INFRAINGUINAL PAD INTERVENSION JOURNEL REVIEW Presented by : Dr SHAJUDEEN Second Year Resident Introduction Acute Limb Ischemia Intra Arterial Thrombolysis
Intra Arterial Thrombolysis Vs Initila Surgery Percutaneous Aspiration Embolectomy Ultra Sound Enhanced Thrombolysis FEMOROPOPLITEAL PTA vs Surgery DEB in FP Lesion Stenting in Femoro Popliteal Disease
Balloon Angioplasty vs Stenting In FP Disease DES vs BMS In FP Disease DES in FP Disease Covered Stent Vs BMS in FP Disease Laser Atherectomy in FP Disease IVUS in FP Disease INFRA POPLITEAL DISEASE
PTA in IP DISEASE PTA vs BYEPASS IN IP DISEASE DEB IN IP DISEASE STENTING IN INFRA POPLITEAL DISEASE AHA GUIDELINES TASC 11 CLASSIFICATION OF FEMOROPOPLITEAL DISEASE
TASC 11 CLASSIFICATION OF FEMOROPOPLITEAL DISEASE ACUTE LIMB ISCHEMIA Not able to download
Intra arterial thrombolysis (IAT) was used as first line treatment for 100 occlusions causing acute, subacute or chronic ischaemia. Streptokinase : 90 cases and TPA: 10 . Complete lysis=55% of cases Partial lysis in 20% Major complications =7 cases ( 5 major haemorrhage, 2 died and 2 had haemorrhagic CVA)
The 1 year patency rate following complete lysis was 58 per cent. The 1 year patency rate after successful treatment commencing within 1 week of symptoms starting was 71 per cent, compared with 36 per cent for later treatment Objective of study: To determine outcomes following lower extremity bypass for ALI
Study Design : Retrospective multicenter registry data N = 323 STUDY GROUPS: SURGERY FOR ALI vs CHRONIC LIMB ISCHEMIA Primary Outcome:
Bypass graft occlusion, major amputation, and mortality at 1 year postoperatively Secondary outcome: Hospital MACE, Freedom from major adverse limb events and amputation-free survival at 1 year. Statistical Analysis: Intention to treat /treatment received protocol Base Line CX ( ALI VS C/C ISCHEMIA)
Age (66 vs 67; P = .084) Sex ( 68% male vs 69% male; P = 0.617) On RX with aspirin (63% vs 75%; P < .0001) or Statin (55% vs 68%; P < .0001). Smoking status (49% vs 39%; P < .0001), Prior Ipsilateral bypass (33% vs 24%; P = .004) or Prior Ipsilateral Percutaneous intervention (41% vs 29%, P = .001).
Results Of Primary Outcome: Surgical Bye pass for ALI had no difference in rates of graft occlusion (18.1% vs 18.5%; P = .77), but have significantly higher rates of limb loss (22.4% vs 9.7%; P < .0001) and mortality (20.9% vs 13.1%; P < .0001) at 1 year. Bypasses performed for acute limb ischemia were longer in duration (270 vs 244 minutes; P = .007), had greater
blood loss (363 vs 272 mL; P < .0001) ALI Surgical bye pass Has increased rate of in-hospital MAE compared with those undergoing bypass for all other indications (19.8% vs 11.6%; P < .0001). They had higher rates of postoperative myocardial infarctions (7.5% vs 3.6%; P = .001), CHF exacerbations (5.6% vs 3.3%; P = .028),
deterioration in renal function (6.6% vs 4.4%; P = .001), and respiratory complications (3.7% vs 1.4%; P = .004) 1 YEAR OUTCOME Amputation-free survival at 1 year was significantly lower for patients undergoing lower extremity bypass for acute ischemia compared with patients undergoing bypass for all other indications (62.8% vs 77.4%; P < 0001) .
Freedom from major adverse limb events was lower in patients undergoing lower extremity bypass for acute ischemia (60.4% vs 66.7%; P < .0001). On Multivariable analysis Acute ischemia was an independent predictor of both amputation (hazard ratio, 2.16;CI , 1.383.40; P < .0001) and mortality at 1 year (hazard ratio,
1.41;CI , 1.091.83; P = .0009) CONCLUSION: Surgical treatment for ALI involves more complex operations and increased rates of perioperative adverse events. Despite equivalent graft patency rates, patients undergoing lower extremity bypass for acute ischemia have significantly higher rates of
major amputation and mortality at 1 year. Methods: Patients with limb-threatening ischemia of less than 7 days duration were randomly assigned to
intra arterial catheter-directed urokinase therapy or Operative intervention. The primary end points: Limb salvage and survival.
N= 57 ( Thrombolysis vs Operative Treatment) Thrombolytic therapy resulted in dissolution of the occluding thrombus in 40 (70%) patients. Cumulative limb salvage rate was similar in the two treatment groups (82% at 12 months),
Cumulative survival rate was significantly improved in patients randomized to the thrombolysis group (84% vs 58% at 12 months, p = 0.01). (The mortality differences primarily attributable to an increased frequency of in-hospital cardiopulmonary complications in the operative treatment group (49% vs 16%, P = 0.001)) Conclusions:
Intraarterial thrombolytic therapy was associated with a reduction in the incidence of in-hospital cardiopulmonary complications and a corresponding increase in patient survival rates STILE TRIAL : Surgery versus Thrombolysis for Ischemia of the Lower Extremity
Objective of study :To evaluate intra-arterial thrombolytic therapy in non embolic arterial and graft occlusion Study Population : Native arterial or bypass graft occlusion N= 393(144 Sx : 137 r Tpa: UKS 112 ) Study Design : Prospectively Randomised Study (Surgical procedure VS intra- arterial, catheter-directed thrombolysis with recombinant tissue plasminogen activator (rt-PA) or urokinase (UK)).
