David C. Portnoy, MD

Clinical question: Does renal underdosing and overdosing of non–vitamin K antagonist oral anticoagulants (NOACs) impact the risk of thrombotic and bleeding complications?

Background: All of the NOACs have at least partial renal clearance, but compliance with Food and Drug Administration–labeled renal dosing recommendations is inconsistent. This study examines the risk of adverse thrombotic and bleeding events in patients with improper anticoagulant dosing.

Study design: Retrospective cohort study.

Setting: United States (OptumLabs data warehouse, a database of over 100 million patients hospitalized in the United States in the last 20 years).

Synopsis: With use of data from the OptumLabs data warehouse of privately insured and Medicare Advantage enrollees, 14,865 patients with nonvalvular atrial fibrillation who were started on NOACs (apixaban, dabigatran, or rivaroxaban) were identified. Creatinine values within the year before treatment were used to calculate an estimated glomerular filtration rate (eGFR).

Of patients qualifying for renal dose reduction, 43% received the standard dosing (overdose). Of patients not qualifying for renal dose reduction, 13% received a reduced dose (underdose). The overdosed group had a higher rate of bleeding events, compared with controls (hazard ratio, 2.19; 95% CI, 1.07-4.46). The underdosed group had a higher rate of stroke (HR, 4.87; 95% CI, 1.30-18.26).

Bottom line: Excessive dosing of NOACs in patients with renal insufficiency is common and is associated with bleeding.Citation: Yao X, Shah ND, Sangaralingham LR, Gersh BJ, and Noseworthy PA. Non–vitamin K antagonist oral anticoagulant dosing in patients with atrial fibrillation and renal dysfunction. JACC. 2017;69(23):2779-90.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does renal underdosing and overdosing of non–vitamin K antagonist oral anticoagulants (NOACs) impact the risk of thrombotic and bleeding complications?

Background: All of the NOACs have at least partial renal clearance, but compliance with Food and Drug Administration–labeled renal dosing recommendations is inconsistent. This study examines the risk of adverse thrombotic and bleeding events in patients with improper anticoagulant dosing.

Study design: Retrospective cohort study.

Setting: United States (OptumLabs data warehouse, a database of over 100 million patients hospitalized in the United States in the last 20 years).

Synopsis: With use of data from the OptumLabs data warehouse of privately insured and Medicare Advantage enrollees, 14,865 patients with nonvalvular atrial fibrillation who were started on NOACs (apixaban, dabigatran, or rivaroxaban) were identified. Creatinine values within the year before treatment were used to calculate an estimated glomerular filtration rate (eGFR).

Of patients qualifying for renal dose reduction, 43% received the standard dosing (overdose). Of patients not qualifying for renal dose reduction, 13% received a reduced dose (underdose). The overdosed group had a higher rate of bleeding events, compared with controls (hazard ratio, 2.19; 95% CI, 1.07-4.46). The underdosed group had a higher rate of stroke (HR, 4.87; 95% CI, 1.30-18.26).

Bottom line: Excessive dosing of NOACs in patients with renal insufficiency is common and is associated with bleeding.Citation: Yao X, Shah ND, Sangaralingham LR, Gersh BJ, and Noseworthy PA. Non–vitamin K antagonist oral anticoagulant dosing in patients with atrial fibrillation and renal dysfunction. JACC. 2017;69(23):2779-90.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does renal underdosing and overdosing of non–vitamin K antagonist oral anticoagulants (NOACs) impact the risk of thrombotic and bleeding complications?

Background: All of the NOACs have at least partial renal clearance, but compliance with Food and Drug Administration–labeled renal dosing recommendations is inconsistent. This study examines the risk of adverse thrombotic and bleeding events in patients with improper anticoagulant dosing.

Study design: Retrospective cohort study.

Setting: United States (OptumLabs data warehouse, a database of over 100 million patients hospitalized in the United States in the last 20 years).

Synopsis: With use of data from the OptumLabs data warehouse of privately insured and Medicare Advantage enrollees, 14,865 patients with nonvalvular atrial fibrillation who were started on NOACs (apixaban, dabigatran, or rivaroxaban) were identified. Creatinine values within the year before treatment were used to calculate an estimated glomerular filtration rate (eGFR).

Of patients qualifying for renal dose reduction, 43% received the standard dosing (overdose). Of patients not qualifying for renal dose reduction, 13% received a reduced dose (underdose). The overdosed group had a higher rate of bleeding events, compared with controls (hazard ratio, 2.19; 95% CI, 1.07-4.46). The underdosed group had a higher rate of stroke (HR, 4.87; 95% CI, 1.30-18.26).

