Sirolimus-Eluting Stents vs BMS in Infrapopliteal Artery Lesions
Sirolimus-Eluting Stents vs BMS in Infrapopliteal Artery Lesions
Aims Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery.
Methods and results 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford–Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford–Becker classification after 1 year was −2 (−3 to −1) in the sirolimus-eluting stent group and −1 (−2 to 0) in the bare-metal stent group, respectively (P= 0.004).
Conclusion Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford–Becker classification reveal a significant advantage for the sirolimus-eluting stent.
Peripheral artery disease with intermittent claudication (IC) or critical limb ischaemia (CLI) represents a major challenge for all healthcare specialists involved in the treatment of atherosclerotic disease. Greater life expectancy and the increasing prevalence of diabetes mellitus in the developed countries lead to a progressively rising number of patients with CLI and IC due to infrapopliteal artery (IPA) disease. Moreover, there is increasing evidence that patency rates after femoro-popliteal artery interventions are positively affected by the number of patent IPA in patients with IC.
Today the endovascular approach has become the first-line strategy for the treatment of IPA lesions. Although advances have been made in innovative technologies such as lesion modification and atheroablation, balloon angioplasty (PTA) continues to be the mainstay of endovascular therapy for the treatment of infrapopliteal disease. Stent placement is currently reserved for suboptimal results after PTA such as significant recoil, flow-limiting dissection, or residual stenosis. However, PTA and bare-metal stents (BMS) have failed to demonstrate durability, restenosis following BMS placement continue to exceed 50% after 1 year. The use of sirolimus-eluting stents (SES) with their proven efficacy in the treatment of coronary artery disease could be of major advance in the treatment of patients with infrapopliteal lesions. The rationale of this double-blinded randomized study was to prove the concept of using SES to improve primary patency rates after interventional therapy of focal lesions of IPA.
Abstract and Introduction
Abstract
Aims Preliminary reports indicate that sirolimus-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. We conducted a prospective, randomized, multi-centre, double-blind trial comparing a polymer-free sirolimus-eluting stent with a placebo-coated bare-metal stent in patients with either intermittent claudication or critical limb ischaemia who had a de-novo lesion in an infrapopliteal artery.
Methods and results 161 patients were included in this trial. The mean target lesion length was 31 ± 9 mm. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent-restenosis (luminal narrowing of ≥50%) detected with duplex ultrasound if not appropriate with angiography. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, and changes in Rutherford–Becker classification after 1 year. Twenty-five (15.5%) patients died during the follow-up period. One hundred and twenty-five patients reached the 1-year examinations. The 1-year primary patency rate was significantly higher in the sirolimus-eluting stent group (80.6%) than in the bare-metal stent group (55.6%, P= 0.004), and the 1-year secondary patency rates were 91.9 and 71.4% (P= 0.005), respectively. The median (interquartile range) change in Rutherford–Becker classification after 1 year was −2 (−3 to −1) in the sirolimus-eluting stent group and −1 (−2 to 0) in the bare-metal stent group, respectively (P= 0.004).
Conclusion Mid-term patency rates of focal infrapopliteal lesions are substantially improved with sirolimus-eluting stent compared with bare-metal stent. Corresponding to the technical results, the changes in Rutherford–Becker classification reveal a significant advantage for the sirolimus-eluting stent.
Introduction
Peripheral artery disease with intermittent claudication (IC) or critical limb ischaemia (CLI) represents a major challenge for all healthcare specialists involved in the treatment of atherosclerotic disease. Greater life expectancy and the increasing prevalence of diabetes mellitus in the developed countries lead to a progressively rising number of patients with CLI and IC due to infrapopliteal artery (IPA) disease. Moreover, there is increasing evidence that patency rates after femoro-popliteal artery interventions are positively affected by the number of patent IPA in patients with IC.
Today the endovascular approach has become the first-line strategy for the treatment of IPA lesions. Although advances have been made in innovative technologies such as lesion modification and atheroablation, balloon angioplasty (PTA) continues to be the mainstay of endovascular therapy for the treatment of infrapopliteal disease. Stent placement is currently reserved for suboptimal results after PTA such as significant recoil, flow-limiting dissection, or residual stenosis. However, PTA and bare-metal stents (BMS) have failed to demonstrate durability, restenosis following BMS placement continue to exceed 50% after 1 year. The use of sirolimus-eluting stents (SES) with their proven efficacy in the treatment of coronary artery disease could be of major advance in the treatment of patients with infrapopliteal lesions. The rationale of this double-blinded randomized study was to prove the concept of using SES to improve primary patency rates after interventional therapy of focal lesions of IPA.
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