Background In participants with concomitant chronic coronary disease and advanced chronic kidney disease (CKD), the effect of treatment strategies on the timing of dialysis initiation is not well characterized. Methods and Results In ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease), 777 participants with advanced CKD and moderate or severe ischemia were randomized to either an initial invasive or conservative management strategy. Herein, we compare the proportion of randomized participants with non-dialysis-requiring CKD at baseline (n=362) who initiated dialysis and compare the time to dialysis initiation between invasive versus conservative management arms. Using multivariable Cox regression analysis, we also sought to identify the effect of invasive versus conservative chronic coronary disease management strategies on dialysis initiation. At a median follow-up of 23 months (25th-75th interquartile range, 14-32 months), dialysis was initiated in 18.9% of participants (36/190) in the invasive strategy and 16.9% of participants (29/172) in the conservative strategy (P=0.22). The median time to dialysis initiation was 6.0 months (interquartile range, 3.0-16.0 months) in the invasive group and 18.2 months (interquartile range, 12.2-25.0 months) in the conservative group (P=0.004), with no difference in procedural acute kidney injury rates between the groups (7.8% versus 5.4%; P=0.26). Baseline clinical factors associated with earlier dialysis initiation were lower baseline estimated glomerular filtration rate (hazard ratio [HR] associated with 5-unit decrease, 2.08 [95% CI, 1.72-2.56]; P<0.001), diabetes (HR, 2.30 [95% CI, 1.28-4.13]; P=0.005), hypertension (HR, 7.97 [95% CI, 1.09-58.21]; P=0.041), and Hispanic ethnicity (HR, 2.34 [95% CI, 1.22-4.47]; P=0.010). Conclusions In participants with non-dialysis-requiring CKD in ISCHEMIA-CKD, randomization to an invasive chronic coronary disease management strategy (relative to a conservative chronic coronary disease management strategy) is associated with an accelerated time to initiation of maintenance dialysis for kidney failure. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01985360.
Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
Introduction: Cardiac arrest (CA) is the cessation of cardiac mechanical activity confirmed by the absence of signs of circulation. Data suggest that race and gender could impact the survival rate of CA (1,2). We aim to describe the temporal trend of the age-adjusted mortality rate of gender and race reported as any-mention cause of cardiac arrest death from 1990 to 2019. Methods: The United States statistics mortality data from the CDC WONDER database from 1999 to 2019 were used. The diagnosis of CA was stablished using the ICD-10 codes: I46.0, I46.1, I46.9 and I49.0. Mortality rate was calculated for all ages. Age-adjusted mortality rates per 100000 were calculated using 95% confidence intervals. Results: The study included 7435677 subjects with any-mention of CA death. Most deaths occurred in older individuals (90.7 % of the death reported in those 55 years or older). Cardiac Arrest deaths decreased from 138.1 in 1999 to 91.5 in 2019. Temporal trend depicted a gradual decline in the age-adjusted mortality rate per year (IRR 0.97 95 % CI 0.95 to 0.99). There was a progressive decrease mortality rate across both male (167.6 in 1999 to 110 in 2019 IRR 0.97 95% CI 0.96 to 0.98) and female (117.5 1999 to 76.5 in 2019 IRR 0.97 95% CI 0.96 to 0.98). The age-adjusted mortality rate was significantly higher in males compared to females (126.7 vs 91.3 IRR 1.39 95 % CI 1.27 to 1.52). There was a significant decrease in the mortality rate through 1999 to 2019 seen in all the races. Conclusions: There was an association in the CA mortality rate that persisted over the years favoring male over females. The Black race had the highest mortality rate among the races. American Native had the lowest mortality rate. The phenomenon underlying the race difference is not fully understood (3). Quality-improvement efforts have been associated with improvement of survival (4,5). The present data demonstrates a gradual decline of CA-related mortality associated with significant high gender and racial disparities.
