Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries

Table 4 Evidence quality grade assessment of pooled outcomes of interest

Outcome	Source of data	Num of participants	Pooled HR (DES vs control)	Certainty of the evidence (GRADE)a	Alteration to initial rating
ACD-free survival	2 RCTs	277	0.91 (95%CI: 0.38-2.18)	Moderate	-1b
ACD-free survival	3 cohort studies	2001	1.15 (95%CI: 0.68-1.95)	Low	+1c
MA-free survival	3 cohort studies	2001	1.20 (95%CI: 0.84-1.71)	Low	+1c
TLR-free survival	2 cohort studies	184	2.65 (95%CI: 1.56-4.50)	High	+3d
AE-free survival	3 RCTs	498	1.57 (95%CI: 1.23-2.01)	Moderate	-1b
PP survival	2 cohort studies	184	5.67 (95%CI: 3.56-9.03)	High	+3d

^aHigh certainty: We are very confident that the true effect lies close to that of the estimate of the effect; moderate certainty: We are moderately confident in the effect estimate; low certainty: Our confidence in the effect estimate is limited; very low certainty: We have very little confidence in the effect estimate.

^bThe reason for lowering rating was a suspect of overall bias.

^cThe reason for raising rating was a consideration of plausible confounding.

^dThe reason for raising rating was a consideration of large magnitude of effect, dose-response gradient, and plausible confounding. ACD: All-cause death; MA: major amputation; TLR: Target lesion revascularization; AE: Adverse event; PP: Primary patency; RCT: Randomized controlled trial; Num: number; HR: Hazard ratio; CI: Confidence interval; GRADE: Grading of recommendations assessment: Development and evaluation.