Impact of Insulin-Treated and Noninsulin-Treated Diabetes Mellitus in All-Comer Patients Undergoing Percutaneous Coronary Interventions With Polymer-Free Biolimus-Eluting Stent (from the RUDI-FREE Registry).

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.

Tirofiban Positively Regulates ß1 Integrin and Favours Endothelial Cell Growth on Polylactic Acid Biopolymer Vascular Scaffold (BVS).

An unexpectedly high incidence of thrombosis in patients that received the polylactic acid bioresorbable vascular scaffold (BVS) suggests a delayed/incomplete endothelial repair with this stent. The anti-platelet agent tirofiban stimulates endothelial cell migration and proliferation, mediated by VEGF production. We investigated the tirofiban effect on the migration and adhesion of endothelial cells to BVS, in vitro. We performed human umbilical endothelial cell (HUVEC) cultures in the presence of BVS. Tirofiban, similarly to VEGF, increased the ability of HUVEC to grow on the vascular scaffold, compared to unstimulated or abciximab-treated cells. Tirofiban increased HUVEC expression of ß1 and ß3 integrins along with collagen and fibronectin. A role for ß1 integrin in the "pro-adhesive and -migratory" signals elicited by tirofiban was suggested by use of an anti-ß1-blocking antibody that prevented poly-levo-lactic acid vascular scaffold colonization. Our study suggests that tirofiban may improve the outcomes of patients receiving BVS by accelerating stent endothelization.

Synergy between direct coronary stenting technique and use of the novel thin strut cobalt chromium Skylor™ stent: the MACE in follow up patients treated with Skylor stent [MILES Study].

BACKGROUND: Despite significant improvements in stent platform, currently available bare-metal stents (BMS) are still associated with restenosis. Thin-strut design cobalt-chromium alloys hold the promise of improving results of BMS, especially when implanted with direct technique. We performed an observational study to appraise outcomes of the novel Skylor™ stent, stratifying outcomes according to stenting technique. METHODS AND RESULTS: We included all consecutive patients undergoing coronary stenting with Skylor™ at 2 centers between 2006 and 2009. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. death, myocardial infarction (MI), coronary artery bypass grafting (CABG) or target vessel revascularization (TVR)). As pre-specified analysis, we compared patients undergoing direct stenting versus those stent implantation following predilation. A total of 1020 patients were included (1292 Skylor™ stents), with procedural success obtained in 99%. Comparing patients undergoing direct stenting (66%) versus pre-dilation (34%) at 16±7 months of follow-up, MACE had occurred in, respectively, 8% versus 14% (p=0.001), with death in 1% versus 2= (p=0.380), MI in 1% versus 2% (p=0.032), CABG in 0.2% versus 2% (p=0.012), and TVR in 6% versus 9% [p=0.071]. Even at multivariable analysis with propensity adjustment, direct stenting was associated with significantly fewer MACE [hazard ratio 0.60 [0.38-0.93], p=0.024]. CONCLUSIONS: This observational study suggests the presence of a beneficial synergy between direct coronary stenting technique and use of the novel thin-strut cobalt-chromium Skylor™ stent in real-world patients undergoing PCI.