Summary Background Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the ...underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. Methods The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov , number NCT00998127. Findings We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94–2·12; p=0·10) and to disruption was 1·50 (1·14–1.97; p=0·004). Within 7 days, 8–30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31–14·95), 2·17 (0·97–4·88), and 1·3 (0·97–1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 0·46–0·86). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. Interpretation In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Funding Bristol-Myers Squibb and Sanofi-Aventis.
Abstract Objectives The aim of this study was to compare the incidence and impact of cessation of dual-antiplatelet therapy (DAPT) in women and men treated with percutaneous coronary intervention. ...Background Nonadherence to cardiovascular medications and female sex are associated with worse outcomes. However, the patterns and impact of DAPT cessation in women compared with men following percutaneous coronary intervention have not been studied. Methods Baseline characteristics, patterns of DAPT cessation, and 2-year clinical outcomes were compared in 5,031 patients (1,279 women, 3,739 men) enrolled following successful percutaneous coronary intervention with stents in the PARIS (Patterns of Non-Adherence to Antiplatelet Regimens in Stented Patients) study. DAPT cessation was adjudicated as physician-guided discontinuation, interruption for surgery, or disruption due to bleeding or noncompliance. Clinical endpoints were major adverse cardiac events (a composite of cardiac death, definite or probable stent thrombosis, spontaneous myocardial infarction, or clinically indicated target lesion revascularization), a second restricted definition of major adverse cardiac events excluding target lesion revascularization, and bleeding. Results DAPT cessation was more common in women than men (59.1% vs. 55.9%, p = 0.007) and comprised increased rates of discontinuation, disruption for bleeding, and disruption due to noncompliance. The impact of DAPT cessation was similar regardless of sex and varied according the mode; in particular, disruption was associated with increased risk for both ischemic and bleeding events. After adjusting for differences in baseline and treatment characteristics as well as DAPT cessation events, female sex remained an independent predictor of bleeding but not of ischemic events. Conclusions DAPT cessation was more common in women, but its impact was similar in women and men. Female sex was an independent predictor of bleeding but not of ischemic events after adjustment for differences in DAPT cessation and baseline and treatment characteristics.
Temporary interruption of dual antiplatelet therapy (DAPT) is not infrequently required in patients undergoing percutaneous coronary intervention (PCI). We sought to describe the procedures and ...outcomes associated with DAPT interruption in patients treated with DAPT following successful PCI from the Patterns of non-adherence to anti-platelet regimens in stented patients registry (n = 5018). DAPT interruption was prespecified as physician recommended cessation for <14 days. Of the study cohort, 490 patients (9.8%) experienced 594 DAPT interruptions over 2 years following PCI. Only 1 antiplatelet agent was interrupted in 57.2% cases and interruption was frequently recommended by noncardiologists (51.3%). Where type of surgery was reported, majority of DAPT interruptions occurred for minor surgery (68.4% vs 31.6%) and a similar cessation pattern of single versus dual antiplatelet cessation was observed regardless of minor or major surgery. Subsequent to DAPT interruption, 12 patients (2.4%) experienced 1 thrombotic event each, of which 5 (1.0%) occurred during the interruption period. All events occurred in patients who either stopped both agents (8 of 12) or clopidogrel-only (4 of 12), with no events occurring due to aspirin cessation alone. In conclusion, in the Patterns of Non-adherence to Anti-platelet Regiments in Stented Patients registry, 1 in 10 patients were recommended DAPT interruption for surgery within 2 years of PCI. Interruption was more common for a single agent rather than both antiplatelet agents regardless of severity of surgery, and was frequently recommended by noncardiologists. Only 1% of patients with DAPT interruption experienced a subsequent thrombotic event during the interruption period, which mainly occurred in patients stopping both antiplatelet agents.
Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing risk for major ...bleeding (MB). Metrics to accurately predict the occurrence of each respective event and inform clinical decision making are lacking.
The aim of this study was to develop and validate separate models to predict risks for out-of-hospital thrombotic and bleeding events after percutaneous coronary intervention with drug-eluting stents.
Using data from 4,190 patients treated with drug-eluting stents and enrolled in the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients) registry, separate risk scores were developed to predict CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). External validation was performed in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry.
Over 2 years, CTEs occurred in 151 patients (3.8%) and MB in 133 (3.3%). Independent predictors of CTEs included acute coronary syndrome, prior revascularization, diabetes mellitus, renal dysfunction, and current smoking. Independent predictors of MB included older age, body mass index, triple therapy at discharge, anemia, current smoking, and renal dysfunction. Each model displayed moderate levels of discrimination and adequate calibration.
