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A novel bare-metal stent for blocked leg arteries appears safe and can ease pain, a registry study showed.

Among patients treated with the Xpert infrapopliteal stent, 78% were alive without any amputation at 12 months, Krishna J. Rocha-Singh, MD, of Prairie Education and Research Cooperative in Springfield, Ill., and colleagues found.

Pain relief was significant in the less severe Rutherford class 4 critical limb ischemia patients over 12 months (P<0.05), with significant relief also for more severe class 5 patients through 6 months and a trend thereafter (P<0.001 and P=0.051, respectively).

The "results compare favorably with previous studies using bare metal stents for treating critical limb ischemia," despite 14% of patients being in the severe Rutherford class 6, a group which is often excluded or under-represented in trials, the researchers wrote online in Catheterization and Cardiovascular Interventions.

The limb salvage rate was 90% overall (100% in class 4, 91% in class 5, and 70% in class 6) compared with 92% to 100% at 1-year follow-up with other bare-metal stents.

Percutaneous angioplasty of the diseased vessels has been the standard of care for critical limb ischemia, but primary patency rates are only around 47% to 58% at one year.

To tackle restenosis in an attempt to improve clinical results, Rocha-Singh's group studied the novel stent in the multicenter Xpert Nitinol Stenting For Critically IschEmic Lower Limbs (XCELL) trial.

The registry included 120 patients who received a total of 212 self-expanding Xpert nitinol stents; some patients were treated in both legs.

The cohort included infrapopliteal lesions of 4 to 15 cm in length causing critical limb ischemia, classified as Rutherford class 4 to 6.

Early outcomes reflected the challenging patient population, with one death at day 32 after stent placement due to exacerbation of pre-existing congestive heart failure, and two below-the-knee amputations by 1 month follow-up.

One target lesion revascularization occurred over the same period following periprocedural acute vessel closure, which resolved with thrombectomy and use of another of the same stents.

At 6 months, the stent restenosis rate was up to 69%. Still, the primary endpoint of 12-month amputation-free survival showed good results, with rates of 100% in patients initially at a Rutherford class 4, 77% for those at Rutherford class 5 at baseline, and 55% in the Rutherford class 6 patients.

Nine patients had an amputation over the mid-term, evenly divided across the period from 1 to 12 months after stent placement. All but one were below the knee. Reasons were worsening leg pain, intractable wound infection, or gangrene.

The 12-month rate of freedom from clinically driven target-lesion revascularization was 70%.

For the 97 patients with wounds at baseline, 49% had healed completely by month 6 and 54% by month 12, a rate comparable to that of open surgery for critical limb ischemia, Rocha-Singh's group pointed out.

However, "we were unable to draw any direct conclusions regarding the patency of the wound-related artery and subsequent wound healing rates or limb salvage, as we did not evaluate the patency of pedal vessels or the status of collateral vessels at the ankle," they noted.

Other limitations were the single-arm, nonrandomized design as well as the relatively limited follow-up period.

From the American Heart Association:

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