Key result
In complex PCI, biodegradable polymer drug-eluting stents were associated with a higher 5-year risk of MACE compared to durable polymer stents (aHR 1.256; 95% CI 1.078-1.462; P=0.003).
Why the study?
Data comparing clinical outcomes of complex percutaneous coronary intervention using biodegradable polymer vs second-generation durable polymer drug-eluting stents were limited.
Does the use of biodegradable polymer drug-eluting stents compared to second-generation durable polymer drug-eluting stents reduce major adverse cardiac events in patients undergoing complex percutaneous coronary intervention?
Cohort (n=7,712)
No
Does the use of biodegradable polymer drug-eluting stents compared to second-generation durable polymer drug-eluting stents reduce major adverse cardiac events in patients undergoing complex percutaneous coronary intervention?
Hazard Ratio: 1.256 (95% CI 1.078–1.462)
p-value: p=0.003
In patients undergoing complex percutaneous coronary intervention, biodegradable polymer drug-eluting stents were associated with a higher risk of 5-year major adverse cardiac events compared to second-generation durable polymer drug-eluting stents.
Warrants caution with BP-DES in complex PCI; leaves open confirmation by randomized trials.
BACKGROUND: There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up. METHODS: Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization. RESULTS: Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years. CONCLUSIONS: Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
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Xu et al. (2023) conducted a cohort in Complex percutaneous coronary intervention (CPCI) (n=7,712). Biodegradable polymer drug-eluting stents (BP-DES) vs. Second-generation durable polymer drug-eluting stents (DP-DES) was evaluated on major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (aHR 1.256, 95% CI 1.078-1.462, p=0.003). In complex PCI, biodegradable polymer drug-eluting stents were associated with a higher 5-year risk of MACE compared to durable polymer stents (aHR 1.256; 95% CI 1.078-1.462; P=0.003).
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