Background: ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches—Chronic Kidney Disease) reported an initial invasive treatment strategy did not reduce the risk of death or nonfatal myocardial infarction (MI) compared with a conservative treatment strategy in patients with advanced chronic kidney disease, stable coronary disease, and moderate or severe myocardial ischemia. The cumulative frequency of different MI type after randomization and subsequent prognosis have not been reported. Methods: MI classification was based on the Third Universal Definition for MI. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary MI definition used cTn (cardiac troponin); both definitions included elevated biomarker-only events with higher thresholds than nonprocedural MIs. The cumulative frequency of MI type according to treatment strategy was determined. The association of MI with subsequent all-cause death and new dialysis initiation was assessed by treating MI as a time-dependent covariate. Results: The 3-year incidence of type 1 or 2 MI with the primary MI definition was 11.2% in invasive treatment strategy and 13.6% in conservative treatment strategy (hazard ratio [HR], 0.66 [95% CI, 0.42–1.02]). Procedural MIs were more frequent in invasive treatment strategy and accounted for 9.8% and 28.3% of all MIs with the primary and secondary MI definitions, respectively. Patients had an increased risk of all-cause death after type 1 MI (adjusted HR, 4.35 [95% CI, 2.73–6.93]) and after procedural MI with the primary (adjusted HR, 2.75 [95% CI, 0.99–7.60]) and secondary MI definitions (adjusted HR, 2.91 [95% CI, 1.73–4.88]). Dialysis initiation was increased after a type 1 MI (HR, 6.45 [95% CI, 2.59–16.08]) compared with patients without an MI. Conclusions: In ISCHEMIA-CKD, the invasive treatment strategy had higher rates of procedural MIs, particularly with the secondary MI definition, and lower rates of type 1 and 2 MIs. Procedural MIs, type 1 MIs, and type 2 MIs were associated with increased risk of subsequent death. Type 1 MI increased the risk of dialysis initiation. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01985360.
Background: The aim of this study was to summarize our single-center real-world experience with percutaneous coronary intervention (PCI) stenting of unprotected left main coronary artery (ULMCA). PCI-stenting of the ULMCA, while controversial, is emerging as an alternative to coronary artery bypass graft (CABG) surgery in select patients and clinical situations. Methods: Between January 2005 and December 2008, PCI-stenting was performed on 125 patients with ULMCA lesions at our institution. Clinical and procedural data were recorded at the time of procedure, and patients were followed prospectively (mean 1.7 years; range 1 day-4.1 years) for outcomes, including death, myocardial infarction (MI), and target vessel revascularization (TVR). Results: The majority of cases were urgent or emergent (82.5%), 50.4% of patients were non-surgical candidates, and 63.2% had 3 vessel disease. Many emergent patients presented in shock (62.1%), were not surgical candidates (89.7%), and had high mortality (20.7% in-hospital, 44.8% long-term). Mortality in the elective group was 6.3%. Cumulative death and TVR rates were 28.8% and 13.6%, respectively. Independent predictors of mortality were ejection fraction (EF) ≤ 35% (HR 2.4, CI 1.1 - 5.4) and left main bifurcation (HR 2.7, CI 1.2 - 5.7). Conclusions: PCI-stenting is a viable option in patients with LMCA disease and extends options to patients who are poor candidates for CABG. Elective PCI in low-risk CABG patients results in good long-term survival. Cumulative TVR is 13.6%. EF ≤ 35% and left main bifurcation are independently associated with increased mortality. Cardiol Res. 2012;3(3):100-108 doi: https://doi.org/10.4021/cr165w
The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial prespecified an analysis to determine whether accounting for recurrent cardiovascular events in addition to first events modified understanding of the treatment effects.Patients with stable coronary artery disease (CAD) and moderate or severe ischaemia on stress testing were randomized to either initial invasive (INV) or initial conservative (CON) management. The primary outcome was a composite of cardiovascular death, myocardial infarction (MI), and hospitalization for unstable angina, heart failure, or cardiac arrest. The Ghosh-Lin method was used to estimate mean cumulative incidence of total events with death as a competing risk. The 5179 ISCHEMIA patients experienced 670 index events (318 INV, 352 CON) and 203 recurrent events (102 INV, 101 CON). A single primary event was observed in 9.8% of INV and 10.8% of CON patients while ≥2 primary events were observed in 2.5% and 2.8%, respectively. Patients with recurrent events were older; had more frequent hypertension, diabetes, prior MI, or cerebrovascular disease; and had more multivessel CAD. The average number of primary endpoint events per 100 patients over 4 years was 18.2 in INV [95% confidence interval (CI) 15.8-20.9] and 19.7 in CON (95% CI 17.5-22.2), difference -1.5 (95% CI -5.0 to 2.0, P = 0.398). Comparable results were obtained when all-cause death was substituted for cardiovascular death and when stroke was added as an event.In stable CAD patients with moderate or severe myocardial ischaemia enrolled in ISCHEMIA, an initial INV treatment strategy did not prevent either net recurrent events or net total events more effectively than an initial CON strategy.ISCHEMIA ClinicalTrials.gov number, NCT01471522, https://clinicaltrials.gov/ct2/show/NCT01471522.
