10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents
Key result
Polymer-free DES show no benefit over durable polymer stents for 10-year clinical outcomes or stent thrombosis.
Why the study?
Do polymer-free drug-eluting stents improve 10-year outcomes compared to durable polymer drug-eluting stents in patients requiring coronary stenting?
Key Points
- This study aims to evaluate the 10-year outcomes of polymer-free versus durable polymer drug-eluting stents in coronary artery disease patients.
- Randomized trial with 3,002 patients assigned to polymer-free sirolimus- and probucol-eluting stents or durable polymer zotarolimus-eluting stents.
- Primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.
- Follow-up assessments included individual components of composite endpoints and stent thrombosis incidence.
- At 10 years, DOCE rates were 43.8% for polymer-free and 43.0% for durable polymer, HR 1.01, p=0.90.
- POCE rates were 66.2% for polymer-free and 67.7% for durable polymer, HR 0.94, p=0.22.
- Stent thrombosis rates were low: 1.6% for polymer-free and 1.9% for durable polymer, HR 0.85, p=0.58.
Study Design
Type
RCT
Structured PICO
Do polymer-free drug-eluting stents improve 10-year outcomes compared to durable polymer drug-eluting stents in patients requiring coronary stenting?
P
Population
Patients treated with drug-eluting coronary stents
I
Intervention
Polymer-free drug-eluting stents (sirolimus- and probucol-eluting)
C
Comparator
Durable polymer drug-eluting stents (zotarolimus-eluting)
O
Outcome
Clinical outcomes at 10 years
At 10-year follow-up, polymer-free DES showed comparable outcomes and stent thrombosis rates to durable polymer DES, with high overall adverse event rates in both groups.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In the end, we didn't see any difference between this polymer-free technology and the permanent-polymer device at all. On the one hand, that's quite disappointing because there was no additional benefit, but on the other hand it also means that with these new-generation drug-eluting stents, the polymer-free drug-eluting stent does have the same safety and efficacy as a current benchmark stent, which is good news.”
“There are a lot of histopathological reasons why polymers may be the cause of late events, such as stent thrombosis and neoatherosclerosis. The idea is that it might be some sort of inflammation and hypersensitivity to the polymer, as well as endothelial dysfunction. In theory, it makes a lot of sense, but then you try to translate that into clinical practice and it looks like, from this study, if there is a difference [between the stent technologies] it's very small.”
Implication
No long-term benefit from polymer-free DES in practice; challenges hypothesis that durable polymers drive excess very late events.
Abstract
BACKGROUND: Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant. OBJECTIVES: Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial. METHODS: A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis. RESULTS: The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58). CONCLUSIONS: At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533).
Discussion
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Cite This Study
Kufner et al. (2020) conducted an RCT in Coronary artery disease requiring stenting. Polymer-free drug-eluting stents (sirolimus- and probucol-eluting) vs. Durable polymer drug-eluting stents (zotarolimus-eluting) was evaluated on Clinical outcomes and stent thrombosis. Polymer-free drug-eluting stents showed no measurable differences in clinical outcomes or stent thrombosis compared to durable polymer stents at 10-year follow-up.