Biodegradable Polymer DES vs. Second-Generation Durable Polymer DES
What is the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES)?
The authors searched PubMed and Scopus databases for randomized clinical trials (RCTs) comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, the authors performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The investigators used performed fixed-effect analysis when the I2 was up to 25% and the p value was at least 0.05 or higher; otherwise, they used random effect.
The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), they observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio, 0.83; 95% confidence interval, 0.64-1.09; p = 0.19). The landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio, 0.87, 95% confidence interval, 0.49-1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (<6 months vs. >6 months), the strut thickness of the BP-DES (thin <100 µm vs. thick >100 µm), or the DAPT duration (≥6 months vs. ≥12 months).
The authors concluded that BP-DES have similar safety and efficacy profiles to second-generation DP-DES.
This study reports that both DP-DES and BP-DES platforms have similar safety and efficacy profiles, and BP-DES are not associated with significantly reduced risk of ST beyond 1 year compared with DP-DES. Additional clinical trials comparing BP-DES to second-generation DP-DES with different durations of dual antiplatelet therapy with long-term follow-up are needed to individualize stent therapy based on patient risk factors and attributes.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Prevention
Keywords: Drug-Eluting Stents, Myocardial Infarction, Polymers, Primary Prevention, Randomized Controlled Trials as Topic, Risk Factors, Sirolimus, Stainless Steel, Stents, Thrombosis
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