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Editorial: The need for standardized feedback systems for interventional cardiologists [Editorial]
Rao, Sunil V; Bailey, Eric
PMID: 39043551
ISSN: 1878-0938
CID: 5723582
Outcomes with distal transradial access in patients with advanced chronic kidney disease
Mosarla, Ramya C; Ahmed, Hamza; Rao, Shaline D; Kadosh, Bernard S; Cruz, Jennifer A; Goldberg, Randal I; Saraon, Tajinderpal; Gelb, Bruce E; Mattoo, Aprajita; Rao, Sunil V; Bangalore, Sripal
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.
PMID: 39150435
ISSN: 1557-2501
CID: 5727012
Restrictive versus Liberal Transfusion in Myocardial Infarction - A Patient-Level Meta-Analysis
Carson, Jeffrey L; Fergusson, Dean A; Noveck, Helaine; Mallick, Ranjeeta; Simon, Tabassome; Rao, Sunil V; Cooper, Howard; Stanworth, Simon J; Portela, Gerard T; Ducrocq, Gregory; Bertolet, Marnie; DeFilippis, Andrew P; Goldsweig, Andrew M; Kim, Sarang; Triulzi, Darrell J; Menegus, Mark A; Abbott, J Dawn; Lopes, Renato D; Brooks, Maria Mori; Alexander, John H; Hébert, Paul C; Goodman, Shaun G; Steg, P Gabriel
BACKGROUND:Clinical guidelines have concluded that there are insufficient data to provide recommendations for the hemoglobin threshold for the use of red cell transfusion in patients with acute myocardial infarction (MI) and anemia. After the recent publication of the Myocardial Infarction and Transfusion (MINT) trial, we performed an individual patient-level data meta-analysis to evaluate the effect of restrictive versus liberal blood transfusion strategies. METHODS:We conducted searches in major databases. Eligible trials randomly assigned patients with MI and anemia to either a restrictive (i.e., transfusion threshold of 7-8 g/dl) or liberal (i.e., transfusion threshold of 10 g/dl) red cell transfusion strategy. We used individual patient data from each trial. The primary outcome was a composite of 30-day mortality or MI. RESULTS:We included 4311 patients from four trials. The primary outcome occurred in 334 patients (15.4%) in the restrictive strategy and 296 patients (13.8%) in the liberal strategy (relative risk [RR] 1.13, 95% confidence interval [CI], 0.97 to 1.30). Death at 30 days occurred in 9.3% of patients in the restrictive strategy and in 8.1% of patients in the liberal strategy (RR 1.15, 95% CI, 0.95 to 1.39). Cardiac death at 30 days occurred in 5.5% of patients in the restrictive strategy and in 3.7% of patients in the liberal strategy (RR 1.47, 95% CI, 1.11 to 1.94). Heart failure (RR 0.89, 95% CI, 0.70 to 1.13) was similar in the transfusion strategies. All-cause mortality at 6 months occurred in 20.5% of patients in the restrictive strategy compared with 19.1% of patients in the liberal strategy (hazard ratio 1.08, 95% CI, 1.05 to 1.11). CONCLUSIONS:Pooling individual patient data from four trials did not find a definitive difference in our primary composite outcome of MI or death at 30 days. At 6 months, a restrictive transfusion strategy was associated with increased all-cause mortality. (Partially funded by a grant from the U.S. National Heart, Lung, and Blood Institute [R01HL171977].).
PMID: 39714935
ISSN: 2766-5526
CID: 5767312
Inflammation in the Peri-ACS Period: Ready for Prime Time?
Rao, Sunil V; Lerner, Johanna Ben-Ami
Inflammation has been demonstrated to negatively impact patients in the peri-ACS period. This narrative review outlines the inflammatory response in ACS, highlighting the role of the NLRP3 inflammasome pathway following acute plaque rupture and coronary intervention and its potential as a pharmacologic target. RECENT: nvestigators have leveraged medications targeting the NLRP3 inflammasome currently used for other inflammatory pathologies, including colchicine, tocilizumab and anakinra. Investigation into these drugs in the peri-ACS period has yielded varying results, with the most encouraging findings in ACS patients treated with tocilizumab. More conflicting data exists for the role of colchicine and anakinra, with many studies limited in their power to detect clinical outcomes and heterogeneity in their patient populations and endpoints. Despite conflicting data, the NLRP3 remains an attractive therapeutic target in the peri-ACS period. Further investigation is required to prove benefit and safety with large clinical trials adequately powered for clinical outcomes.
PMID: 39714732
ISSN: 1534-6242
CID: 5767282
Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism
Sista, Akhilesh K; Troxel, Andrea B; Tarpey, Thaddeus; Parpia, Sameer; Goldhaber, Samuel Z; Stringer, William W; Magnuson, Elizabeth A; Cohen, David J; Kahn, Susan R; Rao, Sunil V; Morris, Timothy A; Goldfeld, Keith S; Vedantham, Suresh
BACKGROUND:The optimal management of patients with intermediate-risk pulmonary embolism (PE), who have right heart dysfunction (determined by a combination of imaging and cardiac biomarkers) but a normal blood pressure, is uncertain. These patients suffer from reduced functional capacity and a lower quality of life over the long-term, despite use of anticoagulant therapy. Catheter-directed therapy (CDT) is a promising treatment for acute PE that rapidly removes thrombus and potentially improves cardiac dysfunction. However, CDT has risk and is costly, and it is not known whether it improves long-term cardiorespiratory fitness and/or quality of life compared with anticoagulation alone. METHODS:) with cardiopulmonary exercise testing at 3 months and reduce New York Heart Association (NYHA) Class at 12 months compared with No-CDT. These 2 primary efficacy outcomes will be analyzed sequentially using a "gatekeeping" procedure; for NYHA class to be compared, peak oxygen consumption must first be shown to be significantly increased by CDT. Safety and cost-effectiveness will also be assessed. CONCLUSION/CONCLUSIONS:When completed, PE-TRACT will provide important evidence regarding the benefits and risks of CDT to treat intermediate-risk PE compared with anticoagulation alone. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov: NCT05591118.
PMID: 39638275
ISSN: 1097-6744
CID: 5780192
Restrictive Versus Liberal Transfusion in Patients with Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the Myocardial Ischemia and Transfusion (MINT) Trial
DeFilippis, Andrew P; Abbott, J Dawn; Herbert, Brandon M; Bertolet, Marnie H; Chaitman, Bernard R; White, Harvey D; Goldsweig, Andrew M; Polonsky, Tamar S; Gupta, Rajesh; Alsweiler, Caroline; Silvain, Johanne; de Barros E Silva, Pedro G M; Hillis, Graham S; Daneault, Benoit; Tessalee, Meechai; Menegus, Mark A; Rao, Sunil V; Lopes, Renato D; Hébert, Paul C; Alexander, John H; Brooks, Maria M; Carson, Jeffrey L; Goodman, Shaun G; ,
BACKGROUND:The MINT trial raised concern for harm from a restrictive versus liberal transfusion strategy in patients with acute myocardial infarction (MI) and anemia. Type 1 and type 2 MI are distinct pathophysiological entities that may respond differently to blood transfusion. This analysis sought to determine if the effects of transfusion varied among patients with a type 1 or a type 2 MI and anemia. We hypothesized that the liberal transfusion strategy would be of greater benefit in type 2 than in type 1 MI. METHODS:We compared rates of death or MI at 30 days in patients with type 1 (n=1460) and type 2 (n=1955) MI and anemia who were randomly allocated to a restrictive (threshold of 7 to 8 g/dL) or a liberal (threshold of 10 g/dL) transfusion strategy. RESULTS:= 0.16). CONCLUSIONS:The concern for harm with a restrictive transfusion strategy in patients with acute MI and anemia raised in the MINT primary outcome manuscript may be more apparent in patients with type 1 than type 2 MI. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov number, NCT02981407.
