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.

Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention / Madhavan, M. V.; Kirtane, A. J.; Redfors, B.; Genereux, P.; Ben-Yehuda, O.; Palmerini, T.; Benedetto, U.; Biondi-Zoccai, G.; Smits, P. C.; von Birgelen, C.; Mehran, R.; Mcandrew, T.; Serruys, P. W.; Leon, M. B.; Pocock, S. J.; Stone, G. W.. - In: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. - ISSN 0735-1097. - 75:6(2020), pp. 590-604. [10.1016/j.jacc.2019.11.058]

Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention

Biondi-Zoccai G.;
2020

Abstract

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.
2020
clinical trials; late events; major adverse cardiovascular events; PCI; stents; Humans; Postoperative Complications; Stents; Percutaneous Coronary Intervention
01 Pubblicazione su rivista::01a Articolo in rivista
Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention / Madhavan, M. V.; Kirtane, A. J.; Redfors, B.; Genereux, P.; Ben-Yehuda, O.; Palmerini, T.; Benedetto, U.; Biondi-Zoccai, G.; Smits, P. C.; von Birgelen, C.; Mehran, R.; Mcandrew, T.; Serruys, P. W.; Leon, M. B.; Pocock, S. J.; Stone, G. W.. - In: JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. - ISSN 0735-1097. - 75:6(2020), pp. 590-604. [10.1016/j.jacc.2019.11.058]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1474502
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