Background
The aim of this study was to evaluate the world’s largest drug-eluting stent registry that used the Seattle Angina Questionnaire (SAQ) to assess changes in angina frequency (AF) and quality of life (QoL) across angiographically important groups receiving exclusively XIENCE V at the index procedure.
Methods
We conducted a prospective, multicenter, unrestricted real-world registry of consecutively enrolled patients undergoing percutaneous coronary intervention (PCI) with the XIENCE V stent. Asymptotic normality test comparing change from baseline values against a threshold of 10 points was used to assess the significance of changes within each group even though group mean changes in SAQ scores of ≥5 points are considered clinically significant.
Methods
We conducted a prospective, multicenter, unrestricted real-world registry of consecutively enrolled patients undergoing percutaneous coronary intervention (PCI) with the XIENCE V stent. Asymptotic normality test comparing change from baseline values against a threshold of 10 points was used to assess the significance of changes within each group even though group mean changes in SAQ scores of ≥5 points are considered clinically significant.
Results
Of the 4852 patients who had at least one valid score at baseline, 3830 (79%) completed 6-month follow-up. Mean age was 64.7±11.1 years, 69% were men, 35.3% had diabetes, and 39% had two or more diseased vessels. Shown below are SAQ AF and QoL scores at baseline and clinically relevant improvements at 6 months in the total population, near on-label and off-label subgroups, various angiographic cohorts, and four angina burden categories. Innovative analysis comparing scores within the 10 Medicare geographic regions will also be presented.
Conclusion
Marked improvement in patients’ health status was observed across angiographic and angina subgroups. Those with daily or weekly angina prior to PCI with XIENCE V reported the greatest improvements in QoL.
| Patient Category | Baseline Angina Frequency (n) | Δ Angina Frequency (n) | P | Baseline Quality of Life (n) | Δ Quality of Life (n) | P |
|---|---|---|---|---|---|---|
| Total population | 73.1±25.1 (4787) | 17.0±25.2 (3746) | <.0001 | 55.3±25.8 (4681) | 21.1±26.6 (3559) | <.0001 |
| Near on-label vs. Off-label | 74.2±24.3 (1864) 72.5±25.6 (2923) | 16.3±24.5 (1487) 17.4±25.7 (2259) | <.0001 <.0001 | 56.9±25.9 (1822) 54.3±25.8 (2859) | 20.4±26.3 (1403) 21.6±26.8 (2156) | <.0001 <.0001 |
| Pre-dilation (single lesion) vs. Direct stenting (single lesion) | 72.5±25.4 (2061) 73.7±24.9 (1256) | 18.1±25.6 (1607) 16.4±25.1 (985) | <.0001 <.0001 | 55.1±25.7 (2019) 55.4±25.6 (1232) | 21.4±27.0 (1531) 21.0±25.9 (941) | <.0001 <.0001 |
| Lesion length <20 mm vs. Lesion length ≥20 mm | 73.0±25.1 (2926) 73.5±25.4 (1585) | 17.0±25.2 (2296) 16.9±25.1 (1237) | <.0001 <.0001 | 55.9±25.7 (2859) 55.4±26.3 (1545) | 20.8±26.6 (2182) 20.9±26.7 (1164) | <.0001 <.0001 |
| Stent diameter ≤2.75 mm vs. Stent diameter>2.75 mm | 72.4±25.8 (1617) 73.5±24.8 (3151) | 16.8±25.3 (1241) 17.1±25.2 (2492) | <.0001 <.0001 | 55.5±26.1 (1585) 55.2±25.7 (3078) | 18.9±27.0 (1172) 22.3±26.4 (2376) | <.0001 <.0001 |
| Non-bifurcation vs. Bifurcation | 73.1±25.2 (4275) 73.4±23.7 (502) | 17.0±25.4 (3355) 17.0±23.7 (388) | <.0001 <.0001 | 55.1±25.8 (4168) 57.3±25.9 (503) | 21.3±26.6 (3177) 20.2±26.6 (379) | <.0001 <.0001 |
| No overlap vs. Overlap | 72.8±25.3 (3821) 73.6±24.8 (792) | 17.4±25.4 (3002) 15.8±24.5 (607) | <.0001 <.0001 | 55.5±25.7(3743)53.5±26.5(767) | 21.3±26.6 (2861) 21.0±26.7 (567) | <.0001 <.0001 |
| Daily angina (0-30) vs. Weekly angina (31-60) vs. Monthly (61-90) vs. Angina-free during previous 4 wks (100) | 30.6±18.8 (392) 40.9±19.8 (1297) 55.6±21.0 (1691) 77.5±21.3 (1259) | 33.4±27.0 (304) 30.6±25.6 (1007) 21.9±24.5 (1272) 6.4±23.3 (953) | <.0001 <.0001 <.0001 NS |
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