Coronary Endothelium‐Dependent Vasomotor Function After Drug‐Eluting Stent and Bioresorbable Scaffold Implantation

Background Early generation drug‐eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium‐dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device‐related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable‐polymer everolimus‐eluting Xience (n=44), bioresorbable‐polymer sirolimus‐eluting Orsiro (n=35), polymer‐free biolimus‐eluting Biofreedom (n=24), bioactive endothelial‐progenitor cell‐capturing sirolimus‐eluting Combo DES (n=25), polymer‐based everolimus‐eluting Absorb (n=44), and Mg‐based sirolimus‐eluting Magmaris BRS (n=34) underwent endothelium‐dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow‐up. Crude vasomotor responses of distal segments to low‐dose acetylcholine (10 −6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (−8.4%±12.6%) and durable‐polymer DES had the most physiologic (−0.4%±11.8%; P =0.014). High‐dose acetylcholine (10 −4 mol/L) showed similar responses between groups (ranging from −10.8%±11.6% to −18.1%±15.4%; P =0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable‐polymer DES) to 2.5%±4.5% (bioactive DES; P =0.056). In multivariate models, endothelium‐dependent vasomotor response was associated with age, bioresorbable‐polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low‐dose and 68.9% with high‐dose acetylcholine, without differences between groups. Conclusions At follow‐up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.

Clinical outcomes in percutaneous coronary interventions with polymer-free vs. durable-polymer stents: a metanalysis of randomized clinical trials

Background Polymer-free (PF) stents were designed as an alternative to durable-polymer (DP) drug-eluting stents to minimize the time on dual antiplatelet treatment for patients at high-risk of bleeding. Nonetheless, the efficacy and safety of PF vs. DP stents in patients undergoing percutaneous coronary intervention (PCI) remain controversial. Methods We performed a metanalysis with currently available studies that assessed the effect of PF-stents vs. DP-stents after performing a systematic search. The endpoints analyzed were all-cause death, myocardial infarction, target lesion revascularization (TLR) and probable or definite stent thrombosis. The raw numbers of incident end-points reported in each study were used. We performed analyses in short and long term (<1 or >1 year follow-up) studies. Results We included 12464 patients from 8 studies (5 short-term and 3 long-term): 6723 treated with PF-stents and 5741 with DP stents. Females represented 23.3% (n=3284) and 33.7% (n=4202) were included in the setting of acute coronary syndromes. As shown in the figure, PF-stents were associated to lower incidence of all-cause mortality (HR: 0.91 95% CI 0.84–0.98; p=0.016) and TLR (HR: 0.88 95% CI 0.80–0.96; p=0.003). No differences were observed in the risk of cardiovascular death (HR: 0.96 95% CI 0.86–1.06 p=0.415), myocardial infarction (HR: 0.90 95% CI 0.80–1.01; p=0.061) or probable-definite stent thrombosis (HR: 0.92 95% CI 0.74–1.14; p=0.447). Finally, no differences in the primary end-point (HR: 0.92 95% CI 0.83–1.03; p=0.143) were detected with PF-stents vs. DP-stents. No significant heterogenicity was observed in any of the endpoints, except for the incidence of stent thrombosis. Conclusions Under current PCI techniques the use of PF-stent might be associated to better outcomes, especially in terms of all-cause mortality and TLR. FUNDunding Acknowledgement Type of funding sources: None.

Early and chronic phased local coagulative responses following bioresorbable-polymer drug-eluting stent implantation

Background Neointimal maturation after bioresorbable-polymer (BP) drug-eluting stent (DES) implantation will not be complete in the absorption phase of the polymer. We have previously reported local persistent hypercoagulation after sirolimus-eluting stent (SES) implantation by measuring local plasma prothrombin fragment 1+2 (F1+2) levels. The aim of this study is to examine time-dependent local coagulative response after BP-DES implantation. Methods Sixty-four patients who were treated about ten months earlier with coronary angioplasty, with no evidence of restenosis, were studied [durable-polymer (DP)-DES {SES; Cypher®: 26pts and everolimus-eluting stent (EES); Xience®: 16pts} and BP-DES (BP-EES; Synergy®: 10pts and BP-SES; Ultimaster®: 12pts)]. We measured plasma levels of F1+2 sampled in coronary sinus (CS) and sinus of Valsalva (V) at the early (2±1 months) and chronic (10±2 months) phases. The transcardiac gradient (Δ) was defined as CS level minus V level. Results No significant differences were observed in the percent diameter stenosis between the DP- and BP- DES groups (11.5±15.5 vs 14.1±11.9%). The ΔF1+2 was significantly lower in the BP-DES group than in the DP-DES group at the chronic phase (7.5±16.1 vs 16.4±17.1pmol/l, p<0.05). In the BP-DES group, the ΔF1+2 did not differ significantly between the early and chronic phases (7.0±14.1 vs 7.5±16.1pmol/l, NS). Conclusion Lower local coagulative response was observed at the chronic phase after BP-DES implantation compared to DP-DES implantation, and local hypercoagulation after BP-DES implantation was not observed at the early phase compared to the chronic phase. These findings might lead to the possibility of shorter dual antiplatelet therapy after BP-DES implantation. FUNDunding Acknowledgement Type of funding sources: None.