CLI remains an under-recognized condition associated with high rates of major amputation and disparities in care. Optimal medical therapy can reduce the risk of major adverse cardiovascular and limb events, but revascularization combined with close wound care remains the cornerstone of amputation prevention. Endovascular revascularization has become more common over time and has been associated with a reduction in amputation rates. Ongoing clinical trials will help inform best practices for revascularization strategies and techniques. Vascular care is inconsistent across the USA, with significant variation in access to care revascularization rates and rates of major amputation. Major amputation can be prevented in patients with CLI when optimal medical therapy, lifestyle modification, and revascularization are provided in a multidisciplinary setting.
Purpose: Balloon angioplasty for the treatment of femoropopliteal lesions is often complicated by postangioplasty dissections. While dissections are known to affect patency and reintervention after balloon angioplasty, the association between dissections and major adverse limb event (MALE) after drug-coated balloon (DCB) angioplasty remains uncertain. Thus, the postangioplasty dissection and bailout stenting patterns were investigated. Materials and Methods: This was a single-center retrospective study enrolling patients with de novo femoropopliteal lesions treated with DCB with/without stenting. Postangioplasty target vessel dissection was graded based to the coronary artery classification grades A-F, with grade C-F considered “severe.” Cox regression analysis was performed to examine the association of dissection severity with outcomes during 2-year follow up, among nonstented cases. Results: In 85.3% of the cases (N=203/238) a postangioplasty dissection was observed. The average dissection length was 55.57 mm (SD 36.71 mm), with 1 dissection present in 91.8% (N=180/196) and 2 or more dissections present in 8.2% (N=16/196). Dissection severity was grade A (19.8%), B (20.6%), C (23.1%), D (10.9%), E (10.1%), and F (0.8%). Bailout stenting was required in 40.4% of the patients, being more prevalent among grade C and grade E cases. Among 142 nonstented cases, dissections were present in 85.2%. A total of 75 (52.8%) of these dissections were grade A and B, while 46 (32.4%) were grade C to F. Among nonstented cases, grade C (hazard ratio [HR] 5.83; 95% CI 1.25 to 27.31; p=0.025) and grade D (HR 6.32; 95% CI 1.39 to 28.86; p=0.017) vs grade A dissections were associated with a higher risk for 2-year MALE. Multivariate analysis adjusting for several lesion characteristics demonstrated a statistically significant higher risk for 2-year MALE among the severe dissection group (HR 2.94; 95% CI 1.27 to 6.79; p = 0.012). Interestingly, the risks of limb loss (HR 1.30; 95% CI 0.22 to 7.79; p=0.774) and repeat revascularization (HR 0.95; 95% CI 0.40 to 2.26; p=0.905) during follow-up were similar between the 2 groups. Conclusion: This study indicated that nonstented moderate and severe postangioplasty dissections after DCB angioplasty were associated with higher risk for MALE. Future studies are needed to validate our results and determine other dissection characteristics (eg, total dissection length, lumen area, total number of dissections) that may affect the efficacy of DCB.
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