August 29, 2007Heart
Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials
Why the study?
Does incomplete stent apposition after sirolimus-eluting stent implantation impact major adverse cardiac events at 4 years?
Population
325 patients from the RAVEL, E-SIRIUS and SIRIUS trials with intravascular ultrasound at angiographic…
Comparison
Sirolimus-eluting stent (SES) (n=180) vs Bare-metal stents (BMS) (n=145)
Design
Meta-analysis, randomised (original trials)
Follow-up
4 years
Authors
Discussion
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Implication
ISA after SES does not worsen 4-year MACE-free survival; confirms ISA lacks prognostic impact despite higher rates versus BMS.
Key Points
- To assess the frequency, clinical predictors, and four-year clinical impact of intravascular ultrasound-detected incomplete stent apposition following sirolimus-eluting stent implantation.
- Pooled analysis of 325 patients (SES: n = 180, BMS: n = 145) from three multicenter, randomized trials: RAVEL, E-SIRIUS, and SIRIUS.
- Intravascular ultrasound (IVUS) was performed at angiographic follow-up to detect incomplete stent apposition (ISA), defined as one or more unapposed stent struts.
- All patients underwent clinical follow-up for a total duration of 4 years to record major adverse cardiac events.
- ISA occurred significantly more frequently in the SES group (25.0%, n = 45) than in the BMS group (8.3%, n = 12, p < 0.001).
- Predictors of ISA after SES placement included baseline Canadian Cardiovascular Society class III or IV angina (OR = 4.69, 95% CI 2.15 to 10.23, p < 0.001) and the absence of diabetes (OR = 3.42, 95% CI 1.05 to 11.1, p = 0.041).
- Among SES-treated patients, 4-year major adverse cardiac event-free survival rates were not significantly different between patients with and without follow-up ISA (11.1% vs 16.3%, p = 0.48).
Structured PICO
Does incomplete stent apposition after sirolimus-eluting stent implantation impact major adverse cardiac events at 4 years?
P
Population
325 patients from the RAVEL, E-SIRIUS and SIRIUS trials with intravascular ultrasound (IVUS) at angiographic follow-up
I
Intervention
Sirolimus-eluting stent (SES) (n=180)
C
Comparator
Bare-metal stents (BMS) (n=145)
O
Outcome
Frequency of incomplete stent apposition (ISA) and major adverse cardiac events at 4 yearscomposite
Incomplete stent apposition is more common after sirolimus-eluting stent implantation compared to bare-metal stents but does not significantly impact long-term major adverse cardiac events.
Cite This Study
Hoffmann et al. (2007) studied this question.