THROMBOLYSIS STRATEGY Thrombolysis patients required successful catheter placement into the occlusion before infusion of either rt-PA at 0.5 mg/kg/hr for up to 12 hours (Max Dose 100 mg) or UK of 250,000 units bolus followed by 4000 units/min X 4 hours, then 2000 units/min for up to 32 hours. Follow up Angio: At 4 hours, 8 hours, and at the end drug infusion. ( Thrombolysis patient received 5000 units of heparin as an
IV at the time of thrombolysis, followed by 1000 units/hr intravenously, which was titrated to maintain the APTT of 1.5 to 2.0 times control. Primary outcome : A composite clinical outcome of death, ongoing/ recurrent ischemia, major amputation, and major morbidity. Secondary outcome:
Reduction in surgical procedure, clinical outcome classification, length of hospitalization. RESULTS: Failure of catheter placement occurred in 28% (considered treatment failures) At 30 day event rate for the composite clinical outcome for thrombolysis patients was 61.7%
compared with 36. 1% for surgical patients (p < 0.001) primarily because of a reduction in ongoing/recurrent ischemia (p < 0.001). Clinical outcome classification at 30 days was similar. Results continued
Stratification by duration of ischemia : 0 to 14 days had lower amputation rates with thrombolysis (p = 0.052) and shorter hospital stays (p < 0.04). Patients with ischemic deterioration of > 14 days who were treated surgically had less ongoing/recurrent ischemia (p < 0.001) and
trends toward lower morbidity (p = 0.1). Patients randomized to Catheter-directed thrombolysis had significantly greater ongoing/recurrent ischemia (54% vs. 25.7%; p < 0.001), life-threatening hemorrhage (5.6% vs.0.7%; p = 0.014), and more vascular complications (9.7% vs. 3.5%; p = 0.032) compared with surgical patients. Three of the patients with life-threatening hemorrhages.
At 6-month follow-up Improved amputation-free survival in acutely ischemic patients treated with Thrombolysis (p = 0.01). In chronically ischemic patients> 14 days) who were treated surgically had significantly lower major amputations rates (P = 0.01). More than half of thrombolysis patients (55.8%) had a
reduction in magnitude of their surgical procedure (p < 0.001). There was no difference in efficacy or safety between rt-PA and UK CONCLUSION Patients with acute ischemia (0-14 days) who were treated with thrombolysis had improved amputation-free survival and shorter hospital stays.
For patients with chronic ischemia (> 14 days), surgical revascularization was more effective and safer than thrombolysis. Combining a treatment strategy of catheter-directed thrombolysis for acute limb ischemia with surgical revascularization for chronic limb ischemia offers the best overall results. STUDY DESIGN :Randomized, Multicenter trial N= 272 per group acute arterial obstruction of the legs for 14 days or
less. Study Vs Control: Thrombolysis 272 VS Surgery 272 PRIMARY OUTCOME: The primary end point was the amputation- free survival rate at 6 months. STATISTICAL ANALYSIS: Intention to treat /treatment received protocol RESULTS :Amputation-free survival rates for Urokinase group = 71.8% at 6 months and 65.0% at 1 year, for surgery group 74.8% and 69.9 % (P=0.43 & P=0.23 respectively).
At six months the surgery group had undergone 551 open operative procedures (excluding amputations), as compared with 315 in the thrombolysis group. Major hemorrhage occurred in 32 patients in the Urokinase group (12.5 percent) as compared with 14 patients in the surgery group (5.5 percent) (P 0.005). There were four episodes of intracranial hemorrhage in the urokinase group (1.6 percent), one of which was fatal. There were no
episodes of intracranial hemorrhage in the surgery group. Conclusions Despite its association with a higher frequency of hemorrhagic complications,
intraarterial infusion of urokinase reduced the need for open surgical procedures, with no significantly increased risk of amputation or death.
Objective of study: To report the first use of Purified Plasmin for acute lower extremity arterial or bypass graft thrombosis in a phase I doseescalation study of a catheter-delivered agent. METHODOLOGY: 83 patients with Non-embolic occlusion of infrainguinal native arteries or bypass grafts were enrolled into seven sequential dose cohorts to receive 25175 mg of plasmin by intrathrombus infusion over 5 h. Arteriograms were performed at baseline, 2 h, and 5 h, and subjects
were monitored for 30 days for clinical outcomes. RESULTS: Major bleeding occurred in four patients (4.8%), and minor bleeding alone in 13 (15.7%), with no trend towards more bleeding
at higher dosages of plasmin. Thrombolysis (50%) occurred in 79% of subjects receiving 125175 mg of plasmin, as compared with 50% who received 25100 mg. PERCUTANEOUS ASPIRATION EMBOLECTOMY NO ACCESS
ABSTRACT N= 102 patients,62.7% had limb-threatening ischemia (stages III and IV according to the Fontaine classification); 86.3% had cardiac disease that caused the embolic occlusion. The clinical success rate was 87.3% . Major complications occurred in 8.8% (n = 9) of the cases. The 30day mortality was 3.9% (n = 4). In comparison with Fogarty-catheter Embolectomy, PAE has a
higher success rate and a lower mortality. PAE has several advantages: It is a simple technique with reduced invasiveness, combines a diagnostic and a therapeutic procedure, enables treatment of tibial and pedal vessels, and can be combined with all other angioplastic me
No accsess Objective : To evaluate percutaneous aspiration embolectomy (PAE) as a therapeutic alternative to surgical embolectomy. METHODS: N=85, ( 90 PAEs for embolic occlusions ) Study design: Prospective observational Time period: 1987 and 1992
RESULTS: The first PAE was clinically successful in 77 limbs (86%). In eight cases, major amputation was necessary. The success rate was independent of the time interval from embolism to the PAE procedure. The 30-day mortality rate was 3.5%. The cumulative primary patency rate at 1 and 4 years was 68% and
58%, respectively. The limb salvage rate was 88% after 1 year and 86% after 4 years. The patency rate was significantly better and the mortality was significantly lower in patients receiving long-term anticoagulation with coumadin. CONCLUSION: PAE is highly effective in the treatment of embolic occlusions of the lower leg arteries and should be considered as an alternative to
Fogarty balloon embolectomy. Purpose: To evaluate the safety and performance of ultrasoundenhanced thrombolysis in the treatment of acute thrombotic or embolic occlusion of the lower limb arteries. STUDY PERIOD: April 2005 to July 2006, N=25 patients (15 men; mean age 64.1 years, range 37 82) presenting
with acute (14 days old) occlusions of the lower limb arteries were treated with local thrombolysis [recombinant tissue plasminogen activator (rtPA)] in a dosage of 1.0 mg/h using the EKOS Lysus Peripheral Catheter System with an ultrasound core. No bolus injection of rtPA was given. The mean occlusion length was 25.1 cm (range 270). Results: The technical success rate was 100%. Total clot removal was achieved in 22 (88%) patients after 16.9 hours (range 524) using a
mean 17 mg (range 525) of rtPA. In 8 cases, total clot removal of the main lesion was achieved after 6 hours (6 mg of rtPA). In 1 patient,lysis was stopped after 2.5 hours because of bleeding due a dislocation of the introducer sheath. In 2 cases, total clot removal could not be achieved; these patients were successfully treated with thrombo aspiration.
