Key result
Inspiron sirolimus-eluting stents reduce six-month in-segment late loss ~67% versus bare-metal Cronus stents.
Why the study?
The safety and efficacy of the Inspiron sirolimus-eluting stent with abluminal biodegradable polymer and thin cobalt-chromium alloy had not been evaluated in humans.
Does the Inspiron sirolimus-eluting stent reduce in-segment late loss compared to a bare metal stent in patients requiring coronary stenting?
RCT (n=58)
randomised
Yes
Does the Inspiron sirolimus-eluting stent reduce in-segment late loss compared to a bare metal stent in patients requiring coronary stenting?
Absolute Event Rate: 0.19% vs 0.58%
p-value: p=<0.001
The novel Inspiron sirolimus-eluting stent with an abluminal biodegradable polymer significantly reduced in-segment late loss and neointimal obstruction at 6 months compared to a bare metal stent.
Inspiron reduced 6-month late loss versus bare-metal stent; leaves open confirmation of clinical benefit in larger trials.
AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.
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Ribeiro et al. (2014) conducted an RCT in Coronary artery disease (n=58). Inspiron drug-eluting stent vs. Cronus bare-metal stent was evaluated on in-segment late loss (LLL) at six months (p=<0.001). The Inspiron sirolimus-eluting stent significantly reduced in-segment late loss at six months compared to the bare-metal Cronus stent (0.19 mm vs. 0.58 mm; p<0.001).
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