PMID: 39206549
ISSN: 1524-4539
CID: 5729912
Optimizing Health Care Resource Allocation, Workforce "Right-Sizing," and Stakeholder Collaboration
Young, Michael N; Asgar, Anita W; Goldsweig, Andrew M; Hermiller, James B; Khalique, Omar; Manoukian, Steven V; Rao, Sunil V; Smith, Triston B B J; Szerlip, Molly; Kliger, Chad; ,; Canpa, Katie; Church, Michael; Deible, Regina; Ferguson, Robert; Haddad, Mounia; Maguire, Liz; Nelson, Devin; Shetler, Jennifer; Sultana, Nusrath
PMCID:11725150
PMID: 39807239
ISSN: 2772-9303
CID: 5776522
Factor XIa inhibition as a therapeutic strategy for atherothrombosis
Bailey, Eric; Lopes, Renato D; Gibson, C Michael; Eikelboom, John W; Rao, Sunil V
When selecting an anticoagulant, clinicians consider individual patient characteristic, the treatment indication, drug pharmacology, and safety and efficacy as demonstrated in randomized trials. An ideal anticoagulant prevents thrombosis with little or no increase in bleeding. Direct oral anticoagulants represent a major advance over traditional anticoagulants (e.g., unfractionated heparin, warfarin) but still cause bleeding, particularly from the gastrointestinal tract which can limit their use. Epidemiological studies indicate that patients with congenital factor XI (FXI) deficiency have a lower risk of venous thromboembolism (VTE) and ischemic stroke (IS) than non-deficient individuals, and do not have an increased risk of spontaneous bleeding, even with severe deficiency. These observations provide the rationale for targeting FXI as a new class of anticoagulant. Multiple FXI inhibitors have been introduced and several are being evaluated in Phase III trials. In this review, we explain why drugs that target FXI may be associated with a lower risk of bleeding than currently available anticoagulants and summarize the completed and ongoing trials.
PMID: 39078536
ISSN: 1573-742x
CID: 5731382
Radiation Exposure: The Risk Shared by Patient and Physician [Editorial]
Rao, Sunil V; Ben-Ami Lerner, Johanna
PMID: 39453371
ISSN: 1876-7605
CID: 5740322
Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data
Portela, Gerard T; Carson, Jeffrey L; Swanson, Sonja A; Alexander, John H; Hébert, Paul C; Goodman, Shaun G; Steg, Philippe Gabriel; Bertolet, Marnie; Strom, Jordan B; Fergusson, Dean A; Simon, Tabassome; White, Harvey D; Cooper, Howard A; Abbott, J Dawn; Rao, Sunil V; Chaitman, Bernard R; Fordyce, Christopher B; Lopes, Renato D; Daneault, Benoit; Brooks, Maria M; ,
BACKGROUND/UNASSIGNED:The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain. OBJECTIVE/UNASSIGNED:To estimate the efficacy of 4 individual hemoglobin thresholds (<10 g/dL [<100 g/L], <9 g/dL [<90 g/L], <8 g/dL [<80 g/L], and <7 g/dL [<70 g/L]) to guide transfusion in patients with acute MI and anemia. DESIGN/UNASSIGNED:Prespecified secondary analysis of the MINT (Myocardial Ischemia and Transfusion) trial using target trial emulation methods. (ClinicalTrials.gov: NCT02981407). SETTING/UNASSIGNED:144 clinical sites in 6 countries. PARTICIPANTS/UNASSIGNED:3492 MINT trial participants with acute MI and a hemoglobin level below 10 g/dL. INTERVENTION/UNASSIGNED:Four transfusion strategies to maintain patients' hemoglobin concentrations at or above thresholds of 10, 9, 8, or 7 g/dL. Protocol exceptions were permitted for specified adverse clinical events. MEASUREMENTS/UNASSIGNED:Data from the MINT trial were leveraged to emulate 4 transfusion strategies and estimate per protocol effects on the composite outcome of 30-day death or recurrent MI (death/MI) and 30-day death using inverse probability weighting. RESULTS/UNASSIGNED:The 30-day risk for death/MI was 14.8% (95% CI, 11.8% to 18.4%) for a <10-g/dL strategy, 15.1% (CI, 11.7% to 18.2%) for a <9-g/dL strategy, 15.9% (CI, 12.4% to 19.0%) for a <8-g/dL strategy, and 18.3% (CI, 14.6% to 22.0%) for a <7-g/dL strategy. Absolute risk differences and risk ratios relative to the <10-g/dL strategy for 30-day death/MI increased as thresholds decreased, although 95% CIs were wide. Findings were similar and imprecise for 30-day death. LIMITATION/UNASSIGNED:Unmeasured confounding may have persisted despite adjustment. CONCLUSION/UNASSIGNED:The 30-day risks for death/MI and death among patients with acute MI and anemia seem to increase progressively with lower hemoglobin concentration thresholds for transfusion. However, the imprecision around estimates from this target trial analysis precludes definitive conclusions about individual hemoglobin thresholds. PRIMARY FUNDING SOURCE/UNASSIGNED:National Heart, Lung, and Blood Institute.
PMID: 39348705
ISSN: 1539-3704
CID: 5757882