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Clinical and Angiographic Results With the Next-Generation Resolute Stent System

A Prospective, Multicenter, First-in-Human Trial

Ian T. Meredith, MBBS, PhD^_*,_*, Stephen Worthley, MBBS, Robert Whitbourn, MBBS, Darren L. Walters, MBBS, Dougal McClean, MD^||, Mark Horrigan, MBBS^¶, Jeffrey J. Popma, MD^#, Donald E. Cutlip, MD^_**, Ann DePaoli, DVM, Manuela Negoita, MD, Peter J. Fitzgerald, MD for the RESOLUTE Investigators

^_* Monash Heart Monash Medical Centre and University, Melbourne, Australia
Royal Adelaide Hospital, Adelaide, Australia
St. Vincent's Hospital, Melbourne, Australia
Prince Charles Hospital, Brisbane, Australia
^|| Christchurch Hospital, Christchurch, New Zealand
^¶ The Austin Health Medical Centre, Melbourne, Australia
^# Beth Israel Deaconess Medical Center, Boston, Massachusetts
^_** Harvard Clinical Research Institute, Boston, Massachusetts
Medtronic CardioVascular, Santa Rosa, California
Stanford University Hospital, Palo Alto, California

^_* Reprint requests and correspondence: Dr. Ian T. Meredith, Monash HEART and Monash University, Monash Medical Centre, 246 Clayton Road, Melbourne, Victoria, Australia (Email: ian.meredith{at}med.monash.edu.au).

Objectives: The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).

Background: Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.

Methods: The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters 2.5 and 3.5 mm and lesion length 14 and 27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.

Results: The 9-month in-stent late lumen loss was 0.22 ± 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 ± 7.83 mm³, and percent NIH volume obstruction was 3.73 ± 4.05%.

Conclusions: In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079)

Key Words: coronary artery disease • drug-eluting stents • zotarolimus

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   IVUS = intravascular ultrasound   LIA = late incomplete apposition   MACE = major adverse cardiac events   MI = myocardial infarction   MLD = minimal lumen diameter   NIH = neointimal hyperplasia   QCA = quantitative coronary angiography   TLR = target lesion revascularization   TVF = target vessel failure   TVR = target vessel revascularization   ZES = zotarolimus-eluting stent(s)

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