Key result
DES2 reduces very-late MACE versus DES1 and BMS, but risk increases ~2% annually across all stents.
Why the study?
Most stent-related MACE after PCI are believed to occur within the first year, leaving very-late (>1-year) stent-related MACE not well described.
Does stent type (BMS, DES1, DES2) affect the frequency of very-late MACE between 1 and 5 years after percutaneous coronary intervention?
Meta-Analysis (n=25,032)
Yes
Does stent type (BMS, DES1, DES2) affect the frequency of very-late MACE between 1 and 5 years after percutaneous coronary intervention?
Absolute Event Rate: 8.3% vs 9.7%
p-value: p=<0.0001
Very-late stent-related adverse events occur at a steady rate of ~2% per year between 1 and 5 years after PCI regardless of stent type, indicating an ongoing risk that requires new long-term management approaches.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“While we can't extrapolate our 5-year results to 20 years, one would think these risks persist beyond 5, 10, or 15 years for the patients, many of whom are undergoing revascularization in their 50s and 60s. For the individual patient, these risks are certainly real, and finding strategies to mitigate this risk over time is crucially important.”
“A large proportion of the patients we treat are middle-aged and have a life expectancy that goes out beyond 12 months or the 2 or 3 years we do in clinical trials. These 5- and 10-year follow-up data give us a better picture of the entire life cycle of the devices we implant. These studies are important, and we should be doing them as much as possible even though it's challenging to reach out and maintain contact.”
Warrants vigilance for ongoing ischemic risk years after PCI; extends randomized trial data confirming need for novel long-term prevention strategies.
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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Madhavan et al. (2020) conducted a meta-analysis in Percutaneous coronary intervention (n=25,032). Second-generation drug-eluting stents (DES2) vs. Bare-metal stents (BMS) and first-generation drug-eluting stents (DES1) was evaluated on Very-late MACE (composite of cardiac death, MI, or ischemia-driven TLR) between 1 and 5 years (p=<0.0001). Very-late MACE between 1 and 5 years after PCI occurred in 8.3% of patients with DES2, 11.0% with DES1, and 9.7% with BMS (p<0.0001), increasing linearly at ~2%/year across all stent types.
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