Amar Vedamurthy, MBBS, MS

Background: MRSA carriers are at higher risk of infection and rehospitalization after hospital discharge. Education regarding hygiene, environmental cleaning, and decolonization of MRSA carriers have been used as possible preventive strategies. Decolonization has been effective in reducing surgical-site infections, recurrent skin infections, and infections in ICU. However, there is sparsity of data on the efficacy of routine decolonization of MRSA carriers after hospital discharge.

Study design: Multicenter, randomized, unblinded controlled trial.

Setting: A total of 17 hospitals and seven nursing homes in Southern California.

Synopsis: The study included 2,121 inpatients hospitalized within the previous 30 days and found to be MRSA carriers. Patients were randomized to education only (1,063) or decolonization plus education (1,058), with both groups followed for 12 months after discharge. Decolonization consisted of 4% rinse-off chlorhexidine for daily bathing or showering, 0.12% chlorhexidine mouthwash twice daily, and 2% nasal mupirocin twice daily. The primary outcome was MRSA infection as defined by the CDC. Secondary outcomes included MRSA infection based on clinical judgment, infection from any cause, and infection-related hospitalization. Per protocol analysis showed that MRSA infection occurred in 9.2% in the education group and 6.3% in the decolonization plus education group, with 30% reduction in the risk of infection (HR, 0.70; 95% CI, 0.51-0.99; number needed to treat to prevent one infection, 30). The decolonization group also had a lower hazard of clinically judged infection from any cause (HR, 0.83; 95% CI, 0.70-0.99) and infection-related hospitalization (HR, 0.76; 95% CI, 0.62-0.93).

Limitations of the study include unblinded intervention, missing of milder infections that might not have required hospitalization, and frequent insufficient documentation in charts for events to be deemed infection according to the CDC criteria.

Bottom line: Decolonization of MRSA carriers post discharge may lower MRSA-related infections and infections more than hygiene education alone.

Citation: Huang SS et al. Decolonization to reduce postdischarge infection risk among MRSA carriers. N Eng J Med. 2019;380:638-50.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.

Background: MRSA carriers are at higher risk of infection and rehospitalization after hospital discharge. Education regarding hygiene, environmental cleaning, and decolonization of MRSA carriers have been used as possible preventive strategies. Decolonization has been effective in reducing surgical-site infections, recurrent skin infections, and infections in ICU. However, there is sparsity of data on the efficacy of routine decolonization of MRSA carriers after hospital discharge.

Study design: Multicenter, randomized, unblinded controlled trial.

Setting: A total of 17 hospitals and seven nursing homes in Southern California.

Synopsis: The study included 2,121 inpatients hospitalized within the previous 30 days and found to be MRSA carriers. Patients were randomized to education only (1,063) or decolonization plus education (1,058), with both groups followed for 12 months after discharge. Decolonization consisted of 4% rinse-off chlorhexidine for daily bathing or showering, 0.12% chlorhexidine mouthwash twice daily, and 2% nasal mupirocin twice daily. The primary outcome was MRSA infection as defined by the CDC. Secondary outcomes included MRSA infection based on clinical judgment, infection from any cause, and infection-related hospitalization. Per protocol analysis showed that MRSA infection occurred in 9.2% in the education group and 6.3% in the decolonization plus education group, with 30% reduction in the risk of infection (HR, 0.70; 95% CI, 0.51-0.99; number needed to treat to prevent one infection, 30). The decolonization group also had a lower hazard of clinically judged infection from any cause (HR, 0.83; 95% CI, 0.70-0.99) and infection-related hospitalization (HR, 0.76; 95% CI, 0.62-0.93).

Limitations of the study include unblinded intervention, missing of milder infections that might not have required hospitalization, and frequent insufficient documentation in charts for events to be deemed infection according to the CDC criteria.

Bottom line: Decolonization of MRSA carriers post discharge may lower MRSA-related infections and infections more than hygiene education alone.

