TY - JOUR
T1 - Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention
AU - Madhavan, Mahesh V.
AU - Kirtane, Ajay J.
AU - Redfors, Björn
AU - Généreux, Philippe
AU - Ben-Yehuda, Ori
AU - Palmerini, Tullio
AU - Benedetto, Umberto
AU - Biondi-Zoccai, Giuseppe
AU - Smits, Pieter C.
AU - von Birgelen, Clemens
AU - Mehran, Roxana
AU - McAndrew, Thomas
AU - Serruys, Patrick W.
AU - Leon, Martin B.
AU - Pocock, Stuart J.
AU - Stone, Gregg W.
PY - 2020/2/18
Y1 - 2020/2/18
N2 - Background: The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described. Objectives: The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type. Methods: Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons. Results: Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis. Conclusions: In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.
AB - Background: The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described. Objectives: The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type. Methods: Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons. Results: Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis. Conclusions: In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.
KW - clinical trials
KW - late events
KW - major adverse cardiovascular events
KW - PCI
KW - stents
UR - http://www.scopus.com/inward/record.url?scp=85078780080&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2019.11.058
DO - 10.1016/j.jacc.2019.11.058
M3 - Article (Academic Journal)
C2 - 32057373
AN - SCOPUS:85078780080
SN - 0735-1097
VL - 75
SP - 590
EP - 604
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 6
ER -