A 30-Day Pooled Analysis of Acetyl Salicylic Elimination Trials (ASET) In Brazil and Japan: Synergy Stent With Prasugrel Monotherapy Without Aspirin
Yuki Ishibashi1, Shinichiro Masuda2, Takashi Muramatsu3, Ken Kozuma4, Hideyuki Kawashima4, Gaku Nakazawa5, Kuniaki Takahashi6, Kengo Tanabe7, Norihiro Kogame8, Masato Nakamura9, Taku Asano10, Takayuki Okamura11, Yosuke Miyazaki11, Hiroki Tateishi11, Yukio Ozaki12, Shimpei Nakatani6, Yuki Katagiri13, Yoshihiro Morino14, Kai Ninomiya2, Shigetaka Kageyama2, Nozomi Kotoku2, Patricia O. Guimarães15, Pedro Lemos15, Yoshinobu Onuma2, Patrick W. Serruys2
St. Marianna University School of Medicine, Japan1, University of Galway, Ireland2, Fujita Health University Hospital, Japan3, Teikyo University Hospital, Japan4, Kindai Univerisity, Japan5, Osaka Police Hospital, Japan6, Mitsui Memorial Hospital, Japan7, Ota Memorial Hospital, Japan8, Toho University Ohashi Medical Center, Japan9, St. Luke's International Hospital, Japan10, Yamaguchi University Hospital, Japan11, Fujita Health University, Japan12, Sapporo Higashi Tokushukai Hospital, Japan13, Iwate Medical University, Japan14, University of Sao Paulo, Brazil15
The safety of P2Y12 monotherapy without aspirin after coronary artery stent deployment is currently under intensive investigation in multiple countries and continents. Previously, the ASET-Brazil pilot study demonstrated the feasibility and safety of prasugrel monotherapy (10 mg/day) after a successful SYNERGY stent deployment in low-risk chronic coronary syndrome (CCS) patients presenting with anatomical SYNTAX score < 23. As an extension of the ASET Brazil pilot study, the ongoing ASET-Japan trial is conducted to assess the safety of an adjusted dose of monotherapy prasugrel (3.75 mg/day) for CCS and NSTE-ACS patients in East Asian populations. The aim of this study was to assess the 30 days results of prasugrel monotherapy without aspirin after successful SYNERGY stent(s) deployment for CCS and NSTE-ACS patients.
In this pooled analysis of the ASET Brazil and Japan trials, the primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction (MI), and definite stent thrombosis at 30 days follow-up. Primary bleeding endpoints were Bleeding Academic Research Consortium (BARC) type 3 or 5.
A total of 404 with 365 CCS and 39 NSTE-ACS patients were included in the study. Overall, the mean age was 64.4 ± 10.1, and 73.5 % were male. The incidence of diabetes mellitus (DM) was 34.9%. The anatomical SYNTAX score was low, but comparable in the ASET Japan and Brazil (7.8 ± 4.5 vs 7.2 ± 4.5, p = 0.112). The use of intravascular imaging in the ASET-Japan was significantly higher than in the ASET-Brazil (99.1% vs 14.8%, p < 0.001). On the final angiogram, 99.8% of the population achieved TIMI (Thrombolysis in myocardial infarction) grade III flow. The primary BARC 5b bleeding event occurred only in 1 patient (0.2%). No cardiac death, target vessel MI, or stent thrombosis occurred.
Aspirin-free prasugrel monotherapy with various dosages following successful SYNERGY stent(s) deployment showed excellent clinical outcomes without stent thrombosis in selected low-risk CCS and NSTE-ACS patients.