Faculty Bibliography

BACKGROUND:Evidence is limited regarding the comparative effectiveness and safety of mechanical thrombectomy (MT) vs catheter-directed thrombolysis (CDT) for high-risk pulmonary embolism (PE). OBJECTIVES/OBJECTIVE:This observational study aimed to compare the outcomes of older adults with high-risk PE treated with MT vs CDT using a target trial emulation framework. METHODS:We included Medicare fee-for-service beneficiaries aged 65 to 99 years admitted with high-risk PE (defined by cardiac arrest, shock, and vasopressor use) who underwent MT/CDT from 2017 to 2020. We evaluated 1-year mortality using an inverse probability of treatment weighting approach, controlling for 62 baseline covariates. We also evaluated readmissions and in-hospital outcomes, including intracranial hemorrhage. Patients were followed from the date of the index procedure to the outcomes of interest, 1 year, or December 2020. RESULTS:We included 235 and 484 patients in the MT and CDT groups, respectively. The absolute risk of 1-year mortality was 48.4% (95% CI: 34.1%-63.3%) in the MT group and 45.4% (95% CI: 37.8%-55.8%) in the CDT group, with an adjusted HR of 1.16 (95% CI: 0.84-1.59). We found no evidence that all-cause readmission (MT vs CDT; subdistribution HR: 0.89; 95% CI: 0.56-1.40), intracranial hemorrhage (adjusted OR: 0.36; 95% CI: 0.07-1.77), or transfusions (adjusted OR: 0.96; 95% CI: 0.52-1.76) differed significantly between the 2 groups. CONCLUSIONS:Among older adults with high-risk PE treated with catheter-based therapies, the clinical outcomes were similar between the patients treated with MT vs CDT. Randomized trials are needed to confirm our findings.

BACKGROUND/UNASSIGNED:The appropriate use criteria for revascularization of stable ischemic heart disease have not been evaluated using randomized data. Using data from the randomized ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches; July 2012 to January 2018, 37 countries), the health status benefits of an invasive strategy over a conservative one were examined within appropriate use criteria scenarios. METHODS/UNASSIGNED:Among 1833 participants mapped to 36 appropriate use criteria scenarios, symptom status was assessed using the Seattle Angina Questionnaire-7 at 1 year for each scenario and for each of the 6 patient characteristics used to define the scenarios. Coronary anatomy and SYNTAX(Synergy between percutaneous coronary intervention with Taxus and cardiac surgery) scores were measured using coronary computed tomography angiography. Treatment effects are expressed as an odds ratio for a better health status outcome with an invasive versus conservative treatment strategy using Bayesian hierarchical proportional odds models. Differences in the primary clinical outcome were similarly examined. RESULTS/UNASSIGNED:The mean age was 63 years, 81% were male, and 71% were White. Diabetes was present in 28% and multivessel disease in 51%. Most clinical scenarios favored invasive for better 1-year health status. The benefit of an invasive strategy on Seattle Angina Questionnaire angina frequency scores was reduced for asymptomatic patients (odds ratio [95% credible interval], 1.16 [0.66-1.71] versus 2.26 [1.75-2.80]), as well as for those on no antianginal medications. Diabetes, number of diseased vessels, proximal left anterior descending coronary artery location, and SYNTAX score did not effectively identify patients with better health status after invasive treatment, and minimal differences in clinical events were observed. CONCLUSIONS/UNASSIGNED:Applying the randomization scheme from the ISCHEMIA trial to appropriate clinical scenarios revealed baseline symptoms and antianginal therapy to be the primary drivers of health status benefits from invasive management. Consideration should be given to reducing the patient characteristics collected to generate appropriateness ratings to improve the feasibility of future data collection. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

