STROLL at 3 Years: Nitinol Stent Demonstrates Sustained Patency, QoL in SFA Patients

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Patients with superficial femoral/popliteal lesions experience significant and sustained improvements out to 3 years with a self-expanding nitinol stent. Updated data from the STROLL trial, presented January 21, 2014, at the 26th Annual International Symposium on Endovascular Therapy (ISET) in Miami Beach, FL, show minimal recurrence of lower-extremity stenosis or occlusion, with a low rate of stent fracture.

For the multicenter, prospective STROLL trial, Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA) and colleagues looked at 250 patients with stenotic, restenotic or occluded lesions of the native superficial femoral artery (SFA) or proximal popliteal artery who were treated with the Smart self-expanding nitinol stent (Cordis, Miami Lakes, FL) between August 2008 and March 2010 at 39 US centers. Patients had Rutherford class 2-4 symptoms and were treated with standard percutaneous transluminal angioplasty with placement of 1 or more stents.

Clinical Improvements Maintained at 3 Years

Thirty-day freedom from the composite of all-cause death, index limb amputation, and clinically driven TLR (the primary safety endpoint) was 100%. At 3 years, the rate of major adverse events was 31.5%, mortality was 9.9%, and index limb amputation was 0.9%.

The rates of primary patency (defined as the composite of Doppler ultrasound patency and freedom from clinically driven TLR) as well as the individual components remained consistent throughout the 3-year period (table 1).

Table 1. Patency Outcomes

 

1 Year

2 Years

3 Years

Primary Patency

81.7%

74.9%

72.7%

Ultrasound Patency

81.1%

83.5%

83.9%

Freedom from Clinically Driven TLR


87.4%


 79.0%


75.8%


When stenotic and occlusive lesions were compared, the 3-year results were similar for ultrasound patency (85.7% vs. 77.4%; P = 0.276) and absence of clinically driven TLR (77.1% vs. 73.1%; P = 0.575)

Under the study protocol, X-ray of stents was performed at 30 days, 6 months, 1 year, 2 years, and 3 years. The rate of stent fracture at 3 years was 3.6%. All were type I single strut fractures.

Sustained Physical, QoL Improvements

Mean ankle-brachial index improved from 0.66 ± 0.15 at baseline to 0.92 ± 0.20 at 36 months, with no significant difference between year 1 and year 3. There was a significant change in Rutherford score from baseline, with 77.8% of patients maintaining Rutherford class 0/1 at 3 years. Health status and quality of life (QoL) were evaluated using validated patient assessment scales, including the SF-12 and EQ-5D, the Peripheral Artery Questionnaire (PAQ), and Walking Impairment Questionnaire (WIQ).

At 3 years, sustained improvement over baseline was seen on the PAQ summary scale (mean change 28.0 points) and the PAQ QoL (mean change 33.6 points). Patients also showed durable improvements in walking distance and speed in addition to sustained symptom improvement (all P < 0.001).

In an email communication with TCTMD, Dr. Jaff noted that the “durability of patency and physical functioning with this device is impressive without an increase in fracture.”

Study Details

Patients’ mean age was 68 ± 10 years. The average lesion length was 77 ± 31 mm. The incidence of diabetes was 47.2%, while total occlusions were found in 23.6%, and severe calcification in 19.3%.


Source:
Jaff MR. SMART nitinol self-expanding stent in the treatment of obstructive superficial femoral artery disease: Three-year clinical outcomes from the STROLL trial. Presented at: International Symposium on Endovascular Therapy; January 21, 2014; Miami Beach, FL.

 

 

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Disclosures
  • Dr. Jaff reports serving as a noncompensated adviser for Cordis Corporation, and as a board member of VIVA Physicians.

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