First-in-human evaluation of a bioabsorbable polymer-coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I Trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries).
OBJECTIVE
This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.


BACKGROUND
Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.


METHODS
We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up.


RESULTS
The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction.


CONCLUSIONS
At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428).
Mercy Angiography Unit, Auckland, New Zealand; Auckland City Hospital, Auckland, New Zealand. Electronic address: johno@mercyangiography.co.nz.
John
J
Ormiston
Mark
M
Webster
James
J
Stewart
Mathias
M
Vrolix
Robert
R
Whitbourn
Dennis
D
Donohoe
Charlene
C
Knape
Alexandra
A
Lansky
Guilherme F
GF
Attizzani
Peter
P
Fitzgerald
David E
DE
Kandzari
William
W
Wijns
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D060050:Angina, Stable / Q000175:diagnosis / Q000628:therapy; D000789:Angina, Unstable / Q000175:diagnosis / Q000628:therapy; D001315:Australia; D001530:Belgium; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002858:Chromium Alloys; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D003331:Coronary Vessels / Q000187:drug effects / Q000473:pathology; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D058426:Neointima; D009520:New Zealand; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011108:Polymers; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D020123:Sirolimus / Q000008:administration & dosage*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D002317:Cardiovascular Agents; D002858:Chromium Alloys; D010975:Platelet Aggregation Inhibitors; D011108:Polymers; D020123:Sirolimus
AP; APSES; BMS; CI; DAPT; DES; ISA; IVUS; LLL; MACE; MI; MLD; OCT; QCA; SES; ST; TLR; TVR; absorbable polymer; absorbable polymer(s); absorbable polymer-coated, sirolimus-eluting stent(s); bare-metal stent(s); confidence interval; coronary artery disease; coronary stent(s); drug-eluting stent(s); dual antiplatelet therapy; incomplete stent apposition; intravascular ultrasound; late lumen loss; major adverse cardiac event(s); minimal lumen diameter; myocardial infarction; optical coherence tomography; percutaneous coronary intervention; quantitative coronary angiography; sirolimus-eluting stent; sirolimus-eluting stent(s); stent thrombosis; target lesion revascularization; target vessel revascularization