SMART: The microstent's ability to limit restenosis trial

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• Coronary artery disease necessitates effective revascularization strategies.
• Coronary stenting is a primary treatment modality for coronary lesions.
• Evaluating novel stent designs against established ones is crucial for clinical practice.

Purpose of the Study:

• To compare the efficacy and safety of the MicroStent II (MSII) versus the Palmaz-Schatz (PS) stent.
• To assess short-term procedural success and 30-day major adverse events.
• To evaluate long-term clinical and angiographic restenosis rates.

Main Methods:

• Randomized, prospective, multicenter trial involving 661 patients.
• Patients were assigned to receive either the MSII (n=330) or PS stent (n=331).
• Outcomes assessed included procedural success, major adverse events (death, MI, CVA, TLR), and in-stent restenosis at 6 months, with clinical follow-up to 270 days.

Main Results:

• Procedural success rates were high and comparable for both stents (94.4% MSII vs. 95.7% PS, P=0.47).
• 30-day cumulative incidence of major adverse events was similar (6.4% MSII vs. 4.5% PS, P=0.31).
• In-stent binary restenosis at 6 months (25.2% MSII vs. 22.1% PS, P=0.636) and clinically driven target lesion revascularization rates at 270 days (12.8% MSII vs. 12.1% PS, P=0.83) were comparable.

Conclusions:

• The MicroStent II (MSII) and Palmaz-Schatz (PS) stents exhibit comparable performance.
• Both stents provide similar short-term procedural success and safety profiles.
• No significant differences were observed in late clinical or angiographic restenosis between the MSII and PS stents.