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Patient-level characteristics affect outcomes of BMS in femoropopliteal disease
Clinical outcomes of bare-metal stents placed in femoropopliteal arteries in patients with symptomatic peripheral artery disease are significantly affected by patient-level characteristics, according to findings published in Catheterization and Cardiovascular Interventions.
“The optimal management of PAD manifest by intermittent claudication remains unclear, largely because of the lack of comparative trials of various endovascular technologies,” Krishna J. Rocha-Singh, MD, of Prairie Heart Institute at St. John’s Hospital in Springfield, Illinois, and colleagues wrote in the study. “To our knowledge, in the prediction of femoropopliteal stent outcomes of claudicants, this is the first report that finds a significant interaction between objective physiologic measures of the disease state severity and specific lesion severity.”
Researchers abstracted and analyzed patient-level data from six large prospective trials sponsored by medical device manufacturers to identify a cohort of 999 patients with claudication and femoropopliteal artery occlusive disease.
The primary outcomes were 12-month patency as assessed by duplex ultrasonography and target lesion revascularization rates.
Rocha-Singh and colleagues performed meta-regression via mixed-effects logistic regression models with patient-level covariates to characterize the effects of patient characteristics on the outcomes.
The cohort had a mean ankle-brachial index of 0.68±0.18, a mean lesion length of 84±53 mm and mean lesion stenosis was 78%. Approximately two-thirds of patients had mild to severe calcification.
Mean Rutherford clinical category was 2.7±0.6 and was between 2.6 and 2.8 in all studies.
At 12 months, mean patency across all studies was 69.8% and TLR rates were between 9.2% and 19.7%.
Baseline ankle-brachial index and baseline target lesion length predicted both primary patency and TLR, according to multivariable analysis. When used in combination, these two variables interacted significantly to better predict TLR outcomes, Rocha-Singh and colleagues wrote, noting TLR was 9% in those with short lesions and a high ankle-brachial index but 24% in those with long lesions and a low ankle-brachial index.
“As statistical methodology evolves for valid indirect comparisons with quantitatively defined assumption satisfaction and readout of appropriate confidence level in the results, models such as Rocha-Singh’s will supplement and partially supplant [randomized controlled trials],” Arka Chatterjee, MD, from the cardiovascular division at the University of Alabama at Birmingham, and William B. Hillegass, MD, MPH, from the department of biostatistics at the University of Alabama at Birmingham, wrote in an accompanying editorial. “Undoubtedly, this paradigm will be best (and absolutely necessary with increasing health sector resource constraints) to expedite evidence-based progress in personalized treatment of claudicants and critical limb ischemia patients with infrainguinal disease.” – by Dave Quaile
Disclosures: Rocha-Singh reports consulting for Alucent, Amgen, BioMet, ROX Medical and TVA Medical, and is a compensated board member of VIVA Physician. Please see the study for all other authors’ relevant financial disclosures. Chatterjee and Hillegass report no relevant financial disclosures.