IVL and RA in Treatment of Balloon-crossable Severely Calcified Coronary Lesions
Study Details
Study Description
Brief Summary
This study to compare periprocedural safety, angiographic success as well as short and long term outcomes of intravascular lithotripsy and rotational atherectomy as a method of severely calcified coronary lesion preparation before DES implantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Coronary artery calcification (CAC) occurs in over 90% of men and 67% of women older than 70 years old .
Severe coronary calcification may be present in about 20% of patients undergoing percutaneous coronary intervention (PCI) .
Coronary calcification may impair stent delivery and expansion and damage the polymer/drug coating, resulting in impaired drug delivery and predispose to restenosis and stent thrombosis.
Intravascular imaging as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are good tools to assess calcium burden, distribution and thickness. Among the two imaging techniques, OCT was found to be more accurate than IVUS in defining calcium burden, calcium area , thickness and calcium length.
Rotational atherectomy (RA) as a method of severely calcified lesions modification before Drug-Eluting-Stent (DES) implantation has shown good outcomes in recent studies. However, its efficacy is reduced in presence of deep calcification.
Recently, intravascular lithotripsy (IVL) has been introduced as a novel modality for severely calcified coronary lesion preparation with good preliminary outcomes .
Currently the two techniques are regularly being used in combination in order to achieve optimal results . Whether IVL is a method equally good (or superior) to rotablation in cases where anatomy does not exclude the use of either technique (for example balloon-crossable, heavily calcified lesions) has not yet been discussed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients who underwent Rotational atherectomy (RA) The device contains rapidly rotating burr that is coated with microscopic diamond chips, which debulks the calcified plaque by grinding the calcified atheroma into small particles facilitating stent passage and expansion. Both transfemoral or transradial approach can be used. Regular PCI guidewire can be used to cross the often complex anatomy then switching to a rotablation dedicated guidewire over a microcatheter. Burr sizes vary from 1.25mm up to 1.75mm (in certain cases bigger calibers may also be used) aiming to achieve plaque modification . |
Device: Rotational atherectomy
Device used for severely calcified coronary lesion preparation before stent implantation.
|
| Patients who underwent Intravascular lithotripsy (IVL) The Coronary IVL System consists of an IVL Balloon Catheter with 2 integrated emitters, a Lithotripsy Generator, and a Connector Cable. These emitters create sonic pressure waves that selectively fracture calcium and alter vessel compliance facilitating stent passage and expansion. It is available in 2.5- to 4.0-mm diameters and 12 mm in length, with an inflation pressure of 4 atm used for delivering the treatment. Every catheter can emit a maximum of 80 pulses at a rate of one pulse per second. The IVL balloon catheter is chosen based on the reference lumen of the vessel and after pre-dilatation of the lesion (preferably with a non-compliant balloon) 10-30 pulses are given, usually with interval deflation to allow distal perfusion. If the lesion exceeds the 12 mm balloon length, the balloon can be repositioned and the IVL repeated . |
Device: Intravascular lithotripsy
Device used for severely calcified coronary lesion preparation before stent implantation.
|
Outcome Measures
Primary Outcome Measures
- Strategy success [Up to one day]
less than 20% in-stent residual stenosis of the target lesion and no postprocedural complications as no-reflow, dissection or perforation.
Secondary Outcome Measures
- Major Adverse Cardiac Events [after one year]
composite of Death, stroke, myocardial infarction, stent thrombosis, target vessel revascularization, and hospitalization at long term follow up
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged >18 years undergoing PCI because of stable angina (uncontrolled symptoms on optimal medical treatment) or post stabilized acute coronary syndrome (ACS).
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Patients have severe calcification: defined either angiographically or by OCT (or IVUS) as calcium arch >180º in at least one cross section , calcium length >5mm, calcium thickness >0.5 mm (2, 6).
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Vessel diameter ≥2.5mm and ≤4.0mm .
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Heavily calcified lesion length less than 40mm.
