1 Percutaneous Below-The-Knee Stent Implantation Among 468 Patients With Critical Limb Ischemia: Pooled Analysis And Comparison Of Drug-Eluting Versus.

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1 Percutaneous Below-The-Knee Stent Implantation Among 468 Patients With Critical Limb Ischemia: Pooled Analysis And Comparison Of Drug-Eluting Versus Bare-Metal Stents G. Biondi-Zoccai 1, G. Sangiorgi 2, M. Fusaro 3, C. Moretti 1, F. Sciuto 1, P. Omede 1, M. Lotrionte 4, P. Agostoni 5, A. Abbate 6, I. Sheiban 1 1 University of Turin, Turin, Italy 2 Emo Centro Cuore Columbus, Milano,Italy; 3 San Pellegrino Hospital, Castiglione delle Stiviere, Italy; 4 Catholic University, Rome, Italy; 5 AZ Middelheim, Antwerp, Belgium; 6 Virginia Commonwealth University, Virginia, USA ;

2 BACKGROUND Percutaneous transluminal angioplasty (PTA) of below-the-knee (BTK) arterial occlusive disease has been recently proved equivalent to bypass surgery in the management of patients with chronic critical limb ischemia (CLI). However, results of balloon-only PTA are suboptimal in many patients, with a rate of flow- limiting dissections, acute recoil or early restenosis reaching up to 40-50%.

3 BACKGROUND AND AIM BTK stenting on top of PTA has been proposed as a potential improvement of percutaneous revascularization results, yet data are still inconclusive. We thus aimed to perform a systematic and quantitative review of clinical results of BTK stenting in patients with CLI.

4 OBJECTIVES To perform a systematic review of the outcomes of BTK stenting in patients with CLI. To pool major outcomes with meta- analytic techniques and compare indirectly different devices.

5 METHODS PubMed and other databases were systematically searched for pertinent clinical studies published up to December Studies reporting on at least 5 patients treated with BTK stenting for CLI and at least 1-month follow-up were included. acts).

6 METHODS Data were abstracted and pooled to generate risk estimates (with 95% confidence intervals) by means of random- effect methods with generic inverse- variance weighting, with RevMan 4.2 (Cochrane Collaboration). Interaction tests were computed to compare different stent types, exploiting chi-squared tests for heterogeneity between subgroups.

7 METHODS We focused on the following end-points: –binary angiographic restenosis (BAR), defined as in-stent diameter stenosis exceeding 50%, –primary patency, defined as patency of the treated segment or vessel irrespective of residual stenosis, –limb salvage, defined as freedom from above-the-ankle (ie major) amputation.

8 REVIEW PROFILE

9 INCLUDED STUDIES StudyPts with stentsDesign Test deviceControl device Bosier et al (2005)20Registry Balloon-expandable bioabsorbable stent- Bosiers et al (2006)18Registry Sirolimus-eluting stent- Bosiers et al (2007)47Registry Self-expandable BMS- Commeau et al (2006)30Registry Sirolimus-eluting stent- Feiring et al (2004)82Registry Balloon-expandable BMS- Feiring et al (2007)5Case series Sirolimus-eluting stent- Kickuth et al (2007)35Registry Self-expandable BMS- Morgan et al (2005)6Case series Balloon-expandable BMS- Rand et al (2006) 24RCT Balloon-expandable BMSPTA Scheinert et al (2006)60Non-RCT Sirolimus-eluting stentBalloon-expandable BMS Siablis et al (2005)29Non-RCT Sirolimus-eluting stent Siablis et al (2007)29RegistryPaclitaxel-eluting stent- Tepe et al (2007)18RegistrySelf-expandable BMS-

10 RESULTS We retrieved 18 non-randomized studies including 468 patients: 197 treated with balloon-expandable bare-metal stents (BMS), 100 with self-expandable BMS, 151 with drug- eluting stents (DES), and 20 with absorbable metal stents. After a median of 11 months, risk of BAR in the whole cohort was 28.0% (95% confidence interval %), primary patency was obtained in 73.1% ( %) and limb salvage was achieved in 95.7% ( %).

11 RESULTS Stratified analysis according to stent type showed that DES were significantly superior to balloon-expandable BMS in preventing BAR (6.3% [0-15.5%] vs 43.3% [ %], p<0.0001) and increasing primary patency (89.6% [ %] vs 59.6% [ %], p<0.001). Yet they yielded similar rates of limb salvage (95.9% [ %] vs 95.2% [ %], p=0.58).

12 RESULTS DES also appeared associated with a lower risk of BAR in comparison to self-expandable BMS (6.3% [0-15.5%] vs 20.4% [ %], p=0.048). Conversely, DES yielded, in comparison to self-expandable BMS, similar rates of primary patency (89.6% [ %] vs 79.0% [ %]) and limb salvage (95.9% [ %] vs 96.8% [ %], both p>0.05).

