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

Mahesh V. Madhavan, Ajay J. Kirtane, Björn Redfors, Philippe Généreux, Ori Ben-Yehuda, Tullio Palmerini, Umberto Benedetto, Giuseppe Biondi-Zoccai, Pieter C. Smits, Clemens von Birgelen, Roxana Mehran, Thomas McAndrew, Patrick W. Serruys, Martin B. Leon, Stuart J. Pocock, Gregg W. Stone*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

36 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)590-604
Number of pages15
JournalJournal of the American College of Cardiology
Volume75
Issue number6
Early online date10 Feb 2020
DOIs
Publication statusPublished - 18 Feb 2020

Structured keywords

  • Bristol Heart Institute

Keywords

  • clinical trials
  • late events
  • major adverse cardiovascular events
  • PCI
  • stents

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