Monotherapy with a P2Y
inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI).
In a ...double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points.
We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval CI, 0.45 to 0.68; P<0.001). The difference in risk between the groups was similar for BARC type 3 or 5 bleeding (incidence, 1.0% among patients receiving ticagrelor plus placebo and 2.0% among patients receiving ticagrelor plus aspirin; hazard ratio, 0.49; 95% CI, 0.33 to 0.74). The incidence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke was 3.9% in both groups (difference, -0.06 percentage points; 95% CI, -0.97 to 0.84; hazard ratio, 0.99; 95% CI, 0.78 to 1.25; P<0.001 for noninferiority).
Among high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy, ticagrelor monotherapy was associated with a lower incidence of clinically relevant bleeding than ticagrelor plus aspirin, with no higher risk of death, myocardial infarction, or stroke. (Funded by AstraZeneca; TWILIGHT ClinicalTrials.gov number, NCT02270242.).
Aims To determine 3-year event rates in outpatients with vascular disease enrolled in the REduction of Atherothrombosis for Continued Health (REACH) Registry. Methods and results REACH enrolled 67 ...888 outpatients with atherothrombosis established coronary artery disease (CAD), cerebrovascular disease, or peripheral arterial disease (PAD), or with at least three atherothrombotic risk factors, from 44 countries. Among the 55 499 patients at baseline with symptomatic disease, 39 675 were eligible for 3-year follow-up, and 32 247 had data available (81% retention rate). Among the symptomatic patients at 3 years, 92% were taking an antithrombotic agent, 91% an antihypertensive, and 76% were on lipid-lowering therapy. For myocardial infarction (MI)/stroke/vascular death, 1- and 3-year event rates for all patients were 4.2 and 11.0%, respectively. Event rates (MI/stroke/vascular death) were significantly higher for patients with symptomatic disease vs. those with risk factors only at 1 year (4.7 vs. 2.3%, P < 0.001) and at 3 years (12.0 vs. 6.0%, P < 0.001). One and 3-year rates of MI/stroke/vascular death/rehospitalization were 14.4 and 28.4%, respectively, for patients with symptomatic disease. Rehospitalization for a vascular event other than MI/stroke/vascular death was common at 3 years (19.0% overall; 33.6% for PAD; 23.0% for CAD). For patients with symptomatic vascular disease in one vascular bed vs. multiple vascular beds, 3-year event rates for MI/stroke/vascular death/rehospitalization were 25.5 vs. 40.5% (P < 0.001). Conclusion Despite contemporary therapy, outpatients with symptomatic atherothrombotic vascular disease experience high rates of recurrent vascular events and rehospitalizations.
Management of cardiogenic shock Thiele, Holger; Ohman, E Magnus; Desch, Steffen ...
European heart journal,
05/2015, Letnik:
36, Številka:
20
Journal Article
Recenzirano
Odprti dostop
Cardiogenic shock (CS) remains the most common cause of death in patients with acute myocardial infarction although mortality could be reduced from formerly ∼80% to 40-50%. In addition to ...percutaneous coronary intervention or coronary artery bypass grafting, catecholamines, fluids, intraaortic balloon pumping (IABP), and also active assist devices are widely used for CS management. However, there is only limited evidence for any of the above treatments except for early revascularization and the relative ineffectiveness of IABP. This updated review will therefore outline the management of CS complicating acute myocardial infarction with major focus on evidence-based revascularization techniques, intensive care unit treatment including ventilation, transfusion regimens, adjunctive medication, and mechanical support devices.
Aims The presence of peripheral arterial disease (PAD) or cerebrovascular disease (CVD) is associated with higher likelihood of significant coronary artery disease (CAD). We sought to assess the ...prevalence of PAD, CVD, prior CAD, or pre-existent disease in multiple arterial territories (‘polyvascular’ disease) in patients presenting with non-ST-segment elevation acute coronary syndrome and its impact on adverse events. Methods and results Data from 95 749 patients enrolled from February 2003 to September 2006 at 484 sites in the CRUSADE registry were analysed. Patients were categorized as having prior 0, 1, 2, or 3 affected arterial beds. The rates of in-hospital mortality, myocardial infarction, stroke, and congestive heart failure were analysed, as were the rates of non-bypass surgery-related red blood cell transfusion and major bleeding. On presentation, 11 345 (11.9%) patients had established PAD, 9973 (10.4%) had documented CVD, and 41 404 (43.2%) had prior CAD. In this cohort, 0, 1, 2, and 3 arterial bed disease before presentation was present in 46 814 (48.9%, 95% CI 48.6–49.2%), 36 704 (38.3%, 95% CI 37.8–39.0%), 10 675 (11.2%, 95% CI 10.9–11.9%), and 1556 (1.6%, 95% CI 1.5–1.8%) patients, respectively. The rates of ischaemic events increased with the number of affected vascular beds. The adjusted odds ratio for the composite of in-hospital ischaemic events for pre-existent disease in 1, 2, or 3 arterial beds (compared with 0 arterial bed involvement) increased from 1.07 to 1.26 to 1.31 (P < 0.001). Similarly, the adjusted odds ratio for transfusion increased with greater disease burden from 1.11 to 1.28 to 1.30 (P < 0.001), although the adjusted rates of protocol-defined non-bypass surgery-related major bleeding did not. Conclusion Prior polyvascular disease increases the risk of in-hospital adverse events, including mortality. Identification of these patients in clinical trial and real world populations may provide an opportunity to reduce their excess risk with intensive secondary prevention efforts.