At the 1-month follow-up, the treated vessel was patent in 20 patients. Two re occlusions occurred There were no cases of amputation or death during followup. There were no side effects related to rtPA or the catheter system. Conclusion: This study demonstrates that local lysis of acute arterial occlusions using the Lysus Peripheral Catheter System is safe and
effective. Blood flow is restored quickly. Femoro Popliteal intervension PTA vs BYEPASS FOR FEMOROPOPLITEAL DISEASE Objective: To evaluate whether angioplasty or aboveknee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions
Study Design: Multicentre RCT N=56 (PTA Group =31 Bye pass Group =25) Lesion length : 515 cm long occlusive lesion of SFA Primary endpoint : Re-occlusion of the SFA Results: Cumulative 1-year primary patency after PTA was 43% and 82% after bypass surgery. After PTA more than half of the patients
had a re-occlusion with an absolute risk reduction of 31% (CI: 6 56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.95.58) Conclusion: For every Three patients treated with bypass surgery instead of PTA, one additional reocclusion is prevented. So for long SFA stenoses or occlusions, surgery is better than PTA
Methods : STUDY PERIOD: 2001 - 2009 Study Design: Retrospective cohort review N=113 bypass grafts and 105 PTA Stenting Study inclusion: Those patients undergoing first intervention for claudication due to SFA disease. Outcomes analysed: Complications, Restenosis, Symptom Recurrence, Reinterventions, Major amputation,
& Mortality. Results : Byepass vs PTA/S Mean length of stay : 3.9 versus 1.2 days (P<.01). Perioperative (2% vs 0%; [NS]) or 3-year mortality (9% vs 8%; NS). Wound infection w: (16% vs 0%; P < .01). Bypass showed improved freedom from restenosis (73% vs 42% at 3 years; hazard ratio [HR], 0.4; 95% confidence interval
[CI], .23-.71), symptom recurrence (70% and 36% at 3 years; HR, 0.37; 95% CI, .2-.56), There was no difference in freedom from reintervention (77% vs 66% at 3 years; NS). Multivariable analysis Restenosis: Predicted by PTA/S (HR, 2.5; 95% CI, 1.4-4.4) and TASC D (HR, 3.7; 95% CI, 3.5-9) lesions.
Recurrence of symptoms: Predicted by PTA/S (HR, 3.0; 95% CI, 1.8-5) and TASC D lesions (HR, 3.1; 95% CI, 1.4-7). Statin use postoperatively was predictive of patency (HR, 0.6; 95% CI, .35-.97) and freedom from recurrent symptoms (HR, 0.6; 95% CI, .36-.93). Conclusions Surgical bypass for the Primary treatment of
claudication showed improved freedom from Restenosis and Symptom relief despite treatment of more extensive disease, but was associated with increased LOS and wound infection. Statins improved freedom from restenosis and symptom recurrence overall. Drug Eluting Balloon In Femoro Popliteal Disease
Objective: The FREERIDE study investigates the inhibition of restenosis by the Paclitaxel DCB Freeway versus standard balloon PTA in the treatment of de-novo occluded, stenotic or reoccluded lesions in peripheral arteries (SFA and popliteal artery/P1 segment) Study Design : RCT N= 84 patients enrolled till date (62 completed the 6 months follow up) Primary Endpoint: Rate of TLR at 6 months
Secondary End Point: Late lumen loss and Patency rate at 6 months. TLR at 12, 24 months follow up (FU).
Change in the Ankle-brachial index (ABI) & Rutherford class at FU. MAE.
Interim results There was remarkably more bail out stenting after POBA compared with Freeway PTA (8.9% vs. 25.6%; p=0.04). There were clear positive trends in the TLR rate for the Freeway arm (5.4% vs. 20%; p=0.07). MAE were significant lower in the Freeway arm compared to POBA (5.4% vs. 28%; p=0.01).
