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Stent-Related Adverse Events >1 Year After PCI
Study Questions:
What is the frequency of very late stent-related clinical events?
Methods:
Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very late major adverse cardiovascular events (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 approximately 2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI.
Perspective:
This is a first of its kind analysis evaluating PCI-related events 1-5 years after implantation. Pooled individual patient data from 19 stent trials were analyzed. Although the cohort studied includes a heterogenous spectrum of patients, authors were able to compare very late clinical events among patients undergoing BMS, DES1, and DES2. Findings show that although MACE rates improved as stent technology evolved, very late events continued to occur at about 2%/year through 5 years of follow-up. It does appear that DES2 have the lowest rates of stent-related events including definite or probable stent thrombosis, and that DES1 were associated with the highest risk. Study findings are a reminder that PCI is a targeted treatment option for a systemic disease and that focus on medical and lifestyle therapy should occur in concert with mechanical treatment.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, SCD/Ventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure
Keywords: Cardiology Interventions, Death, Sudden, Cardiac, Drug-Eluting Stents, Heart Failure, Myocardial Infarction, Percutaneous Coronary Intervention, Myocardial Revascularization, Stents, Thrombosis
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