Background
Women with coronary artery disease are believed to have a higher risk for adverse outcomes than men after coronary interventions. Many of the assumptions regarding cardiovascular disease in women are derived from modest-sized studies where women have been under-represented. Further, whether the safety and efficacy of different drug-eluting stents vary in women with coronary artery disease is unknown. We therefore sought to evaluate the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, CA, USA) everolimus-eluting stent (EES) compared to the TAXUS (Boston Scientific, Natick, MA, USA) paclitaxel-eluting stent (PES) in women.
Methods
SPIRIT IV, which is the largest prospective, multicenter randomized controlled trial to date to compare two drug-eluting stents, which presented primary endpoint data, randomized 3687 subjects at 66 US institutions of whom 32.2% ( n =1189) were women. All patients underwent PCI of up to three native de novo coronary artery lesions ≤28 mm in length and with reference vessel diameter between 2.5 and 4.25 mm.
Methods
SPIRIT IV, which is the largest prospective, multicenter randomized controlled trial to date to compare two drug-eluting stents, which presented primary endpoint data, randomized 3687 subjects at 66 US institutions of whom 32.2% ( n =1189) were women. All patients underwent PCI of up to three native de novo coronary artery lesions ≤28 mm in length and with reference vessel diameter between 2.5 and 4.25 mm.
Results
In the SPIRIT IV Trial, women were older, had more hypertension, diabetes mellitus, and unstable angina when compared to men, but fewer reported prior cardiac interventions or MIs. Gender-based outcomes are shown in Table 1 .
| Data variable | Women ( n =1189) | Men ( n =2498) | ||||
|---|---|---|---|---|---|---|
| XIENCE V ( n =793) | TAXUS ( n =396) | P value ⁎ | XIENCE V ( n =1665) | TAXUS ( n =833) | P value ⁎ | |
| Target lesion failure (TLF) : cardiac death, target vessel MI, ID-TLR | 4.1%, 32/777 | 7.8%, 30/384 | .012 | 4.2%, 69/1639 | 6.3%, 51/811 | .029 |
| Major adverse cardiac event (MACE): cardiac death, all MI, ID-TLR | 4.1%, 32/777 | 8.1%, 31/384 | .008 | 4.3%, 70/1639 | 6.3%, 51/811 | .037 |
| Cardiac death | 0.5%, 4/777 | 0.5%, 2/384 | 1.000 | 0.4%, 6/1639 | 0.4%, 3/811 | 1.000 |
| Target vessel MI | 1.7%, 13/777 | 3.6%, 14/384 | .040 | 1.9%, 31/1639 | 2.6%, 21/811 | .297 |
| Ischemic TLR | 2.3%, 18/777 | 5.5%, 21/384 | .009 | 2.6%, 43/1639 | 4.2%, 34/811 | .048 |
| Bleeding complications | 4.0%, 31/772 | 4.7%, 18/380 | .642 | 2.7%, 43/1621 | 2.0%, 16/802 | .401 |
| Vascular complications | 1.4%, 11/770 | 1.1%, 4/378 | .784 | 1.1%, 18/1619 | 0.2%, 2/802 | .030 |
| ARC-defined stent thrombosis (definite/probable) | 0.1%, 1/770 | 1.6%, 6/379 | .006 | 0.4%, 6/1621 | 0.9%, 7/802 | .139 |
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