Bottom line: Excessive dosing of NOACs in patients with renal insufficiency is common and is associated with bleeding.Citation: Yao X, Shah ND, Sangaralingham LR, Gersh BJ, and Noseworthy PA. Non–vitamin K antagonist oral anticoagulant dosing in patients with atrial fibrillation and renal dysfunction. JACC. 2017;69(23):2779-90.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does coronary artery bypass grafting (CABG) have superior mortality outcomes to percutaneous coronary intervention (PCI) for left main coronary disease, and how do these interventions compare with medical therapy alone?

Background: Optimal therapy for left main coronary disease is a highly researched topic with CABG having been standard therapy of choice for several decades. However, most studies have not included data comparing CABG to newer drug-eluting stent (DES) generations and no studies have directly compared PCI with DES to medical therapy alone (MTA).

Study design: Meta-analysis.

Setting: Largely European acute care hospitals as well as some VA hospitals.

Synopsis: With PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a review of PubMed and Cochrane databases was conducted, yielding eight RCTs, including a total of 4,850 patients. Six of the RCTs compared CABG with DES, while two compared CABG with MTA. Network meta-analysis was used to compare DES with MTA. At 5 years there were no differences in all-cause mortality between CABG and DES groups (RR, 0.94; 95% CI, 0.68-1.32), though both groups had lower mortality than MTA (RR, 0.21; 95% CI, 0.09-0.47 for CABG vs. MTA and RR, 0.20; 95% CI, 0.08-0.46 for DES vs MTA).

PCI did have higher risk of revascularization at 5 years (RR, 1.68; 95% CI, 1.36-2.08) and lower risk of stroke at 1 year (RR, 0.21; 95% CI, 0.07-0.63), compared with CABG, suggesting younger patients might prefer CABG to avoid revascularization, and older patients may prefer PCI to avoid postprocedural morbidity.

Bottom line: For patients with left main disease, CABG and PCI with DES appear equally effective with regards to prevention of all-cause mortality and both are superior to MTA.

Citation: Shah R, Morsy MS, Weiman DS, and Vetrovec GW. Meta-analysis comparing coronary artery bypass grafting to drug-eluting stents. Am J Cardiol. 2017;120:63-8.
 

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does coronary artery bypass grafting (CABG) have superior mortality outcomes to percutaneous coronary intervention (PCI) for left main coronary disease, and how do these interventions compare with medical therapy alone?

Background: Optimal therapy for left main coronary disease is a highly researched topic with CABG having been standard therapy of choice for several decades. However, most studies have not included data comparing CABG to newer drug-eluting stent (DES) generations and no studies have directly compared PCI with DES to medical therapy alone (MTA).

Study design: Meta-analysis.

Setting: Largely European acute care hospitals as well as some VA hospitals.

Synopsis: With PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a review of PubMed and Cochrane databases was conducted, yielding eight RCTs, including a total of 4,850 patients. Six of the RCTs compared CABG with DES, while two compared CABG with MTA. Network meta-analysis was used to compare DES with MTA. At 5 years there were no differences in all-cause mortality between CABG and DES groups (RR, 0.94; 95% CI, 0.68-1.32), though both groups had lower mortality than MTA (RR, 0.21; 95% CI, 0.09-0.47 for CABG vs. MTA and RR, 0.20; 95% CI, 0.08-0.46 for DES vs MTA).

PCI did have higher risk of revascularization at 5 years (RR, 1.68; 95% CI, 1.36-2.08) and lower risk of stroke at 1 year (RR, 0.21; 95% CI, 0.07-0.63), compared with CABG, suggesting younger patients might prefer CABG to avoid revascularization, and older patients may prefer PCI to avoid postprocedural morbidity.

Bottom line: For patients with left main disease, CABG and PCI with DES appear equally effective with regards to prevention of all-cause mortality and both are superior to MTA.

Citation: Shah R, Morsy MS, Weiman DS, and Vetrovec GW. Meta-analysis comparing coronary artery bypass grafting to drug-eluting stents. Am J Cardiol. 2017;120:63-8.
 

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does coronary artery bypass grafting (CABG) have superior mortality outcomes to percutaneous coronary intervention (PCI) for left main coronary disease, and how do these interventions compare with medical therapy alone?

Background: Optimal therapy for left main coronary disease is a highly researched topic with CABG having been standard therapy of choice for several decades. However, most studies have not included data comparing CABG to newer drug-eluting stent (DES) generations and no studies have directly compared PCI with DES to medical therapy alone (MTA).

Study design: Meta-analysis.

Setting: Largely European acute care hospitals as well as some VA hospitals.

