Stenting reduced mortality risk in patients undergoing interventions for peripheral arterial disease (PAD) by more than 30% when compared to plain balloon angioplasty, and 40% contrasted with atherectomy, a recent propensity-matched analysis found.
The Vascular Quality Initiative (VQI)-derived data drew sharp conclusions from lead investigator of the study, Dipankar Mukherjee, MD, who trailed his probe into the effects of PAD interventions on survival to most recent follow-up by highlighting that most of these procedures involve claudication patients.
“Expensive interventions do not necessarily correlate with good results,” Mukherjee told attendees of the International Symposium on Endovascular Therapy (ISET) held in Miami (May 9–11), where he presented his findings. “What has been good for the bottom line of the OBL [office-based lab] may be fatal for the patient. We recommend a critical reappraisal of the treatment paradigm for PAD patients presenting with claudication. We believe the current CMS [Centers for Medicare & Medicaid Services] reimbursement for atherectomy has resulted in unintended consequences.”
Mukherjee, chief of vascular surgery at Inova Fairfax Hospital in Falls Church, Virginia, earlier set out the current context of PAD interventional practice: While PAD interventions double every decade, the more severe form of the disease, critical limb ischemia (CLI), occurs in only a small percentage. More than a decade ago, there were CMS payment system changes governing the outpatient setting. That led to the rise of the OBL. Most PAD interventions are now carried out in OBLs. Atherectomy, most frequently performed in OBLs, is the most highly compensated PAD intervention at between $15,000 and $18,000. “This massive increase in OBL volume has not resulted in cost savings as it was originally intended,” Mukherjee added.
To arrive at their conclusions, Mukherjee and colleagues plumbed the VQI database for claudication and CLI interventions between May 2011 and February 2020, linking the data extracted with survival statistics from the Social Security death index—the primary outcome measure being survival to most recent follow-up. PAD interventions were classified as either balloon angioplasty alone, stenting with and without a balloon, and atherectomy with or without stenting or a balloon.
The researchers compared three matched cohorts: those receiving balloon angioplasty versus those who underwent stenting; patients who received balloon angioplasty versus patients undergoing atherectomy; and those who had a stent placed versus the atherectomy patients.
A total of 15,281 patients were included in the study: 9,441 received balloon angioplasty, 3,547 got a stent and 2,293 had atherectomy. After propensity matching, a group of 3,047 remained to compare between balloon angioplasty and stenting; 2,016 for comparison of angioplasty and atherectomy; and 1,656 between stenting and atherectomy.
Patients were almost equally divided between claudicants and CLI. Most interventions were performed in the femoropopliteal-tibial segment, with the exception of a larger proportion of stenting having been carried out in the aortoiliac segment.
Results showed a “highly, highly significant” hazard ratio (HR) of 0.7 in favor of stenting vs. balloon angioplasty (95% confidence interval [CI], 0.6–0.82; p<0.001), Mukherjee revealed. The research team uncovered no difference between balloon angioplasty and atherectomy (HR, 1.02; CI 0.88–1.19; p=0.776 ), while stenting was found to be superior to atherectomy (HR, 0.6; CI, 0.48–0.75; p<0.001).
When claudication patients were separated from those with CLI, Mukherjee and colleagues discovered a survival benefit in favor of stenting over balloon angioplasty (HR, 0.49; CI 0.4–0.59; p<0.001). They detected no difference between angioplasty and atherectomy, but their data demonstrated a “highly significant” HR of 0.55 in favor of stenting vs. atherectomy (CI, 0.43–0.69; p<0.001).
“When we look at CLI alone, there was a trend toward significant—but with a confidence interval exceeding 1, these numbers are not considered statistically significant,” Mukherjee added.
Discussing his findings, Mukherjee told ISET delegates that investigators have reported “almost universal evidence” of distal embolization with peripheral atherectomy. “We know that intermittent claudication has a relatively benign course with a very small annual mortality risk. I have previously shown, using ICD-9 billing data, that the results of intervention with atherectomy for patients presenting with claudication symptoms were worse than the natural history of the condition.”
Mukherjee conceded there were limitations to his study, primarily owing to its observational nature, but nevertheless concluded that he and colleagues had demonstrated “stenting has 30% better survival than angioplasty and 40% better than atherectomy after propensity matching.”