Abstract
Aims We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. Methods and results In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (P INT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (P INT = 0.024). Conclusions This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD - but not ACS - patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy.
| Original language | English |
|---|---|
| Pages (from-to) | 1242-1251 |
| Number of pages | 10 |
| Journal | European Heart Journal |
| Volume | 36 |
| Issue number | 20 |
| DOIs | |
| Publication status | Published - May 21 2015 |
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Keywords
- Bleeding
- Clopidogrel
- Drug-eluting stents
- Dual-antiplatelet therapy
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation : A pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial. / Costa, Francesco; Vranckx, Pascal; Leonardi, Sergio; Moscarella, Elisabetta; Ando, Giuseppe; Calabro, Paolo; Oreto, Giuseppe; Zijlstra, Felix; Valgimigli, Marco.
In: European Heart Journal, Vol. 36, No. 20, 21.05.2015, p. 1242-1251.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Impact of clinical presentation on ischaemic and bleeding outcomes in patients receiving 6- or 24-month duration of dual-antiplatelet therapy after stent implantation
T2 - A pre-specified analysis from the PRODIGY (Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia) trial
AU - Costa, Francesco
AU - Vranckx, Pascal
AU - Leonardi, Sergio
AU - Moscarella, Elisabetta
AU - Ando, Giuseppe
AU - Calabro, Paolo
AU - Oreto, Giuseppe
AU - Zijlstra, Felix
AU - Valgimigli, Marco
PY - 2015/5/21
Y1 - 2015/5/21
N2 - Aims We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. Methods and results In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (P INT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (P INT = 0.024). Conclusions This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD - but not ACS - patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy.
AB - Aims We investigated if acute coronary syndrome (ACS) rather than stable coronary artery disease (SCAD) presentation is an outcome modifier with respect to the duration of dual-antiplatelet therapy (DAPT) in patients undergoing coronary stenting. Methods and results In the Prolonging Dual-Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia (PRODIGY) trial, a total of 1465 (74.3%) patients presented ACS whereas 505 (25.7%) had SCAD and were randomized to 6- or 24-month DAPT. At 24 months, the composite of death, myocardial infarction (MI), or cerebrovascular accident (CVA) did not differ between the long- and short-term DAPT arms in both ACS (11.1 vs. 11.7%; P = 0.67) and SCAD (7.5 vs. 4.8%; P = 0.21) patients, respectively. Long-term DAPT was associated with a 75% increase of Bleeding Academic Research Consortium (BARC)-class 2, 3, or 5 bleeding in ACS [7.1 vs. 4.1%; hazard ratio (HR) 1.75, 95% confidence interval (CI) 1.11-2.74, P = 0.015; number needed to treat for harm (NNTH): 33.3] and a five-fold increase in SCAD (8.2 vs. 1.6%; HR 5.37, 95% CI 1.84-15.74, P = 0.002; NNTH: 15.1) patients, with a borderline quantitative interaction (P INT = 0.056). As a result, net adverse cardiovascular events (death, MI, CVA, BARC class 2, 3, or 5 bleeding) were more than doubled in SCAD patients receiving 24-month DAPT, whereas they did not differ in ACS patients (P INT = 0.024). Conclusions This analysis suggests that clinical presentation may be a treatment modifier with respect to DAPT duration after stenting consistent with the hypothesis that SCAD - but not ACS - patients are exposed to a significant increase in bleeding and net adverse clinical events when treated with 24-month compared with 6-month therapy.
KW - Bleeding
KW - Clopidogrel
KW - Drug-eluting stents
KW - Dual-antiplatelet therapy
UR - http://www.scopus.com/inward/record.url?scp=84930025400&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84930025400&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehv038
DO - 10.1093/eurheartj/ehv038
M3 - Article
C2 - 25718355
AN - SCOPUS:84930025400
VL - 36
SP - 1242
EP - 1251
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 20
ER -