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2.
EuroIntervention ; 2019 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-31422925

RESUMO

AIMS: To investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). METHODS AND RESULTS: The IMP-IT study was a multicenter observational national registry that enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centers from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change: 39.8%; 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and 1-year all-cause death in patients with CS were 46.9% and 57.0%, respectively. 18.5% underwent left ventricular assist device or heart transplant at 1 year. Rates of in-hospital and 1-year all-cause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively. CONCLUSIONS: Use of Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.

3.
Ann Thorac Surg ; 2019 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-31400333

RESUMO

BACKGROUND: Epiaortic ultrasound detects and localizes ascending aortic atherosclerosis. In this analysis we investigated the association between epiaortic ultrasound-based atheroma grade during surgical aortic valve replacement (SAVR) and perioperative adverse outcomes. METHODS: SAVR patients in a randomized trial of two embolic protection devices underwent a protocol-defined 5-view epiaortic ultrasound read at a core-laboratory. Aortic atherosclerosis was quantified with Katz atheroma grade and patients were categorized into mild (grade I-II) versus moderate/severe (grade III-V). Multivariable logistic regression was used to estimate associations between atheroma grade and adverse outcomes including death, clinically apparent stroke, cerebral infarction on diffusion-weighted magnetic resonance imaging (DW-MRI), delirium, and acute kidney injury (AKI) by 7 and 30 days. RESULTS: Of the 383 randomized patients, 326 (85.1%) had pre-cannulation epiaortic ultrasound data available. Of these, 106 (32.5%) had moderate/severe Katz atheroma grade at any segment of the ascending aorta. While there were no significant differences in the composite of death, stroke or cerebral infarction on DW-MRI by 7 days, moderate/severe atheroma grade was associated with a greater risk of AKI by 7 days (adjusted odds ratio [OR]: 2.63; 95% confidence interval [CI]: 1.24-5.58; p=0.01). At 30 days, patients with moderate/severe atheroma grade had a greater risk of death, stroke or AKI (adjusted OR: 1.97; 95%CI: 1.04-3.71; p=0.04). CONCLUSIONS: Moderate/severe aortic atherosclerosis was associated with an increased risk of adverse events following SAVR. Epiaortic ultrasound may serve as a useful adjunct for identifying patients who may benefit from strategies to reduce atheroembolic complications during SAVR.

4.
Circ Cardiovasc Interv ; 12(7): e007734, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31288561

RESUMO

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<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization. CONCLUSIONS: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.

5.
Eur Heart J ; 2019 Jul 03.
Artigo em Inglês | MEDLINE | ID: mdl-31270529

RESUMO

AIMS: The effect of low-density lipoprotein cholesterol-lowering therapy with alirocumab or evolocumab on individual clinical efficacy and safety endpoints remains unclear. We aimed to evaluate the efficacy and safety of alirocumab and evolocumab in patients with dyslipidaemia or atherosclerotic cardiovascular disease. METHODS AND RESULTS: We performed a review of randomized controlled trials (RCTs) comparing treatment with alirocumab or evolocumab vs. placebo or other lipid-lowering therapies up to March 2018. Primary efficacy endpoints were all-cause death, cardiovascular death, myocardial infarction (MI), and stroke. We estimated risk ratios (RR) and 95% confidence intervals (CI) using random effect models. We included 39 RCTs comprising 66 478 patients of whom 35 896 were treated with proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors (14 639 with alirocumab and 21 257 with evolocumab) and 30 582 with controls. Mean weighted follow-up time across trials was 2.3 years with an exposure time of 150 617 patient-years. Overall, the effects of PCSK9 inhibition on all-cause death and cardiovascular death were not statistically significant (P = 0.15 and P = 0.34, respectively). Proprotein convertase subtilisin-kexin type 9 inhibitors were associated with lower risk of MI (1.49 vs. 1.93 per 100 patient-year; RR 0.80, 95% CI 0.74-0.86; I2 = 0%; P < 0.0001), ischaemic stroke (0.44 vs. 0.58 per 100 patient-year; RR 0.78, 95% CI 0.67-0.89; I2 = 0%; P = 0.0005), and coronary revascularization (2.16 vs. 2.64 per 100 patient-year; RR 0.83, 95% CI 0.78-0.89; I2 = 0%; P < 0.0001), compared with the control group. Use of these PCSK9 inhibitors was not associated with increased risk of neurocognitive adverse events (P = 0.91), liver enzymes elevations (P = 0.34), rhabdomyolysis (P = 0.58), or new-onset diabetes mellitus (P = 0.97). CONCLUSION: Proprotein convertase subtilisin-kexin type 9 inhibition with alirocumab or evolocumab was associated with lower risk of MI, stroke, and coronary revascularization, with favourable safety profile.

