Safety and efficacy of balloon angioplasty compared to stent-based-strategies with pulmonary vein stenosis: A systematic review and meta-analysis

Table 4 Summary of evidence

Outcomes	Anticipated absolute effectsa (95%CI)		Relative effect (95%CI)	No. of participants (studies)	Certainty of the evidence (GRADE)b
	Risk with PSI	Risk with PBA
Restenosis	251 per 1000	493 per 1000 (278 to 711)	OR 2.91 (1.15 to 7.37)	487 (8 observational studies)	⊕⊕⊕◯ MODERATEc
Procedure related complications	87 per 1000	82 per 1000 (21 to 264)	OR 0.94 (0.23 to 3.76)	191 (3 observational studies)	⊕⊕⊕◯ MODERATEc

^aThe risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95%CI).

^bGRADE Working Group grades of evidence: (1) High certainty: We are very confident that the true effect lies close to that of the estimate of the effect; (2) Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different; (3) Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect; and (4) Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

^cRated down for imprecision as the 95% confidence interval overlaps with no effect and fails to exclude important benefit or important harm. PBA: Pulmonary vein balloon angioplasty; PSI: Pulmonary vein stent implantation.