{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T05:44:44Z","timestamp":1793598284010,"version":"4.5.0"},"reference-count":38,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"10","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83\u00b10.47 mm, and residual stenosis was 32.7\u00b110.4%, which further decreased to 7.8\u00b17.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non\u2013Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4\u00b12.6 fractures per lesion, measuring 5.5\u00b15.0 mm in length.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      . Unique identifier: NCT03328949.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.119.008434","type":"journal-article","created":{"date-parts":[[2019,9,25]],"date-time":"2019-09-25T11:00:39Z","timestamp":1569409239000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":357,"title":["Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses"],"prefix":"10.1161","volume":"12","author":[{"given":"Ziad A.","family":"Ali","sequence":"first","affiliation":[{"name":"St. Francis Hospital, Roslyn, NY (Z.A.A.)."},{"name":"NewYork-Presbyterian Hospital, Columbia University (Z.A.A., A.M.)."},{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"Nef","sequence":"additional","affiliation":[{"name":"Department of Cardiology, University of Giessen, Frankfurt, Germany (H.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Escaned","sequence":"additional","affiliation":[{"name":"Hospital Cl\u00ednico San Carlos IDISSC, Complutense University of Madrid, Spain (J.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikos","family":"Werner","sequence":"additional","affiliation":[{"name":"Krankenhaus der Barmherzigen Br\u00fcder Trier, Germany (N.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian P.","family":"Banning","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Oxford University Hospitals, United Kingdom (A.P.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan M.","family":"Hill","sequence":"additional","affiliation":[{"name":"King\u2019s College Hospital, London, United Kingdom (J.M.H.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"De Bruyne","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Cardiovascular Research Centre, OLV Hospital, Aalst, Belgium (B.D.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matteo","family":"Montorfano","sequence":"additional","affiliation":[{"name":"San Raffaele Hospital, Milan, Italy (M. Montorfano)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Lefevre","sequence":"additional","affiliation":[{"name":"Institut Cardiovasculaire Paris Sud, H\u00f4pital Priv\u00e9 Jacques Cartier, G\u00e9n\u00e9rale de Sant\u00e9, Massy, France (T.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregg W.","family":"Stone","sequence":"additional","affiliation":[{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.)."},{"name":"The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Crowley","sequence":"additional","affiliation":[{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsuaki","family":"Matsumura","sequence":"additional","affiliation":[{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiko","family":"Maehara","sequence":"additional","affiliation":[{"name":"NewYork-Presbyterian Hospital, Columbia University (Z.A.A., A.M.)."},{"name":"Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (Z.A.A., G.W.S., A.C., M. Matsumura, A.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra J.","family":"Lansky","sequence":"additional","affiliation":[{"name":"Yale University Medical Center, New Haven, CT (A.J.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Fajadet","sequence":"additional","affiliation":[{"name":"Clinique Pasteur, Toulouse, France (J.F.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Di Mario","sequence":"additional","affiliation":[{"name":"Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (C.D.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.cj-09-0080"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.22347"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jconrel.2017.08.037"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.26000"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e31823ba622"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu278"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-18-00139"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2017.09.031"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2012.07.017"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2006.06.028"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2007.07.036"},{"key":"e_1_3_3_13_2","first-page":"379","article-title":"Beta-blocker use is not associated with slow flow during rotational atherectomy.","volume":"24","author":"Sakakura K","year":"2012","unstructured":"Sakakura, K, Ako, J, Wada, H, Naito, R, Arao, K, Funayama, H, Kubo, N, Momomura, S. Beta-blocker use is not associated with slow flow during rotational atherectomy. J Invasive Cardiol. 2012;24:379\u2013384.","journal-title":"J Invasive Cardiol"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2012.04.021"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.118.036531"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-18-01056"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.09.079"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2017.05.012"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.01.034"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.iccl.2016.12.004"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.cj-14-0108"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.102.5.523"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.110.959791"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2013.12.043"},{"key":"e_1_3_3_25_2","first-page":"429","article-title":"Predictors of stent strut malapposition in calcified vessels using frequency-domain optical coherence tomography.","volume":"25","author":"Lindsay AC","year":"2013","unstructured":"Lindsay, AC, Paulo, M, Kadriye, K, Tejeiro, R, Alegr\u00eda-Barrero, E, Chan, PH, Foin, N, Syrseloudis, D, Di Mario, C. Predictors of stent strut malapposition in calcified vessels using frequency-domain optical coherence tomography. J Invasive Cardiol. 2013;25:429\u2013434.","journal-title":"J Invasive Cardiol"},{"key":"e_1_3_3_26_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehv711"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019071"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1253\/circj.66.659"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2013.12.196"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007415"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0304(199808)44:4<453::AID-CCD21>3.0.CO;2-I"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2003.10.039"},{"key":"e_1_3_3_33_2","first-page":"177","article-title":"Early experience with directional coronary atherectomy: documentation of the learning curve.","volume":"9","author":"Kimball BP","year":"1993","unstructured":"Kimball, BP, Bui, S, Cohen, EA, Carere, RG, Adelman, AG. Early experience with directional coronary atherectomy: documentation of the learning curve. Can J Cardiol. 1993;9:177\u2013185.","journal-title":"Can J Cardiol"},{"key":"e_1_3_3_34_2","first-page":"529","volume-title":"In: Smith\u2019s Textbook of Endourology","author":"Cleveland RO","year":"2012","unstructured":"Cleveland, RO, McAteer, JA. Physics of Shock-Wave Lithotripsy. Smith, A. D., Badlani, G. H., Preminger, G., Kavoussi, L. R., eds. In: Smith\u2019s Textbook of Endourology. 3rd ed. Volume I. Hoboken, NJ: Wiley-Blackwell; 2012:529\u2013558.","edition":"3"},{"key":"e_1_3_3_35_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)31922-5"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.01.158"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.02.004"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2014.11.012"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2017.05.014"}],"container-title":["Circulation: Cardiovascular Interventions"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/CIRCINTERVENTIONS.119.008434","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,12]],"date-time":"2024-05-12T22:22:22Z","timestamp":1715552542000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/CIRCINTERVENTIONS.119.008434"}},"subtitle":["The Disrupt CAD II Study"],"short-title":[],"issued":{"date-parts":[[2019,10]]},"references-count":38,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2019,10]]}},"alternative-id":["10.1161\/CIRCINTERVENTIONS.119.008434"],"URL":"https:\/\/doi.org\/10.1161\/circinterventions.119.008434","relation":{},"ISSN":["1941-7640","1941-7632"],"issn-type":[{"value":"1941-7640","type":"print"},{"value":"1941-7632","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10]]},"assertion":[{"value":"2019-08-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-08-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-09-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e008434"}}