1

Introduction

Several studies have shown that stenting of the femoropopliteal artery (FP) leads to higher long term patency and less target lesion revascularization (TLR) . Stenting however, has several disadvantages including a continued high rate of restenosis and stent fractures . Treatment of these in-stent restenotic (ISR) lesions has a high procedural success rate but distal embolization (DE), the need for additional stenting and recurrent restenosis remain prevalent . Several methods have been proposed to treat in-stent FP lesions including plain old balloon angioplasty (POBA) , PolarCath (Boston Scientific, Natick, Mass) cryoplasty , cutting balloons , drug-eluting self-expanding stents (Zilver X) (Cook Medical, Bloomington, IN, USA) , atherectomy with (Rotarex S) (Staub Medical AG, Wangs, Switzerland) or without (SilverHawk) (Covidien, Mansfield, MA) embolectomy, and laser ablation (Excimer laser) (Spectranetics, Colorado Springs, Co, USA) with adjunctive covered stents (Viabahn) (W.L. Gore and Associates, Newark, DE) .

Debulking of in-stent restenotic FP lesions have been attempted to reduce restenotic tissue burden and theoretically delay or reduce the rate of repeat revascularization. The off label use of SilverHawk atherectomy (Covidien, Mansfield, MA) in these lesions has been shown to have high procedural success but skills and techniques of the operator are important to avoid complications . To our knowledge there are no published randomized data to date on angioplasty versus stenting or debulking (with the SilverHawk or the Excimer laser) of in-stent restenotic FP lesions.

Coronary studies have shown that laser effectively ablates restenotic tissue and thrombus, commonly found in occlusive in-stent restenosis of FP lesions . Excimer laser also suppresses platelet aggregation and therefore potentially reduces the chance of platelet mediated thrombotic reocclusion . Although acute results appear to be satisfactory in ablating restenotic tissue, the long term outcome has been variable and may be related to the extent of tissue debulking . In this study, we evaluate the acute procedural and long term outcome of ISR FP lesions treated with the excimer laser. Secondary endpoints included the safety of the laser within stented segments, bail-out stenting and distal embolization.

2

Methods

457 patients with FP disease were treated by 2 operators at our medical center from February 2005 to April 2010. Patients were included if their index lesions were restenotic, in-stent and were only in the FP arteries. Patients were excluded if they had de novo lesions or non FP segments treated during the index procedure or if they were treated with a non excimer laser atherectomy device. There were no prespecified guidelines to the choice of the device which was based on operator’s judgment.

Demographics, clinical, procedural and angiographic variables were retrospectively reviewed from a prospective peripheral vascular database developed at our institution. One-year follow up was achieved on all patients by reviewing medical records by a dedicated research coordinator. The study was approved by the Institutional Review Board (IRB).

In-hospital and 1-year major adverse events including amputation (major and minor, planned and unplanned), death, vessel perforation, distal embolization (as captured by an embolic filter or distally embolized and requiring further treatment with pharmacologic or mechanical means), major bleeding, myocardial infarction, stroke, access complications, acute renal failure, and acute or subacute vessel closure. Major bleeding was defined as a drop of > 3 gm/dl Hb with a clear source of bleed, retroperitoneal bleed, or intracranial bleed. Acute renal failure was defined as an increase in creatinine within 48–72 h of the procedure by > 0.5 mg per dl. The Trans-Atlantic Inter-Society Consensus (TASC I) was used to classify lesion complexity.

The primary effectiveness endpoint was acute procedural success defined as obtaining angiographically less than 30% residual narrowing respectively with no serious adverse events at the end of the procedure . Secondary endpoints included acute device success defined as a residual narrowing of < 50% by the ELA device alone and before adjunctive treatment, DE, clinically driven TLR and TVR at one year based on symptom recurrence, ankle brachial indices (ABI) and Rutherford–Becker class at one month, 6 months and one year in TLR-free patients, death, and amputation. Patients were followed up at approximately 1 month, 6 month and one year intervals in the office. Follow-up ABI testing was not part of a mandatory protocol but was generally done on the majority of patients.

Descriptive analysis was done on all variables. Continuous variables were presented as mean ± SD and dichotomous variables as percentages. Kaplan–Meier survival curve for TLR was plotted.

2

Methods

457 patients with FP disease were treated by 2 operators at our medical center from February 2005 to April 2010. Patients were included if their index lesions were restenotic, in-stent and were only in the FP arteries. Patients were excluded if they had de novo lesions or non FP segments treated during the index procedure or if they were treated with a non excimer laser atherectomy device. There were no prespecified guidelines to the choice of the device which was based on operator’s judgment.