CONCLUSION The interim results
indicate that the (Paclitaxel)-coated balloon Freeway might provide an advantage for PTA in SFA lesions
and PI segment STUDY ONGOING NOT MUCH DATA AVILABLE Objective : To investigates the inhibition of restenosis by Paclitaxeleluting balloon Post dilatation after stenting versus Post dilatation with plain balloon after stenting in the treatment of the SFA Study Design :Multicenter RCT N= Intends to enroll 200 patients , randomized in a 1:1 relation to either
nitinol stenting followed by drug-coated balloon Freeway Postdilatation or stenting with plain balloon post dilatation. Primary endpoint: Primary endpoint is clinically driven TLR at 6 months. Secondary End Point : Secondary safety and efficacy endpoints are Late Results The results show a favorable outcome for the
DCB arm in relation to the TLR rate in patient population who with occlusions presented predominately Type of study: Registry Data Objective : To evaluate the safety and efficacy, at 1 year, of the use of DEB
for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR). N= 39 consecutive patients underwent PTA of SFA-ISR in our institution. PTA with stenting with post-dilation with paclitaxel-eluting balloons FOLLOW UP: Patients were evaluated up to 30 days , 3,6, 12 months MEAN LESION LENGTH: Mean lesion length was 82.9 78.9 mm. PRIMARY END POINT: Primary patency at 1 year
Primary endpoint: Primary patency defined as PVR of >2.4 documented by duplex ultrasound at 12 months without target lesion revascularization (TLR). Secondary endpoints. 1) Freedom from TLR at 1 year. 2) Secondary patency at 1 year. 3) Clinical success
Hemodynamic success. RESULTS Technical and procedural success : 100%. Primary patency rate at 12 months= 92.1% (35 patients). (4 patients had restenosis at 6 months) At 1 year patients were asymptomatic for claudication, No recurrent restenosis (100% rate
of secondary patency) CONCLUSION This study suggest that adjuvent use of DEB for the treatment of SFA-ISR represents a potentially safe and effective therapeutic strategy
STENTING IN FEMORO POPLITEAL DISEASE PTA VS STENTING The randomized BalloonAngioplasty Versus Stenting With Nitinol Stents in theSuperficial Femoral Artery (ABSOLUTE) trial Objective of study: To assess the rate of 2 years Restenosis
rate of femoro popliteal CLI treated with with Primary stenting vs PTA with Optional stenting. Type of study: RCT (Primary stenting vs PTA with Provisional Stenting) N= 104 @(PS=46 /98, PTA With Optional Stenting=52/98) Average Length Of Lesion :132mm in 10 STENTING and 127 mm in bail out Stenting Primary Endpoint: Retenosis Rate (>50% by duplex US)
Secondary End Point: Tread Mill Walking Distance & ABI @ 98 completed 2 yr follow up INCLUSION CRITERIA PAD with severe IC (Rutherford class 3) or CLI with
either rest pain (Rutherford class 4) or Ischemic ulcers (Rutherford class 5) and a >50% stenosis or occlusion of the ipsilateral SFA with a target lesion length >30 mm and at least 1 patent (<50% stenosis) tibioperoneal run off vessel. RESULTS
RESTENOSIS RATE : Intention-to-treat analysis: Stenting VS PTA with bailout stenting 45.7% (21 of 46) versus 69.2% (36 of 52) P=0.031 Treatment-received analysis. Stenting vs POBA 49.2% (63/104) VS 74.3% (35/104) P=0.028 Results Of Secondary Endpoints. Primary stent group showed a trend toward better treadmill walking capacity (average, 302m versus 196 m; P=0.12) &
better ABI (average, 0.88 versus 0.78; P=0.09) at 2 years. Rutherford class: Does not show any significant difference between the two group(P=0.74). Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P 0.14 Multivariable analysis : There is significantly reduced risk for Restenosis at 2 years for primary
stenting (adjusted risk ratio, 0.52; 95% confidence interval, 0.24 to 0.93) after adjustment for age, gender, diabetes mellitus, smoking, PAD stage, and lesion length. Conclusions: At 2 years primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions
yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting. RESULTS: From Analysis By a Treatmentreceived Protocol Stent implantation (whether primary or secondary) was superior to plain balloon angioplasty with respect to the occurrence of restenosis at 2 years (31 of 63 [49.2%] versus 26 of 35 [74.3%]; P0.03).
Rutherford stages of PAD at 2 years were not significantly different between the 2 groups (P=0.53). Stent group showed no significant difference in walking capacity on the treadmill (268 m versus 189 m P=0.25) and ABI (0.84 0.19] versus 0.77 0.16 (P0.36) compared with patients after plain balloon angioplasty. Reintervention rates trended to be lower after stenting compared with balloon angioplasty, but this also was not statistically significant (26 of 63 [41.3%] versus 19 of 35 [54.3%]; P0.30).
FAST TRIAL PTA VS STENT i Mean lesion length was 45 mm. Primary end point : Ultrasound-assessed binary restenosis at
one year Secondary end points : Target lesion revascularization, absolute walking distance, ABI, Rutherford category, major adverse event Luminexx stent : self-expanding open-cell stent made of nitinol (a nickel-titanium alloy)
RESULTS Technical Success was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%). BINARY RESTENOSIS at 1 year : 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%) (Absolute treatment difference, 6.9%; 95% CI, 19.7% to 6.2%; P0.377). Target lesion revascularization at 1 year were 18.3% and 14.9%, respectively
(Absolute treatment difference, 3.3%; 95% CI, 13.0% to 6.4%; P=0.595). Rutherford category: No statistically significant difference between treatment groups was observed at 12 months. Conclusion: No statistically significant difference was found between the 2 treatment modalities in the primary end point of binary restenosis or TLR or improvement in Rutherford class.
Subset study showed that patient who received stents showed greater improvement in median walking distance (52m vs 20 m). PTA VS STENT Objective Of the study : Evaluated The Benefit Of Primary implantation of a self-expanding nitinol (nickeltitanium) stent vs PTA with optional secondary
stenting. Study Design : RCT, N=104, Inclusion criteria : Severe claudication or chronic limb ischemia due to stenosis or occlusion of the SFA Mean Lesion length: Mean (SD) length of the treated segment was 13271 mm in the stent group and 12755 mm in the angioplasty group. Primary stent implantation (51 patients) or angioplasty (53 patients) Clinical outcomes were assessed at 6 and 12 months.
Bailout stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group The mean (SD) length was 13271 mm in the stent group and 12755 mm in the angioplasty group. At 6 months, the Rate of Restenosis on angiography was 24% in the stent group and 43% in the angioplasty group (P = 0.05); At 12 months the rates on duplex ultrasonography stenosis were 37%
and 63% respectively (P = 0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group. The ABI was also significantly better at 12 months in the stent group than in the angioplasty group (P = 0.03). Conclusions Intermediate term result of patients treatment of
superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with of balloon angioplasty with optional secondary stenting. First angiographically controlled, randomized, double blind trial evaluating the 6-month outcomes of drug-eluting stent
implantation in long-segment obstructions of the SFA. February 2001 to July 2001 DES VS BMS Objective of study: To evaluate the effectiveness of SMART nitinol selfexpanding stents coated with a polymer impregnated with sirolimus (rapamycin) vs uncoated SMART stents in the SFA Obstruction Study Design : Prospective Double-blind, Multicenter randomized trial.
