What is the stent failure rate of Drug-Eluting Stents (DES)?

Drug-Eluting Stent Failure Rates

Drug-eluting stents (DES) have a stent thrombosis rate of approximately 0.5-1.0% within the first month after implantation, with an additional 0.2% per year risk between years 1-4 compared to bare-metal stents. 1

Stent Thrombosis Rates by Timeframe

Early Stent Thrombosis (≤30 days)

• Subacute stent thrombosis: 0.5-1.0% 1
• Early stent thrombosis (within 30 days): 0.44% for DES vs 0.5% for BMS (p=0.74) 1

Late Stent Thrombosis (>30 days to 1 year)

• Late stent thrombosis (1-12 months): 0.19% in DES registry 1
• Overall late stent thrombosis (>30 days): 0.5% for DES vs 0.28% for BMS (p=0.22) 1

Very Late Stent Thrombosis (>1 year)

• Very late stent thrombosis (>1 year): 0.5% for DES vs 0% for BMS (relative risk 5.02) 1
• Ongoing risk of approximately 0.2% per year between years 1-4 after DES implantation 1

Overall Stent Failure Rates

• In-stent restenosis: 3-20% depending on patient and lesion characteristics 2
• Overall stent thrombosis (by any criterion): approximately 3% for both DES and BMS over 4 years of follow-up 1
• Target lesion revascularization (TLR): 4.7-7.2% at 9 months for DES vs 11.3-22.9% for BMS 1

Clinical Impact of Stent Thrombosis

• Stent thrombosis is a significant clinical event with high morbidity and mortality
• Death or MI occurs in 64.4% of patients with documented BMS thrombosis 1
• Mortality rates due to presumed or documented DES thrombosis range from 20-45% 1

Risk Factors for Stent Thrombosis

Clinical Risk Factors

• Premature discontinuation of antiplatelet therapy (HR: 90, p<0.001) 1
• Renal failure (HR: 6.49, p<0.001) 1
• Diabetes mellitus (HR: 3.71, p=0.001) 1
• Lower ejection fraction (HR: 1.09 for each 10% decrease, p<0.001) 1
• Advanced age 1
• Acute coronary syndrome 1
• Prior brachytherapy 1

Angiographic Risk Factors

• Bifurcation lesions (HR: 6.42, p<0.001) 1
• Long stents 1
• Multiple lesions 1
• Overlapping stents 1
• Ostial or bifurcation lesions 1
• Small vessels 1
• Suboptimal stent results (underexpansion, malaposition, or residual dissection) 1

DES vs BMS Comparison

• DES significantly reduce target lesion revascularization compared to BMS (4.7-7.2% vs 11.3-22.9%) 1
• DES show particular benefit in high-risk scenarios:
  • Long lesions (>23mm) 3
  • Small vessels 1
  • Diabetes 1, 4
  • Left main disease 1, 5
  • In-stent restenosis 1
  • Bifurcations 1
  • Multiple lesions 1
  • Saphenous vein grafts 1

Important Clinical Considerations

• The greatest risk for DES thrombosis is early discontinuation of dual antiplatelet therapy (DAPT) 1
• DES should not be used when there are:
  • Financial barriers to continuing prolonged DAPT
  • Social barriers limiting patient compliance
  • Medical issues involving bleeding risks
  • Need for invasive or surgical procedures within a year that would interrupt antiplatelet therapy 1
• Median time to late sirolimus-eluting stent thrombosis: 15.5 months (range 173-773 days) 1
• Median time to paclitaxel-eluting stent thrombosis: 18 months (range 40-548 days) 1

Dual Antiplatelet Therapy Recommendations

• Current guidelines recommend DAPT for at least 12 months after DES implantation 1
• Continuation beyond 1 year may be considered based on individual risk/benefit assessment 1
• Premature discontinuation of DAPT markedly increases the risk of catastrophic stent thrombosis and death or MI 1

The failure rate of DES must be considered in the context of both stent thrombosis and in-stent restenosis. While DES have significantly reduced restenosis rates compared to BMS, the risk of stent thrombosis remains an important concern, particularly when DAPT is discontinued prematurely.