Rate Of First Events Research Articles

Ischemic and Bleeding Events After First Major Bleeding Event in Patients Undergoing Coronary Stent Implantation

There is a scarcity of data on ischemic and bleeding events in patients who experienced major bleeding after percutaneous coronary intervention (PCI). Moreover, there also is a shortage of data on comparative outcomes between patients with and without interruption of an antithrombotic drug after major bleeding. We evaluated the incidence and prognostic impacts of ischemic (myocardial infarction or ischemic stroke) and bleeding (Bleeding Academic Research Consortium type 3 or 5) events after major bleeding in 12,691 consecutive patients who underwent first PCI in the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI registry cohort-3. In the entire cohort, incidence of the first ischemic event and bleeding event was 2.3 per 100 person-years and 3.8 per 100 person-years, respectively. Major bleeding (Bleeding Academic Research Consortium type 3) occurred in 2,142 patients during a median follow-up of 5.7 years. In patients with major bleeding, cumulative 30-day, 1-year, and 5-year incidence of an ischemic event was 2.6%, 4.8%, and 13.2% (3.2 per 100 person-years), respectively, whereas that of a bleeding event was 6.3%, 16.1%, and 29.2% (8.5 per 100 person-years), respectively. Ischemic and bleeding events were independently associated with mortality (hazard ratio 2.36, 95% confidence interval 1.87 to 2.96, p <0.001, and hazard ratio 2.85, 95% confidence interval 2.42 to 3.37, p <0.001). The cumulative 180-day incidence of ischemic and bleeding events was not significantly different between patients with and without interruption of an antithrombotic drug in patients with major bleeding. In conclusion, the incidence of an ischemic event after the first major bleeding was approximately 1/3 of that of recurrent major bleeding, and the rates of ischemic and bleeding events after the first major bleeding were higher than the rates of first events in the general PCI population. Both ischemic events and bleeding events were strongly associated with subsequent mortality. The incidence of ischemic and recurrent bleeding events was not different between patients with and without interruption of an antithrombotic drug.

Incidence, recurrence and prevalence of stroke in an ageing population

Background Populations are ageing and survival from many diseases including stroke has improved substantially over the past decades. Even if stroke incidence is declining as well, at least in the population 65 years and above, there is concern that the burden of stroke will increase in the coming decades, when the population grow larger and older. However, few studies have explored how incidence, recurrence and prevalence have developed in parallel with population ageing. It needs to be further investigated whether or not the decline in incidence is large enough to compensate for the ageing of the population, and, how the incidence of recurrent stroke has developed when survival from the first stroke has improved, before we can make any clear statements of the future burden of stroke. Aim and setting In this population-based study based on Swedish register data we explore how the rate of recurrent events of stroke has developed in relation to the rate of first events. Further, how the prevalence of stroke has developed when survival has improved and the population has become older, and, finally, how the absolute number of stroke events developed. Trends are estimated for the period 1994 to 2014. Based on the findings, we discuss the future disease burden of stroke. Results We found clear declines in both incidence of first as well as recurrent stroke in Sweden between 1994 and 2014 for all ages between 60 and up to 90. For ages above 90 years the trends have remained stable. Despite improved survival of stroke the prevalence has not increased but decreased during the period, both as a proportion and as absolute number of events. Conclusion Based on the development the past 15 years in Sweden in the population 65 and older we do not find support for an increasing burden of stroke, despite an ageing population.

Incident Type 2 Myocardial Infarction in a Cohort of Patients Undergoing Coronary or Peripheral Arterial Angiography.

Despite growing recognition of type 2 myocardial infarction (T2MI; related to supply/demand mismatch), little is known about its risk factors or its association with outcome. A single-center cohort of patients undergoing coronary or peripheral angiography with or without intervention was prospectively enrolled and followed for incident type 1 and T2MI, and major adverse cardiovascular events (MACE, a composite of all-cause death, nonfatal myocardial infarction [MI], heart failure, stroke, transient ischemic attack, peripheral arterial complication, and cardiac arrhythmia), as well. T2MI was adjudicated using criteria from the Third Universal Definition of MI. Baseline characteristics, blood samples, and angiography information were obtained. Major end points subsequent to first MI were assessed using landmark analyses to compare the rates of first events only where everyone with a prior history of any MACE before MI were censored and adjusted for follow-up times. Cox proportional hazard models were used for time-to-event analyses with age and sex forced into all models and additional covariates evaluated by using the stepwise option for the selection. One thousand two hundred fifty-one patients were enrolled and followed for a median of 3.4 years. Of these patients, 152 (12.2%) had T2MI during follow-up; T2MI was frequently recurrent. Multivariable predictors of T2MI were older age, lower systolic blood pressure, history of coronary artery disease, heart failure, chronic obstructive pulmonary disease, diabetes mellitus, nitrate use, and elevated concentrations of glucose, N-terminal pro-B type natriuretic peptide, and cystatin C. Patients with T2MI had higher rates of subsequent adverse events than those without T2MI (per 100 person-years: MACE, 53.7 versus 21.1, P<0.001; all-cause death, 23.3 versus 3.3, P<0.001; cardiovascular death, 17.5 versus 2.6, P<0.001; heart failure events, 22.4 versus 7.4, P<0.001); these rates are similar to those seen in patients with type 1 MI. Incident diagnosis of T2MI strongly predicted risk for subsequent MACE (adjusted hazard ratio, 1.90; 95% confidence interval, 1.46-2.48; P<0.001), all-cause death (adjusted hazard ratio, 2.96; 95% confidence interval, 2.01-4.36; P<0.001), and cardiovascular death (adjusted hazard ratio, 2.16; 95% confidence interval, 1.36-3.43; P=0.001). T2MI is common and associated with poor prognosis. Studies evaluating treatment strategies for management of T2MI are needed. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00842868.

Prognostic factors of young women (≤ 35 years) with node positive breast cancer: possible influence on post-therapeutic follow-up

PurposeAlthough young age at diagnosis is an independent prognostic factor of poor survival; no specific recommendation are provided concerning the timing and modalities of follow-up for this population. These patients are followed similarly to older women during post-therapeutic surveillance. The objective of this study is to examine patterns of recurrence in a large series of positive lymph node breast cancer women aged 35 years or below and treated within adjuvant chemotherapy trials. MethodsData of 200 patients (≤35 years) included in three UNICANCER adjuvant trials for node positive breast cancer were used. Competing risks methodology was used to identify prognostic factors associated with time to first failure according to type of event. ResultsAfter a median follow-up of 52.4 months, 84 pts had disease related events (17 loco-regional, five contralateral, and 62 distant metastasis). Variables associated with an increased rate of first event were the number of involved lymph nodes and the type of surgery. In univariate analysis, prognostic factors associated with high potential curative recurrence were number of positive lymph nodes and vascular invasion. Only number of positive lymph node remained significant in multivariate analysis. Concerning distant metastasis, only the number of lymph node involved was associated to an increased risk of metastasis. ConclusionUsing the number of positive nodes as important prognostic factors, it should be possible to identify patients at a higher risk of loco-regional relapse or contralateral breast cancer, in order to propose more individualized follow-up.

Evidence for risk stratification when monitoring for toxicities following initiation of combination antiretroviral therapy.

Laboratory monitoring is recommended during combination antiretroviral therapy (cART), but the pattern of detected abnormalities and optimal monitoring are unknown. We assessed laboratory abnormalities during initial cART in 2000-2010 across the United States. Observational study in the Centers for AIDS Research Network of Integrated Clinical Systems Cohort. Among patients with normal results within a year prior to cART initiation, time to first significant abnormality was assessed by Kaplan-Meier curves stratified by event type, with censoring at first of regimen change, loss to follow-up, or 104 weeks. Incidence rates of first events were estimated using Poisson regression; multivariable analyses identified associated factors. Results were stratified by time (16 weeks) from therapy initiation. A total of 3470 individuals contributed 3639 person-years. Median age, pre-cART CD4, and follow-up duration were 40 years, 206 cells/μl, and 51 weeks, respectively. Incidence rates for significant abnormalities (per 100 person-years) in the first 16 weeks post-cART initiation were as follows: lipid=49 [95% confidence interval (CI) 41-58]; hematologic=44 (40-49); hepatic=24 (20-27); and renal=9 (7-11), dropping substantially during weeks 17-104 of cART to lipid=23 (18-29); hematologic=5 (4-6); hepatic=6 (5-8); and renal=2 (1-3) (all P<0.05). Among patients receiving initial cART with no prior abnormality (N=1889), strongest associations for hepatic abnormalities after 16 weeks were hepatitis B and C [hazard ratio=2.3 (95% CI 1.2-4.5) and hazard ratio=3.0 (1.9-4.5), respectively]. The strongest association for renal abnormalities was hypertension [hazard ratio=2.8 (1.4-5.6)]. New abnormalities decreased after week 16 of cART. For abnormalities not present by week 16, subsequent monitoring should be guided by comorbidities.

Antiphospholipid antibodies and thrombosis: strength of association.

Antiphospholipid antibodies, that is, lupus anticoagulants and anticardiolipin antibodies, are associated with thrombosis and obstetric complications in the antiphospholipid syndrome. Venous thrombosis occurs mostly in the lower limbs, with or without pulmonary embolism, and cerebral ischemia and transient ischemic attacks are the most common arterial events. Overall, the prevalence of thrombosis is about 30%, the rate of first event approximates 1%/year, and that of recurrence of patients not receiving anticoagulation is about 10-29%/year. The presence of lupus anticoagulants carries an odds ratio for thrombosis ranging from 5 to 16, and that of anticardiolipin antibodies from nonsignificant to 18. The detection of anti-beta2-glycoprotein I, but not antiprothrombin, antibodies might also help to identify antiphospholipid-positive patients at risk of thrombosis. Unfractionated or low-molecular-weight heparin followed by oral anticoagulation represents the current treatment of both arterial and venous thrombosis. However, uncertainty still exists about the optimal duration and intensity of oral anticoagulation following the first event. Several therapeutic clinical trials are currently being conducted, which soon clarify these issues. The prevalence of obstetric complications is about 15-20%. The presence of lupus anticoagulants carries an odds ratio for recurrent miscarriages and fetal death ranging from 3.0 to 4.8, whereas that of anticardiolipin antibodies goes from 0.86 to 20. Unfractionated or low-molecular-weight heparin in combination with low-dose aspirin represents the current standard of treatment of pregnant antiphospholipid-positive women to prevent recurrent obstetric complications. Upon treatment, the live birth rate increases from 0-40% to 70-80%.

The Effect of Recurrent Events on Register-Based Estimates of Level and Trends in Incidence of Acute Myocardial Infarction

Although changes in incidence of first acute myocardial infarctions (AMI) are of primary interest in the evaluation of preventive efforts, only few studies have used this measure. In the present study, the risk of recurrence over time in subjects with first AMI is analyzed, and the effect of inclusion of recurrent cases on the estimation of level and trend in the incidence of AMI is evaluated. The National Patient Register of Hospital Discharges and the Causes-of-Death Register were linked, and all cases of admission for AMI and fatal manifestation of the disease since 1977 and until 1992 in the Danish population were identified. New events occurred during the following 12 years in 46% of men and 42% of women with their first AMI in 1980. Ninety percent of the recurrent events occurred during the first 5 years. Using absence of events during only 1 preceding year as the inclusion criteria, the incidence rate would be overestimated by about 20%–30%. However, if the preceding event-free period was of the same duration throughout the study period, the trends in AMI rates were not altered by expanding the event-free period up to 14 years before the index event. Although rates of AMI based on the total number of affected persons without AMI in the previous year overestimate the true incidence by 20%–30%, trends in these rates reflect trends in rates of first events with reasonable accuracy.