TY - JOUR
T1 - Outcomes of Patients Receiving Downstream Revascularization After Initial Medical Management for Non–ST-Segment Elevation Acute Coronary Syndromes (From the TRILOGY ACS Trial)
AU - Hinohara, Tomoya T.
AU - Roe, Matthew T.
AU - White, Harvey D.
AU - Fox, Keith A.A.
AU - Bhatt, Deepak L.
AU - Hamm, Christian
AU - Gurbel, Paul A.
AU - Aylward, Philip E.
AU - Wiviott, Stephen D.
AU - Huber, Kurt
AU - Neely, Megan L.
AU - Ohman, E. Magnus
N1 - Funding Information:
Prof. Fox reports research grants from Lilly, Bayer, Johnson & Johnson, and AstraZeneca; speakers bureau payments from Bayer, Johnson & Johnson, AstraZeneca, and Sanofi-Aventis; and consulting/other payments from Lilly, Bayer, Johnson & Johnson, AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, and Eli Lilly.
Funding Information:
Dr. Wiviott reports grants from Amgen, Arena, AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Janssen, Merck and Sanofi-Aventis. Reports consulting fees from ARENA, AstraZeneca, Aegerion, Allergan, Angelmed, Boehringer-Ingelheim, Boston Clinical Research Institute, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Eli Lilly, Icon Clinical, Janssen, Lexicon, Merck, St Jude Medical, Xoma. Spouse, Dr. Caroline Fox, is an employee of Merck.
Funding Information:
Funding Sources: The TRILOGY ACS study was supported by Daiichi Sankyo Incorporated and Eli Lilly and Company. The study sponsors had no role in the conception or design of this manuscript, which was funded internally by the Duke Clinical Research Institute .
Funding Information:
Prof. White reports research grants from GlaxoSmithKline, Sanofi-Aventis, Eli Lilly and Company, National Institute of Health, Merck Sharp & Dohme, George Institute, Omthera Pharmaceuticals, Pfizer New Zealand, Intarcia Therapeutics Inc., Elsai Inc., Daiichi-Sankyo, DalCor Pharmaceuticals; advisory board/ lecture fees from AstraZeneca and Acetelion; site and steering board member for Luitpold Pharmaceuticals Ltd and CSL Behring LLC.
Funding Information:
Prof. Aylward reports research support from Eli Lilly; research support, advisory board, and honoraria from Sanofi Aventis, AstraZeneca, Boehringer Ingelheim, Novartis, CSL, AMGEN, Merck, Bayer, Pfizer, and Bristol-Myers Squibb.
Funding Information:
Funding Sources: The TRILOGY ACS study was supported by Daiichi Sankyo Incorporated and Eli Lilly and Company. The study sponsors had no role in the conception or design of this manuscript, which was funded internally by the Duke Clinical Research Institute.
PY - 2018/10/15
Y1 - 2018/10/15
N2 - Patients with non–ST-segment elevation acute coronary syndromes (NSTE ACS) are sometimes treated with medical management alone rather than an invasive strategy. Among those medically managed without revascularization and discharged, a proportion will require revascularization later on, but little is known about this population. In TRILOGY ACS, 9,326 patients with NSTE ACS who were selected for medical management alone were randomized to treatment with prasugrel or clopidogrel and discharged without revascularization. Patient characteristics and ischemic and bleeding outcomes through 30 months were compared between patients who underwent downstream revascularization after the index hospitalization and those who did not. A total of 662 patients (7.1%) underwent later revascularization by percutaneous coronary intervention (73.1%), coronary artery bypass graft surgery (26.4%), or the two (0.5%). Median time to revascularization was 121 days (twenty-fifth, seventy-fifth percentiles: 41, 326). Revascularized patients were younger, more likely to be male, and had higher rates of hyperlipidemia, diabetes mellitus, prior myocardial infarction, and prior revascularization compared with those not revascularized. Europe and North America had the highest rates of revascularization. During the follow-up period, those who underwent revascularization had a higher rate of the composite outcome of cardiovascular death, myocardial infarction, or stroke occurring after revascularization compared with those not revascularized (hazard ratio [HR] 2.73 [95% confidence interval {CI} 2.21 to 3.38], p < 0.001) as well as a higher rate of each of the individual outcomes. Major bleeding was also higher in those who underwent revascularization (GUSTO severe or life-threatening: HR 2.61 [95% CI 1.02 to 6.67], p = 0.045; TIMI major: HR 2.24 [95% CI 1.12 to 4.48], p = 0.022). There was no evidence that bleeding and ischemic outcomes varied by treatment with clopidogrel versus prasugrel. In conclusion, among patients initially medically managed after NSTE ACS, a small proportion later require revascularization and have a high rate of ischemic and major bleeding outcomes compared with those not requiring downstream revascularization.
AB - Patients with non–ST-segment elevation acute coronary syndromes (NSTE ACS) are sometimes treated with medical management alone rather than an invasive strategy. Among those medically managed without revascularization and discharged, a proportion will require revascularization later on, but little is known about this population. In TRILOGY ACS, 9,326 patients with NSTE ACS who were selected for medical management alone were randomized to treatment with prasugrel or clopidogrel and discharged without revascularization. Patient characteristics and ischemic and bleeding outcomes through 30 months were compared between patients who underwent downstream revascularization after the index hospitalization and those who did not. A total of 662 patients (7.1%) underwent later revascularization by percutaneous coronary intervention (73.1%), coronary artery bypass graft surgery (26.4%), or the two (0.5%). Median time to revascularization was 121 days (twenty-fifth, seventy-fifth percentiles: 41, 326). Revascularized patients were younger, more likely to be male, and had higher rates of hyperlipidemia, diabetes mellitus, prior myocardial infarction, and prior revascularization compared with those not revascularized. Europe and North America had the highest rates of revascularization. During the follow-up period, those who underwent revascularization had a higher rate of the composite outcome of cardiovascular death, myocardial infarction, or stroke occurring after revascularization compared with those not revascularized (hazard ratio [HR] 2.73 [95% confidence interval {CI} 2.21 to 3.38], p < 0.001) as well as a higher rate of each of the individual outcomes. Major bleeding was also higher in those who underwent revascularization (GUSTO severe or life-threatening: HR 2.61 [95% CI 1.02 to 6.67], p = 0.045; TIMI major: HR 2.24 [95% CI 1.12 to 4.48], p = 0.022). There was no evidence that bleeding and ischemic outcomes varied by treatment with clopidogrel versus prasugrel. In conclusion, among patients initially medically managed after NSTE ACS, a small proportion later require revascularization and have a high rate of ischemic and major bleeding outcomes compared with those not requiring downstream revascularization.
UR - http://www.scopus.com/inward/record.url?scp=85051626020&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2018.06.052
DO - 10.1016/j.amjcard.2018.06.052
M3 - Article
C2 - 30135019
AN - SCOPUS:85051626020
VL - 122
SP - 1322
EP - 1329
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 8
ER -