Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design.

INTRODUCTION: Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance. MATERIALS AND METHODS: PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years. DISCUSSION: PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.

Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions).

OBJECTIVES: This study sought to evaluate procedural and clinical outcomes among patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI) using contemporary methods and everolimus-eluting stents (EES). BACKGROUND: Limited studies have detailed the procedural and late-term safety and efficacy of CTO revascularization among multiple centers applying modern techniques and with newer-generation drug-eluting stents. METHODS: Among 20 centers, 250 consecutive patients were enrolled for attempted CTO PCI. Procedural and in-hospital clinical outcomes were examined in addition to the 1-year primary endpoint of death, myocardial infarction, and target lesion revascularization (major adverse cardiac events [MACE]). RESULTS: Demographic, lesion, and procedural characteristics included prior bypass surgery: 9.9%; diabetes: 40.1%; lesion length: 36.1 ± 18.5 mm; and stent length: 51.7 ± 27.2 mm. Procedural success, defined as guidewire recanalization with no in-hospital MACE, was 96.4%. Success with antegrade-only methods was 97.9% and 86.2% by retrograde/combined methods, respectively. Compared with a pre-specified performance goal derived from 6 prior CTO drug-eluting stent trials (1-year MACE: 24.4%), treatment with EES was associated with significantly lower composite adverse events for both intent-to-treat (18.5%, 1-sided upper confidence interval: 23.4%, p = 0.025) and per-protocol populations (8.2%, 1-sided upper confidence interval: 12.3%, p < 0.0001). Target lesion revascularization at 1 year was 6.3%. Dual antiplatelet therapy adherence was 53.9% at 1 year, yet subacute definite stent thrombosis occurred in only 2 patients (0.9%), and late probable stent thrombosis occurred in 1 patient (0.5%). CONCLUSIONS: In a multicenter registration trial representing contemporary technique and EES, favorable procedural success and late-term clinical outcomes support CTO PCI in a patient population with high lesion complexity. (EXPERT CTO: Evaluation of the XIENCE PRIME LL and XIENCE Nano Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions; NCT01435031).

Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the TriMaxx trial.

BACKGROUND: The TriMaxx coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. OBJECTIVES: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. METHODS: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 x 15 or 3 x 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. RESULTS: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 +/- 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 +/- 0.57 mm. CONCLUSIONS: These results demonstrate that the TriMaxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.

Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the triMaxx trial

Background: The TriMaxxTM coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. Objectives: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. Methods: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 3 15 or 3 3 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. Results: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 6 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 6 0.57 mm. Conclusions: These results demonstrate that the Tri-Maxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.