One-year outcome of a prospective trial stopping dual antiplatelet therapy at 3 months after everolimus-eluting cobalt-chromium stent implantation: ShortT and ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2015-10-30

AUTHORS

Masahiro Natsuaki, Takeshi Morimoto, Erika Yamamoto, Hiroki Shiomi, Yutaka Furukawa, Mitsuru Abe, Koichi Nakao, Tetsuya Ishikawa, Kazuya Kawai, Kei Yunoki, Shogo Shimizu, Masaharu Akao, Shinji Miki, Masashi Yamamoto, Hisayuki Okada, Kozo Hoshino, Kazushige Kadota, Yoshihiro Morino, Keiichi Igarashi, Kengo Tanabe, Ken Kozuma, Takeshi Kimura

ABSTRACT

There has been no previous prospective study evaluating dual antiplatelet therapy (DAPT) duration shorter than 6 months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration after CoCr-EES implantation. The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding at 1 year. Between September 2012 and October 2013, a total of 1525 patients were enrolled from 58 Japanese centers, with complete 1-year follow-up in 1519 patients (99.6 %). Thienopyridine was discontinued within 4 months in 1444 patients (94.7 %). The event rates beyond 3 months were very low (cardiovascular death: 0.5 %, MI: 0.1 %, ST: 0 %, stroke: 0.7 %, and TIMI major/minor bleeding: 0.8 %). Cumulative 1-year incidence of the primary endpoint was 2.8 % [upper 97.5 % confidence interval (CI) 3.6 %], which was lower than the pre-defined performance goal of 6.6 % (P < 0.0001). Using the CoCr-EES group in the RESET trial as a historical comparison group, where nearly 90 % of patients had continued DAPT at 1 year, cumulative incidence of the primary endpoint tended to be lower in the STOPDAPT than in the RESET (2.8 versus 4.0 %, P = 0.06) and adjusted hazard ratio was 0.64 (95 % CI 0.42–0.95, P = 0.03). The cumulative incidence of definite/probable ST was lower in the STOPDAPT than in the RESET [0 patient (0 %) versus 5 patients (0.3 %), P = 0.03]. In conclusion, stopping DAPT at 3 months in selected patients after CoCr-EES implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group. More... »

PAGES

196-209

Journal

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12928-015-0366-9

DOI

http://dx.doi.org/10.1007/s12928-015-0366-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1014636325

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/26518420


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    "description": "There has been no previous prospective study evaluating dual antiplatelet therapy (DAPT) duration shorter than 6\u00a0months after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. STOPDAPT trial is a prospective multi-center single-arm study evaluating 3-month DAPT duration after CoCr-EES implantation. The primary endpoint was a composite of cardiovascular death, myocardial infarction (MI), stroke, definite stent thrombosis (ST) and TIMI major/minor bleeding at 1\u00a0year. Between September 2012 and October 2013, a total of 1525 patients were enrolled from 58 Japanese centers, with complete 1-year follow-up in 1519 patients (99.6\u00a0%). Thienopyridine was discontinued within 4\u00a0months in 1444 patients (94.7\u00a0%). The event rates beyond 3\u00a0months were very low (cardiovascular death: 0.5\u00a0%, MI: 0.1\u00a0%, ST: 0\u00a0%, stroke: 0.7\u00a0%, and TIMI major/minor bleeding: 0.8\u00a0%). Cumulative 1-year incidence of the primary endpoint was 2.8\u00a0% [upper 97.5\u00a0% confidence interval (CI) 3.6\u00a0%], which was lower than the pre-defined performance goal of 6.6\u00a0% (P\u00a0<\u00a00.0001). Using the CoCr-EES group in the RESET trial as a historical comparison group, where nearly 90\u00a0% of patients had continued DAPT at 1\u00a0year, cumulative incidence of the primary endpoint tended to be lower in the STOPDAPT than in the RESET (2.8 versus 4.0\u00a0%, P\u00a0=\u00a00.06) and adjusted hazard ratio was 0.64 (95\u00a0% CI 0.42\u20130.95, P\u00a0=\u00a00.03). The cumulative incidence of definite/probable ST was lower in the STOPDAPT than in the RESET [0 patient (0\u00a0%) versus 5 patients (0.3\u00a0%), P\u00a0=\u00a00.03]. In conclusion, stopping DAPT at 3\u00a0months in selected patients after CoCr-EES implantation was at least as safe as the prolonged DAPT regimen adopted in the historical control group.", 
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358 grid-institutes:grid.412305.1 schema:alternateName Division of Cardiology, Teikyo University Hospital, Tokyo, Japan
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362 schema:name Division of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan
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364 grid-institutes:grid.415466.4 schema:alternateName Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan
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380 schema:name Division of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan
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382 grid-institutes:grid.416948.6 schema:alternateName Division of Cardiology, Osaka City General Hospital, Osaka, Japan
383 schema:name Division of Cardiology, Osaka City General Hospital, Osaka, Japan
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385 grid-institutes:grid.419430.b schema:alternateName Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan
386 schema:name Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan
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388 grid-institutes:grid.452236.4 schema:alternateName Division of Cardiology, Chikamori Hospital, Kochi, Japan
389 schema:name Division of Cardiology, Chikamori Hospital, Kochi, Japan
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