3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS

Korábbi kezelés

• Major surgery planned into the next 6 months that requires double antiplatelet treatment discontinuation.

Más betegség

• A known hypersensitivity or contraindication to any of the following: aspirin, heparin, ticagrelor, prasugrel, bivalirudin, clopidogrel, scaffold material, contrast media, sirolimus.
• Ongoing infection, including active endocarditis.
• NSTE/ACS due to in stent/scaffold thrombosis/restenosis.
• Active severe bleeding (Bleeding Academic Research Consortium classification ≥III) (21).
• Diffuse severe coronary artery disease that will require coronary artery bypass grafting (CABG) planned in the next 6 months.

Laborértékek

• Chronic kidney disease with eGFR<15 ml/min or under dialysis.

Egyéb

• Severely tortuous, angulated or calcified coronary arteries resulting in not successful pre-dilatation or complication as described in exclusion criteria 10.
• Culprit vessel left main.
• Ostial target lesion (within 5.0 mm of vessel origin).
• Bifurcation target lesions Medina 1,1,1 with upfront planned 2-stent technique.
• Bifurcation side branch target lesions Medina 0,0,1.
• Known thrombocytopenia (PLT<100,000/mm3).
• Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections).
• Culprit lesion requiring preparation with technique other than semi/non-compliant and/or cutting/scoring balloons (eg rotational/orbital atherectomy, shockwave lithotripsy).
• Planned PCI in more lesions than the culprit one at the index procedure.
• Culprit vessel located or supplied by bypass graft.
• Life expectancy less than 1 year.
• Cardiogenic shock.
• Enrolment in another study that competes or interferes with this study.
• Subject will not be able to comply with the follow-up requirements according to investigators' opinion.
• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study.

• Adults ≥18 years old.
• Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
• Patient has given written consent to participate in the trial.
• Patients presenting with NSTE/ACS documented in an emergency department or cath lab fulfilling the NSTE/ACS definition of the ESC guidelines (18, 20).
• Patients undergoing PCI for the index NSTE/ACS.
• Reference index vessel diameter between 2.5-4.2 mm and length ≤28mm by visual estimation.
• Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and Thrombolysis in Myocardial Infarction (TIMI) flow >2 and residual stenosis <20%.
• Culprit lesion treatment only in the index procedure with planned implantation of one only RMS.
• Patients who have no contraindication for.dual antiplatelet therapy (DAPT).