N= 36 (18 Sirolimus-eluting SMART stents and 18 patients received uncoated SMART stents ). Study Group: All had obstructive, Native, de novo, or Restenotic lesions with a diameter stenosis 70% over a length that ranged from 7 to 20 cm or occlusions that ranged from 4 to 20 cm, in the SFA ( TASC C) Inclusion Criteria : Symptomatic POAD classified as
Rutherford stage 2 to 4 Primary End Point In-stent mean percent diameter stenosis measured by quantitative angiography at 6 months. Secondary End Point Duplex Doppler ultrasound ,ABI , Hemodynamic failure,
Results At 6 months In-stent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group(P=0.294). In-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P=0.047)
The occlusion rate was 0% in the sirolimus-coated stent group and 5.9% (N=1) in the uncoated stent group. The binary in-lesion restenosis rate was 0% in the sirolimus coated stent group and 23.5% (P=0.10) in the uncoated stent group. No secondary revascularization procedures were require in either treatment group.
CONCLUSION The use of Sirolimus-eluting SMART stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
Objective of study :Review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents Study Design: Randomized, multicenter, double-blinded study N= 93 (47 DES vs 46 BMS) Primary Endpoint : In-stent mean lumen diameter stenosis at 6 months as determinedby quantitative angiography (QA). Secondary Endpoint
Restenosis as determined by QA (>50% stenosis), Hemodynamic failure of the stented lesion ABI. Clinical patency.
Technical success Procedural success. Incidence of serious MACE. Bms vs des
Inclusion Criteria: Rutherford stage 1 (mild claudication) to 4 (rest pain) CLI and SFA occlusions or stenoses (average lesion length 8.3 cm). The stenotic length : 7 - 20 cm in the first phase 7-14.5 cm in the second phase. The occlusions varied in length from 4 to 20 cm in the first phase and 4 to 14.5 cm in the second phase.
Important Baseline Differences Sirolimus group had more severe Lesion calcification (57% versus 35% for the bare stent group, p=0.03). Follow Up: Mean 24 months. Statistical Analysis: Intention- to-treat analysis RESULTS
The TLR was 6% in the Sirolimus group and 13% in the BMS group CONCLUSION These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24
months. No significant difference could be found between the sirolimus-eluting and the bare SMART stents. . Study design Inclusion
criteria: Rutherford category 2, 50% diameter stenosis, Reference vessel diameter 4 to 9 mm, lesion length up to 14 cm, and at least 1 patent runoff vessel with
<50% stenosis throughout its course. Study Design : A prospective, multinational RCT and a complementary singlearm study Objective of study: 2-year safety and effectiveness of a Paclitaxel-coated DES in patients with SFA
lesions. Mean lesion length was approximately 65 40 mm in the randomized trial and 99.5 82.1 mm in the single-arm study. Single arm study included: Lesions up to 28 cm also. Primary End Point : Safety and effectiveness
Folow up data : ABI, Rutherford Classification, WIQ Before And At 2 Years Patency In Single Arm Study Only One Year Patency Assessed 2 year Results: SAFETY: EFS for the primary DES
Vs PTA (86.6% vs. 77.9%, log rank P= 0.02) . The 2-year EFS rate for primary DES placement in the single arm study was 79.3%. TLR The 2-year freedom from TLR rate with Primary DES placement was 86.6% in the randomized trial and 80.5% in the single-arm study
PATENCY: 74.8% for the Primary DES group and 26.5% for the Long-term PTA subgroup (log-rank p < 0.01) ( ACUTE PTA FAILURES TAKEN AS LOSS OF PATENCY) 2-year primary patency rate for the Primary DES group was:
1) Significantly superior (log-rank p < 0.01) to the 53.4% rate for the optimal PTA group (a group that excluded patients who experienced acute PTA failure); 2) Significantly superior (log-rank p < 0.01) to the 57.3% rate for the patients with optimal PTA and provisional BMS placement after acute PTA failure 3) Significantly superior (log-rank p = 0.01) to the 64.3% rate for the overall PTA control group that consisted of patients with optimal PTA (50%) and with provisional BMS (25%) or provisional DES (25%) placement after acute PTA
2 YEAR PATENCY : PROVISIONAL STENTING WITH BMS VS DES primary patency rate of 83.4% for provisional DES compared with 64.1% for provisional BMS (log-rank p < 0.01) . AT 2 years, there was no significant difference in patency for primary DES compared with provisional DES placement (log-rank p =0.11).
Clinical benefit. The Rutherford classification, ABI, and WIQ score each significantly improved (p =0.01) from pre procedure to 2 years in both the primary DES and
PTA groups in the randomized trial, with no significant differences between the groups. In the single-arm study, these scores also significantly improved (p < 0.01) from pre treatment to 2 years. Results in a nut shell: The primary DES group demonstrated significantly superior 2-year
event-free survival (86.6% vs. 77.9%, p= 0.02) and primary patency (74.8% vs. 26.5%, p < 0.01). The provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p < 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p =0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the
RCT. Conclusions The 2-year outcomes from the Zilver PTX studies support the sustained safety and effectiveness of the DES in patients with de novo or restenotic femoro popliteal arterial lesions, the superiority of the DES to PTA, and the long-term benefit of
the drug coating over the corresponding BMS. Covered stent vs BMS Covered vs bms in femoropolplitel disease Study Design: Prospective, randomized, single-blind, multicenter study.
N= 141 (Viabahn 72) or BMS (69) Follow up : Clinical outcomes and Patency rates were assessed at 1, 6, and 12 months. Mean lesion length: 19.0 6.3 cm in the Viabahn group and 17.3 6.6 cm in the BMS group. Primary End Point Safety endpoint : Composite of serious procedural adverse events
Efficacy endpoint: Primary patency rate measured at 1 year post-procedure. Secondary Endpoint: Clinical improvement: Rutherford category at 1, 6, and 12 months, walking distance according to the walking impairment questionnaire (WIQ), change of the anklebrachial Doppler index (ABI) at discharge and 1, 6, and 12 months, secondary patency, and freedom from TLR
Inclusion Criteria: Symptomatic PAD in the Rutherford-Becker clinical stage 2 to 5 de novo arteriosclerotic stenosis or occlusion of the SFA and Proximal Popliteal artery Important Exclusion Criteria: Untreated inflow lesions, Any previous Stenting or Surgery in the target artery. RESULTS
12-month Primary patency Viabahn vs BMS group: By ITT 70.9% (95% CI: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p =0.11). By Treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23
[95% CI: 1.14 to 4.34) (log-rank test p =0.009). In TASC- D lesions the 12-month patency rate was significantly longer in Viabahn patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from TLV:
84.6% for Viabahn (95% CI: 0.72 to 0.91) 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). ABI Viabahn group significantly increased to 0.94 0.23 compared with the BMS group (0.85 0.23; p < 0.05) at 12 months CONCLUSION
Significant clinical and patency benefits for heparin bonded covered stents compared with BMS in lesions 20 cm ( TASC D ) and for all lesions in the TPP analysis. LASER ATHERECTOMY IN FEMORO POPLITEAL DISEASE
The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. Objective of study : Safety and Efficacy of excimer laser atherectomy (ELA) with adjunctive PTA versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).
