December 8, 2014EuroInterventionOpen Access

Left atrial appendage closure monitoring without sedation: a pilot study using intracardiac echocardiography through the oesophageal route

Q: What is the clinical evidence from this study?

Study design: RCT. Population: De novo coronary artery lesions (n=80). Intervention: BuMA stent (PLGA-polymer sirolimus-eluting stent) vs. EXCEL stent (PLA-polymer sirolimus-eluting stent). Primary outcome: OCT-evaluated stent strut coverage at three months (Difference 4.2%, 95% CI 3.7%-4.8%, p=<0.0001 for superiority).

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Key result

The BuMA PLGA-polymer sirolimus-eluting stent was superior to the EXCEL PLA-polymer stent in stent strut coverage at three months (94.2% vs. 90.0%, difference 4.2%, p<0.0001 for superiority).

Why the study?

Does the BuMA sirolimus-eluting stent improve OCT-evaluated stent strut coverage at three months compared to the EXCEL sirolimus-eluting stent in patients with de novo coronary artery lesions?

Population

80 patients with de novo coronary artery lesions, mean age 57, 63% male, single-center. Key inclusion…

Comparison

BuMA stent. Post-PCI treatment included 6 months… vs EXCEL stent. Post-PCI treatment included 6…

Design

RCT, 1:1 ratio, performed centrally after diagnostic coronary angiography and…

Follow-up

3 months

Discussion

Member takes

Implication

May inform stent selection for faster early healing; extends randomized OCT evidence on polymer effects in sirolimus-eluting stents.

Study Design

Type

RCT (n=80)

Blinding

Single-blind (OCT analysts blinded)

Randomization

1:1 ratio via sealed envelope

Multicenter

Structured PICO

Does the BuMA sirolimus-eluting stent improve OCT-evaluated stent strut coverage at three months compared to the EXCEL sirolimus-eluting stent in patients with de novo coronary artery lesions?

Population

80 adults with de novo coronary artery lesions and myocardial ischemia were randomized to receive either a BuMA or EXCEL sirolimus-eluting stent and followed for 3 months.

Intervention

BuMA stent (PLGA-polymer with electro-grafting base layer sirolimus-eluting stent). Post-PCI treatment included 6 months of dual antiplatelet therapy (100 mg aspirin and 75 mg clopidogrel daily).

Comparator

EXCEL stent (PLA-polymer sirolimus-eluting stent). Post-PCI treatment included 6 months of dual antiplatelet therapy (100 mg aspirin and 75 mg clopidogrel daily).

Outcome

OCT-evaluated stent strut coverage at three monthssurrogate

Main Result

Mean Difference: 4.2 (95% CI 3.7–4.8)

Absolute Event Rate: 94.2% vs 90%

p-value: p=<0.0001 for superiority

The novel BuMA PLGA-polymer sirolimus-eluting stent demonstrated superior early stent strut coverage at three months compared to the EXCEL PLA-polymer stent, potentially indicating faster vascular healing.

Limitations

Small sample size
Differing baseline confounders between groups (e.g., post-dilation rates, stent length)
Lack of baseline OCT examination precludes ruling out baseline differences in strut apposition and plaque type
Clinical relevance of OCT-evaluated early vascular responses remains to be proven
Short-term (≤1 year) span for OCT evaluation
Single-centre design

Cite This Study

A 2014 study conducted an RCT in De novo coronary artery lesions (n=80). BuMA stent (PLGA-polymer sirolimus-eluting stent) vs. EXCEL stent (PLA-polymer sirolimus-eluting stent) was evaluated on OCT-evaluated stent strut coverage at three months (Difference 4.2%, 95% CI 3.7%-4.8%, p=<0.0001 for superiority). The BuMA PLGA-polymer sirolimus-eluting stent was superior to the EXCEL PLA-polymer stent in stent strut coverage at three months (94.2% vs. 90.0%, difference 4.2%, p<0.0001 for superiority).

synapsesocial.com/papers/6a95d11338908a4de3250508 https://doi.org/10.4244/eijy14m07_17

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Left atrial appendage closure monitoring without sedation: a pilot study using intracardiac echocardiography through the oesophageal route

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Left atrial appendage closure monitoring without sedation: a pilot study using intracardiac echocardiography through the oesophageal route

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider