Clinical Impact of DES Failure Depends on Timing

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Although drug-eluting stents (DES) can fail at any time, patients who experience in-stent restenosis or stent thrombosis a year or more after implantation have more aggressive, nonfocal disease. They also are more likely to progress to acute myocardial infarction (MI) and have worse outcomes following retreatment than those who present with early DES failure, according to research published online July 19, 2014, ahead of print in Catheterization and Cardiovascular Interventions.

Methods
Investigators led by Seung-Jung Park, MD, PhD, of Asan Medical Center (Seoul, Korea), looked at medical records of 633 patients (676 lesions) who experienced a first instance of DES failure after non-left main PCI between October 2003 and December 2011 that necessitated retreatment. First-generation DES were used during the index procedure in 79% of patients, while second-generation devices were implanted in the remainder. Clinical presentations at the time of failure included stable angina (69.4%), unstable angina (19.9%), and acute MI (10.7%).
Median time to failure was 10.1 months. Failure type was DES restenosis in 86.6% and stent thrombosis in 13.4%. DES failure was treated with:
  • Medical therapy (n = 161)
  • Balloon angioplasty (n = 160)
  • Drug-eluting balloon (n = 14)
  • Repeat DES (n = 256)
  • CABG (n = 42)
 

 

Later Failure Linked to Diffuse Disease, Worse Outcomes

Patients were grouped according to the time from the index procedure to DES failure:

  • Early (< 12 months; n = 343)
  • Late (12-36 months; n = 138)
  • Very late (≥ 36 months; n = 152)

Rates of acute MI and definite stent thrombosis were higher in those who presented with late or very late failure compared with those who presented earlier. Additionally, those who presented earlier were more likely to have total occlusion or focal (< 10 mm) rather than diffuse stenosis (table 1).

Table 1. Clinical, Angiographic Patterns of DES Failurea

 

Early

Late

Very Late

Acute MI

5.5%

13.0%

20.4%

Definite Stent Thrombosis

7.3%

16.7%

24.3%

Focal Stenosis

63.0%

52.9%

38.8%

Diffuse Stenosis

25.1%

29.7%

30.9%

Total Occlusion

11.9%

17.4%

30.3%

aP < .001 for all comparisons. 

In multivariate analysis, longer time to DES failure (very late vs early; P < .001) and longer stent length (P = .003) were predictors of nonfocal DES failure.

At a median follow-up of 52.8 months, patients with very late DES failure had higher risk of death from any cause (adjusted HR 2.97; 95% CI 1.31-6.74; P = .009); death or MI (adjusted HR 2.74; 95% CI 1.24-6.02; P = .012); and death, MI, or TLR (adjusted HR 1.57; 95% CI 0.88-2.81; P = .126) than those who presented early.

Late, Very Late DES Failure a Complex Phenomenon

Dr. Park and colleagues note that early stent thrombosis occurring within 30 days of implantation is thought to be related to incomplete healing, while the mechanisms behind late or very late stent thrombosis are more complex and “may be related to acute thrombus formation due to either incomplete stent healing or in-stent plaque rupture from neoatherosclerosis.” Furthermore, they contend that late and very late DES failure “will become an increasingly common problem.”

Despite advances in technology, they add, the optimal treatment strategy for patients with DES failure remains unclear.

The study authors acknowledge that interpretation of the study is limited by its retrospective nature, lack of data on invasive imaging and antiplatelet therapy, and use of first-generation DES in the majority of patients.


Source: 
Lee CW, Ahn J-M, Yoon S-H, et al. Temporal patterns of drug-eluting stent failure and its relationship with clinical outcomes. Catheter Cardiovasc Interv. 2014;Epub ahead of print. 

Disclosures:

  • The study was sponsored by grants from the Cardiovascular Research Foundation and the Ministry of Health & Welfare, Republic of Korea.
  • Dr. Park reports no relevant conflicts of interest.

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