Citation: Huang SS et al. Decolonization to reduce postdischarge infection risk among MRSA carriers. N Eng J Med. 2019;380:638-50.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.

Background: MRSA carriers are at higher risk of infection and rehospitalization after hospital discharge. Education regarding hygiene, environmental cleaning, and decolonization of MRSA carriers have been used as possible preventive strategies. Decolonization has been effective in reducing surgical-site infections, recurrent skin infections, and infections in ICU. However, there is sparsity of data on the efficacy of routine decolonization of MRSA carriers after hospital discharge.

Study design: Multicenter, randomized, unblinded controlled trial.

Setting: A total of 17 hospitals and seven nursing homes in Southern California.

Synopsis: The study included 2,121 inpatients hospitalized within the previous 30 days and found to be MRSA carriers. Patients were randomized to education only (1,063) or decolonization plus education (1,058), with both groups followed for 12 months after discharge. Decolonization consisted of 4% rinse-off chlorhexidine for daily bathing or showering, 0.12% chlorhexidine mouthwash twice daily, and 2% nasal mupirocin twice daily. The primary outcome was MRSA infection as defined by the CDC. Secondary outcomes included MRSA infection based on clinical judgment, infection from any cause, and infection-related hospitalization. Per protocol analysis showed that MRSA infection occurred in 9.2% in the education group and 6.3% in the decolonization plus education group, with 30% reduction in the risk of infection (HR, 0.70; 95% CI, 0.51-0.99; number needed to treat to prevent one infection, 30). The decolonization group also had a lower hazard of clinically judged infection from any cause (HR, 0.83; 95% CI, 0.70-0.99) and infection-related hospitalization (HR, 0.76; 95% CI, 0.62-0.93).

Limitations of the study include unblinded intervention, missing of milder infections that might not have required hospitalization, and frequent insufficient documentation in charts for events to be deemed infection according to the CDC criteria.

Bottom line: Decolonization of MRSA carriers post discharge may lower MRSA-related infections and infections more than hygiene education alone.

Citation: Huang SS et al. Decolonization to reduce postdischarge infection risk among MRSA carriers. N Eng J Med. 2019;380:638-50.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.

Background: Factor Xa inhibitors have become increasingly popular in the treatment and prevention of thrombotic events, but the lack of specific reversal agents in the event of life-threatening or uncontrolled bleeding may limit their use. Andexanet alfa is a new Food and Drug Administration–approved reversal agent which rapidly reduces anti–factor Xa activity, thereby reversing the anticoagulation effects of factor Xa inhibitors.

Study design: A prospective, open-label, single-group cohort study.

Setting: An industry-sponsored, multicenter study.

Synopsis: The study evaluated 352 adult patients who had acute major bleeding (such as intracranial hemorrhage [64%] or GI bleeding [26%] within 18 hours after administration of a factor Xa inhibitor, including apixaban, rivaroxaban, or edoxaban). Efficacy was assessed in 254 patients who met criteria for severe bleeding and elevated baseline anti–factor Xa activity. Patients were administered a bolus dose of andexanet alfa followed by a 2-hour infusion. The median anti–factor Xa activity reduced by 92% each among patients receiving apixaban or rivaroxaban. The majority (82%) of evaluable patients achieved excellent or good hemostasis at 12 hours after andexanet alfa administration, which compares favorably with the hemostatic efficacy of 72% observed with prothrombin complex concentrate used to reverse anticoagulation in patients treated with vitamin K antagonists. Of patients in the study, 10% experienced a thrombotic event during the 30-day follow-up period, and 14% died.

Limitations of the study include lack of a control group and absence of a significant relationship between a reduction in anti–factor Xa activity and hemostasis. The sponsor is planning to conduct a randomized trial with FDA guidance in the near future.

Bottom line: Andexanet alfa is an FDA-approved agent and appears effective in achieving hemostasis in patients with a factor Xa inhibitor–associated major acute bleeding.