Simple risk scores of baseline clinical variables may be useful to predict risks for ischemic and bleeding events after PCI with DES, thereby facilitating clinical decisions surrounding the optimal duration of DAPT. (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients PARIS; NCT00998127).
This study aimed to evaluate the effect of sex on the chemical composition, fatty acid profile, and nutritional indexes of the Longissimus lumborum muscle of feedlot cattle fed a whole shelled corn ...diet. A total of 40 Nellore cattle were used, of which 20 animals were uncastrated bulls and 20 were heifers, with an average body weight of 411 ± 20.82 and 274 ± 17.80 kg, respectively. The diet was composed of 85 % whole shelled corn and 15 % protein–vitamin–mineral supplement. The chemical composition, fatty acid profile, and the nutritional value of the meat of the animals were evaluated. The chemical composition of the Longissimus lumborum muscle was similar among sexes (p>0.05). Differences were observed in the saturated (17 : 0, 18 : 0, and 21 : 0) and monounsaturated (16 : 1 cis-9, 17 : 1
cis-10, 18 : 1 cis-9, and 18 : 1 trans-7) fatty acid composition between sexes (p<0.05), and the polyunsaturated fatty acid (18 : 2 cis-9 and cis-12, 18:2
cis-9 and trans-11, 20 : 3 n-6, and 22 : 6 n-3) content also showed sex differences (p<0.05). The total number of saturated and polyunsaturated fatty acids was higher in bulls, and the total number of monounsaturated fatty acids was higher in heifers (p<0.05). Indicators of nutritional quality, such as the n-6 : n-3 ratio, thrombogenicity index, and Δ-9-desaturase C14, Δ-9-desaturase C16, and Δ-9-desaturase C18 indexes, were different between the sexes (p<0.05). In conclusion, sex was not found to influence chemical composition but did affect the fatty acid profile and nutritional indexes in the meat of feedlot cattle fed a whole shelled corn diet.
The aim of this study was to evaluate the effects of dietary inclusion of palm kernel cake (PKC) on the feeding behavior of feedlot-finished cattle. Forty uncastrated crossbred bulls with an average ...age of 24.2 ± 2 months and an average weight of 331.1 ± 36.2 kg were distributed into four treatment groups in a completely randomized design with ten replicates. The treatments consisted of 0, 8, 16, or 24% PKC inclusion in the diet (dry matter basis). Palm kernel cake inclusion influenced feeding time (
P
< 0.05), which increased linearly. The inclusion of the ingredient also affected (
P
< 0.05) rumination time (min/day), total chewing time, and the time spent on other activities. The number of cuds ruminated per day showed a linear response to the PKC inclusion levels (
P
< 0.05). The number of feeding bouts increased linearly (
P
< 0.05). Dry matter (DM) intake and DM feeding efficiency decreased linearly (
P
< 0.05). There were no effects of PKC inclusion (
P
> 0.05) on neutral detergent fiber feeding (NDF) efficiency or DM rumination efficiency. NDF rumination efficiency increased linearly (
P
< 0.05). Palm kernel cake can be included at levels up to 24% in the total diet of feedlot-finished crossbred bulls, as it does not affect their dry matter intake or feeding behavior.
The aim of this study was to examine the independent associations between actionable bleeding (AB) and coronary thrombotic events (CTE) on mortality risk after percutaneous coronary intervention ...(PCI).
The independent impact of AB and CTE on mortality risk after PCI remains poorly characterized.
A post hoc analysis was conducted of the PARIS (Patterns of Non-Adherence to Dual Antiplatelet Therapy in Stented Patients) registry, a real-world cohort of 5,018 patients undergoing PCI with stent implantation. CTE included definite or probable stent thrombosis or myocardial infarction. AB was defined as Bleeding Academic Research Consortium type 2 or 3. Associations between CTE and AB, both of which were modeled as time-dependent covariates, and 2-year mortality risk were examined using extended Cox regression.
Over 2 years, the cumulative incidence of CTE, AB, and all-cause mortality was 5.9% (n = 289), 8.1% (n = 391), and 4.7% (n = 227), respectively. Adjusted hazard ratios for mortality associated with CTE and AB were 3.3 (95% confidence interval: 2.2 to 4.9) and 3.5 (95% confidence interval: 2.3 to 5.4), respectively. Temporal gradients in risk after either event were highest in the first 30 days and declined rapidly thereafter. Thrombotic events occurring while patients were on versus off dual-antiplatelet therapy were associated with a higher mortality risk, whereas risk related to AB was not influenced by dual-antiplatelet therapy status at the time of bleeding.
Intracoronary thrombosis and AB are associated with mortality risks of comparable magnitude over a 2-year period after PCI, findings that might inform risk/benefit calculations for extension versus discontinuation of dual-antiplatelet therapy.
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