Observational investigation of thrombolysis with the tissue-type plasminogen activator monteplase for acute pulmonary embolism in Japan.
BACKGROUND
In Japan, the safety and efficacy of thrombolytic therapy using tissue-type plasminogen activator for acute pulmonary embolism (PE) in the real world remain unclear.


RESULTS
A total of 1,254 patients with acute PE covered by the post-marketing surveillance of thrombolytic therapy using monteplase were divided into 3 groups: cardiopulmonary arrest (CPA)/collapse group (n=85); massive group, patients with unstable hemodynamics without CPA/collapse (n=217); and submassive group, patients with stable hemodynamics and right ventricular dysfunction (RVD) (n=465). In the efficacy analysis of 767 cases, the response rate to monteplase was 94.6% according to pulmonary circulation assessment and 93.3% according to clinical efficacy judged by symptoms and signs. Overall survival rates at 30 days after monteplase administration were 89.2% overall, 41.2% for the CPA/collapse group, 93.0% for the massive group, and 96.3% for the submassive group. When the safety of monteplase was analyzed in 1,241 cases, severe bleeding complications occurred in 100 patients (8.1%). Intracranial hemorrhage (ICH) occurred in 21 patients (1.7%), but no significant independent predictors were found in multivariate analysis.


CONCLUSIONS
Thrombolytic therapy is highly effective in Japanese acute PE patients and offers acceptable safety, but attention is needed regarding severe bleeding complications, including ICH.
Department of Cardiology, Hiratsuka Kyosai Hospital, 9-11 Oiwake, Hiratsuka 254-8502,Japan. niwa-a@kkr.hiratsuka.kanagawa.jp
Akihiro
A
Niwa
Mashio
M
Nakamura
Natsumi
N
Harada
Takashi
T
Musha
D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D018572:Disease-Free Survival; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000401:mortality; D007564:Japan; D008297:Male; D008875:Middle Aged; D010960:Plasminogen Activators / Q000009:adverse effects / Q000627:therapeutic use*; D011652:Pulmonary Circulation / Q000187:drug effects; D011655:Pulmonary Embolism / Q000188:drug therapy* / Q000401:mortality* / Q000503:physiopathology; D015996:Survival Rate; D015912:Thrombolytic Therapy; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D018497:Ventricular Dysfunction, Right / Q000188:drug therapy / Q000401:mortality / Q000503:physiopathology
C468277:monteplase; D010960:Plasminogen Activators; D010959:Tissue Plasminogen Activator