Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: two-year angiographic and three-year clinical results from the SPIRIT II study.

BACKGROUND: Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions. METHODS: The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed. RESULTS: The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). CONCLUSIONS: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material.

The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels: a European Registry (FASTER) was designed to demonstrate that (1) the Proxis embolic protection system can control anterograde flow and reverse blood flow in native coronary arteries and saphenous vein grafts; and (2) this system can capture embolic debris. Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease, but is associated with the risk of major adverse cardiac events. This prospective, nonrandomized, multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection (Proxis system). Proxis was successfully used 95% of the time, and embolic debris was qualitatively identified in all cases. Major adverse cardiac events occurred in 2 patients (5.0%): 1 late in-stent thrombosis resulting in death and 1 non-Q-wave infarction when a lesion was crossed before deployment of the Proxis system. Mean vessel occlusion time was 4.3 +/- 2.4 minutes. Native flow reversal was sufficient in 31 patients, with a mean aspirate volume of 11.8 +/- 6.5 ml. When the infusion catheter was used to augment reflow, mean occlusion time was 4.6 minutes. In conclusion, this trial is the first to demonstrate that retrograde blood flow can be achieved during proximal occlusion and that the Proxis system can be used safely during intervention of saphenous vein grafts and native coronary arterial lesions to capture embolic material.

Six-month clinical and angiographic results of the STENTYS® self-apposing stent in bifurcation lesions.

AIMS: We report the clinical and angiographic results of the OPEN I study, a multicentre prospective single-arm study evaluating both the drug-eluting and bare metal STENTYS® stents in the treatment of coronary bifurcation lesions. METHODS AND RESULTS: The STENTYS® stent is a provisional, self-expanding, nitinol stent with small interconnections that can be disconnected by balloon angioplasty in between the stent struts to provide access to the side branch (SB) and full ostium coverage. In nine European centres, 60 stents (33 BMS, 27 DES) were implanted in 63 patients (procedural success of 95.2%). Angiographic QCA and IVUS were used to measure acute gain and late loss. The Medina classification showed 35 patients (58%) had disease affecting the SB (true bifurcations) and 19 patients (32%) had disease in all three arms. The average bifurcation angulation pre-stenting was 60°±21°. Post-stenting, disconnection was performed on 90% of the stents implanted. In 18 cases, disconnection was followed by SB stenting with all SB stents successfully implanted. Post-stenting, the bifurcation angle was 51°. The primary clinical endpoint, cumulative MACE at six months, was low for DES (3.7%) but higher for BMS (27.3%) with the latter driven exclusively by clinically-driven TLR rates (3.7% vs. 24.2%). No cardiac deaths were recorded at six months and one patient had a non-Q wave infarct. The secondary angiographic endpoint of late luminal loss (LLL) was measured for both DES (paclitaxel) and BMS stents in the proximal main branch (MB), MB, distal MB as well as the SB. The values for DES were 0.39 mm, 0.42 mm, 0.40 mm and 0.16 mm, respectively. The values for BMS were 0.86 mm, 0.87 mm, 0.85 mm and 0.54 mm, respectively. Observed results using matched IVUS analysis at six months revealed an increase in mean stent area (mm²) for DES from 7.52±1.86 at baseline to 12.32±2.90 at six month follow-up (p <0.001); and for BMS from 7.95±1.40 to 11.56±2.22 (p <0.001), with no decrease in minimum lumen area (MLA) for DES (5.10 to 4.91) and a minimal decrease for BMS (5.74 to 5.15). CONCLUSIONS: This first-in-man (FIM) study on the STENTYS® stent showed excellent procedural success and a relatively low MACE with competitively low LLL in both MB and SB at six months for the DES version and LLL comparable to other BMS for the BMS version. The disconnectable struts offered excellent "cross over" to T- stenting when necessary and the increased gains in stent area over time.

First-in-man (FIM) study of the Stentys bifurcation stent--30 days results.

AIMS: We report the acute and 30 day results of the OPEN I study, a multicentre prospective single arm study evaluating the safety and feasibility of the Stentys bifurcation stent. METHODS AND RESULTS: The Stentys stent is a provisional, self-expanding nitinol drug eluting or bare metal stent with small interconnections that can be disconnected by balloon angioplasty to provide access to the side-branch and full ostium coverage. Forty patients with de novo coronary bifurcation lesions were enrolled to be clinically followed-up over four years. In addition to angiographic QCA evaluation, documentary IVUS and/or OCT were used in all cases to assess the stent's deployment. The patient population consisted of 85% males with an average age of 62 years. Almost half had previous PCI, 31% previous MI and 5% previous CABG. The majority of lesions (80%) involved the LAD-D, 42% of the patients had disease affecting the side-branch, with all three arms diseased in 24% of the cases. The average lesion length in the main branch was 12.95 +/- 3.63 mm with a bifurcation angle of 55 degrees (range 30 degrees - 80 degrees). Procedural success was achieved in 39/40 cases (95.5%) due to inability to track the stent in one patient with an extremely tortuous vessel. In total 6 (15%) paclitaxel eluting and 33 (85%) BMS Stentys stents were successfully implanted, and simple disconnection of the stent mesh overlying the SB ostium was achieved in 37/39 cases (94.9%); in two cases, disconnection was not attempted. The MACE at 30 days was 5.1% as a result of one non Q-wave MI following the procedure and one ischemia-driven revascularisation six days after the procedure. CONCLUSIONS: This first-in-man (FIM) study demonstrates that the Stentys stent is safe and feasible resulting in an excellent procedural success rate and a low MACE rate. The struts can be easily and safely disconnected to perform provisional stenting.

A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial.

BACKGROUND: Everolimus has been successfully tested in humans using both an erodable and a durable polymer in small previous studies. METHODS: This single blind multi-centre non-inferiority randomised (3:1) controlled trial evaluated the safety and performance of the XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) versus the TAXUS Paclitaxel Eluting Coronary Stent System (TAXUS(R) PECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different epicardial vessels. Three hundred patients with evidence of myocardial ischaemia were allocated to stent implantation with an everolimus-eluting stent (n=223) or a paclitaxel-eluting stent (n=77). Suitable lesions had a diameter stenosis of <50-99%, a length of <28 mm, and a reference vessel diameter between 2.5 mm and 4.25 mm. The primary endpoint was in-stent late loss (LL) at 180 days. Percentage in-stent volume obstruction (%VO) was measured by intravascular ultrasound (IVUS) in a subset of 152 patients. Clinical secondary endpoints included ischaemia driven major adverse cardiac events (ID-MACE) at 180 days. RESULTS: At 6 months, the in-stent LL was 0.11+/-0.27 mm in the everolimus-eluting stent arm, as compared to 0.36+/-0.39 mm in the paclitaxel-eluting stent arm (p<0.0001). Percentage VO in the everolimus-eluting stent arm was 2.5+/-4.7% versus 7.4+/-7.0% in the paclitaxel-eluting stent arm (p<0.0001). Hierarchical MACE was 2.7% (6/222) in the everolimus-eluting stent arm vs. 6.5% (5/77) in the paclitaxel-eluting stent arm. CONCLUSION: This non-inferiority randomised trial not only met its primary endpoint, but also demonstrated the superiority of the everolimus-eluting stent over the paclitaxel-eluting stent in terms of in-stent late loss.