新世代の薬剤溶出ステントの有効性が示された

LEADERSスタディ：生分解性biolimusステントは'real world'のスタディで冠動脈形成術を施行される患者に対し安全で有効なようである
LEADERS: Biodegradable biolimus stent appears safe and effective in patients undergoing percutaneous coronary intervention in 'real world' study
この種のスタディでは初めてであるが、外側の表面のみに生分解性ポリマーを適用した薬剤溶出ステント（DES）は、日常臨床と同じ状況下において、最も広く用いられているDESと同様に安全で有効であることが示された、と2008年European Society of Cardiology学会で発表されLancetオンライン版に掲載された。LEADERS（Limus Eluted from A Durable versus ERodable Stent coating）スタディでは、1,707人の患者（2,472病変）を生分解性ポリマーを用いたbiolimus溶出ステントまたは耐久性ポリマーを用いたシロリムス溶出ステントを埋め込む群に無作為に割り付けた。9ヵ月後に、biolimus溶出ステント群とシロリムス溶出ステント群の患者のうち一次エンドポイントに到達したのは同じ割合であった（9.2%対10.5%；RR=0.88；95% 信頼区間0.64～1.19；非劣性p=0.003）。Biolimusおよびシロリムス溶出ステント群の死亡率（2.6%対2.8%；p=0.74）、心臓死（1.6%対2.5%；p=0.22）、心筋梗塞（5.7%対4.6%；p=0.30）、または臨床上適応とされた標的血管血行再建術（4.4%対5.5%；p=0.29［p値は優性に対する値］）は同等であった。Biolimus溶出ステントはまた、このスタディの主要な血管造影上のエンドポイントであるステント内内径狭窄率においても非劣性を示した（20.9%対23.3%；p=0.001）。
Full Text

In the first study of its kind, a drug-eluting stent (DES) with a biodegradable polymer applied only to the outer surface has been demonstrated as safe and effective as one of the most established and widely used types of DES with a durable polymer, in equivalent conditions to everyday clinical practice. Results were presented in a Hot Line session at the European Society of Cardiology Congress 2008 and published online in The Lancet.

The LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) study randomly assigned 1,707 patients with 2,472 lesions to treatment with either a biolimus-eluting stent with a biodegradable polymer or a sirolimus-eluting stent with a durable polymer. The study involved a broad range of patients for whom a stenting procedure was considered suitable, designed to reflect routine clinical practice.

Nine months after the procedure, a similar proportion of patients with biolimus-eluting stents and sirolimus-eluting stents reached the primary endpoint (9.2% vs 10.5%; RR=0.88; 95% CI 0.64 to 1.19; p=0.003 for noninferiority). Regarding individual safety and efficacy outcomes at 9 months, patients in the biolimus- and sirolimus groups had similar rates of death (2.6% vs 2.8%; p=0.74), cardiac death (1.6% vs 2.5%; p=0.22), MI (5.7% vs 4.6%; p=0.30), or clinically indicated TRV (4.4% vs 5.5%; p=0.29) (p values for superiority). Biolimus-eluting stents were also non-inferior to sirolimus-eluting stents in in-stent percent diameter stenosis (20.9% versus 23.3%, p=0.001 for noninferiority), the principal angiographic endpoint of the study.

"The results from LEADERS are significant, as they demonstrate for the first time that a drug-eluting stent with a biodegradable polymer is just as safe and effective as a conventional drug-eluting stent with a durable polymer, under conditions which resemble those of routine clinical practice", commented LEADERS Principle Investigator Professor Stephan Windecker, University Hospital, Bern, Switzerland. "The next stage will be to investigate whether a biodegradable polymer leads to a lower risk of stent thrombosis in the longer term"