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Published on: May 14, 2013
Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention
Mahesh V Madhavan1, Ajay J Kirtane1, Björn Redfors2
1NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.
Insights
Very-late stent-related events after percutaneous coronary intervention (PCI) occur at approximately 2% per year, with no plateau observed for bare-metal stents (BMS) or drug-eluting stents (DES). New strategies are needed to enhance long-term outcomes post-PCI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- Major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are typically concentrated within the first year post-procedure.
- However, very-late stent-related MACE (occurring >1 year after PCI) remain incompletely characterized.
- Understanding these long-term events is crucial for optimizing patient care and stent technology.
Purpose of the Study:
- To determine the frequency and identify predictors of very-late stent-related events and MACE.
- To compare these outcomes across different stent types: bare-metal stents (BMS), first-generation drug-eluting stents (DES1), and second-generation drug-eluting stents (DES2).
Main Methods:
- Pooled individual patient data from 19 prospective, randomized metallic stent trials.
- Assessment of very-late MACE (cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) and target lesion failure between 1 and 5 years post-PCI.
- Network meta-analysis to compare stent types directly and indirectly.
Main Results:
- Across 25,032 patients, very-late MACE occurred in 9.4% between years 1 and 5, at a rate of approximately 2% per year.
- Rates of very-late MACE were 9.7% for BMS, 11.0% for DES1, and 8.3% for DES2 (p < 0.0001), showing a linear increase over time.
- MACE rates within the first year were significantly lower for DES1 and DES2 compared to BMS.
Conclusions:
- Very-late stent-related events continue to occur at a consistent rate of approximately 2% per year between 1 and 5 years after PCI, irrespective of stent type.
- No plateau in event rates was observed, indicating ongoing risk.
- Novel approaches are essential to mitigate long-term stent-related complications and improve patient outcomes after PCI.
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.
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