P2Y12 Inhibitor-based SAPT Following 1-month DAPT Versus Conventional DAPT After PCI With Biofreedom Ultra Drug-coated Stent for Unprotected Left Main Disease (ULTRA-LM)

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The management of patients with unprotected left main coronary artery (LMCA) disease undergoing percutaneous coronary intervention (PCI) in contemporary interventional cardiology practice remains matter of intense debate. Particularly, the combination of the optimal drug-eluting stent (DES) selection and antiplatelet regimen for patients who require LMCA PCI remains undetermined.

Newest-generation thin-strut polymer-free drug-coated stents have the potential to further mitigate chronic inflammation and promote faster re-endothelialization. In the LEADERS FREE randomized trial, PCI with the early-generation BioFreedom (Biosensors International, Switzerland) thick-strut stainless-steel drug-coated stent group was associated with significantly lower rates of the primary safety endpoint, defined as a composite of cardiac death, myocardial infarction, or stent thrombosis at 12 months compared to bare-metal stents among 2,466 patients at high-risk of bleeding who received one-month dual antiplatelet therapy (DAPT), a difference driven by a significantly lower risk for clinically driven target-lesion revascularization. In the ONE-MONTH DAPT randomized study, which enrolled 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions, the rates of the primary composite endpoint of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding within 12 months occurred similarly in patients treated with 1-month DAPT after PCI with early-generation thick-strut stainless-steel polymer-free drug-coated stent (BioFreedom, Biosensors International, Switzerland) and those treated with 6- to 12-month DAPT after newer-generation biodegradable polymer DES (Biomatrix, Biosensors International, Switzerland or Ultimaster, Terumo Corp., Japan) implantation. However, no dedicated randomized clinical trial to date has evaluated the safety and efficacy of newest-generation thinner-strut cobalt-chromium polymer-free drug-coated stents combined with a short DAPT regiment among patients undergoing complex PCI, such as those treated for LMCA disease.

Recent evidence from a large-scale meta-analysis of several randomized clinical trials including >32'000 patients indicated that 1-3 months of DAPT followed by P2Y12 inhibitor single antiplatelet therapy (SAPT) after second-generation DES implantation was associated with lower risk for major bleeding and similar risk for adverse ischemic outcomes compared with conventional DAPT. These findings suggest that P2Y12 inhibitor SAPT following a short DAPT course (1-3 months) may represent a valuable treatment option for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT, but this strategy has never been investigated in dedicated randomized clinical trials focused on patients at highest-risk for ischemic events, such as patients undergoing left main PCI.

The ULTRA-LM randomized trial aims at filling this current gap of knowledge, which may have large impact on clinical practice and international guidelines. ULTRA-LM will be the first randomized clinical trial to investigate the safety and efficacy of a novel thin-strut cobalt-chromium BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) combined with P2Y12 inhibitor single antiplatelet therapy after a short one-month DAPT course among patients undergoing PCI for LMCA disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IGLESIAS Juan Fernando
• Collaborator: University of Bern

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Patient with chronic or acute coronary syndrome (unstable angina, or non-ST-elevation acute coronary syndrome).

• Subject with significant unprotected (ostial, mid-shaft, or distal) LMCA stenosis who underwent successful LMCA PCI with ≥1 BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) according to current ESC guidelines on myocardial revascularization and/or local Heart Team decision.

• Subject willing to participate and able to understand, read and sign the informed consent document before the planned procedure.

Exclusion Criteria:

• Contraindications to PCI and/or DES implantation.

• Inability to adhere to DAPT for at least 6 months.

• Patient already on DAPT.

• Patients on oral anticoagulation.

• Previous coronary artery bypass surgery.

• LMCA in-stent restenosis or stent thrombosis.

• Recent ST-elevation myocardial infarction <5 days prior to randomization.

• Cardiogenic shock/hemodynamic instability at the time of intervention and/or need for mechanical/pharmacologic hemodynamic support.

• Participation or planned participation in another clinical trial, except for observational registries.

• Life expectancy <1 year.

• Pregnancy.