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