6.
JACC Heart Fail ; 7(6): 481-490, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31146872

RESUMO

OBJECTIVES: This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR). BACKGROUND: Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown. METHODS: Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years. RESULTS: Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjß: -10.4; 95% CI: -23.4 to 2.6; p = 0.12). CONCLUSIONS: Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040).

7.
Artigo em Inglês | MEDLINE | ID: mdl-31197962

RESUMO

BACKGROUND: Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Data on the distribution of stroke occurrence post-PCI and its impact on mortality are scarce. OBJECTIVES: We sought to determine the incidence, predictors and impact of stroke on mortality in ACS patients undergoing PCI. METHODS: A total of 19,914 ACS patients underwent PCI in the PROMETHEUS multicenter observational study. We calculated the cumulative stroke incidence at 30 days and 1 year using the Kaplan Meier method. We also compared the distribution of stroke, myocardial infarction (MI), and bleeding across time and evaluated their overlap. Predictors of stroke were identified through multivariable Cox-regression. Stroke, MI, and bleeding were assessed as time-updated covariates to estimate how each impacts subsequent mortality. RESULTS: We found that 244 patients had a stroke within 1 year, a cumulative incidence of 1.5%. Previous cerebrovascular disease was the strongest predictor for post-PCI stroke, followed by ST-elevation MI presentation, hypertension, non-ST-elevation MI presentation, smoking, female sex, and age. Mortality risk was significantly higher among those who had a stroke versus those who did not (adjusted HR 4.84, p < .0001). However, the association attenuated over time with a much larger effect in the first 30 days of its occurrence (adjusted HR 17.7; 95% CI: 12.3-25.4, p < .0001) versus beyond 30 days (adjusted HR 1.22; 95% CI: 0.6-2.46, p = .58). CONCLUSIONS: Stroke occurrence within 1 year was not uncommon for ACS patients undergoing PCI. When compared with MI and bleeding, stroke had a substantial impact on mortality that attenuated rapidly over time.

8.
J Am Coll Cardiol ; 73(19): 2401-2409, 2019 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-31097159

RESUMO

BACKGROUND: Data on the impact of residual inflammatory risk (RIR) in patients undergoing percutaneous coronary intervention (PCI) with baseline low-density lipoprotein cholesterol (LDL-C) ≤70 mg/dl are scarce. OBJECTIVES: The purpose of this study was to characterize the prevalence and impact of persistent high RIR after PCI in patients with baseline LDL-C ≤70 mg/dl. METHODS: All patients undergoing PCI between January 2009 and December 2016 in a single tertiary center, with baseline LDL-C ≤70 mg/dl and serial high-sensitivity C-reactive protein (hsCRP) assessments (at least 2 measurements ≥4 weeks apart) were retrospectively analyzed. High RIR was defined as hsCRP >2 mg/l. Patients were categorized as persistent low RIR (first low then low hsCRP), attenuated RIR (first high then low hsCRP), increased RIR (first low then high hsCRP), or persistent high RIR (first high then high hsCRP). Primary endpoint of interest was major adverse cardiac and cerebrovascular accident (MACCE) (death, myocardial infarction, or stroke), within 1 year of the second hsCRP measurement. RESULTS: A total of 3,013 patients were included, with persistent low, attenuated, increased, and persistent high RIR in 1,225 (41.7%), 414 (13.7%), 346 (11.5%), and 1,028 (34.1%) patients, respectively. Overall, there was a stepwise increase in the incidence rates of MACCE, transitioning from the persistent low to the attenuated, increased, and persistent high RIR (respectively, 64.4 vs. 96.6 vs. 138.0 vs. 152.4 per 1,000 patient-years; p < 0.001). After adjustment, the presence of persistent high RIR remained strongly associated with MACCE (adjusted hazard ratio: 2.10; 95% confidence interval: 1.45 to 3.02; p < 0.001). CONCLUSIONS: Among patients undergoing PCI with baseline LDL-C ≤70 mg/dl, persistent high RIR is frequent and is associated with increased risk of MACCE. Targeting residual inflammation in patients with optimal LDL-C control may further improve outcomes after PCI.

9.
Int J Cardiol ; 287: 59-61, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-30982549

RESUMO

BACKGROUND: The risk of stent thrombosis (ST) or target lesion revascularization (TLR) is increased with smaller stent diameters (SD). Whether SD has a deleterious effect in women treated with early- vs. new-generation drug-eluting stents (DES) is unknown. METHODS: We pooled patient-level data from 26 randomized control trials of DES. Only women treated with DES were included. Subjects were stratified according to SD: small, SD ≤ 2.75 mm; intermediate, 2.75 mm < SD ≤ 3.25 mm; and large, SD ≥ 3.25 mm. Endpoints of interest were 3-year definite ST, TLR, major adverse cardiac events (MACE: the composite of death, myocardial infarction or TLR) and death. RESULTS: Of 6413 women, 2274 (35.0%) had a small SD, 2448 (38.0%) had an intermediate SD, and 1691 (26.0%) had a large SD. By multivariable analysis, stent diameter (per 0.25 mm decrease) was associated with an increased risk of TLR and ST, which was uniform in terms of magnitude and direction between early- and new-generation DES. There were no differences in MACE or death across groups. CONCLUSION: Small SD in women undergoing PCI is associated with an increased risk of definite ST and TLR, consistently with both early- and new-generation DES.

11.
Cardiorenal Med ; 9(3): 160-167, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30844810

RESUMO

BACKGROUND: Data on the associations between serum osmolality (sOsmo) and acute kidney injury (AKI) as well as short- and long-term mortality in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: To investigate the association between sOsmo and development of AKI and clinical outcomes in patients undergoing PCI. METHODS: We investigated 1,927 consecutive patients undergoing PCI from the registry of a single center. Patients were divided into quartiles according to sOsmo at admission (Q1-Q4). sOsmo was calculated using the following equation: (1.86 × serum sodium [mmol/L]) + (glucose [mg/dL] / 18) + (blood urea nitrogen [mg/dL] / 2.8) + 9. The primary endpoint was AKI, per Kidney Disease: Improving Global Outcomes (KDIGO) definition. The secondary endpoints were 30-day and 1-year all-cause mortality. RESULTS: Patients with the highest sOsmo (Q4) were older and more likely female, with significantly more cardiovascular risk factors and comorbidities compared to those with lower sOsmo (Q1-Q3). Incidence of AKI was highest in Q4 and lowest in Q2. In the multivariate logistic regression model, high sOsmo independently predicted the development of AKI (OR 2.00, 95% CI 1.26-3.19, p = 0.003). Patients with Q4 had a higher risk of 1-year mortality compared to patients with Q2 (HR 2.11, 95% CI 1.10-4.15; p = 0.031), but not after adding AKI to the multivariate model (HR 1.71, 95% CI 0.87-3.39; p = 0.12). CONCLUSION: sOsmo is a valid and easily obtainable predictor of AKI after PCI. High sOsmo is associated with increased risk of AKI and 1-year mortality in patients undergoing PCI. Further research is warranted to clarify whether the use of an sOsmo-directed hydration protocol might reduce the incidence of AKI in patients undergoing PCI.


Assuntos
Lesão Renal Aguda/sangue , Doença da Artéria Coronariana/sangue , Intervenção Coronária Percutânea/efeitos adversos , Lesão Renal Aguda/etiologia , Lesão Renal Aguda/mortalidade , Idoso , Causas de Morte/tendências , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/cirurgia , Creatinina/sangue , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Concentração Osmolar , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia
12.
Int J Cardiol ; 280: 30-37, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30595357

RESUMO

BACKGROUND: Percutaneous coronary intervention (PCI) has been established as an alternative treatment option to coronary artery by-pass graft (CABG) surgery in patients with left main coronary artery disease (LMCAD). Whether the findings of randomized controlled trials are applicable to a real-world patient population is unclear. METHODS: We compared the outcomes of PCI with new-generation DES in the all-comer, international, multicenter DELTA-2 registry retrospectively evaluating mid-term clinical outcomes with the historical CABG cohort enrolled in the DELTA-1 registry according to the EXCEL key inclusion or exclusion criteria. The primary endpoint was the composite of death, myocardial infarction, or stroke at the median time of follow-up time of 501 days. The consistency of the effect of DELTA-2 PCI versus DELTA-1 CABG according to the EXCEL enrollment criteria was tested using propensity score-adjusted Cox regression models. RESULTS: Out of 3986 patients enrolled in the DELTA-2 PCI registry, 2418 were EXCEL candidates and 1568 were not EXCEL candidates. The occurrence of the primary endpoint was higher among non-EXCEL candidates compared with EXCEL candidates (15.4% vs. 6.9%; hazard ratio 2.52; 95% confidence interval 2.00-3.16; p < 0.001). Among 901 patients enrolled in the historical DELTA-1 CABG cohort, 471 were EXCEL candidates and 430 were not EXCEL candidates. When comparing the DELTA-2 PCI with the DELTA-1 CABG cohort, the occurrence of the primary endpoint was lower in the PCI group compared with the historical CABG cohort among EXCEL candidates (6.9% vs. 10.7%; adjusted hazard ratio: 0.65; 95% confidence interval: 0.45-0.92), while no significant difference was observed among non-EXCEL candidates (15.4% vs. 12.5%; adjusted hazard ratio: 0.94; 95% confidence interval: 0.67-1.33) with evidence of statistical interaction (adjusted interaction p-value = 0.002). CONCLUSIONS: In a real-world population, PCI can be selected more favorably as an alternative to CABG in patients fulfilling the enrollment criteria of the EXCEL trial.

