16 research outputs found
Bleeding events and maintenance dose of prasugrel: BLESS pilot study
OBJECTIVE: To evaluate changes in residual platelet reactivity (RPR) over time, and bleeding and ischaemic events rate using 5 vs 10â
mg maintenance dose (MD) regimens of prasugrel 1â
month after acute coronary syndrome (ACS). BACKGROUND: The optimal level of RPR with prasugrel may change over time after an ACS. METHODS: After 60â
mg loading dose of prasugrel (T0) followed by 10â
mg/day for 1â
month, patients were randomised to receive prasugrel 10â
mg/day (n=95, group A) or 5â
mg/day MD (n=98, group B) up to 1â
year. RPR was assessed at T0, 37 (T1) and 180â
days (T2). The primary end point was Bleeding Academic Research Consortium (BARC) bleeding events â„2 between 1 and 12â
months, and the secondary composite end point was cardiac death, myocardial infarction, stroke and definite/probable stent thrombosis. RESULTS: From T0 to T1, RPR significantly increased in both groups A and B and the increase was higher for group B (ÎŽ ADP 10â
”mol: 13.8%±14.7% vs 23.5%±19.2%, p=0.001). At T2 a lower rate of high RPR patients were found in group A (2.6% vs13.3%; p=0.014). The BARC type â„2 bleeding occurred in 12.6% of group A versus 4.1% of group B (OR 0.29, 95% CI 0.09 to 0.94) and secondary end point in 2.1% vs 1.0% (p=0.542), respectively, without stent thrombosis. CONCLUSIONS: RPR increases shifting from 60â
mg loading dose to 10â
mg/day prasugrel MD with a further increase of RPR reducing prasugrel MD to 5â
mg 1â
month after ACS. Clinical value of these pharmacodynamic findings should be proved in larger clinical trials. TRIAL REGISTRATION NUMBER: NCT01790854
Safety of immediate reversal of anticoagulation by protamine to reduce bleeding complications after infarct artery stenting for acute myocardial infarction and adjunctive abciximab therapy
Infarct artery stenting with adjunctive abciximab therapy is widely used treatment for patients with acute myocardial infarction (AMI). However, bleeding complications have been associated with a worse clinical outcome. Randomized trials in elective patients have shown that postprocedural protamine administration is safe and associated with a significant reduction in bleeding complications. The aim of the current study was to evaluate in STEMI patients undergoing primary percutaneous coronary intervention (PCI) with abciximab and stenting whether immediate reversal of anticoagulation by protamine is safe and associated with a reduction in the occurrence of bleeding complications. From January 2004 to June 2005, 254 patients with STEMI had immediate reversal of anticoagulation by protamine administration after infarct artery stenting and received abciximab therapy without heparin infusion (Group 1). These patients were compared with a control group of 265 patients (June 2002âDecember 2003) treated with the standard heparin therapy: bolus in order to achieve an activated coagulation time of 250â300 s during PCI plus 12-h infusion (7 UI/kg/h; Group 2). We excluded patients undergoing IABP implantation. The two groups were similar in all baseline characteristics. There were no differences in in-hospital mortality, reinfarction, urgent target vessel revascularization, stroke or acute or subacute stent thrombosis, while Group 1 patients showed a lower incidence of major bleeding complications (ACUITY scale: 1.1 vs. 4.0%, P = 0.035) and a shorter length of hospital stay (3.5 ± 1.7 vs. 4.0 ± 1.6 days, P = 0.002) as compared with heparin treated patients. Among patients undergoing primary stenting with abciximab administration, immediate post-PCI reversal anticoagulation by protamine without associated heparin infusion is safe and associated with a significant reduction in major bleeding complications
Not-high before-treatment platelet reactivity in patients with STEMI: prevalence, clinical characteristics, response to therapy and outcomes
Platelet reactivity (PR) has been indicated as a pathophysiological key element for ST-Elevation Myocardial Infarction (STEMI) development. Patients with not-high before-treatment platelet reactivity (NHPR) have been poorly studied so far. The aim of this study is to investigate the prevalence, clinical characteristics, response to therapy and outcomes of baseline prior to treatment NHPR among patients with STEMI undergoing primary PCI. We analyzed the data from 358 STEMI patients with assessment of PR by VerifyNow before P2Y12 inhibitor loading dose (LD). Blood samples were obtained at baseline, and after 1 hour, 2Â hours, 4â6Â hours and 8â12Â hours after LD. High platelet reactivity (HPR) was defined as Platelet Reactivity Unit values â„208, while patients with values <208 at baseline were defined as having NHPR. Overall, 20% patients had NHPR. Age and male gender both resulted independent predictors of NHPR, even after propensity score adjustment. The percentage of inhibition of PR after ticagrelor or prasugrel LD was similar between HPR and NHPR patients at each time point. However, patients with HPR showed worse in-hospital clinical outcomes, and the composite adverse outcome endpoint of death, reinfarction, stroke, acute kidney injury or heart failure was significantly higher (10.0% vs 1.4%; p =Â .017) as compared with the NHPR group. In conclusion, a significant proportion of patients presenting with STEMI has a baseline NHPR that is associated with better in-hospital outcomes as compared with patients with HPR. Further studies are needed to better elucidate the potential therapeutic implications of NHPR in terms of secondary prevention
Clinical events beyond one year after an acute coronary syndrome: Insights from the RECLOSE 2-ACS study
AIMS:
The optimal duration of dual antiplatelet therapy after an acute coronary syndrome (ACS) is still unknown and debated. We sought to assess the incidence of adverse clinical events beyond 12 months after an ACS in patients treated by percutaneous coronary intervention (PCI) and clopidogrel.
METHODS AND RESULTS:
Among 1,592 consecutive ACS patients treated by PCI enrolled in the RECLOSE 2-ACS study and without event within one year, 1,310 (82%) patients presented at least one risk factor such as age 6565 years, diabetes, prior myocardial infarction (MI), chronic kidney disease and multivessel coronary disease. The primary endpoint rate (the composite of cardiac death, MI, stroke and any urgent coronary revascularisation) was 3.7% per year after the first 12 months. The adverse event rate beyond 12 months was higher in patients with at least one risk factor as compared with patients without (8.1% vs. 1.8%, p<0.001). Each additional risk factor was associated with a relative risk for long-term adverse events of 1.66 (95% CI: 1.41-1.96; p=0.0001). Independent predictors of late events were age 6565 years (OR 2.11, 95% CI: 1.38-3.37, p=0.002), insulin-treated diabetes mellitus (OR 2.29, 95% CI: 1.41-3.71, p=0.001), chronic kidney disease (OR 1.93, 95% CI: 1.21-3.09, p=0.006), prior MI (OR 2.71, 95% CI: 1.85-3.97, p=0.0001), and multivessel coronary disease (OR 1.53, 95% CI: 1.18-1.97, p=0.01).
CONCLUSIONS:
Patients at risk of adverse events beyond 12 months after an ACS may be identified by simple clinical and angiographic characteristics such as age, diabetes, chronic kidney disease, prior MI and multivessel CAD. The risk of adverse events progressively increases with the number of these high-risk features