Survival and Causes of Death Among Veterans With Lower Extremity Revascularization With Paclitaxel‐Coated Devices: Insights From the Veterans Health Administration

Abstract

BACKGROUND The long‐term safety of paclitaxel‐coated devices (PCDs; drug‐coated balloon or drug‐eluting stent) for peripheral endovascular intervention is uncertain. We used data from the Veterans Health Administration to evaluate the association between PCDs, long‐term mortality, and cause of death. METHODS AND RESULTS Using the Veterans Administration Corporate Data Warehouse in conjunction with International Classification of Diseases, Tenth Revision ( ICD‐10 ) Procedure Coding System, Current Procedural Terminology, and Healthcare Common Procedure Coding System codes, we identified patients with peripheral artery disease treated within the Veterans Administration for femoropopliteal artery revascularization between October 1, 2015, and June 30, 2019. An adjusted Cox regression, using stabilized inverse probability–weighted estimates, was used to evaluate the association between PCDs and long‐term survival. Cause of death data were obtained using the National Death Index. In total, 10 505 patients underwent femoropopliteal peripheral endovascular intervention; 2265 (21.6%) with a PCD and 8240 (78.4%) with a non‐PCD (percutaneous angioplasty balloon and/or bare metal stent). Survival rates at 2 years (77.4% versus 79.7%) and 3 years (70.7% versus 71.8%) were similar between PCD and non‐PCD groups, respectively. The adjusted hazard for all‐cause mortality for patients treated with a PCD versus non‐PCD was 1.06 (95% CI, 0.95–1.18, P =0.3013). Among patients who died between October 1, 2015, and December 31, 2017, the cause of death according to treatment group, PCD versus non‐PCD, was similar. CONCLUSIONS Among patients undergoing femoropopliteal peripheral endovascular intervention within the Veterans Administration Health Administration, there was no increased risk of long‐term, all‐cause mortality associated with PCD use. Cause‐specific mortality rates were similar between treatment groups.

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

“…The results demonstrated sustained safety and clinical benefit of the 150 mm long IN.PACT Admiral DCB for long lesions with low rates of reinterventions and low major amputations through 5 years. Previously, a meta-analysis reported an association between the use of paclitaxel-coated devices Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving participants c Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving participants d Immediate hemodynamic improvement is defined as an ABI improvement of C 0.1 or to an ABI C 0.9 e Sustained hemodynamic improvement is defined as persistent improvement of ABI values with C 0.1 as compared to baseline values or to an ABI C 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving participants f Device success was defined as successful delivery, inflation, deflation, and retrieval of the intact study balloon device without burst below the rated burst pressure g Procedural success defined as residual stenosis of B 50% (non-stented participants) or B 30% (stented participants) by visual estimate h Clinical success defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge i Percentages are cumulative incidence based on Kaplan-Meier estimate (number of patients with events) j CD-TVR is defined as any reintervention at the target vessel due to symptoms or drop of ABI C 20% or [ 0.15 when compared with post-index procedure baseline ABI k CD-TLR is defined as any reintervention within the target lesion due to symptoms or drop in ABI C 20% or [ 0.15 when compared to post-index procedure baseline ABI and late mortality [20], although patient-level meta-analyses and large real-world registries could not authenticate the findings [21][22][23][24][25][26][27][28][29][30][31]. Nonetheless, to address the concern of long-term safety in this cohort, safety outcomes were analyzed out to 5 years and results showed sustained safety throughout the 5 year follow-up.…”

Efficacy analysis following polymer coated drug eluting stent and bare metal stent deployment for femoropopliteal arterial disease

“…8,9 On the contrary, recent meta-analyses, studies of large-scale registries and single-center experiences could not confirm this finding. [10][11][12][13][20][21][22][23] Although RCTs are considered the most scientifically rigorous clinical study design, patients included in prospective trials are highly selected, carry a different atherosclerotic profile and have a decreased comorbidity compared to real-world pragmatic cohorts. 22,24 Unlike RCTs, registries and insurance claim data provide information on a more generalizable group of patients and physician practices.…”

Progress on developing an effective below-the-knee drug-coated balloon

“…The FDA issued a first warning letter to physicians in January 2019 and eventually convened an advisory panel in June 2019. Patient-level data analyses questioning this mortality signal along with its mechanism swiftly followed [79][80][81][82][83][84][85].…”