BACKGROUND AND AIMS/OBJECTIVE:Multiple randomized trials have shown that renal denervation (RDN) reduces blood pressure (BP) when compared with sham control but the antihypertensive efficacy of radiofrequency vs. ultrasound-based RDN is uncertain. We aimed to compare the outcomes of radiofrequency RDN (rRDN) and ultrasound RDN (uRDN), when compared with sham in patients with hypertension. METHODS:PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized sham-controlled trials (RCTs) of rRDN or uRDN or for trials of rRDN vs. uRDN. Primary efficacy outcome was 24-h ambulatory SBP. A mixed treatment comparison meta-analysis was performed comparing the efficacy and safety against sham and against each other. RESULTS:Among 13 RCTs that enrolled 2285 hypertensive patients, rRDN reduced 24-h ambulatory SBP [(MD = 2.34 mmHg; 95% confidence interval (95% CI): 0.72-3.95], office SBP (MD = 5.04 mmHg; 95% CI: 2.68-7.40)], and office DBP (MD = 2.95 mmHg; 95% CI: 1.68-4.22) when compared with sham. Similarly, uRDN reduced 24-h ambulatory SBP (MD = 4.74 mmHg; 95% CI: 2.80-6.67), day-time ambulatory SBP (MD = 5.40 mmHg; 95% CI: 3.68-7.13), night-time ambulatory SBP (MD = 3.84 mmHg; 95% CI: 0.02-7.67), and office SBP (3.98 mmHg; 95% CI: 0.78-7.19) when compared with sham. There was significantly greater reduction in 24-h ambulatory SBP (MD = 2.40 mmHg; 95% CI: 0.09-4.71), day-time ambulatory SBP (MD = 4.09 mmHg; 95% CI: 1.61-6.56), and night-time ambulatory SBP (MD = 5.76 mmHg; 95% CI: 0.48-11.0) with uRDN when compared with rRDN. For primary efficacy outcome, uRDN ranked #1, followed by rRDN (#2), and sham (#3). CONCLUSION/CONCLUSIONS:In hypertensive patients, rRDN and uRDN significantly reduced 24-h ambulatory and office SBP when compared with sham control with significantly greater reduction in ambulatory BP with uRDN than with rRDN at 4 months (mean) of follow-up. A large-scale randomized head-to-head trial of rRDN or uRDN is warranted to evaluate if there are differences in efficacy.

BACKGROUND/UNASSIGNED:Elevated perceived stress is associated with adverse outcomes following myocardial infarction (MI) and may account for poorer recovery among women vs men. OBJECTIVES/UNASSIGNED:This randomized controlled trial tested effects of a mindfulness-based intervention on stress levels among women with MI. METHODS/UNASSIGNED:Women with elevated stress (Perceived Stress Scale [PSS-4]≥6) at least 2 months after MI were enrolled from 12 hospitals in the United States and Canada and via community advertising. Participants were randomized to a remotely delivered mindfulness intervention (MBCT-Brief) or heart disease education, both 8 weeks long. Follow-up was 6 months. Changes in stress (PSS-10; primary outcome) and secondary outcomes (depressive symptoms, anxiety, quality of life, disease-specific health status, actigraphy-assessed sleep) were compared between groups. RESULTS/UNASSIGNED: = 0.036). CONCLUSIONS/UNASSIGNED:MBCT-Brief was associated with greater 6-month reductions in stress than an active control among adherent participants. More frequent mindfulness practice was associated with greater improvements in psychological outcomes. Strategies to engage women with MI in mindfulness training and support regular home practice may enhance these effects.

BACKGROUND:In patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease, most but not all randomized trials have reported that complete revascularization (CR) offers advantages over culprit vessel-only revascularization. In addition, the optimal timing and assessment methods for CR remain undetermined. OBJECTIVES/OBJECTIVE:The purpose of this study was to identify the optimal revascularization strategy in patients with STEMI and multivessel disease, using a network meta-analysis of randomized controlled trials. METHODS:We searched PUBMED and EMBASE for randomized trials evaluating revascularization strategies in patients with STEMI and multivessel disease through July 2024. A network meta-analysis was performed analyzing CR vs culprit vessel-only revascularization as well as the timing of CR (immediate CR vs staged CR). Outcomes were also assessed with 4 CR strategies based on whether revascularization was immediate or staged and whether it was angiographically guided or functionally guided. The primary outcome was major adverse cardiovascular events (MACE). RESULTS:A total of 26 randomized trials that enrolled 15,902 patients were included. The mean weighted duration of follow-up was 25.2 ± 15.7 months. MACE was reduced with both immediate CR and staged CR compared with culprit-vessel-only treatment (RR: 0.48; 95% CI: 0.36-0.64 and RR: 0.65; 95% CI: 0.52-0.82, respectively), whether with angiographic or functional guidance. Immediate CR was associated with reduced MACE compared with staged CR (RR: 0.74; 95% CI: 0.56-0.97), whether CR was guided angiographically or functionally (RR: 0.77; 95% CI: 0.61-0.99 and RR: 0.49; 95% CI: 0.27-0.89, respectively) caused by reductions in MI. However, when the analysis was restricted to studies that reported both all MI and nonprocedural MI, the benefit of immediate CR in reducing MI compared with staged CR was diminished after excluding procedural MI (RR: 0.44; 95% CI: 0.27-0.71 with procedural MI vs RR: 0.65; 95% CI: 0.36-1.16 without procedural MI). CONCLUSIONS:Among patients with STEMI and multivessel disease, outcomes were better with immediate or staged CR compared with culprit vessel-only treatment, whether with angiographic or functional guidance.

