the TAVR UNLOAD (Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure) trial, in which patients with moderate AS and HFrEF are randomized to guideline-directed heart failure therapy alone versus guideline-directed heart failure therapy plus TAVR.

16.
Catheter Cardiovasc Interv ; 94(2): 172-180, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-30690854

RESUMO

OBJECTIVES: We sought to identify clinical, electrocardiographic (ECG), and angiographic characteristics that are predictive of 3-year mortality after primary percutaneous coronary intervention (PCI) in patients with non-anterior ST-elevation myocardial infarction (NA-STEMI) from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. BACKGROUND: Which patients with NA-STEMI undergoing PCI have a poor prognosis is uncertain. METHODS: NA-STEMI was defined as ST-segment elevation in lateral (V5, V6, I, aVL), inferior (II, III, aVF), or inferolateral (I, II, III, aVF, and V5-V6) ECG leads or posterior myocardial infarction with ST-segment depression of ≥1 mm in ≥2 contiguous anterior leads. Cox regression was used to identify independent predictors of 3-year mortality. Missing data were imputed using multiple imputation. RESULTS: In HORIZONS-AMI, 2,578/3,602 patients had no prior coronary artery bypass grafting, underwent single-vessel PCI, and had baseline ECG data assessed in an independent core laboratory. Among them, 1,495 (58.0%) had NA-STEMI. Patients with NA-STEMI had lower 3-year mortality risk than those with anterior STEMI (4.5% versus 7.1%, P = 0.004). The independent predictors of increased 3-year mortality in NA-STEMI were older age (median > 59.0 years), diabetes, reduced LVEF (≤50%), Killip class ≥2, post-procedure TIMI flow 0-2 versus 3, renal insufficiency, and ST-resolution <30% at 60 min post-PCI. Patients with 0, 1, 2, 3, and ≥4 of these risk factors had 3-year mortality rates of 1.8%, 2.3%, 3.1%, 6.1%, and 36.3%, respectively (P < 0.0001). CONCLUSIONS: Although NA-STEMI carries a better prognosis than anterior STEMI, high-risk patient cohorts with NA-STEMI may be identified who have substantial 3-year mortality.

17.
Coron Artery Dis ; 30(2): 143-149, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30531253

RESUMO

OBJECTIVES: There is a paucity of data on the effect of baseline lipid-lowering therapy (LLT) in patients undergoing revascularization for left main (LM) coronary artery disease (CAD). We compared outcomes for patients with LMCAD randomized to percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) according to the presence of baseline LLT in the EXCEL trial. PATIENTS AND METHODS: The EXCEL trial randomized 1905 patients with LMCAD and SYNTAX scores up to 32 to PCI with everolimus-eluting stents versus CABG. Patients were categorized according to whether they were medically treated with LLT at baseline, and their outcomes were examined using multivariable Cox proportional hazards regression. The primary endpoint was a composite of death, stroke, or myocardial infarction at 3 years. RESULTS: Among 1901 patients with known baseline LLT status, 1331 (70.0%) were medically treated with LLT at baseline. There were no significant differences between the PCI and CABG groups in the 3-year rates of the primary endpoint in patients with versus without baseline LLT (Pinteraction=0.62). Among patients with baseline LLT, the 3-year rate of ischemia-driven revascularization was higher after PCI compared with CABG (13.7 vs. 5.3%; adjusted hazard ratio=2.97; 95% confidence interval: 1.95-4.55; P<0.0001), in contrast to patients without baseline LLT (9.8 vs. 12.1%; adjusted hazard ratio=0.79; 95% confidence interval: 0.47-1.33; P=0.39) (Pinteraction=0.0003). CONCLUSION: In the EXCEL trial, 3-year major adverse event rates after PCI versus CABG for LMCAD were similar and consistent in patients with and without LLT at baseline; however, revascularization during follow-up was more common after PCI compared with CABG in patients with baseline LLT, but not in those without baseline LLT.

18.
JACC Cardiovasc Interv ; 11(24): 2467-2476, 2018 Dec 24.
Artigo em Inglês | MEDLINE | ID: mdl-30573057

RESUMO

OBJECTIVES: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. BACKGROUND: Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). METHODS: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. RESULTS: The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients. CONCLUSIONS: Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

19.
JACC Cardiovasc Interv ; 11(21): 2207-2216, 2018 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-30409278

RESUMO

OBJECTIVES: The aim of this study was to further evaluate clinical outcomes in patients with and without PCS. BACKGROUND: Prior cardiac surgery (PCS) is associated with increased surgical risk and post-operative complications following surgical aortic valve replacement (SAVR), but whether this risk is similar in transcatheter aortic valve replacement (TAVR) is unclear. METHODS: In the PARTNER 2A (Placement of Aortic Transcatheter Valve) trial, 2,032 patients with severe aortic stenosis at intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. Adverse clinical outcomes at 30 days and 2 years were compared using Kaplan-Meier event rates and multivariate Cox proportional hazards regression models. The primary endpoint of the PARTNER 2 trial was all-cause death and disabling stroke. RESULTS: Five hundred nine patients (25.1%) had PCS, mostly (98.2%) coronary artery bypass grafting. There were no significant differences between TAVR and SAVR in patients with or without PCS in the rates of the primary endpoint at 30 days or 2 years. Nevertheless, an interaction was observed between PCS and treatment arm; whereas no-PCS patients treated with TAVR had higher rates of 30-day major vascular complications than patients treated with SAVR (adjusted hazard ratio: 2.66; 95% confidence interval: 1.68 to 4.22), the opposite was true for patients with PCS (adjusted hazard ratio: 0.27; 95% confidence interval: 0.11 to 0.66) (pinteraction <0.0001). A similar interaction was observed for life-threatening or disabling bleeding. CONCLUSIONS: In the PARTNER 2A trial of intermediate-risk patients with severe aortic stenosis undergoing SAVR versus TAVR, the relative risk for 2-year adverse clinical outcomes was similar between TAVR and SAVR in patients with or without PCS.

20.
Artigo em Inglês | MEDLINE | ID: mdl-30489011

RESUMO

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

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