Mahesh V Madhavan1, Ajay J Kirtane1, Björn Redfors2, Philippe Généreux3, Ori Ben-Yehuda1, Tullio Palmerini4, Umberto Benedetto5, Giuseppe Biondi-Zoccai6, Pieter C Smits7, Clemens von Birgelen8, Roxana Mehran9, Thomas McAndrew10, Patrick W Serruys11, Martin B Leon1, Stuart J Pocock12, Gregg W Stone13. 1. NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 2. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden. 3. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Quebec, Canada. 4. Unità Operativa di Cardiologia, Policlinico S. Orsola, Bologna, Italy. 5. University of Bristol, Bristol, United Kingdom. 6. Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy. 7. Maasstad Zienkenhuis, Rotterdam, the Netherlands. 8. Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. 9. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 10. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 11. Imperial College of Science, Technology and Medicine, London, United Kingdom. 12. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. 13. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gregg.stone@mountsinai.org.
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.
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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