The ACC 2020 丨 LBCT Ⅲ quick reference! VOYAGER PAD, spyral-htn-off-med, Caravaggio, etc

On March 29, 2020, the American college of cardiology and the world congress of cardiology (ACC. 20 / WCC) presented at the annual scientific meeting of the American college of cardiology and the world congress of cardiology (ACC.

The latest data show that rivaroxaban reduces the risk of VTE by 75% without increasing the risk of bleeding.

This international, double-blind, randomized, controlled trial is the first to compare rivaroxaban with enoxaparin in preventing the risk of thrombus in patients requiring immobilization after non-major orthopedic surgery.

Postoperative immobilization in patients can help facilitate postoperative recovery, but even short-term activity restrictions can increase the risk of thrombosis, leading to deep vein thrombosis (DVT), which can lead to pulmonary embolism.

"In these patients, we must prevent deep vein thrombosis, which can lead to fatal pulmonary embolism," said Dr. Nadia rosencher, senior consultant and anesthesiologist at the university of Paris in France.

"This study demonstrates that once a day oral anticoagulants can be more effective in preventing blood clots in patients after surgery, which is a big step forward in our treatment."

Enoxaparin needs to be injected, Dr. Rosencher said, an operation that requires a nurse and can be very difficult for patients.

In addition, younger patients in their 40s in the study needed to return to work or care for their families, and oral medication was more convenient and did not increase complications.

Rivaroxaban works by blocking the activity of factor Xa, which has a strong anticoagulant effect, so the researchers said they were surprised to find that rivaroxaban had the same bleeding risk as enoxaparin.

Although most current clinical guidelines recommend in major orthopedic surgery have a higher risk of venous thromboembolism (including total knee and total hip replacement) after use of anticoagulants to prevent thrombosis, but in patients with moderate risk (for example, the ankle surgery, ligament repair or the arthroscopic examination) consensus is less, the United States each year, millions of people to accept this kind of surgery, may need to prevent thrombosis.

"In Europe, all guidelines recommend that patients with a risk of clotting should consider anticoagulation, but there is no consensus among groups of patients at moderate risk who still need to be fixed during recovery," rosencher said.

"Many of the data suggest that anticoagulation is a win-win for patients, preventing clots without increasing the risk of major bleeding."

The study included 3,604 patients from 10 countries who were considered by the researchers to have a moderate risk of venous thrombosis after surgery and who had to be immobilized for more than 15 days.

The patients were randomly divided into two groups: rivaroxaban (oral 10mg QD) and enoxaparin (subcutaneous 0.4ml QD).

The study was double-blind, and all patients received both injections and tablets. The rivaroxaban group received a placebo injection along with an oral dose each day.

Overall, the disability rate was reduced at 28 days, with one-third of patients requiring braking for 1 to 2 months and two-thirds requiring braking for 2 weeks to 1 month.

The primary outcome endpoints included symptomatic distal or proximal DVT during treatment and within one month of follow-up, pulmonary embolism, vte-related death, and asymptomatic proximal DVT at the end of treatment.

Of these, 4/1661 (0.24%) occurred in the rivaroxaban group and 18/1640 (1.1%) in the enoxaparin group.

Secondary endpoints included major bleeding, clinically related non-major bleeding, significant thrombocytopenia (low platelet count) as defined in other studies, and death from any cause.

There was no significant difference in the incidence of hemorrhage between the rivaroxaban group and the enoxaparin group.

The incidence of major bleeding was 0.57% and 0.69%, respectively.

None of the other two groups died, except for one patient who died at the end of the follow-up period after liver transplantation.

"In the low-molecular-weight heparin group, ultrasound observed a large number of patients with very dangerous asymptomatic proximal DVT, which can lead to pulmonary embolism, leading to higher mortality," rosencher said.

"Based on the data from this study, we expect rivaroxaban indications to expand appropriately."

Rivaroxaban is currently approved by the fda to prevent DVT after elective knee or hip replacement and to prevent pulmonary embolism.

In some countries, rivaroxaban has a wider range of indications after lower extremity orthopedic surgery.

The study was also published online in the New England journal of medicine.

The trial was supported by the central hospital of the university of saint-etienne (France) and bayer.