Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES

• Status: Recruiting
• Trial end date: 2023-10-24
• Target enrollment: 0
• Participant gender: All

Summary

New-generation metallic drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention (PCI). Currently, few data are available as regards to the safety and efficacy of the Cre8 amphilimus-eluting stent (Cre8 AES, Alvimedica, Instanbul, Turkey) in comparison with the biodegradable polymer everolimus-eluting stent (Synergy EES, Boston Scientific, Marlborough, MA, USA). Results from randomized trials and meta-analyses consistently indicate that prolonged dual antiplatelet therapy (DAPT) after PCI reduces ischemic events, but invariably conveys an excess of clinically relevant bleeding, which is proportional to the duration of treatment. It has been estimated, indeed, that for every non-fatal ischemic event avoided with prolonged DAPT, two or more clinically relevant bleeding events have to be expected. Given the trade-off between benefits and risks and the lack of mortality benefit in favor of prolonged DAPT, expert consensus suggests that DAPT duration should be individualized based on ischemic versus bleeding risks. At this regard, the DAPT score has been recently proposed as standardized tool to identify patients who derive benefit or lack from a prolonged course of DAPT. However, a prospective assessment of the DAPT score is lacking and whether a personalized duration of DAPT based on the DAPT score improves the net clinical benefit remains unknown.

The objective of the study is to compared the safety and the efficacy of the Cre8 AES with the Synergy EES and a personalized DAPT duration based on the DAPT score with a standard DAPT duration among patients undergoing PCI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Collaborator: AdvicePharma Group
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

1. Age ≥18 years;

2. Clinical evidence of coronary artery disease requiring PCI with DES implantation;

3. Any coronary lesion sized 2.25-4.5 mm by visual estimation.

Exclusion Criteria:

1. Inability to provide informed consent;

2. Active bleeding requiring medical attention (BARC ≥2);

3. Need for chronic oral anticoagulant therapy;

4. Planned surgery within 3 months;

5. Known hypersensitivity or allergy to aspirin or any P2Y12 receptor inhibitor (clopidogrel, prasugrel, ticagrelor), heparin, contrast agent, or any DES-components;

6. Previous treatment with bioresorbable vascular scaffolds;

7. Participation in another study that has not reached the primary endpoint;

8. A life expectancy of less than 24 months;

9. Female of childbearing potential;

10. Under judicial protection, tutorship or curatorship.