Author + information
- Dean Kereiakes1,
- Stephen Ellis2,
- Runlin Gao3,
- Takeshi Kimura4,
- Yoshinobu Onuma5,
- Karine Piard-Ruster6,
- Yunlong Zhang6,
- Kai Koo6,
- Patrick Serruys7 and
- Gregg Stone8
- 1The Christ Hospital, Cincinnati, Ohio, United States
- 2Cleveland Clinic Foundation, Cleveland, Ohio, United States
- 3Fuwai Hospital, CAMS&PUMC, Beijing, China
- 4Kyoto University Hospital, Kyoto, Japan
- 5Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
- 6Abbott Vascular, Santa Clara, California, United States
- 7Imperial College, London, United Kingdom
- 8Cardiovascular Research Foundation, Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York, United States
Absorb bioresorbable vascular scaffolds (BVS) provide drug delivery and mechanical support functions similar to metallic DES, followed by resorption with recovery of more normal vascular structure and function, potentially improving very late clinical outcomes. In a prior patient-level meta-analysis of 4 randomized trials, Absorb BVS was not significantly different from XIENCE everolimus-eluting stents (EES) for 1-year target lesion failure (TLF). As women are under-represented in stent trials, we sought to assess the sex-specific relative safety and efficacy of BVS compared with EES.
The ABSORB II, ABSORB III, JAPAN, and CHINA trials were pooled (3389 total pts; 932 [28%] women). Baseline clinical, angiographic and procedural variables and 1-year outcomes including TLF, target vessel MI (TVMI), ischemic target lesion revascularization (TLR) and device thrombosis (ST; ARC def/pro) were analyzed stratified by sex and device.
Women were older, more often diabetic (insulin-treated) and hypertensive, but had less prior PCI, 3-vessel disease and smoking (all p≤0.001). 1-year TLF and ST rates were similar in women and men (6.9% vs. 5.7%, P=0.20, and 1.2% vs. 1.0%, P=0.60, respectively). TLF rates were similar with BVS vs. EES (6.6% vs 5.2% respectively, p=0.17), with no interaction by sex (P=0.77). ST was non-significantly greater with BVS vs. EES (1.3% vs. 0.6%; p=0.08), more so in men than in women (Table), although Pinteraction=0.13).
|Gender||Absorb||Xience||RR [95% CI]|
|TLF||Male||6.2% (96/1558)||5.0% (44/877)||1.23 [0.87, 1.74]|
|Female||7.6% (45/589)||5.7% (19/335)||1.35 [0.80, 2.26]|
|TVMI||Male||4.6% (72/1558)||3.1% (27/877)||1.50 [0.97, 2.32]|
|Femal||6.5% (38/589)||3.9% (13/335)||1.66 [0.90, 3.08]|
|ID-TLR||Male||2.6% (40/1558)||2.2% (19/877)||1.19 [0.69, 2.03]|
|Femal||2.9% (17/589)||2.7% (9/335)||1.07 [0.48, 2.38]|
|Det/Prob ST||Male||1.4% (21/1546)||0.3% (3/871)||3.94 [1.18, 13.18]|
|Female||1.2% (7/584)||1.2% (4/333)||1.00 [0.29, 3.38]|
Despite differing demographic profiles, the relative effects of BVS and EES for 1-year TLF were similar in men and women. The trend toward greater ST for BVS (vs. EES) was driven by a low ST rate (0.3%) in EES-treated men.
CORONARY: Bioresorbable Vascular Scaffolds