Abstract

Introduction: Drug-eluting Stent(DESs) have demonstrated improved patency and freedom from target lesion revascularization compared with Bare-Metal stents or Percutaneous Transluminal Angioplasty(PTA); however, the effect on clinical outcome parameters, such as limb salvage and wound healing, remains unidentified. We present a direct comparison of clinical outcomes in patients who underwent DES vs PTA. Methods: We collected data of patients who underwent infra-popliteal arterial interventions at our institution. Clinical end points analyzed were all cause mortality, target vessel revascularization, primary vessel patency, and target limb major and minor amputations. Differences between two groups were analyzed by chi square for categorical variables and t test for continuous variables. Statistical significance was considered for P values less than .05 in a 2-sided test. Results: Total of 83 cases, n=42 in DES group and n=41 in PTA group were analyzed. Mean age was 71.6 years (range 49-95). Out of the total 83 patients in the study 45 had a history of diabetes (54%) and 51 (61%) were current /past smokers. Average follow up period of 14 months for both the groups. Primary vessel patency was defined as absence of ≥50% restenosis on follow up. During the follow up period vessel patency in DES group [69% (n=29/42)] was significantly higher as compared to 36% (15/41) in PTA group (P=0.04, odds ratio 3.867, 95% Confidence interval: 1.5 - 9.6). Target vessel revascularization in DES group was 24% (10/42) as compared to 32% (13/28) in PTA group (P=0.47, odds ratio 0.67, 95% confidence interval: 0.26 - 1.77). Target limb amputation was 10% (4/42) in DES group as compared to 24% (10/41) in PTA group (P = 0.085), odds ratio 0.33, 95% confidence interval: 0.09 - 1.14). All cause mortality in both the groups were at 10%, 4/42 in DES group and 4/41 in PTA group (P=1, odds ratio 0.97, 95% confidence interval: 0.23 - 4.19). Conclusion: To conclude primary vessel patency was superior in DES group as compared to PTA group. Target limb amputation rates were higher in PTA group but not statistically significant. Target vessel revascularization and all cause mortality were similar in both the groups. Thus primary treatment with DES should be considered in patients with infra-popliteal PAD.

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