Type of study:The multicenter, prospective, randomized, controlled N = 250 patients FOLLOW UP : Study Vs Control: ELA + PTA and PTA groups by a 2:1 ratio
Important baseline features : Mean lesion length was 19.6 12.0 cm versus 19.3 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. PRIMARY END POINT: The primary efficacy endpoint : TLR at 6-month follow up. The primary safety endpoint: Major adverse event (death, amputation, or
TLR) at 30 days post-procedure. INCLUSION CRITERIA : Rutherford Class 1 to 4 PAD, and with Resting or abnormal exercise ABI <0.9 in the target limb . Angiographic inclusion criteria: Significant ISR > 50% diameter stenosis (DS) by visual assessment within previously deployed femoro popliteal stent(s), target lesion length > 4 cm, and reference vessel diameter between 5 and 7
mm. A minimum of 1 patent tibial vessel or Peroneal artery to the foot containing <50% DS by visual estimate that did not require intervention prior to the 1- Results ELA + PTA Vs PTA Superior procedural success (93.5% vs. 82.7%. p =0.01) with significantly fewer procedural
complications. 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001). ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).
EFFICACY OUTCOMES. Procedural success was 93.5% in the ELA + PTA group and 82.7% in the PTA group (p = 0.01). Dissection (7.7% vs. 17.2%; p = 0.03), bailout stenting (4.1% vs. 11.1%; p = 0.05) and TLR (5.3% vs. 16.0%; p = 0.008) occurred significantly less frequently in the ELA + PTA group compared with the PTA alone group.
SAFETY OUTCOMES. Freedom from any MAE was 94.2% in the ELA + PTA group and 79.5% in the PTA group (p < 0.001), demonstrating that ELA + PTA was
superior to PTA alone for the primary safety endpoint. IVUS IN FEMORO POPLITEAL INTERVENSION Study design: Retrospective multicenter database of 1198 limbs from 965 PAD patients with TASC II class A to C lesions, who underwent provisional stenting from April 2004 to December 2011.
Primary patency was compared between the groups with and without IVUS use. Results: The mean age was 72 9 years and 72% were male. The prevalence of CLI was 28%. The proportion of TASC II class A, B, and C was 37%, 37%, and 26%, respectively. IVUS was used in a total of 268 cases (22%). In this population, mean follow-up period was 1.91.5 years. The group with IVUS use had a significantly higher rate of primary patency compared to the group without IVUS use.
Five-year primary patency rates were 656%
and 356% (Mean SE) in the groups with and without IVUS use, respectively (p < 0.001). Conclusion: IVUS use in femoro-popliteal stenting for TASC II
class A to C lesions was associated with a higher rate of primary patency in PAD patients. INFRA POPLITEAL INTERVENTION REVIEW ARTICLE PTA IN INFRA POPLITEAL DISEASE N= 40 consecutive (PTA) procedures
Results: T 1 technical failure , 39 limbs were all clinically improved by 24 h and this improvement was maintained at 3 months in 36 (90%). No deaths Nor limb loss The primary and secondary patencies at 24 months were 59 and 79% respectively. The actuarial limb salvage rate at 1 year for the 20 limbs presenting with critical ischaemia was 77% 10 of the 14 procedures performed for ulceration or gangrene resulted in healing with only minor surgical intervention.
Conclusions: Infrapopliteal PTA is a safe, worthwhile and durable procedure. STUDY PERIOD : March 2002 to June 2006 Primary end points : Primary patency, assisted patency, Secondary endpoint : Limb salvage, and Patient survival N = 155 PTA (144 PATIENTS) . TASC A (7%), B (18%), C (39%), and D (35%)) Clinical Status: 14% lifestyle-limiting claudication 86% CLI with rest pain/tissue loss
Procedure: PTA was confined to the infrapopliteal segment in 40 (26%), and 115(74%) underwent multilevel treatment. Five patients (3%) received stents. Mean follow up: The mean follow-up was 22 months (range, 0-54 months). RESULTS:
Technical success : 95%. The 30-day mortality was 2%, and major morbidity was 3%. 40-month actuarial Primary patency was 62% with assisted patency (infrapopliteal re-PTA, 25[16%]) of 90% Nonhealing ulcers occurred in 76% of which 64% healed during follow-up. Of the 42 unhealed ulcers, 15 (13%) required major amputations for a 40-month limb salvage of 86.2% At 40-months, patient survival was 54%.
ARTICLE NOT ABLE TO DOWN LOAD N= 1023 patients treated for CLI ( 262 endovascular and 761 surgical revascularization ) to their crural or pedal arteries.
Results: PTA and bypass surgery achieved similar 5-year leg salvage (75.3% vs 76.0%), survival (47.5% vs 43.3%), and amputation-free survival (37.7% vs 37.3%) rates whereas freedom from surgical revascularization was higher after bypass surgery (94.3% vs 86.2%, P < 0.001). In a subgroup of patients who underwent isolated infrapopliteal revascularization, PTA was associated with better leg salvage (75.5% vs 68.0%, P = 0.042).
Conclusions: Infrapopliteal PTA as a first-line strategy is expected to achieve similar long-term results to bypass surgery in CLI DEB IN INFRA POPLITEAL ARTERY First large, multicenter, randomized, controlled trial of IA-DEB and PTA in CLI patients.
