Key result
MicroStent II shows comparable restenosis and TLR rates versus the Palmaz-Schatz stent.
Why the study?
Does the MicroStent II improve restenosis rates compared to the Palmaz-Schatz stent in patients with de novo or restenotic coronary lesions?
RCT (n=661)
randomized
Yes
Does the MicroStent II improve restenosis rates compared to the Palmaz-Schatz stent in patients with de novo or restenotic coronary lesions?
The MicroStent II and Palmaz-Schatz stents demonstrated comparable short-term procedural success, complications, and late clinical and angiographic restenosis rates.
MicroStent II offers no restenosis or TLR advantage over Palmaz-Schatz; confirms equivalence in this RCT.
In this randomized, prospective, multicenter trial (n = 661) of patients with de novo or restenotic coronary lesions, 330 patients received the MicroStent(R) II (MSII), and 331 received the Palmaz-Schatz (PS) stent. The short-term procedural success rates were 94.4% and 95.7%, respectively (P = 0.47). The 30-day cumulative incidence of major adverse events [death, myocardial infarction, CVA, target lesion revascularization (TLR)] was 6.4% for the MSII and 4.5% for the PS stent (P = 0.31). The in-stent binary restenosis rate at 6 months was 25.2% for the MSII and 22.1% for the PS stent (P = 0.636). Using Kaplan-Meier estimates, the incidence of clinically driven TLR was 8.9% for the MSII and 9.2% for the PS stent at 180 days; at 270 days, it was 12.8% and 12.1%, respectively (P = 0.83). MSII and the PS stents were comparable with respect to short-term procedural success, complications, and late clinical and angiographic restenosis.
No takes yet. Share an insight, caveat, or question.
Heuser et al. (2001) conducted an RCT in de novo or restenotic coronary lesions (n=661). MicroStent II vs. Palmaz-Schatz stent was evaluated on In-stent binary restenosis rate at 6 months (p=0.636). The MicroStent II was comparable to the Palmaz-Schatz stent for 6-month in-stent binary restenosis (25.2% vs 22.1%; P=0.636) and 270-day target lesion revascularization (12.8% vs 12.1%; P=0.83).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: