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. 2006 Apr 1;6(12):1–97.

Table 25: Overall Quality of Evidence on High-Risk Lesions.

Outcome Design Quality Consistency Directness Overall Quality
Long Lesions
Significant ⇓6m
MLD

Significant ⇓ 6-m restenosis, 1-yr MACE & TLR
1 small RCT N=144
Narrow spectrum
Blinded Angiographic analysis
Power calculation
ITT
Some limitation*
NA Criteria for optimal stent implantation
Definition for outcomes
Moderate
Needs to be confirmed with larger
RCTs
Diabetes
No significant difference in
MACE, death, MI or TVR
1 small subgroup analysis of RCT Prospectively designed subgroup analysis of
RCT
Small sample (N = 54)
Significant limitations**
NA Same as above Weak evidence – hypothesis generating
Unprotected left main C artery
No significant difference in angio outcome sor
MACE
2 small non-randomized
Case-controlled Studies
Small samples (N = 58&127)
Use of lVUS @ discretion of operator
Selection bias
No power calculation
Possible type 2 error
Measured different parameters Criteria for optimal stent implantation Poor

Cannot draw conclusion

m month; MLD minimal lumen diameter; MACE major adverse cardiac event; TLR target lesion revascularization; TVR target vessel revascularization; MI myocardial infarction

*

Limitations: single center, small sample, narrow spectrum (de novo, native coronary, non-ostial, only one type of stent)

**

Limitations: subgroup analysis, small sample, inadequate power to detect a difference