2026-11-02 マウントサイナイ医療システム（MSHS）
米国マウントサイナイ病院の研究チームは、冠動脈の石灰化結節によってステントが十分に拡張できなくなる問題に対し、2種類の治療技術を組み合わせる方法をランダム化臨床試験NODULE-SHOCKで検証した。重度の冠動脈石灰化を有する患者120人を登録し、このうち石灰化結節が認められた66人を、回転式アテレクトミーと血管内衝撃波治療（IVL）の併用群、IVL単独群に分けて比較した。併用群では、回転式器具で突出した石灰を削り、続いて衝撃波で深部の石灰を破砕する。その結果、最終ステント断面積は併用群で平均7.41 mm²、IVL単独群で6.23 mm²となり、約19％増加した。また、ステントはより円形かつ対称的に拡張した。一方、石灰化結節のない患者54人では、IVLの照射回数を増やしても拡張効果は改善しなかった。本研究は、石灰化病変の形態に応じて治療法を使い分ける個別化治療の重要性を示している。
＜関連情報＞
- https://www.mountsinai.org/about/newsroom/2026/new-treatment-approach-for-calcified-nodules-shown-to-improve-coronary-stent-expansion-in-mount-sinai-clinical-trial
- https://www.jacc.org/doi/10.1016/j.jcin.2026.10.001
冠動脈石灰化結節に対する回転式アテレクトミー＋血管内結石破砕術と血管内結石破砕術単独の比較：NODULE-SHOCK試験 Rotational Atherectomy Plus Intravascular Lithotripsy Versus Intravascular Lithotripsy Alone for Coronary Calcified Nodules: The NODULE-SHOCK Trial
Annapoorna S. Kini, Keisuke Yasumura, Sho Nakao, Angelo Oliva, Pruthvi C. Revaiah, Yuliya Vengrenyuk, Amit Hooda, … , and Samin K. Sharma
JACC: Cardiovascular Interventions Published:1 November 2026
Abstract
Optimal lesion preparation for coronary calcified nodules (CNs) and intravascular lithotripsy (IVL) pulse delivery for severe calcification remain uncertain.
This study sought to evaluate phenotype-specific calcium modification in severe calcification with and without CNs.
In this single-center randomized trial using a new-generation coronary IVL catheter, patients with optical coherence tomography-defined CNs (Cohort A) were assigned 1:1 to rotational atherectomy (RA) plus IVL or IVL alone; patients with severe calcification without CNs (Cohort B) were assigned 1:1 to maximum or operator-determined IVL pulses. Primary endpoints were minimum stent area (MSA) at the CN site in Cohort A and at the maximum calcium arc site in Cohort B.
Among 120 patients, 66 (55%) were in Cohort A (33 per group) and 54 (45%) in Cohort B (27 per group). MSA at the CN site was 7.41 ± 2.12 mm2 with RA plus IVL vs 6.23 ± 1.55 mm2 with IVL alone (mean difference: 1.18 mm2; 95% CI: 0.27-2.09; P = 0.012). In Cohort B, MSA at the maximum calcium arc site was 5.50 ± 1.19 mm2 with maximum IVL pulses vs 5.56 ± 1.45 mm2 with operator-determined IVL pulses (mean difference: −0.06 mm2; 95% CI: −0.78 to 0.67; P = 0.873).
RA plus IVL increased final stent area vs IVL alone in CN lesions, whereas maximum IVL pulses did not significantly increase final stent area compared with operator-determined pulses in severe calcification without CNs. These findings warrant validation in larger multicenter trials with clinical endpoints. (Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs Intravascular Lithotripsy Alone: A Prospective, Randomized Trial [NODULE-SHOCK]; ClinicalTrials.gov: NCT07000045)
