Notes

Outline

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PTA for CLI:  Historical Results

PTA for Critical Limb  Ischemia 307 procedures in 257 patients (63% diabetic) 66 tibial PTA procedures PVR’s  and ABI’s 1 and 6 weeks post PTA and every 3 months thereafter 1 year patency for tibial vessels 15%, Limb salvage rate 25%

PTA for Critical Limb  Ischemia “PTA should not be considered as a primary treatment modality for patients with infrainguinal arterial occlusive disease who also have limb-threatening ischemia, except in unusual circumstances”

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LACI Trial Historical Perspective Should we do a randomized trial? What do we randomize against? Will it be possible to complete a multicenter trial of this nature? Will it be possible to complete the trial in a reasonable amount of time? All CLI patients or only those who are poor/non-surgical candidates?

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Vascular Lesion Locations

Lesion Types

Procedure Results

Angiographic Results Visual assessment

6-Month Results

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Critiquing the Limb Salvage Data Rating the Quality of Evidence Level 1: Randomized allocation Multicenter (>100 patients) Single center ( < 20 patients) Level 2: Cohort studies Level 3: Case-control studies Level 4: Case series and registries Level 5: Case reports and expert                   opinion

Study Design Selection of patients Allocation of patients to treatment groups Therapeutic regimen Study administration Withdrawals from the study Outcome measurement Statistical analysis Patient blinding (randomized clinical trials only)

Cohort Studies Evaluating Data Quality Multicenter vs single center Prospective vs retrospective Independent data and safety monitoring Independent research organization Core laboratories (angio, Duplex, etc) Conflicted investigators? Undue influence of industry sponsor?

LACI Trial Strengths First multicenter, prospective trial of PTA/new device for CLI patient population Independent data monitoring Core lab (digital morphometry) Real world approach

LACI Trial Weaknesses Non-randomized Short term follow-up Not all ulcers healed by 6 months 11 patients lost to follow-up No patency data Unable to separate out benefit of laser from other endovascular therapies employed (PTA, stent)

The Gold Standard?

Excellent Long Term Primary Patency and Limb salvage rates

New Modalities for Tibial Intervention Cutting balloon (Ansel, et al) – single center, retrospective Balloon expandable stents (Fiering, et al) – single center, retrospective Excisional atherectomy (Kandzari, et al) – multicenter, retrospective? Cryoplasty (Das, McNamara, et al) – multicenter, prospective, non-randomized

New Modalities for Tibial Intervention Bioabsorbable stents (Peeters, Bosiers) – prospective, 2 centers, non-randomized Drug eluting stents (Scheinert, Biamino, et al) – prospective, single center, randomized (<100 patients)

Level of Evidence

PTA vs. Surgery in CLI

30 Day results

Early Morbidity Bypass 57% (110/194) PTA 41%  (89/216)                                                        NS Morbidity events: mainly infection, wound, and cardiovascular complications

PTA vs. Surgery in CLI – BASIL-study

BASIL Trial Limitations Patient selection (VS and IR had to agree that patients were candidates for both) Only balloon angioplasty 20% failure rate?? Doesn’t reflect modern practice

Conclusions LACI was a landmark trial of a new treatment strategy for the high risk CLI patient, but it had many limitations Numerous prospective, good quality registries being performed in the modern era, but there is disappointing paucity of randomized data