Objective :To assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI). Study Design :prospective, multicenter, randomized, controlled trial Sample size :358 CLI patients were randomized 2:1 to IA-DEB or PTA. Primary end point : Clinically driven target lesion revascularization (CDTLR) and late lumenloss (LLL) Primary Safety End Point:Primary safety endpoint through 6 months was a
composite of all-cause mortality, Major amputation & CD-TLR. Important baseline differences: Prior TLR was significantly higher in the IA-DEB (32.2%) versus the PTA (21.8%) arm (p = 0.047).
Impaired inflow was significantly higher in the IADEB arm (40.7%) versus the PTA (28.8%) arm (p = 0.035). Target lesions were significantly longer (12.9 9.5 cm vs. 10.2 9.1 cm) in the PTA arm versus the
IA-DEB arm (p = 0.002). Total occlusions were 38.6% in the IA-DEB arm and 45.9% in the PTA arm (p = 0.114). Statistical Analysis: Intention-to-treat principle.
Results: Primary efficacy of IA-DEB versus PTA CD-TLR of 9.2% versus 13.1% (p = 0.291) LLL of 0.61 0.78 mm Vs 0.62 0.78 mm (p = 0.950). Primary safety results 17.7% versus 15.8% (p = 0.021) and met the non
inferiority hypothesis. Major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080). 12-month follow-up (IA-DEB versus the PTA arm) Binary stenosis : (41.0% vs. 35.5%; p = 0.609) Reocclusion rates (11.5% vs. 16.1%; p =0.531)
PRIMARY SAFETY RESULTS. The composite of all cause death, major amputation, and CDTLR rates through 6 months were 17.7% in the IA-DEB arm and 15.8% in the PTA arm (p = 0.021 for non inferiority). CONCLUSIONS: In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary
safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. Objective of study: Efficacy of DEBs in long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. Study Design : Observation study N= 104 Patients (109 LIMBS), Mean lesion length of the arteries treated
was 176 88 mm Methods : Consecutive patients with critical limb ischemia (CLI) (82.6%) or severe claudication (17.4%) and BTK lesions (stenosis: 70% or occlusions) with a lesion length of 80 mm or more were treated with a paclitaxel-eluting balloon Primary End point: The primary endpoint was the angiographic binary restenosis at 3 months Clinical outcome was assessed at 3 and 12 months after angioplasty.
. RESULTS Angiography studied in 84 treated arteries at 3 months showed a focally Restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) In 9.5% entire
treated segment restenosed or reoccluded. Clinical improvement was seen in 75.8% of the treated limbs, 22.2% were unchanged, and 2.0% were clinically worse. Complete wound healing was noted in 41.9% of the Rutherford-Becker category 5 limbs. RESULTS CONTINUED.
During a follow-up period of 37865 days, clinical improvement was present in 91.2% Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia CONCLUSION
The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment balloons(69%).
with DEBs uncoated INTERVENSION IN INFRA POPLITEAL VESSELS
PTA Studies Stent in IP disease STENTING IN INFRA POPLITEAL DISEASE FULL ARTICLE NOT ABLE TO DOWNLOAD
Study Design: Prospective RCT trial in CLI, comparing the effect of PTA versus 10stenting in IP arteries Primary outcome: 1-year clinical benefit and Reobstruction rate. Results: N= 54 , primary stenting 21 (balloon expandable stent) or PTA 33 alone,. The whole follow up period of 12 months was completed by 46 patients.
Improvement by at least one Rutherford classification was reached by a total of 33 (75.0 %) of patients at month 12, (22 (81.5 %) in the PTA group and 11 (64.7 %) in the stent group). A complete ulcer healing at 1 year occcured in 21(63.6 %) patients (PTA alone 16 (80.0 %) vs 5 (38.5 %). 50.0 % of all patients showed Re-obstruction over the follow-up period, (39.4 % of the PTA and 66.7 % of the stent group)
3 month primary patency rate was nearly equal in both groups (76.7 % PTA vs 75.0 % stent. At 12 month primary patency in the PTA group of 48.1 % vs 35.3 % in the stent group. As for secondary patency at month 12 the PTA group showed a patency rate of 70.4 %, vs 52.9 % in the stent group. Conclusions: Primary stenting with balloon expandable stents in the infrapopliteal arteries does not outway the benefit of PTA alone with the application of modern hydrophilic balloon catheters in patients with CLI
Study Design : Prospective, randomized, multi-centre, double-blind trial N= 161 Target Lesion Length: Mean target lesion length was 319 mm.
Study subjects : Polymer-free sirolimus-eluting stent VS placebo-coated BMS in patients with either IC or CLI who had a de-novo lesion in an infrapopliteal artery Primary Endpoint : 1-year primary patency rate,
Secondary endpoints: 6-month primary patency rate, RESULTS: 25 (15.5%) patients died during the follow-up period. 125 patients reached the 1-year examinations.
The 1-year primary patency rate in the sirolimus-eluting stent group (80.6%) and in the bare-metal stent group (55.6%, P = 0.004), and the 1year secondary patency rates were 91.9% and 71.4% (P = 0.005), respectively. The median (interquartile range) change in RutherfordBecker classification after 1 year was -2 (-3 to -1) in the sirolimus-eluting stent group and -1 (-2 to 0) in the bare-metal stent group, respectively (P = 0.004) Conclusion
Mid-term patency rates of focal infrapopliteal lesions are substantially improved
with sirolimus-eluting stent compared with baremetal stent. Corresponding to the technical results, the changes in RutherfordBecker classification reveal a significant advantage for the sirolimus-eluting stent.
Objective of study: To determine the clinical outcome and the success of stent application for highgrade lesions of the infrapopliteal arteries compared with treatment with PTA in critical limb ischemia (CLI). Study Design: randomized prospective N= 131 lesion 88 patients with CLI Primary Outcome Clinical improvement after endovascular treatment and limb salvage rate. Secondary Outcome:
Secondary end points were defined by the minimal lumen diameter (MLD) before and after the revascularization procedure, percentage of residual diameter stenosis (DS), binary restenosis rate , and RESULTS 3 months, Clinical status in the PTA group was less improved than that in the stent group ( P = .008). At 9 months 5 minor and 2 major amputations in the PTA group and 5
major and 5 minor amputations in the stent group. In Stented Group : MLD was significantly larger and the percentage of DS was significantly less at completion angiography. At 9 months, the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected (MLD, 1.19 mm 0.92 vs 1.02 mm 1.02; DS, Conclusion
Infrapopliteal stent application is an effective treatment modality in CLI. The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months.
