Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST).
Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.
Age ≥18 years and consentable;
Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and/or evidence of myocardial ischemia (e.g. FFR/ iFR, CMR, SPECT or PET-CT);
Angiographically-proven coronary artery disease;
Lesions in non-target vessels requiring PCI may be treated either
Patient experienced an acute STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure;
Any comorbidity or condition which may reduce compliance with this protocol, including follow-up calls/ visits (e.g. advanced dementia);
Any medical, geographic, and/or social factor making study participation impractical or precluding required follow-up.
Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);
Parallel
OPN™ NCB Super High Pressure PCI Balloon
DeviceIn order to permit advancement of the studied medical devices - OPN™ NCB or Shockwave™ IVL balloon catheter - initial lesion preparation using small SCBs or NCBs (≤2mm) or rotablation (Boston Scientific, Marlborough, MA, United States) is allowed, but will be documented. This may be required in selected cases with very calcified and tight lesions. As per protocol, lesion preparation will be performed using either the super-high pressure PCI balloon OPN™ NCB or the Shockwave™ IVL balloon catheter according to random treatment assignment after matching the angiographic and/or OCT inclusion criteria. Following successful lesion preparation all patients will be treated with a latest generation durable polymer everolimus-eluting stent (Xience™ Sierra or Skypoint, Abbott Vascular Inc., Santa Clara, CA, United States) to allow comparison of stent expansion.
Shockwave™ C2 IVL Catheter
DeviceIn order to permit advancement of the studied medical devices - OPN™ NCB or Shockwave™ IVL balloon catheter - initial lesion preparation using small SCBs or NCBs (≤2mm) or rotablation (Boston Scientific, Marlborough, MA, United States) is allowed, but will be documented. This may be required in selected cases with very calcified and tight lesions. As per protocol, lesion preparation will be performed using either the super-high pressure PCI balloon OPN™ NCB or the Shockwave™ IVL balloon catheter according to random treatment assignment after matching the angiographic and/or OCT inclusion criteria. Following successful lesion preparation all patients will be treated with a latest generation durable polymer everolimus-eluting stent (Xience™ Sierra or Skypoint, Abbott Vascular Inc., Santa Clara, CA, United States) to allow comparison of stent expansion.
Final stent expansion (in percentage, %) assessed by OCT
Acceptable stent expansion (>80%) assessed by OCT
Optimal stent expansion (>90%) assessed by OCT
Procedural success
defined as the achievement of angiographic success (residual stenosis of \<30%, no flow-limiting dissection and/or no no-reflow) without any major adverse cardiac events (MACE), which is defined as cardiac death, target vessel related myocardial infarction, TIA/ stroke and repeat revascularization (PCI or CABG) up to 30 days
Strategy success
defined as procedural success using the assigned study device and stent, without requirement for lesion preparation with further devices (i.e. cross-over to the non-assigned study devices or cutting/ scoring balloons).
Coronary perforations (Ellis grade III and/or cavity spilling)
Persistent periprocedural vessel occlusion/MI
Periprocedural ventricular tachycardia/fibrillation (VT/ VF)
Contrast-induced nephropathy (CIN)
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Luzerner Kantonsspital
Lead sponsor
Hôpital Fribourgeois
Collaborator
Hamilton General Hospital
Collaborator
