Transforming medical devices for improved patient outcomes

Propensity Analysis vs. Xience

In a late-breaking session at EuroPCR, the official congress of European Association of Percutaneous Cardiovascular Interventions, in May 2015, data from a retrospective cross-study patient-matched propensity analysis were presented comparing MiStent SES to XIENCE V Everolimus Eluting Coronary Stent System.

The objective of the analysis was to compare the clinical outcomes of the MiStent SES to the durable polymer coated everolimus-eluting cobalt chromium coronary stent (Xience V) at one and three years post-implantation. A retrospective patient level propensity-matched analysis was performed by Dr. Alexandra Lansky, Director, Yale Cardiovascular Clinical Research Program, Yale School of Medicine, New Haven, CT and Dr. Robert Byrne, Interventional Cardiologist, German Heart Center, Munich, Germany, comparing data from the DESSOLVE I and DESSOLVE II studies evaluating the MiStent SES to the everolimus-eluting Xience V arm of the Intracoronary Stenting and Angiographic Results (ISAR)-TEST-4 study using pre-specified baseline and lesion characteristics. ISAR-TEST-4 used very similar event definitions to the DESSOLVE studies, with a Clinical Events Committee (CEC) review process.

Clinical and angiographic endpoints were compared between the two treatment groups in the matched cohort. The pre-specified primary endpoint was TLF at 12 months and three years. The patient level propensity-matched analysis demonstrated statistically significant reduced TLF and TLR rates at one and three years post-implantation of the MiStent SES compared to the durable Xience V stent.

MiStent SES
Xience V
P Value
TLF – 1 Year 2.9% 12.3% 0.010
TLF – 3 Year 5.0% 16.5% 0.006
TLR – 1 Year 1.0% 8.7% 0.009
TLR – 3 Year 2.0% 12.3% 0.004

These results are hypothesized to be due to the key components of MiStent SES: the unique formulation of crystalline sirolimus, the bioabsorbable polymer (PLGA), the ultra-thin cobalt-chromium stent design and the rapid exchange catheter delivery system. Additionally, these results were the basis for the initiation of the DESSOLVE III study to confirm comparative performance in a randomized trial.

Read the publications related to this study:
Comparison of the Absorbable Polymer Sirolimus-Eluting Stent (MiStent) to the Durable Polymer Everolimus-Eluting Stent (Xience) (from the DESSOLVE I/II and ISAR-TEST-4 Studies)