14.
Gut Liver ; 2018 Oct 18.
Artigo em Inglês | MEDLINE | ID: mdl-30400722

RESUMO

Background/Aims: Statins have been postulated to lower the risk of colorectal neoplasia. No studies have examined any possible chemopreventive effect of statins in patients with inflammatory bowel disease (IBD) undergoing colorectal cancer (CRC) surveillance. This study examined the association of statin exposure with dysplasia and CRC in patients with IBD undergoing dysplasia surveillance colonoscopies. Methods: A cohort of patients with IBD undergoing colonoscopic surveillance for dysplasia and CRC at a single academic medical center were studied. The inclusion criteria were IBD involving the colon for >8 years (or any colitis duration if associated with primary sclerosing cholangitis [PSC]) and at least two colonoscopic surveillance exams. The exclusion criteria were CRC or high-grade dysplasia (HGD) prior to or at enrollment, prior colectomy, or limited (<30%) colonic disease. The primary outcome was the frequency of dysplasia and/or CRC in statin-exposed versus nonexposed patients. Results: A total of 642 patients met the inclusion criteria (57 statin-exposed and 585 nonexposed). The statin-exposed group had a longer IBD duration, longer follow-up period, and more colonoscopies but lower inflammatory scores, less frequent PSC and less use of thiopurines and biologics. There were no differences in low-grade dysplasia, HGD, or CRC development during the follow-up period between the statin-exposed and nonexposed groups (21.1%, 5.3%, and 1.8% vs 19.2%, 2.9% and 2.9%, respectively). Propensity score analysis did not alter the overall findings. Conclusion: In IBD patients undergoing surveillance colonoscopies, statin use was not associated with reduced dysplasia or CRC rates. The role of statins as chemopreventive agents in IBD remains controversial.

15.
Thromb Haemost ; 118(11): 1997-2005, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30312975

RESUMO

BACKGROUND: Although several variables have been identified as bleeding determinants (BDs), their occurrence and predictive value in patients undergoing percutaneous coronary intervention (PCI) in the real world remain unclear. We aimed to characterize the rate of BDs in patients undergoing PCI with stent implantation in a large volume tertiary centre. METHODS: We included patients undergoing coronary stenting at our institution from January 2012 to December 2016, and defined post-discharge bleeding (PDB) as bleeding requiring hospitalization or transfusion. Several BDs, identified by the PARIS bleeding and PRECISE-DAPT scores and inclusion criteria of the LEADERS FREE trial, were analysed. RESULTS: In a population of 10,406 subjects who underwent PCI, 2,938 patients (28.2%) had 1, 2,367 (22.8%) had 2 and 2,913 (28.0%) had ≥3 pre-specified BD. Compared with patients without PDB, subjects who experienced PDB were older (70.43 ± 11.94 vs. 65.90 ± 11.54 years, p < 0.0001) with a higher prevalence of common cardiovascular risk factors. One-year PDB occurred in 177 patients (2.4%), and consistently increased according to the number of BDs involved (1.12, 2.11 and 4.35%, respectively; p < 0.0001). Analogously, 1-year rates of post-discharge myocardial infarction or stent thrombosis increased according to the number of BDs (2.44, 3.38 and 4.87%, respectively; p < 0.0001). Only 7 BDs remained independently associated with PDB at 1 year, with anaemia, oral anticoagulant at discharge and malignancy representing the strongest predictors of such risk. CONCLUSION: Many risk factors predispose to PDB; they were often clustered together and conferred additive PDB risk at 1-year of follow-up.

