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. 2020 Sep 29;2020(9):CD006680. doi: 10.1002/14651858.CD006680.pub3

Shammas 2012.

Study characteristics
Methods Randomisation method: sealed envelopes provided to all centres for randomisation, randomisation method for distribution not stated. Randomisation performed only after inclusion and exclusion criteria assessed.
Allocation: sealed envelopes, not stated if opaque
Intervention model: parallel assignment
Blinding: not stated, probably not done
Participants Country: United States of America
No. of participants: participants: 50; vessels: 64
Diamondback atherectomy plus BA: participants: 25; vessels: 29
BA: participants: 25; vessels: 35
Age (mean (years) ± SD):
atherectomy: 70.7 ± 13.4
BA: 71.8 ± 10.9
Inclusion criteria: adults with rest pain or tissue loss (Rutherford class 4 to 6); angiographic stenosis > 50%; fluoroscopically‐visible calcium > 25% of the treated segment; atherectomy wire must cross all lesions with no subintimal wire passage; main target vessel reference diameter > 1.5 mm; more than one patent distal runoff vessel with brisk flow for any treated popliteal segment; distal portion of anterior tibial or posterior tibial target vessel must reconstitute to the ankle or foot and only proximal one third of the peroneal artery to be treated; distal two thirds must reconstitute.
Exclusion criteria:

  1. inability to understand study or history of non‐compliance with medical advice;

  2. unwilling or unable to sign informed consent form;

  3. currently enrolled in another study that may interfere with study endpoints;

  4. unsuccessful treatment of target leg superficial femoral artery or proximal vessel on procedure day;

  5. pregnant or planning to become pregnant within study period;

  6. known sensitivity to contrast media that cannot be adequately premedicated;

  7. chronic renal failure/creatinine level > 2.0 mg/dL unless on chronic dialysis;

  8. one or more of the popliteal or below‐knee lesions to be treated are within a stent;

  9. known allergy to heparin, aspirin, or clopidogrel;

  10. history of bleeding disorders or platelet count < 80,000 cells/mL;

  11. ongoing cardiac problems that would interfere with study procedures;

  12. stroke or transient ischaemic attack within 4 weeks prior to procedure;

  13. anticipated lifespan < 1 year;

  14. known or suspected active systemic infection;

  15. thrombus present or suspected in the target vessel;

  16. concomitant thrombectomy/other atherectomy device treatment in target vessel;

  17. investigator’s medical judgment excludes person from the study.
Interventions BA versus Diamondback atherectomy with adjunctive BA
Outcomes Primary: ability to achieve adequate lumen diameter, defined as < 30% residual stenosis with no bailout stenting or dissection
Secondary:

  1. rate of bailout stenting;

  2. limb salvage at 30 days, 6 months and 12 months;

  3. TLR and TVR at 6 and 12 months; and

  4. major adverse events (a composite of above‐knee amputation, mortality from all causes, and TLR/TVR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sealed envelopes provided to all centres for randomisation, randomisation method for distribution not stated. Randomisation performed only after inclusion and exclusion criteria assessed.
Allocation concealment (selection bias) Low risk Sealed envelopes, not stated if opaque.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not stated, but impractical in trials of this type.
Blinding of outcome assessment (detection bias)
All outcomes High risk Not stated, probably not done.
Incomplete outcome data (attrition bias)
All outcomes High risk Secondary outcomes reported for only 33/50 (66%) participants.
Selective reporting (reporting bias) Low risk All outcomes reported, though significant attrition present.
Other bias High risk No antiplatelet protocol