Demographics, clinical, procedural and angiographic variables were retrospectively reviewed from a prospective peripheral vascular database developed at our institution. One-year follow up was achieved on all patients by reviewing medical records by a dedicated research coordinator. The study was approved by the Institutional Review Board (IRB).

In-hospital and 1-year major adverse events including amputation (major and minor, planned and unplanned), death, vessel perforation, distal embolization (as captured by an embolic filter or distally embolized and requiring further treatment with pharmacologic or mechanical means), major bleeding, myocardial infarction, stroke, access complications, acute renal failure, and acute or subacute vessel closure. Major bleeding was defined as a drop of > 3 gm/dl Hb with a clear source of bleed, retroperitoneal bleed, or intracranial bleed. Acute renal failure was defined as an increase in creatinine within 48–72 h of the procedure by > 0.5 mg per dl. The Trans-Atlantic Inter-Society Consensus (TASC I) was used to classify lesion complexity.

The primary effectiveness endpoint was acute procedural success defined as obtaining angiographically less than 30% residual narrowing respectively with no serious adverse events at the end of the procedure . Secondary endpoints included acute device success defined as a residual narrowing of < 50% by the ELA device alone and before adjunctive treatment, DE, clinically driven TLR and TVR at one year based on symptom recurrence, ankle brachial indices (ABI) and Rutherford–Becker class at one month, 6 months and one year in TLR-free patients, death, and amputation. Patients were followed up at approximately 1 month, 6 month and one year intervals in the office. Follow-up ABI testing was not part of a mandatory protocol but was generally done on the majority of patients.

Descriptive analysis was done on all variables. Continuous variables were presented as mean ± SD and dichotomous variables as percentages. Kaplan–Meier survival curve for TLR was plotted.

3

Results

Of 457 FP treated patients, 123 were treated with excimer laser. 83 patients did not meet the inclusion criteria (de novo lesions = 67; devices used other than balloon or stent post laser = 7; use of balloon or an atherectomy/embolectomy device before laser = 2; non-index procedure in patients treated with 2 separate procedures with the laser in the same FP segment = 7). 40 patients met the inclusion criteria and formed the cohort of this study.

Demographic and clinical variables are presented in Table 1 . Patients had multiple comorbidities with a high frequency of hypertension (85.0%), hyperlipidemia (80.0%), smoking history (82.5%) and diabetes (47.5%). The majority of the patients were claudicants (73.7%) and with subacute ( < 1 month, > 24 h) (55%) or chronic symptoms (> 1 month) (40.0%). Angiographic and procedural variables are presented in Table 2 . The mean lesion length was 210.4 ± 104.0 mm and 47.5% of lesions were TASC D. Procedural and device successes were achieved in 92.5% and 52.0% of patients respectively. Bail out stenting was performed in 50% of patients. Macroembolization occurred in 65.2% of filters. One patient with DE required additional treatment successfully.

Table 2

Angiographic and procedural characteristics.

	n	mean ± SD
Number of runoff vessels of treated leg	40	1.7 ± 1.0
Prestenosis severity (%)	40	93.9 ± 8.9
Poststenosis severity (%)	40	14.0 ± 13.0
Lesion length (mm)	35	210.4 ± 104.0
Lesion diameter (mm)	40	5.6 ± 0.7
Balloon pressure (mmHg)	39	12.4 ± 2.9
Laser parameters
Fluency (mJ/mm 2 )	21	56.2 ± 13.6
Repetitions (Hz)	27	60.0 ± 20.6
Total Pulses	24	11476 ± 9063
Total laser time (s)	24	188.6 ± 138.6
Laser catheter size (mm)	38	2.2 ± 0.3
		Percentage
Intraprocedural anticoagulant-bivalirudin	39/40	97.5
Adjunctive Balloon use	40/40	100.0
Bailout Stent	20/40	50.0
Reason for Bailout stent
> 30% residual	15/20	75.0
> 30% residual and type C or higher dissection	2/20	10.0
Investigator discretion	2/10	10.0
Perforation	1/20	5.0
Device success (< 50% residual with laser alone)	13/25	52.0
Procedural success (< 30% residual at end of treatment)	37/40	92.5
In-hospital major adverse events	0/40	0
TASC type
FP-B	5/40	12.5
FP-C	16/40	40
FP-D	19/40	47.5
Laser type
Elite	30/35	85.7
Booster or tandem	5/35	14.3
Embolic filter use	23/40	57.5
Debris
None	6/23	26.1
Microembolization	2/23	8.7
Macroembolization	15/23	65.2
Distal Embolization requiring treatment a	1/40	2.5

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