Methods: A retrospective analysis of all tibial interventions done for CLI between 2006 and 2009 was performed. Outcomes of isolated tibial (group I) and multilevel interventions (group II) (femoropopliteal and tibial) were compared. N=136 Limbs 123 patients (54 isolated tibial (85% tissue loss) and 82 multilevel (80% tissue loss)
Mean overall follow-up : 12.6 5.3 months The mean ABI was significantly lower prior to intervention in group II (0.53 vs
0.74; P < .001) but was similar post intervention (0.86 vs 0.88; P NS). Wound healing or improvement was achieved in 69% in group I and in 87% in group II (P .05).
Time to healing was significantly longer in group I: 11.5 8.8 months vs 7.7 6.6 months (P .03). Limb salvage : 81% in group I and 95% in group II (P .05). Rate of Reintervention was similar (13% vs 18%, P NS),
Rate of late surgical conversion (0% vs 6%; P NS) Overall mortality rates similar among both groups. Multivariate analysis An isolated tibial intervention was a predictor of limb loss at 1 year. Conclusion
Improved patency is seen with multilevel compared to isolated tibial interventions. Patients with isolated tibial disease appear to have a higher incidence of limb loss secondary to poor initial pedal runoff, more extensive distal disease, and severe
bypass. comorbidities precluding surgical
Methods OBJECTIVE: To evaluate the durability of nitinol stent placement in high-risk patients with CLI and infrapopliteal lesions after suboptimal balloon angioplasty.
Time period: January 2006 and January 2009 N= 53 high-risk patients (30 stenoses and 23 occlusions) (24 women; mean age, 71.8 5.1 years) with CLI underwent infragenicular stent placement with selfexpanding nitinol stent.
The mean stenosis length was 5.5 1.9 cm. The mean occlusion length was 6.5 2.9 cm. The mean follow-up was 24.1 7.3 months and consisted of clinical examination, ABI , and duplex ultrasound imaging. Digital subtraction angiography was performed if restenosis or reocclusion was suspected.
Results: The technical success rate= 98.1%. The 24-month cumulative primary patency rate was 75.5%. The 24-month secondary patency and freedom from amputation rates were 88.7% and 88.7%, respectively. The mean ABI increased significantly at 12 and 24 months (P < .001). No procedure-related deaths were recorded. Risk stratification to detect predictors that influenced the patency rate
Proximal lesions had significant better patency than distal crural lesions (83.3% vs 65.2%, P .04). The morphology of the lesions (stenoses vs occlusions, P .88) did not seem to influence primary patency. Conclusion Conclusions:The 2-year outcome of our series underscores the the value of infrapopliteal nitinol
stent placement as a durable bailout treatment option in high-risk CLI patients with suboptimal angioplasty. NOT ABLE TO DOWNLOAD THE ARTICLE Objective : 6-month and 1-year outcomes of PTA alone, PTA with stenting, and Excimer Laser recanalization for BTK lesions in patients
with CLI Study period: Between September 2002 and June 2005 N= 443 patients (681 BTK lesions)(355 Rutherford category 4, 82 category 5, 6 category 6) Procedure: (PTA = 79, PTA + Stenting =300 patients, Excimer Laser= 64)
Follow up :6 monthly Primary outcome : Limb salvage & Patency of treated areas (DUS) Primary patency and Limb salvage rates of the all treated patients were 85.2% & 97.0% and 74.2% and 96.6% at 6 months and 1 year, respectively. Stratified for the treatment strategy (PTA,PTA +
stenting and Excimer laser) 1-year primary patency rates were 68.6%, 75.5%, and 75.4%, whereas the limb salvage rates were 96.7%, 98.6%, and 87.9% for each modality, respectively. Objective : Safety and efficacy of Primary below-knee stent-supported angioplasty (BKSSA) for restoring straight inline arterial flow in patients with CLI or Lifestyle-limiting claudication (LLC).
N=82 patients (92 limbs) with either CLI (68%) or severe LLC (32%). STUDY PERIOD : 2000- 2003 Clinical end points: Clinical major adverse events (MAEs), Clinical success, RESULTS Mean age 74 17 years.
In 86 limbs, straight inline flow was restored to at least one tibial vessel. Technical success was 94% for de novo lesions and there were no MAEs. ABI increased for all groups (CLI : 0.32 0.13 to 0.9 0.14 and LLC 0.65 0.09 to 0.95 0.12; p <0.0001, pre vs. post). Relief of rest pain and healing of ulcerations and amputations were seen in
96% (47 of 49) of patients with CLI who underwent successful intervention. CONCLUSION Below-knee stent-supported angioplasty for CLI and LLC improves ABI , heals amputations and Ulcerations, Relieves Rest pain, and improves ambulation.
NOT ABLE TO DOWN LOAD ARTICLE Objective: Efficacy of Xpert nitinol stents for the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). STUDY PERIOD: Between May 2005 and November 2007 N= 94 CLI patients (70 male, mean age 73.5 years) received 134 Xpert stents in 102 limbs CLINICAL STATUS: 71.2% in Rutherford Category 4,27.9% in Category 5 and
0.9% in Category 6 Primary endpoint: 2-year duplex derived primary patency. Secondary endpoints : 2-year limb salvage rate and the absence of reintervention after the index procedure. Results 2-year primary patency and limb salvage rates of 54.4% and 90.8%, respectively
Lesion location did not reveal any significant differences in 2-year primary patency rates in proximal and distal below the knee lesions Conclusion Treatment with Nitinol Xpert stents can be considered effective for treating CLI patients, with satisfying patency outcome.
GUIDELINES ENDOVASCULAR INTERVENSION IN CLAUDICATION: RECOMMENDATION THROMBOLYSIS RECOMMENDATIONS
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