Biodegradable Polymer Drug-Eluting Stents Reduce the Risk of Stent Thrombosis at 4 Years in Patients Undergoing Percutaneous Coronary Intervention: A Pooled Analysis of Individual Patient Data From the ISAR-TEST 3, ISAR-TEST 4, and LEADERS Randomized Trials

Study Questions:

What are the long-term outcomes in patients treated with biodegradable polymer drug-eluting stents (DES) versus durable polymer sirolimus-eluting stents (SES)?

Methods:

The investigators pooled individual patient data from three large-scale multicenter randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. The authors performed survival analyses using the Mantel–Cox method stratified by the trial.

Results:

Out of 4,062 patients included in the present analysis, 2,358 were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting, n = 1,501; biolimus-eluting, n = 857), and 1,704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES versus durable polymer SES (hazard ratio, 0.82; 95% confidence interval [CI], 0.68-0.98; p = 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES versus durable polymer SES (hazard ratio, 0.56; 95% CI, 0.35-0.90; p = 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio, 0.22; 95% CI, 0.08-0.61; p = 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES versus durable polymer SES (hazard ratio, 0.59; 95% CI, 0.73-0.95; p = the incidence of myocardial infarction 0.031).

Conclusions:

The authors concluded that biodegradable polymer DES improve safety and efficacy compared with durable polymer SES during long-term follow-up to 4 years.

Perspective:

This pooled analysis suggests that the use of biodegradable polymer DES improves safety and efficacy compared with durable polymer SES during long-term follow-up. There was a statistically significant and likely clinically important risk reduction for definite stent thrombosis and the incidence of myocardial infarction in favor of biodegradable polymer DES compared with durable polymer-based SES at 4 years, and the enhanced safety profile did not occur at the expense of antirestenotic efficacy. It appears that that biodegradable polymer-based DES result in improved arterial healing, which in turn not only minimizes the risk of stent thrombosis, but also improves the long-term durability of the antirestenotic efficacy and may become the preferred DES platform in the future as data from additional larger clinical trials are accrued.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Polymers, Risk Reduction Behavior, Survival Analysis, Confidence Intervals, Sirolimus, Stents, Percutaneous Coronary Intervention


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