Synopsis: With PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a review of PubMed and Cochrane databases was conducted, yielding eight RCTs, including a total of 4,850 patients. Six of the RCTs compared CABG with DES, while two compared CABG with MTA. Network meta-analysis was used to compare DES with MTA. At 5 years there were no differences in all-cause mortality between CABG and DES groups (RR, 0.94; 95% CI, 0.68-1.32), though both groups had lower mortality than MTA (RR, 0.21; 95% CI, 0.09-0.47 for CABG vs. MTA and RR, 0.20; 95% CI, 0.08-0.46 for DES vs MTA).

PCI did have higher risk of revascularization at 5 years (RR, 1.68; 95% CI, 1.36-2.08) and lower risk of stroke at 1 year (RR, 0.21; 95% CI, 0.07-0.63), compared with CABG, suggesting younger patients might prefer CABG to avoid revascularization, and older patients may prefer PCI to avoid postprocedural morbidity.

Bottom line: For patients with left main disease, CABG and PCI with DES appear equally effective with regards to prevention of all-cause mortality and both are superior to MTA.

Citation: Shah R, Morsy MS, Weiman DS, and Vetrovec GW. Meta-analysis comparing coronary artery bypass grafting to drug-eluting stents. Am J Cardiol. 2017;120:63-8.
 

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does continuing antiplatelet therapy through noncardiac surgery increase the risk of postoperative blood transfusion or surgical reintervention for bleeding?

Background: Many prior studies have analyzed the risks and benefits of holding versus continuing antiplatelet therapy in the perioperative setting, but heterogeneity in outcome reporting has limited the ability to compare and contrast studies.

Study design: Meta-analysis.

Risk of surgical reintervention for bleeding, however, was not increased above control whether on aspirin (relative risk, 0.96; 95% CI, 0.76-1.22), clopidogrel (RR, 1.84; 95% CI, 0.87-3.87), or DAPT (RR, 1.51; (95% CI, 0.92-2.49).

Bottom line: In noncardiac surgery, continuing aspirin or DAPT perioperatively increases the need for transfusion, but not the need for surgical reintervention for bleeding.

Citation: Columbo JA, Lambour AJ, Sundling RA, et. al. A meta-analysis of the impact of aspirin, clopidogrel, and dual-antiplatelet therapy on bleeding complications in noncardiac surgery. Ann Surg. 2017;20(20):1-9.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does continuing antiplatelet therapy through noncardiac surgery increase the risk of postoperative blood transfusion or surgical reintervention for bleeding?

Background: Many prior studies have analyzed the risks and benefits of holding versus continuing antiplatelet therapy in the perioperative setting, but heterogeneity in outcome reporting has limited the ability to compare and contrast studies.

Study design: Meta-analysis.

Risk of surgical reintervention for bleeding, however, was not increased above control whether on aspirin (relative risk, 0.96; 95% CI, 0.76-1.22), clopidogrel (RR, 1.84; 95% CI, 0.87-3.87), or DAPT (RR, 1.51; (95% CI, 0.92-2.49).

Bottom line: In noncardiac surgery, continuing aspirin or DAPT perioperatively increases the need for transfusion, but not the need for surgical reintervention for bleeding.

Citation: Columbo JA, Lambour AJ, Sundling RA, et. al. A meta-analysis of the impact of aspirin, clopidogrel, and dual-antiplatelet therapy on bleeding complications in noncardiac surgery. Ann Surg. 2017;20(20):1-9.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.

Clinical question: Does continuing antiplatelet therapy through noncardiac surgery increase the risk of postoperative blood transfusion or surgical reintervention for bleeding?

Background: Many prior studies have analyzed the risks and benefits of holding versus continuing antiplatelet therapy in the perioperative setting, but heterogeneity in outcome reporting has limited the ability to compare and contrast studies.

Study design: Meta-analysis.

Risk of surgical reintervention for bleeding, however, was not increased above control whether on aspirin (relative risk, 0.96; 95% CI, 0.76-1.22), clopidogrel (RR, 1.84; 95% CI, 0.87-3.87), or DAPT (RR, 1.51; (95% CI, 0.92-2.49).

Bottom line: In noncardiac surgery, continuing aspirin or DAPT perioperatively increases the need for transfusion, but not the need for surgical reintervention for bleeding.

Citation: Columbo JA, Lambour AJ, Sundling RA, et. al. A meta-analysis of the impact of aspirin, clopidogrel, and dual-antiplatelet therapy on bleeding complications in noncardiac surgery. Ann Surg. 2017;20(20):1-9.

Dr. Portnoy is hospitalist and instructor of medicine, Icahn School of Medicine of the Mount Sinai Health System.