Can I cancel venous thrombolysis?Direct-SAFE research "raising hands" answer

"Physician Daily Channel" follows us

Physician News (Rong Media Reporter Song Yan) Opening the history of the treatment of acute ischemic strokes, this page in 2015 wrote: a major breakthrough in the treatment of ischemic strokes.

This year, the five RCT tests (MR Clean, EXTEND-IA, Escape, Swift-PRIME, Revascat) were born, unanimously showing that for patients with acute anterior cycle arterial occlusion, arteries were performed on the basis of venous thrombolysis. Take the embolism can significantly improve the clinical ending of patients and reduce the disability rate. So far, for such stroke patients, the bridge scheme (bridge therapy) of venous thrombolytic combined with intravascular intervention treatment is still the first choice. It is worth noting that during the period, some scholars are also exploring whether they can bypass venous thrombolysis and use direct embolism to replace the bridge?

Once this issue is raised, it has become a hot spot and controversy in the field of stroke treatment. Professor Miao Zhongrong, Director of the Neuro intervention center of Beijing Tiantan Hospital of Capital Medical University, introduced that in order to answer this question, six large RCT research on bridge therapy (Direct-MT, DEVT, SKIP, MR Clean-NO IV, Direct-SAFE, SWIFT DIRECT ) It has been carried out around the world, and many units in my country have participated and contributed outstanding contributions.

"Want!" Direct-SAFE research answers whether to dissolve thromboly

Direct MT and DEVT studies have shown that directly taking bolt is not inferior to bridge therapy; while MR Clean-NO IV, SKIP, Swift Direct studies fail to prove the conclusion of non-inferiority. The results of these studies are inconsistent, suggesting that more evidence -based medical evidence is required.

In July 2022, the results of Direct-SAFE, which received much attention from all parties, published in "Liuye Knife". Direct-SAFE is an international, multi-centered, forward-looking, random, open label, ending blind test. Beijing Tiantan Hospital affiliated to Capital Medical University, as the main center of China, joined hands with 11 domestic centers to participate in the entry into the group.

The study was incorporated into 295 patients, and randomly distributed into the direct embolism group or bridge treatment group. The results of the study show that: Compared with bridge treatment, no non -inferiority of directly taking bolt is found. In the pre -determined Asian group analysis, compared with the direct embolism group, patients in Asia have better bridges.

According to Professor Miao Zhongrong, as a long and large-scale multi-center RCT study, Direct-SAFE research answered several major clinical questions.

First answer the question of whether to cancel venous thrombolysis. Judging from the results of the six major research, although it is not yet possible to determine that bridge therapy is better than direct embolism, it is not yet possible to ban venous thrombolysis. Patients with acute anterior circulation large blood vessels occur if they meet venous thrombolytic indicators, and it is still necessary to perform venous thrombolytic treatment.

Secondly, for most domestic grass -roots hospitals, it lacks necessary direct anti -bolt conditions. At the same time, venous thrombolysis can also promote recurrence of blood vessels and improve remote pouring. It can be said that venous thrombolysis is still an important treatment method for grassroots hospitals for a long time.

In addition, the analysis of the Asian and Asian group shows that the treatment of bridge is better, so in the relevant clinical guidelines, the status of venous thrombolysis will continue to be emphasized.

"New starting point!" Direct-Safe research is not the end point

"At this point, the six major studies of bridge therapy have published results. They guided the clinic with actual results to help more patients get timely treatment and better prognosis in the time window." Instead, a new starting point is that the highly targeted acclaim analysis is in full swing, so stay tuned! "" It is not easy to participate in a large international research, it is difficult, the process is twists and turns, but the future will still be actively participating. "Miao Zhongrong Rong in the future." Miao Zhongrong The professor also shared his experience in participating in international cooperation. He said that during the project establishment stage, you must choose to cooperate with well-known international units as much as possible. For example, Direct-SAFE research participating units include the Australian Royal Melbourne Hospital. Domestic doctors are also excellent learning opportunities.

Under the leadership of Beijing Tiantan Hospital, 10 units including Beijing Fengtai You'anmen Hospital, Binzhou People's Hospital, and Jilin University China -Japan Friendship Hospital have joined the research. In the absence of experience, Beijing Tiantan Hospital has held many special training activities to improve the level of researchers to control the quality of research and meet international research requirements. In the research, we should connect with foreign units in a timely manner to accurately transmit data, and timely communicate with the technical problems and research standards, etc. to ensure that the information is symmetrical.

"To connect with each branch center, let them develop the habit of incorporating patients who meet the standards in time." When the research is carried out, the progress of controlling the progress is very important. Important factor for quality completion!

- END -