Key result
The Resolute Integrity drug-eluting stent was non-inferior to the historical Xience control for 12-month target lesion failure (4.3% vs 8.5%, P<0.001 for non-inferiority).
Why the study?
Does the Resolute Integrity drug-eluting stent reduce target lesion failure in patients with symptomatic coronary artery disease compared to the historical benchmark Xience drug-eluting stent?
Cohort (n=1,204)
Open-label
Yes
Does the Resolute Integrity drug-eluting stent reduce target lesion failure in patients with symptomatic coronary artery disease compared to the historical benchmark Xience drug-eluting stent?
Absolute Event Rate: 4.3% vs 8.5%
Absolute Risk Reduction: 4.2%
p-value: p=<0.001 for non-inferiority
The Resolute Integrity drug-eluting stent demonstrated non-inferiority to the historical benchmark Xience stent for 12-month target lesion failure in a real-world Japanese population.
Supports Resolute Integrity in real-world Japanese CAD patients; leaves open randomized comparisons to contemporary stents.
BACKGROUND: The Resolute Integrity coronary drug-eluting stent (DES), the next evolution of the Resolute DES, is designed with thinner stent struts and continuous sinusoidal technology to further enhance performance. This study evaluated the performance of the Resolute Integrity DES compared with the historical performance of Xience V. METHODS AND RESULTS: We assessed the safety, efficacy, and deliverability of Resolute Integrity compared with the Xience DES, the prespecified historical control, in PROPEL, a large, real-world prospective, single-arm, open-label study. A total of 1,204 subjects were enrolled in PROPEL and treated with the Resolute Integrity DES at 76 sites in Japan. Lesion and procedural success rates were 100% and 99%, respectively. Patients were equally complex in the Resolute Integrity and Xience cohorts. At 1 year in the clinical-only cohort, the primary endpoint target lesion failure was 4.3% (34/800) in the Resolute Integrity cohort compared with 8.5% (97/1,142) in the Xience historical controls (P<0.001 for non-inferiority). Target vessel failure, major adverse cardiac events, target vessel myocardial infarction, and the composite cardiac death and target vessel myocardial infarction were all lower with Resolute Integrity compared with Xience, including in "high risk" patients. CONCLUSIONS: In the large, prospective, multicenter PROPEL trial, the performance of the Resolute Integrity DES was non-inferior to that of the benchmark Xience DES used as a historical comparator.
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Nakamura et al. (2018) conducted a cohort in Symptomatic coronary artery disease (n=1,204). Resolute Integrity coronary drug-eluting stent vs. Xience drug-eluting stent (historical control) was evaluated on 12-month target lesion failure (TLF) (95% CI upper bound -2.2%, p=<0.001 for non-inferiority). The Resolute Integrity drug-eluting stent was non-inferior to the historical Xience control for 12-month target lesion failure (4.3% vs 8.5%, P<0.001 for non-inferiority).
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