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Italian Diffuse/Multivessel Disease ABSORB Prospective Registry (IT-DISAPPEARS). Study design and rationale
Luca Testa1, Giuseppe Biondi Zoccai, Fabrizio Tomai
1Istituto Clinico S. Ambrogio, Milan, Italy (TL, BF), La Sapienza Univ, Roma, Italy (BZG), European Hospital, Rome (TF), University of Verona, Verona, Italy (RF), Magna Grecia Univ., Catanzaro, Italy (IC); Ferrarotto Hospital, Catania, Italy,(TC), Centro Cardiologico Monzino, Milan, Italy (BA); Pisa Univ, Pisa, Italy (PAS, DCM).
The IT-DISAPPEARS study evaluates the Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) in complex coronary artery disease. This research aims to assess its performance in patients who may benefit most from this advanced treatment.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- The Absorb Bioresorbable Vascular Scaffold System (Absorb BVS) offers temporary scaffolding and drug delivery for coronary artery disease.
- It presents a potential alternative to metallic stents, with evidence suggesting comparable results to second-generation stents in low-risk patients.
- However, its performance in complex coronary artery disease remains less understood.
Purpose of the Study:
- To investigate the procedural and clinical performance of Absorb BVS in patients with complex coronary artery disease.
- To evaluate Absorb BVS in patients with long (>24mm) single-vessel or multivessel coronary disease.
- To assess the safety and efficacy of Absorb BVS in a high-risk population.
Main Methods:
- The IT-DISAPPEARS study will enroll 1000 patients across 50 Italian centers.
- Patients will have either stable or acute coronary syndromes, including long or multivessel disease.
- Follow-up will extend to 5 years, with a primary endpoint of major adverse cardiac events at 1 year.
Main Results:
- Primary endpoint: cumulative hierarchical incidence of major adverse cardiac events (cardiac death, MI, TLR) at 1 year.
- Secondary evaluations include efficacy and safety parameters.
- Detailed assessment of dual antiplatelet therapy duration and interruption.
Conclusions:
- The IT-DISAPPEARS study aims to provide the first global evidence on Absorb BVS performance in high-risk, diffuse coronary disease.
- Findings will inform the use of Absorb BVS in complex patient subsets.
- This research could establish Absorb BVS as a viable option for challenging cases.
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