Tranilast in the Therapy of Coronary Artery Disease

Area of Science:

• Cardiovascular Medicine
• Pharmacology

Background:

• Restenosis after percutaneous coronary intervention (PCI) remains a clinical challenge, limiting long-term vessel patency despite stent use.
• Intimal hyperplasia within stents is the primary cause of restenosis, particularly in high-risk patient subgroups.
• Existing pharmacologic agents have failed to effectively prevent restenosis.

Purpose of the Study:

• To evaluate the efficacy of tranilast in preventing restenosis after PCI.
• To assess the impact of tranilast on clinical events and angiographic outcomes.
• To determine the optimal dosage and duration of tranilast treatment.

Main Methods:

• The Prevention of Restenosis with Tranilast and its Outcomes (PRESTO) study is a large-scale, double-blind, placebo-controlled trial.
• 11,500 patients will be randomized to receive placebo or two doses of tranilast (300 and 450 mg twice daily) for 1 or 3 months.
• Primary endpoint is the composite clinical event rate at 9 months; secondary endpoints include angiographic restenosis and intimal hyperplasia volume.

Main Results:

• Preliminary studies in Japan suggest tranilast shows promise in reducing restenosis.
• The PRESTO study is designed to provide definitive evidence on tranilast's efficacy and safety.
• Results are anticipated to determine if tranilast can be the first drug to reduce both angiographic and clinical restenosis.

Conclusions:

• Tranilast, an anti-inflammatory agent, targets vascular smooth muscle cell proliferation and migration.
• If PRESTO proves successful, tranilast could offer a novel therapeutic option for preventing restenosis post-PCI.
• This study aims to establish tranilast as the first effective pharmacological treatment for reducing restenosis and improving long-term vessel patency.