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DESSOLVE I: Bioabsorbable Polymer SES Shows Promise in De Novo Lesions

By Yael L. Maxwell

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A novel bioabsorbable-polymer sirolimus-eluting stent shows low, stable in-stent late lumen loss, complete strut coverage and good safety results in patients with de novo lesions at 18 months, according to a study published online September 18, 2013, in JACC: Cardiovascular Interventions.

For DESSOLVE I (DES with Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients with De Novo Lesion in the Native Coronary Arteries), John Ormiston, MB, ChB, of Mercy Hospital (Auckland, New Zealand), and colleagues enrolled 30 patients with symptomatic coronary artery disease (CAD) with stable or unstable angina and > 50% diameter stenosis, amenable to coverage with at least a 23-mm stent in a vessel 2.5-3.5 mm in diameter. All patients were implanted with the MiStent (Micell Technologies, Durham, NC), a cobalt-chromium device with thin struts coated with sirolimus in a fully absorbable polymer, at 5 centers in New Zealand, Belgium, and Australia between November 2010 and March 2011.

The population was split into 3 subgroups of 10 patients each and examined at 4, 6, and 8 months postimplantation, respectively, with repeat angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT). All patients also underwent follow-up at 18 months.

Safety, Efficacy Demonstrated

Throughout follow-up, late loss was low and steady, and minimal lumen diameter (MLD) and percent diameter stenosis both improved (table 1).

Table 1. QCA Results

Median Values

4 Months
(n = 10)

6 Months
(n = 10)

8 Months
(n = 10)

18 Months
(n = 27)

Reference Vessel Diameter, mm

2.8

2.9

2.9

2.9

MLD, mm
In-Stent
In-Lesion


 2.7
2.5


 2.9
2.5


 2.8
2.6


 2.7
2.5

% Diameter Stenosis
In-Stent
In-Lesion


5.6%
12.0%


3.1%
12.6%


6.9%
10.5%


6.1%
16.2%

Late Loss, mm
In-Stent
In-Lesion


0.03
-0.06


0.10
0.02


0.08
-0.02


0.08
0.04

 
The 18-month cumulative in-stent and in-lesion binary restenosis rates were 0.

IVUS in 27 patients found edge dissection and incomplete stent apposition in 4% and 15% of patients, respectively. There was an increase in neointimal obstruction at 8 months, with no further progression at 18 months.

“These IVUS observations were consistent with significant neointimal suppression and a favorable persistent arterial response at 18 months, without late in-stent neointimal ‘catch-up’ phenomenon,” Dr. Ormiston and colleagues write.

On OCT, the median proportion of uncovered stent struts decreased over time from 7% at 4 months to 0 at 18 months.

All patients were prescribed dual antiplatelet therapy after implantation including aspirin, clopidogrel, ticlopidine, or prasugrel, and 73% continued for 12 months. After 18 months, there was no death or stent thrombosis, but 1 patient reported a non-Q-wave MI at 44 days. Cumulative MACE was 3.3%.

Comparable to Available Options

The study confirms “preliminary safety and efficacy,” according to the authors, and findings like no late ‘catch up,’ and stable late loss and neointimal volume and thickness are in contrast to results with “many other SESs.”

MiStent is “at least as effective as the durable polymer-based SES, or newer generation bioabsorbable polymer and bioabsorbable stent platforms,” Dr. Ormiston and colleagues continue. “The antiproliferative efficacy and, in particular, the safety of the stent require confirmation in a larger randomized trial, which has already commenced.”

 

Source:
Ormiston J, Webster M, Stewart J, et al. 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). J Am Coll Cardiol Intv. 2013;Epub ahead of print.

 

 

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Disclosures
  • Dr. Ormiston reports receiving consulting/educational honoraria and research/grant support from Abbott Vascular and Boston Scientific.

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