BACKGROUND/UNASSIGNED:The aim of this study was to examine the impact of early versus delayed catheter-based therapies (CBTs) on clinical outcomes in patients with acute intermediate-risk pulmonary embolism (PE). METHODS/UNASSIGNED:This retrospective cohort study analyzed data from 2 academic centers involving patients with intermediate-risk PE from January 2020 to January 2024. Patients were divided into early (<12 hours) and delayed CBT (≥12 hours) groups. The primary outcome was a composite of 30-day mortality, resuscitated cardiac arrest, hemodynamic instability, and 90-day readmission. Secondary outcomes included a composite of 30-day mortality, resuscitated cardiac arrest, and hemodynamic instability. Inverse probability of treatment weighting was used to balance covariates. RESULTS/UNASSIGNED:=0.046). When patients were stratified by timing of CBT (early/late) and the composite PE shock score (high ≥3; low <3), all 16 patients who experienced the primary composite outcome had a high composite PE shock score, with 14/16 (87.5%) having a high composite PE shock score and delayed intervention. CONCLUSIONS/UNASSIGNED:Early CBT was associated with improved clinical outcomes in patients with acute intermediate-risk PE. The composite PE shock score may help identify patients who will benefit from early CBT. Further prospective studies are needed to validate these findings.

Radial artery occlusion (RAO), a complication of transradial access, has an incidence of 4.0% to 9.1% in patients with advanced chronic kidney disease (CKD) and may preclude its use creation of arteriovenous fistula. Distal transradial access (dTRA) has lower rates of RAO compared with TRA, but prior studies excluded patients with advanced CKD. This was a single center study of patients with advanced CKD who underwent coronary procedures with dTRA from January 1, 2019 to May 12, 2022 who were retrospectively evaluated for radial artery patency in follow-up with reverse Barbeau testing or repeat access of the artery. Of 71 patients, 66% were on hemodialysis and the remainder had CKD 3 to 5. Access was ultrasound-guided, and all received adequate spasmolytic therapy and patent hemostasis. Proximal radial arteries were patent in 100% of the patients at follow-up. Our data suggest that dTRA is safe for patients with advanced CKD and preserves radial artery patency.

BACKGROUND:Randomized trials of bivalirudin in patients with ST elevation myocardial infarction (STEMI) have yielded heterogeneous results. AIMS/OBJECTIVE:Our aim was to evaluate the efficacy and safety of four antithrombin regimens-unfractionated heparin (UFH), bivalirudin (stopped soon after percutaneous coronary intervention [PCI]), extended bivalirudin (continued for a few hours after PCI), and combined UFH and a Gp2b3a inhibitors (GPI) in patients who present with STEMI. METHODS:A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials (RCTs) of the above antithrombin in patients with STEMI. The primary outcome was net adverse cardiovascular events (NACE). The primary ischemic endpoint was major adverse cardiovascular events (MACE), and the primary safety endpoint was major bleeding, and other endpoints included all-cause mortality and stent thrombosis. The primary analysis compared the effect of these antithrombin regimens in reference to UFH using a mixed treatment comparison meta-analysis. RESULTS:In the 14 RCTs evaluating 25,415 patients with STEMI, when compared to UFH monotherapy, extended bivalirudin lowered NACE (OR = 0.71 with 95% CI: 0.53-0.96; moderate level of confidence) driven by a significant decrease in major bleeding (OR = 0.42 with 95% CI: 0.26-0.68; high level of confidence) without any significant difference in MACE or all-cause mortality. When compared with UFH monotherapy, UFH+GPI reduced risk of MACE (OR = 0.76 with 95% CI: 0.60-0.97; high level of confidence) but at the expense of an increase in major bleeding (OR = 1.48 with 95% CI: 1.11-1.98; high level of confidence) with no difference in NACE or all-cause mortality. For major bleeding, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, UFH monotherapy ranked #3, and combined UFH and GPI ranked #4. For NACE, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, combined UFH and GPI ranked #3, and UFH monotherapy ranked #4. Cluster plots for MACE and major bleeding demonstrated that extended bivalirudin had the best balance for efficacy and safety. CONCLUSIONS:In patients undergoing PCI for STEMI, extended bivalirudin offers the best balance for primary ischemic (MACE) and safety (major bleeding) outcomes.