16.
Am J Cardiol ; 122(10): 1638-1646, 2018 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-30270177

RESUMO

The impact of dual antiplatelet therapy (DAPT) cessation after percutaneous coronary intervention with drug eluting stent implantation in patients at high atherothrombotic risk remains unclear. We aimed to characterize the risk for adverse events, and its relation with the mode of DAPT cessation in patients at high atherothrombotic risk (HATR). Considering patients treated with drug-eluting stents among those enrolled in the Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients registry, we defined subjects with prior myocardial infarction (MI), prior stroke or peripheral vascular disease at HATR, while patients without any of these conditions were classified as atherothrombotic risk (LATR). DAPT cessation-modes were defined as physician-recommended discontinuation, temporary interruption, and disruption due to bleeding or poor compliance. Compared to patients with LATR (n = 2867; 68.2%), patients with HATR (n = 1340; 31.8%) were older with a higher prevalence of cardiovascular risk factors. Over 2 years, HATR patients had lower rates of physician-recommended discontinuation (32.5% vs 39.4%; p = 0.002) and trend for disruption (11.5% vs 13.7%, p = 0.051), though no significant difference in the rate of DAPT interruption. Patients with HATR had higher 2-year rates of cardiac death, MI, or stent thrombosis compared with those at LATR (8.7% vs 4.0%; adjusted hazard ratio [aHR]: 1.80; 95% confidence interval [CI]: 1.36-2.39; p < 0.0001). Disruption of DAPT was associated with greater risk for cardiac death, MI, or stent thrombosis in both HATR (aHR: 1.86; 95% CI: 1.05 to 3.46) and LATR (aHR: 2.84; 95% CI: 1.68 to 4.80) patients (pinteraction = 0.40). The degree of atherothrombotic risk influences the pattern and mode of DAPT cessation with less discontinuation among patients considered HATR. Atherothrombotic risk status does not influence the association between DAPT cessation and cardiac risk.

17.
Expert Rev Cardiovasc Ther ; 16(10): 735-748, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30221557

RESUMO

INTRODUCTION: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor constitutes the standard of care to prevent major adverse cardiac events in patients who undergo percutaneous coronary intervention (PCI) with drug-eluting stents (DES). However, the anti-ischemic benefits of DAPT are counterbalanced by an increased risk of hemorrhagic complications, which are known to be associated with increased morbidity and mortality. While the efficacy of DAPT in patients presenting with acute coronary syndrome (ACS) has been well established, the risk-benefit balance of DAPT in other subsets of patients remain controversial. As a result, multiple risk scores to inform optimal duration of DAPT have been developed recently for individuals with various degrees of coronary artery disease. Areas covered: Authors summarize the current evidence and guideline recommendations on the optimal duration and intensity of DAPT across the spectrum of coronary artery disease including those who undergo complex PCI and recapitulated the recently developed risk scores to inform clinical decision on the optimal duration of DAPT. Expert commentary: Clinical decision-making for upfront duration of DAPT after PCI with DES should consider the individual bleeding risk profile, the initial clinical presentation and the complexity of coronary stenting.

18.
J Am Coll Cardiol ; 72(7): 754-765, 2018 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-30092952

RESUMO

BACKGROUND: The optimal revascularization strategy for patients with left main coronary artery disease (LMCAD) and chronic kidney disease (CKD) remains unclear. OBJECTIVES: This study investigated the comparative effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in patients with LMCAD and low or intermediate anatomical complexity according to baseline renal function from the multicenter randomized EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: CKD was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m2 using the CKD Epidemiology Collaboration equation. Acute renal failure (ARF) was defined as a serum creatinine increase ≥5.0 mg/dl from baseline or a new requirement for dialysis. The primary composite endpoint was the composite of death, myocardial infarction (MI), or stroke at 3-year follow-up. RESULTS: CKD was present in 361 of 1,869 randomized patients (19.3%) in whom baseline estimated glomerular filtration rate was available. Patients with CKD had higher 3-year rates of the primary endpoint compared with those without CKD (20.8% vs. 13.5%; hazard ratio [HR]: 1.60; 95% confidence interval [CI]: 1.22 to 2.09; p = 0.0005). ARF within 30 days occurred more commonly in patients with compared with those without CKD (5.0% vs. 0.8%; p < 0.0001), and was strongly associated with the 3-year risk of death, stroke, or MI (50.7% vs. 14.4%; HR: 4.59; 95% CI: 2.73 to 7.73; p < 0.0001). ARF occurred less commonly after revascularization with PCI compared with CABG both in patients with CKD (2.3% vs. 7.7%; HR: 0.28; 95% CI: 0.09 to 0.87) and in those without CKD (0.3% vs. 1.3%; HR: 0.20; 95% CI: 0.04 to 0.90; pinteraction = 0.71). There were no significant differences in the rates of the primary composite endpoint after PCI and CABG in patients with CKD (23.4% vs. 18.1%; HR: 1.25; 95% CI: 0.79 to 1.98) and without CKD (13.4% vs. 13.5%; HR: 0.97; 95% CI: 0.73 to 1.27; pinteraction = 0.38). CONCLUSIONS: Patients with CKD undergoing revascularization for LMCAD in the EXCEL trial had increased rates of ARF and reduced event-free survival. ARF occurred less frequently after PCI compared with CABG. There were no significant differences between PCI and CABG in terms of death, stroke, or MI at 3 years in patients with and without CKD. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

