Background: The ISCHEMIA trial compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes over a median of 3.2 years. Extended follow-up for mortality is ongoing. Methods: ISCHEMIA participants were randomized to an initial invasive strategy (INV) added to guideline-directed medical therapy or a conservative strategy (CON). Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and non-cardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models and Bayesian methods. Undetermined deaths were classified as cardiovascular as pre-specified in the trial protocol. Results: Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23 % women, 16% Hispanic, 4% Black, 42% diabetes, and median EF 0.60. A total of 557 deaths accrued over a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 non-cardiovascular deaths and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate 12.7% in INV, 13.4% in CON; adjusted hazard ratio (HR)=1.00, 95% CI: 0.85-1.18). There was a lower 7-year rate cardiovascular mortality (6.4% vs. 8.6%, adjusted HR=0.78, 95% CI: 0.63-0.96) with an initial invasive strategy but a higher 7-year rate of non-cardiovascular mortality (5.6% vs. 4.4%, adjusted HR=1.44, 95% CI: 1.08-1.91) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease. Conclusions: There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of non-cardiovascular mortality with an initial invasive strategy over a median follow-up of 5.7 years. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04894877; https://clinicaltrials.gov/ct2/show/NCT04894877

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Background and objectivesWith a growing need for non-opioid chronic pain treatments, pain physicians should understand the proper utilization of neuromodulation therapies to provide the most comprehensive care. We aimed to identify the unmet training needs that deter physicians from using spinal cord stimulation (SCS) devices.MethodsInternet-based surveys were fielded to fellows enrolled in pain fellowships during the 2016–2017 academic year accredited by the Accreditation Council for Graduate Medical Education and past pain fellows identified through pain medicine societies and SCS manufacturers.ResultsCurrent fellows were more likely to have received SCS training during fellowship compared with past fellows (100.0% vs 84.0%), yet there was variability in fellows’ SCS experiences with a wide range of trials and implants performed. Forty-six percent of current fellows felt there was an unmet training need regarding SCS. Deficiency in SCS case volume was the most common barrier that was noted (38.5%), followed by lack of SCS curriculum (30.8%) and lack of faculty with SCS expertise (23.1%). Lack of training was a predominant reason for past fellows choosing not to use SCS devices postfellowship. The majority of current and past fellows (79.5% and 55.4%, respectively) strongly supported direct training of fellows by SCS manufacturers.ConclusionsWhile SCS training during pain fellowship has become more universal, the experiences that fellows receive are highly variable, and most rely on industry-sponsored programs to supplement training deficiencies. Standardization of SCS procedures may also enable less experienced providers to navigate the SCS treatment algorithm.