DESSOLVE III - DESSOLVE III

Feb 13, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
European Cardiovascular Research Institute, Micell Technologies, and Stentys
Date Published:
12/01/2017
Date Updated:
02/13/2018
Original Posted Date:
02/13/2018
References

Contribution To Literature:

The DESSOLVE III trial showed that a sirolimus-eluting bioresorbable polymer stent was noninferior compared with an everolimus-eluting durable polymer stent.

Description:

The goal of the trial was to evaluate a sirolimus-eluting bioresorbable polymer stent (MiStent) compared with an everolimus-eluting durable polymer stent (Xience) among patients undergoing percutaneous coronary intervention (PCI). The MiStent polymer degrades over approximately 3 months.

Study Design

  • Randomized
  • Parallel

Patients undergoing PCI were randomized to a sirolimus-eluting bioresorbable polymer stent (n = 703) versus an everolimus-eluting durable polymer stent (n = 695).

Inclusion criteria:

  • Patients at least 18 years of age undergoing PCI in a vessel 2.5-3.75 mm diameter
  • Total number of enrollees: 1,398
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 30%
  • Percentage with diabetes: 26%

Other salient features/characteristics:

  • Indication for PCI: ST-segment elevation myocardial infarction (STEMI) 15%, NSTEMI: 21%

Principal Findings:

The primary outcome, incidence of cardiac death, target-vessel MI, or clinically indicated target lesion revascularization at 12 months, occurred in 5.8% of the sirolimus-eluting stent group compared with 6.5% of the everolimus-eluting stent group (p = 0.57; pnon-inferiority = 0.0001). This finding was the same in numerous tested subgroups.

Secondary outcomes:

  • Target lesion revascularization: 3.4% vs. 4.1% (p = 0.48), respectively, for sirolimus vs. everolimus stents
  • Definite or probable stent thrombosis: 0.7% vs. 0.9% (p = 0.76), respectively, for sirolimus vs. everolimus stents
  • Stent dislodgement: 10 vs. 0, respectively, for sirolimus vs. everolimus stents

Interpretation:

Among patients undergoing PCI, the sirolimus-eluting bioresorbable polymer stent was noninferior compared with an everolimus-eluting durable polymer stent. Composite adverse events were similar between the groups. Stent thrombosis, which is an important device safety outcome, was similar between the groups. There were 10 stent dislodgements in the sirolimus stent group.

References:

de Winter RJ, Katagiri Y, Asano T, et al. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet 2018;391:431-40.

Keywords: Acute Coronary Syndrome, Absorbable Implants, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Polymers, Secondary Prevention, Thrombosis


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