TY - JOUR
T1 - Impact of Diabetes Mellitus in Women Undergoing Percutaneous Coronary Intervention with Drug-Eluting Stents
T2 - From the Women in Innovation and Drug-Eluting Stents Collaborative Patient-Level Pooled Analysis
AU - Baber, Usman
AU - Stefanini, Giulio G.
AU - Giustino, Gennaro
AU - Stone, Gregg W.
AU - Leon, Martin B.
AU - Sartori, Samantha
AU - Aquino, Melissa
AU - Steg, P. Gabriel
AU - Windecker, Stephan
AU - Wijns, William
AU - Serruys, Patrick W.
AU - Valgimigli, Marco
AU - Morice, Marie Claude
AU - Camenzind, Edoardo
AU - Weisz, Giora
AU - Smits, Pieter C.
AU - Kandzari, David E.
AU - von Birgelen, Clemens
AU - Dangas, George D.
AU - Galatius, Soren
AU - Jeger, Raban V.
AU - Kimura, Takeshi
AU - Mikhail, Ghada W.
AU - Itchhaporia, Dipti
AU - Mehta, Laxmi
AU - Ortega, Rebecca
AU - Kim, Hyo Soo
AU - Kastrati, Adnan
AU - Chieffo, Alaide
AU - Mehran, Roxana
PY - 2019/7/1
Y1 - 2019/7/1
N2 - Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.
AB - Background: Data examining the impact of diabetes mellitus (DM) on ischemic risk after percutaneous coronary intervention in women are limited as most clinical trial participants are male. We evaluated (1) the impact of DM on ischemic outcomes in women undergoing drug-eluting stent (DES) implantation and (2) whether the outcomes of new-versus early-generation DES vary by DM status.Methods and Results: We pooled patient-level data of 10 448 women undergoing percutaneous coronary intervention with DES from 26 randomized trials. Baseline characteristics and 3-year clinical outcomes were stratified according to DM status (noninsulin-dependent and insulin-dependent) and DES generation. The primary end point was the composite of all-cause death or myocardial infarction. Secondary end points were definite or probable stent thrombosis and target lesion revascularization. Compared with women without DM (n=7154, 68.5%), adjusted risks (adjusted hazard ratios [95% CI]) for death or myocardial infarction among women with noninsulin-dependent DM (n=2241, 21.4%) and insulin-dependent DM (n=1053, 10.1%) were 1.30 (1.11-1.53) and 1.71 (1.41-2.07), respectively (Ptrend<0.001). Similar trends were observed for def/prob stent thrombosis and target lesion revascularization. Compared with early-generation DES, use of newer-generation DES was associated with significant reductions in death or myocardial infarction in the absence of DM whereas differences were nonsignificant in the presence of DM, with similar findings for def/prob stent thrombosis and target lesion revascularization.Conclusions: The presence of DM is associated with substantial, graded, and durable risks for ischemic events among women undergoing percutaneous coronary intervention with DES. The safety and efficacy profile of newer-generation DES is preserved among women without DM, while benefits are nonsignificant among women with DM.
KW - Diabetes mellitus
KW - Drug-eluting stents (DES)
KW - Myocardial infarction
KW - Percutaneous Coronary Intervention (PCI)
KW - Women
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85069316631&partnerID=8YFLogxK
U2 - 10.1161/CIRCINTERVENTIONS.118.007734
DO - 10.1161/CIRCINTERVENTIONS.118.007734
M3 - Article
C2 - 31288561
AN - SCOPUS:85069316631
SN - 1941-7640
VL - 12
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 7
M1 - e007734
ER -