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All patients must have been discussed in the heart team of the hospital and accepted for coronary intervention
Exclusion Criteria:
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Severe coronary calcification with lesion uncrossable from a balloon.
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PCIs in the setting of STEMI or NSTEMI with persistent complains.
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Patients in cardiogenic shock.
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Heart failure New York Heart Association (NYHA) class IV.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Leiden University Medical Center | Leiden | Netherlands |
Sponsors and Collaborators
- Assiut University
Investigators
- Study Chair: Amr youssef, professor, Assiut University
- Study Chair: Johan W Jukema, professor, Leiden University Medical Center
- Study Director: Iannis Karalis, Doctor, Leiden University Medical Center
- Study Chair: Mohamed Abdelghany, professor, Assiut University
- Study Chair: Salma M Taha, Lecturer, Assiut University
- Principal Investigator: Mohamed AA Mousa, Doctor, Assiut University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions
- Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses
Publications
- Aksoy A, Salazar C, Becher MU, Tiyerili V, Weber M, Jansen F, Sedaghat A, Zimmer S, Leick J, Grube E, Gonzalo N, Sinning JM, Escaned J, Nickenig G, Werner N. Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry. Circ Cardiovasc Interv. 2019 Nov;12(11):e008154. doi: 10.1161/CIRCINTERVENTIONS.119.008154. Epub 2019 Nov 11.
- Barbato E, Carrié D, Dardas P, Fajadet J, Gaul G, Haude M, Khashaba A, Koch K, Meyer-Gessner M, Palazuelos J, Reczuch K, Ribichini FL, Sharma S, Sipötz J, Sjögren I, Suetsch G, Szabó G, Valdés-Chávarri M, Vaquerizo B, Wijns W, Windecker S, de Belder A, Valgimigli M, Byrne RA, Colombo A, Di Mario C, Latib A, Hamm C; European Association of Percutaneous Cardiovascular Interventions. European expert consensus on rotational atherectomy. EuroIntervention. 2015 May;11(1):30-6. doi: 10.4244/EIJV11I1A6.
- Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20.
- De Maria GL, Scarsini R, Banning AP. Management of Calcific Coronary Artery Lesions: Is it Time to Change Our Interventional Therapeutic Approach? JACC Cardiovasc Interv. 2019 Aug 12;12(15):1465-1478. doi: 10.1016/j.jcin.2019.03.038. Review.
- Jurado-Román A, Gonzálvez A, Galeote G, Jiménez-Valero S, Moreno R. RotaTripsy: Combination of Rotational Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Lesions. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e127-e129. doi: 10.1016/j.jcin.2019.03.036. Epub 2019 Jul 17.
- Kassimis G, Didagelos M, De Maria GL, Kontogiannis N, Karamasis GV, Katsikis A, Sularz A, Karvounis H, Kanonidis I, Krokidis M, Ziakas A, Banning AP. Shockwave Intravascular Lithotripsy for the Treatment of Severe Vascular Calcification. Angiology. 2020 Sep;71(8):677-688. doi: 10.1177/0003319720932455. Epub 2020 Jun 22. Review.
- Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, Banning AP. How Should We Treat Heavily Calcified Coronary Artery Disease in Contemporary Practice? From Atherectomy to Intravascular Lithotripsy. Cardiovasc Revasc Med. 2019 Dec;20(12):1172-1183. doi: 10.1016/j.carrev.2019.01.010. Epub 2019 Jan 10. Review.
- Lee MS, Shah N. The Impact and Pathophysiologic Consequences of Coronary Artery Calcium Deposition in Percutaneous Coronary Interventions. J Invasive Cardiol. 2016 Apr;28(4):160-7. Epub 2015 Aug 25. Review.
- Liu W, Zhang Y, Yu CM, Ji QW, Cai M, Zhao YX, Zhou YJ. Current understanding of coronary artery calcification. J Geriatr Cardiol. 2015 Nov;12(6):668-75. doi: 10.11909/j.issn.1671-5411.2015.06.012. Review.
- IVL and RA in calcificaion