Citation: Connolly SJ et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Eng J Med. 2019 Feb 7. doi: 10.1056/NEJMoa1814051.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.

Background: Factor Xa inhibitors have become increasingly popular in the treatment and prevention of thrombotic events, but the lack of specific reversal agents in the event of life-threatening or uncontrolled bleeding may limit their use. Andexanet alfa is a new Food and Drug Administration–approved reversal agent which rapidly reduces anti–factor Xa activity, thereby reversing the anticoagulation effects of factor Xa inhibitors.

Study design: A prospective, open-label, single-group cohort study.

Setting: An industry-sponsored, multicenter study.

Synopsis: The study evaluated 352 adult patients who had acute major bleeding (such as intracranial hemorrhage [64%] or GI bleeding [26%] within 18 hours after administration of a factor Xa inhibitor, including apixaban, rivaroxaban, or edoxaban). Efficacy was assessed in 254 patients who met criteria for severe bleeding and elevated baseline anti–factor Xa activity. Patients were administered a bolus dose of andexanet alfa followed by a 2-hour infusion. The median anti–factor Xa activity reduced by 92% each among patients receiving apixaban or rivaroxaban. The majority (82%) of evaluable patients achieved excellent or good hemostasis at 12 hours after andexanet alfa administration, which compares favorably with the hemostatic efficacy of 72% observed with prothrombin complex concentrate used to reverse anticoagulation in patients treated with vitamin K antagonists. Of patients in the study, 10% experienced a thrombotic event during the 30-day follow-up period, and 14% died.

Limitations of the study include lack of a control group and absence of a significant relationship between a reduction in anti–factor Xa activity and hemostasis. The sponsor is planning to conduct a randomized trial with FDA guidance in the near future.

Bottom line: Andexanet alfa is an FDA-approved agent and appears effective in achieving hemostasis in patients with a factor Xa inhibitor–associated major acute bleeding.

Citation: Connolly SJ et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Eng J Med. 2019 Feb 7. doi: 10.1056/NEJMoa1814051.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.

Background: Factor Xa inhibitors have become increasingly popular in the treatment and prevention of thrombotic events, but the lack of specific reversal agents in the event of life-threatening or uncontrolled bleeding may limit their use. Andexanet alfa is a new Food and Drug Administration–approved reversal agent which rapidly reduces anti–factor Xa activity, thereby reversing the anticoagulation effects of factor Xa inhibitors.

Study design: A prospective, open-label, single-group cohort study.

Setting: An industry-sponsored, multicenter study.

Synopsis: The study evaluated 352 adult patients who had acute major bleeding (such as intracranial hemorrhage [64%] or GI bleeding [26%] within 18 hours after administration of a factor Xa inhibitor, including apixaban, rivaroxaban, or edoxaban). Efficacy was assessed in 254 patients who met criteria for severe bleeding and elevated baseline anti–factor Xa activity. Patients were administered a bolus dose of andexanet alfa followed by a 2-hour infusion. The median anti–factor Xa activity reduced by 92% each among patients receiving apixaban or rivaroxaban. The majority (82%) of evaluable patients achieved excellent or good hemostasis at 12 hours after andexanet alfa administration, which compares favorably with the hemostatic efficacy of 72% observed with prothrombin complex concentrate used to reverse anticoagulation in patients treated with vitamin K antagonists. Of patients in the study, 10% experienced a thrombotic event during the 30-day follow-up period, and 14% died.

Limitations of the study include lack of a control group and absence of a significant relationship between a reduction in anti–factor Xa activity and hemostasis. The sponsor is planning to conduct a randomized trial with FDA guidance in the near future.

Bottom line: Andexanet alfa is an FDA-approved agent and appears effective in achieving hemostasis in patients with a factor Xa inhibitor–associated major acute bleeding.

Citation: Connolly SJ et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Eng J Med. 2019 Feb 7. doi: 10.1056/NEJMoa1814051.

Dr. Vedamurthy is a hospitalist at Massachusetts General Hospital.