19.
Cardiovasc Drugs Ther ; 32(5): 453-461, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30078077

RESUMO

BACKGROUND: Patients with diabetes mellitus (DM) have a high risk for cardiovascular disease (CVD) events after an acute myocardial infarction (AMI). High-intensity statins reduce CVD risk following AMI among patients with and without DM. METHODS: We determined the proportion of Medicare beneficiaries 66 to 75 years of age taking a low/moderate-intensity statin with (n = 6718) and without (n = 6414) DM who titrated to a high-intensity statin dosage (i.e., atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) following an AMI hospitalization in 2014-2015. All patients had a pharmacy claim for a statin fill within 365 days prior to, and within 30 days after their AMI hospitalization. We excluded beneficiaries without Medicare fee-for-service coverage including pharmacy benefits during the study period and those with a pharmacy claim for a high-intensity statin prior to their AMI. RESULTS: The first statin fill following hospital discharge was for a high-intensity dosage among 37.7% and 44.4% of patients with and without DM, respectively. After multivariable adjustment, the risk ratio (RR) for titrating to a high-intensity statin comparing patients with versus without DM was 1.01 (95% CI 0.96, 1.06). Among patients whose first statin fill post-AMI was for a low/moderate-intensity dosage, 7.5% of those with DM titrated to a high-intensity statin within 182 days, compared with 9.2% of those without DM (multivariable-adjusted RR 0.90 [95% CI 0.75, 1.08]). CONCLUSIONS: Most patients taking a low/moderate-intensity statin were not titrated to a high-intensity dosage following AMI irrespective of their diabetes status, potentially leaving substantial residual risk for recurrent CVD events.

20.
Int J Cardiol ; 268: 61-67, 2018 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-30041804

RESUMO

BACKGROUND: Risk stratification after percutaneous coronary intervention (PCI) is mainly based on demographics and clinical presentation (stable coronary artery disease [CAD] vs. acute coronary syndromes [ACS]). We investigated the impact of PCI extent and complexity on 2-year clinical outcomes after successful implantation of drug-eluting stents (DES) and whether this effect is influenced by clinical presentation and/or high platelet reactivity (HPR) on clopidogrel. METHODS AND RESULTS: Patients from the prospective, multicenter Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents study were stratified according to PCI complexity, with complex PCI (C-PCI) defined as ≥3 stents implanted, bifurcation PCI with 2 stents, rotational atherectomy use for severely calcified lesions, or left main or saphenous vein graft (SVG) PCI. Major adverse cardiac events (MACE; cardiac death, myocardial infarction, and stent thrombosis) were compared at 2-year follow-up in patients with and without C-PCI. Successful DES PCI was performed in 8582 patients-2255 (26.3%) with C-PCI. C-PCI was independently associated with higher 2-year risk of MACE (adjusted HR [adjHR]: 1.56; 95%CI: 1.29-1.89; p<0.0001), MI (adjHR: 1.71; 95%CI: 1.37-2.14; p<0.0001), and ST (adjHR: 2.26; 95%CI: 1.42-3.59; p=0.0006). The association between C-PCI vs. non-C-PCI and the risk of MI and ST was greater in stable CAD than in ACS (Pinteraction=0.04 and 0.03, respectively). SVG PCI, 2-stent bifurcation treatment, and implantation of ≥3 stents were independently associated with MACE. CONCLUSIONS: Patients undergoing extensive and more complex PCI experienced worse outcomes after successful PCI. Considering the extent and complexity of PCI revascularization may improve risk stratification.

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