Table 36:
Summary of Findings of the Effect of Pharmacomechanical Thrombectomy Devices in Acute Lower Limb Ischemia (Arterial or Venous)
| Outcome | No. of participants (studies) | Effect | GRADEa | |
|---|---|---|---|---|
| Relative (95% CI) | Absolute (95% CI) | |||
| Arterial Acute Limb Ischemia | ||||
| Limb salvage | 425 (5 Obs) | OR: 1.61 (0.85-3.02) | 51 more per 1,000 (from 22 fewer to 95 more) | ⊕ Very low |
| Complete thrombus removal | 501 (5 Obs) | OR: 1.72 (1.07-2.77) | 101 more per 1,000 (14 more to 168 more) | ⊕ Very low |
| Patency | 403 (4 Obs) | OR: 1.77 (1.09-2.86) | 120 more per 1,000 (20 more to 198 more) | ⊕ Very low |
| Re-thrombosis (and revision rates) | 210 (3 Obs) | OR: 0.55 (0.29-1.06) | 118 fewer per 1,000 (208 fewer to 13 more) | ⊕ Very low |
| Perioperative mortality | 579 (6 Obs) | OR: 0.95 (0.43-2.09) | 3 fewer per 1,000 (32 fewer to 55 more) | ⊕ Very low |
| Adverse events | 602 (7 Obs) | More renal dysfunction/acute kidney injury, hematoma, distal embolization, and mean blood loss among patients who received MT compared to control groups | ⊕ Very low | |
| Volume of thrombolytic (mg) | 147 (2 Obs) | There are inconsistent findings of volume of thrombolytics used among people who received MT compared to control groups | ⊕ Very low | |
| Time of thrombolytic infusion (hours) | 300 (3 Obs) | — | MD: 13.64 lower (34.89 lower to 7.61 higher) | ⊕ Very low |
| Hospital length of stay (days after PMT | 264 (3 Obs) | — | MD: 1.10 lower (1.40 lower to 0.81 lower) | ⊕ Very low |
| Acute Deep Vein Thrombosis | ||||
| Limb Salvage | 151 (1 Obs) | OR: 2.63 (0.11-65.53) | 8 fewer per 1,000 (90 fewer to 12 more) | ⊕ Very low |
| Post thrombotic syndrome | 266 (1 RCT) | OR: 1.11 (0.65-1.91) | 26 more per 1,000 (99 fewer to 160 more) | ⊕⊕⊕ Moderate |
| 993 (6 Obs) | OR: 0.37 (0.26-0.54) | 127 fewer per 1,000 (154 fewer to 89 fewer) | ⊕ Very low | |
| Complete thrombus Removal | 430 (1 RCT) | RR: 1.04 (0.89-1.22) | 29 more per 1,000 (79 more to 158 more) | ⊕ Very low |
| 1,644 (12 Obs) | RR: 1.07 (0.94-1.21) | 43 more per 1,000 (17 fewer to 112 more) | ⊕ Very low | |
| Patency | 489 (6 Obs) | RR: 1.03 (0.94-1.14) | 19 more per 1,000 (39 fewer to 90 more) | ⊕ Very low |
| Re-thrombosis (and revision rates) | 165 (3 Obs) | There were no significant findings between study groups for freedom of re-thrombosis at 12 months, recurrence rates, or success rate where reintervention was required. | ⊕ Very low | |
| Quality of life | 430 (1 RCT) | — | MD: 4.33 higher (2.52 lower to 11.18 higher) | ⊕ Very low |
| Perioperative mortality | 430 (1 RCT) | OR: 1.59 (0.16-15.46) | 5 more per 1,000 (7 fewer to 108 more) | ⊕⊕ Low |
| 623 (4 Obs) | There were no significant differences in mortality reported, with most studies reporting 0 in both study arms | ⊕ Very Low | ||
| Adverse events | 430 (1 RCT) | There were fewer recurrent VTE and no significant difference in rates of bleeding between those who received MT and those who did not. Additionally, there were reported device-related events among 13.6% of patients who had received AngioJet | ⊕⊕⊕ Moderate | |
| 1,823 (13 Obs) | There were more cases of renal dysfunction, acute kidney injury and haemoglobinuria in some studies, while other studies had no statistically significant findings There were no statistically significant findings reported in bleedings or other complications | ⊕ Very low | ||
| Volume of thrombolytic (mg) | 269 (1 RCT) | — | MD: 0 (both study groups reported the same mean volume) | ⊕⊕⊕ Moderate |
| 1,170 (9 Obs) | — | SMD: 2.27 lower (3.6 lower to 0.95 lower) | ⊕ Very low | |
| Time of thrombolytic infusion (hours) | 269 (1 RCT) | MD: 2.0 lower (3.51 lower to 0.49 lower) | ⊕⊕⊕ Moderate | |
| 1,236 (8 Obs) | — | MD: 28.35 lower (45.64 lower to 11.05 lower) | ⊕ Very low | |
| Hospital length of stay (days after PMT) | 359 (4 Obs) | — | MD: 2.6 lower (5.08 lower to 0.12 lower) | ⊕ Very low |
Abbreviations: CI, confidence interval; DVT, deep vein thrombosis; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; MD, mean difference; MT, mechanical thrombectomy; OR, odds ratio; Obs, observational study; PMT, pharmacomechanical thrombectomy; RCT, randomized controlled trial; RR, relative risk; SMD, standardized mean difference; VTE, venous thrombosis embolism.
Note: summary of findings table developed using GRADEpro GDT. GRADEpro Guideline Development Tool [Software]. McMaster University and Evidence Prime, 2022. Available from gradepro.org
We evaluated the quality of the body of evidence for each outcome according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Handbook.70 See Appendix 2 for further details.