Abstract The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) is not well ...understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device. 287 consecutive unselected patients enrolled in the cVAD Registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66±12.5 years, 76% were male, mean left ventricular ejection fraction was 25 ±12 %. Prior to receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump. 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis early implantation of a MCS device prior to PCI (p=0.04) and prior to requiring inotropes and vasopressors (p=0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25 hours from shock onset, 37% when initiated within 1.25-4.25 hours, and 26% when initiated after 4.25 hours (p=0.017). Survival was 68%, 46%, 35%, 35%, 26% for patients requiring 0, 1, 2, 3, ≥4 inotropes prior to MCS support respectively (P<0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and prior to PCI, is independently associated with improved survival in patients presenting with AMICS.
A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We ...examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 95% confidence interval 0.61 to 0.92, p = 0.007) and MACCE (odds ratio = 0.76 95% confidence interval 0.61 to 0.96, p = 0.020) at 90 days postprocedure. In conclusion, hemodynamic support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further supported by multivariate analyses.
Background
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder of unknown etiology; although infection and inflammation have recently been considered as important etiologic ...agents. A recent meta‐analysis showed correlations between cytokine interleukin‐10 (IL‐10) and tumor necrosis factor (TNF) gene polymorphisms and IBS; however, it is still unknown whether patients with IBS have different cytokine profiles compared to healthy population.
Methods
To determine the relationships between serum/plasma levels or mucosal expression of IL‐10/TNF‐α and IBS, we conducted a systematic review and meta‐analysis based on case–control studies retrieved from PubMed and EMBASE search through August 2013. Standardized mean difference (SMD) was generated by using the inverse variance method. Heterogeneity was assessed based on I2 values.
Key Results
Serum/plasma levels of TNF‐α tended to be higher in IBS vs controls (p = 0.09); this reached significance in IBS subtypes vs controls and in female patients with IBS. However, serum/plasma levels of IL‐10 were not significantly different in IBS patients vs controls. Further analysis of serum/plasma IL‐10 levels in IBS subtypes did not show any difference; however, analysis based on gender showed a significantly lower serum/plasma IL‐10 levels in male patients with IBS vs male controls (p = 0.02). Colonic IL‐10 mRNA had a significantly lower expression in IBS vs control (p = 0.001).
Conclusions & Inferences
There is an imbalance of proinflammatory TNF‐α, and anti‐inflammatory IL‐10, cytokines in IBS. Stratifying IBS patients based on cytokine profile may represent an opportunity for personalized treatment of this condition.
There is an imbalance of proinflammatory TNF‐α, and anti‐inflammatory IL‐10, cytokines in IBS. This figure shows circulating TNF‐α levels based on IBS subtypes in patients vs healthy controls. Stratifying IBS patients based on cytokine profile may represent an opportunity for personalized treatment of this condition.
Lipid-lowering agents are known to reduce longterm mortality in patients with stable coronary disease or significant risk factors. However, the effect of lipid-lowering therapy on short-term ...mortality immediately after an acute coronary syndrome has not been determined. We did an observational study using data from two randomised trials to investigate this issue.
We used data from the GUSTO IIb and PURSUIT trials to compare all-cause mortality among patients with acute coronary syndromes who were discharged on lipid-lowering agents (n=3653) with those who were not (n=17 156). A propensity analysis was done to adjust for presumed selection biases in the prescription of lipid-lowering agents.
Lipid-lowering therapy was associated with a smaller proportion of deaths at 30 days (17 0·5% vs 179 1·0%, hazard ratio 0·44 95% Cl 0·27–0·73, p=0·001) and at 6 months (63 1·7% vs 605 3·5%, 0·48 0·37–0·63, p<0·0001). After adjustment for the propensity to be prescribed lipid-lowering agents and other potential confounders, prescription of a lipid-lowering agent at discharge remained associated with a reduced risk of death at 6 months (0·67 0·48–0·95, p=0·023).
Prescription of a lipid-lowering drug at hospital discharge was independently associated with reduced short-term mortality among patients after an acute coronary syndrome.