Summary of findings for the main comparison. Drug‐eluting balloon versus uncoated balloon angioplasty at 12 months.
| Drug‐eluting balloon compared to uncoated balloon angioplasty at 12 months | ||||||
| Patient or population: people with peripheral arterial disease of the lower limbs Setting: hospital Intervention: drug‐eluting balloon angioplasty Comparison: uncoated balloon angioplasty | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with uncoated balloon angioplasty at 12 months | Risk with drug‐eluting balloon angioplasty at 12 months | |||||
| Amputation | Study population | OR 1.56 (0.73 to 3.33) | 1649 (9 RCTs) | ⊕⊕⊕⊕ High 1 | ‐ | |
| 14 per 1000 | 22 per 1000 (10 to 46) | |||||
| Primary vessel patency | Study population | OR 1.92 (1.45 to 2.56) | 882 (3 RCTs) | ⊕⊕⊕⊕ High 1 | ‐ | |
| 479 per 1000 | 638 per 1000 (571 to 702) | |||||
| Moderate | ||||||
| 487 per 1000 | 645 per 1000 (579 to 708) | |||||
| Target lesion revascularization | Study population | OR 0.40 (0.31 to 0.51) | 1900 (11 RCTs) | ⊕⊕⊝⊝ Low 1, 2, 3 | ‐ | |
| 264 per 1000 | 126 per 1000 (100 to 155) | |||||
| Moderate | ||||||
| 368 per 1000 | 189 per 1000 (153 to 229) | |||||
| Binary restenosis | Study population | OR 0.38 (0.15 to 0.98) | 1094 (4 RCTs) | ⊕⊕⊕⊝ Moderate 1, 3 | ‐ | |
| 350 per 1000 | 170 per 1000 (75 to 346) | |||||
| Moderate | ||||||
| 477 per 1000 | 257 per 1000 (120 to 472) | |||||
| Death | Study population | OR 1.09 (0.64 to 1.85) | 1649 (9 RCTs) | ⊕⊕⊕⊕ High 1 | ‐ | |
| 43 per 1000 | 46 per 1000 (28 to 76) | |||||
| Moderate | ||||||
| 45 per 1000 | 49 per 1000 (29 to 80) | |||||
| Change in Rutherford category | ‐ | The mean change in Rutherford category in the intervention group was 0.1 lower (0.29 lower to 0.1 higher) | ‐ | 623 (3 RCTs) | ⊕⊕⊕⊝ Moderate 1 4 | A positive change in Rutherford category reflects a worsening clinical status, although in this case the difference was not statistically significant |
| Change in ankle‐brachial index | ‐ | The mean change in ankle‐brachial index in the intervention group was 0.03 lower (0.07 lower to 0.01 higher) | ‐ | 656 (3 RCTs) | ⊕⊕⊕⊕ High 1 | A negative change in the ankle‐brachial index reflects a worsening clinical status, although in this case the difference was not statistically significant |
| *The 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). CI: confidence interval; OR: odds ratio; RCT: randomized controlled trial. | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 All of the included trials were at a high risk of performance bias due to lack of blinding of operators. However, because this is an intrinsic limitation to intervention trials, we did not downgrade the GRADE class because of performance bias. 2 Funnel plot analysis indicated a likely publication bias, which resulted in downgrading of the GRADE class. 3 There was moderate heterogeneity between the included studies (P < 0.001), which resulted in downgrading of the GRADE class. 4 There was moderate heterogeneity between the included studies (P = 0.04), which resulted in downgrading of the GRADE class.