13 RISK OF BINARY RESTENOSIS Study risk estimate (%) (random) or sub-category risk estimate (%) (SE) 95% CI 01 Balloon-expandable bare-metal stent Siablis (2005) (9.2000) Rand (2006) (8.2000) Scheinert (2006) (8.4000) Cioppa (2007) ( ) Subtotal (95% CI) Test for heterogeneity: Chi² = 22.38, df = 3 (P < ), I² = 86.6% Test for overall effect: Z = 3.88 (P = ) 02 Self-expandable bare-metal stent Bosiers (2007) (5.9000) Subtotal (95% CI) Test for heterogeneity: not applicable Test for overall effect: Z = 3.46 (P = ) 03 Absorbable metal stent Subtotal (95% CI) Test for heterogeneity: not applicable Test for overall effect: not applicable 04 Drug-eluting stent Siablis (2005) (4.3000) Scheinert (2006) (5.6000) Siablis (2007) (7.2000) Subtotal (95% CI) Test for heterogeneity: Chi² = 4.25, df = 2 (P = 0.12), I² = 52.9% Test for overall effect: Z = 1.34 (P = 0.18) Total (95% CI) Test for heterogeneity: Chi² = 96.34, df = 7 (P < 0.001), I² = 92.7% Test for overall effect: Z = 3.20 (P = 0.001)

14 RATE OF PRIMARY PATENCY Study risk estimate (%) (random) or sub-category risk estimate (%) (SE) 95% CI 01 Balloon-expandable bare-metal stent Morgan (2005) ( ) Siablis (2005) ( ) Rand (2006) (7.5000) Scheinert (2006) (6.1000) Cioppa (2007) ( ) Subtotal (95% CI) Test for heterogeneity: Chi² = 59.42, df = 4 (P < ), I² = 93.3% Test for overall effect: Z = 3.07 (P = 0.002) 02 Self-expandable bare-metal stent Bosiers (2007) (6.2000) Kickuth (2007) (6.5000) Tepe (2007) (9.6000) Subtotal (95% CI) Test for heterogeneity: Chi² = 0.40, df = 2 (P = 0.82), I² = 0% Test for overall effect: Z = (P < ) 03 Absorbable metal stent Bosiers (2005) (9.9000) Subtotal (95% CI) Test for heterogeneity: not applicable Test for overall effect: Z = 7.40 (P < ) 04 Drug-eluting stent Siablis (2005) (6.4000) Siablis (2007) (5.6000) Grant (2008) ( ) Subtotal (95% CI) Test for heterogeneity: Chi² = 0.95, df = 2 (P = 0.62), I² = 0% Test for overall effect: Z = (P < ) Total (95% CI) Test for overall effect: Z = 8.80 (P < ) Test for heterogeneity: Chi² = , df = 11 (P < 0.001), I² = 91.5%

15 RATE OF LIMB SALVAGE Study risk estimate (%) (random) or sub-category risk estimate (%) (SE) 95% CI 01 Balloon-expandable bare-metal stent Feiring (2004) (2.2000) Morgan (2005) ( ) Siablis (2005) (7.7000) Rand (2006) (5.5000) Scheinert (2006) (5.5000) Cioppa (2007) ( ) Subtotal (95% CI) Test for heterogeneity: Chi² = 4.25, df = 5 (P = 0.51), I² = 0% Test for overall effect: Z = (P < ) 02 Self-expandable bare-metal stent Bosiers (2007) (2.9000) Kickuth (2007) (5.5000) Subtotal (95% CI) Test for heterogeneity: Chi² = 0.43, df = 1 (P = 0.51), I² = 0% Test for overall effect: Z = (P < ) 03 Absorbable metal stent Bosiers (2005) (5.0000) Subtotal (95% CI) Test for heterogeneity: not applicable Test for overall effect: Z = (P < ) 04 Drug-eluting stent Siablis (2005) (3.6000) Commeau (2006) (5.6000) Scheinert (2006) (5.6000) Bosiers (2007) (5.6000) Feiring (2007) ( ) Siablis (2007) (5.9000) Subtotal (95% CI) Test for heterogeneity: Chi² = 2.78, df = 5 (P = 0.73), I² = 0% Test for overall effect: Z = (P < ) Total (95% CI) Test for heterogeneity: Chi² = 7.85, df = 14 (P = 0.90), I² = 0% Test for overall effect: Z = (P < )

16 CONCLUSIONS This updated and comprehensive quantitative analysis shows that percutaneous BTK stenting is associated with favorable clinical results in patients with CLI. Notwithstanding the limitations of primary studies, DES appear superior to both balloon- expandable and self-expandable BMS in reducing the risk of restenosis and/or improving patency rates.