Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents.

BACKGROUND: The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY. METHODS: Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203). RESULTS: The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%. CONCLUSIONS: SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.

Safety and efficacy of a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: the EVOLVE II diabetes substudy.

AIMS: Bioabsorbable polymer drug-eluting stents (DES) may reduce the inflammation and delayed healing associated with some permanent polymer-coated DES. Whether late clinical outcomes are improved, particularly among patients with medically treated diabetes, is unknown. Therefore, we analysed outcomes from a pre-specified substudy of the EVOLVE II trial to evaluate the safety and effectiveness of the SYNERGY stent in patients with diabetes mellitus. METHODS AND RESULTS: SYNERGY is a thin-strut, platinum-chromium everolimus-eluting stent with an ultra-thin bioabsorbable poly(DL-lactide-co-glycolide) abluminal polymer. The EVOLVE II randomised, controlled trial proved the non-inferiority of the SYNERGY versus the PROMUS Element Plus stent for one-year target lesion failure (TLF: ischaemia-driven target lesion revascularisation [ID-TLR], target vessel myocardial infarction [TVMI], or cardiac death). The pre-specified EVOLVE II diabetes substudy prospectively pooled randomised patients with diabetes (N=263) with a sequential single-arm diabetic cohort (n=203). The substudy primary endpoint was one-year TLF compared with a pre-specified performance goal (14.5%). The primary endpoint occurred in 7.5% of SYNERGY-treated patients with diabetes, significantly less than the performance goal (p<0.0001). The two-year rate of TLF was 11.2% (cardiac death 1.5%, TVMI 6.4%, ID-TLR 6.8%) and definite/probable stent thrombosis occurred in 1.1% of patients. CONCLUSIONS: The EVOLVE II diabetes substudy demonstrates the efficacy and safety of the SYNERGY stent in patients with medically treated diabetes.

Unprotected left main disease managed with drug-eluting stents: long-term outcome of 100 patients with increased surgical risk.

OBJECTIVES: The purpose of this study was to determine long-term clinical outcomes in high surgical risk patients (pts) with unprotected left main (ULM) disease who were managed with drug-eluting stents (DES). BACKGROUND: The long-term efficacy of unprotected left main (ULM) stenting with DES remains uncertain. METHODS: From June 2003 to December 2005, 100 pts with increased surgical risk underwent ULM stenting with DES. Patient risk was estimated by EuroSCORE. Disease was confined to the ostium/main stem in Group A (31 pts) and involved the bifurcation in Group B (69 pts). Study endpoints were MI, TVR, and death. RESULTS: Mean age was 68 +/- 1 years, EF 52 +/- 1%. Mean EuroSCORE was 5.2 +/- 0.4, and 41% pts had a EuroSCORE of >6. In Group A, 87% of lesions were directly stented. In Group B, 61% of pts received one stent and 39% received two stents. Primary success was 95%. Follow-up data (mean 28 +/- 1 months) were obtained in all patients. Restenosis occurred at the proximal stent margin in 5/9 pts. There were 12 cardiac deaths (88% cardiac survival) and 9 noncardiac deaths (79% total survival). In Group B, 5 pts died suddenly: 3 within the first week and 2 additional pts after 1 year. Sudden death did not occur in Group A. All cause event-free survival was 65% in Group A and 67% in Group B. CONCLUSION: A substantial number of late adverse events occurred in both ostial and bifurcation groups with equal frequency. Until definitive data from randomized trials are available, ULM stenting should be performed only in patients with prohibitive surgical risk.

Technique of left main stenting is dependent on lesion location and distal branch protection.

The purpose of this study was to review our experience with left main stenting and evaluate initial results with drug-eluting stents (DESs). Drug-eluting stents delivered with contemporary techniques could change the traditional surgical approach to patients with significant left main disease. One hundred sixty-one patients underwent left main stenting (100 bare metal, 61 drug-eluting) after being excluded from surgery. In group A, disease was confined to the ostium or main stem; in group B, disease involved the bifurcation. Patients were classified as either unprotected (U) or protected (P) depending on the presence of a patent bypass graft. Study endpoints were any major adverse cardiac event (MACE). In-hospital MACE was 6% with no deaths; 74% of patients in group A underwent direct stenting, whereas 89% of the patients in group B had predilatation performed prior to stent implantation. A total of 98% of patients in BU had kissing balloon inflations after stent deployment; provisional side-branch stenting was required in one patient. V-stenting was performed in 13% of patients in group BU. The 1-year mortality in the bare metal stent group was 9% with the majority of deaths in group BU. There was one noncardiac death in the DES group at 6 months and five patients (8.2%) underwent target vessel revascularization for restenosis. Event-free survival at 6 months in group BU treated with DESs was 87%. Significant left main disease presents a spectrum of angiographic abnormalities and different interventional techniques are required depending on lesion location and distal protection. Although in-hospital complications with left main stenting were low in this single-center study, follow-up events were common in patients treated with bare metal stents. A randomized multicenter trial will be required to determine whether drug-eluting stents will improve survival in patients with left main disease.