Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2 - ISAR-DESIRE 2

May 11, 2010
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2009
Date Published:
01/01/2010
Date Updated:
05/11/2010
Original Posted Date:
05/11/2010
References

Description:

Although drug-eluting stents (DES) are routinely used for the treatment of in-stent restenosis (ISR), especially those resulting from prior bare-metal stent use, the most effective strategy for the treatment of ISR secondary to DES is unknown. The current trial sought to evaluate the anti-restenotic efficacy of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) in the treatment of ISR secondary to SES.

Hypothesis:

SES would be superior to PES in the treatment of ISR secondary to SES.

Study Design

  • Parallel

Patients Enrolled: 450
Mean Follow Up: 1 year
Mean Patient Age: 66.8 years
Female: 24

Patient Populations:

  • ISR with SES >50%
  • Symptoms or signs of ischemia

Exclusions:

  • Cardiogenic shock
  • Lesions in left main trunk or grafts
  • Acute MI
  • Malignancy or other comorbid conditions with life expectancy <12 months
  • Known allergy to study medications (sirolimus, paclitaxel)
  • Pregnancy (known, suspected, or planned)

Primary Endpoints:

  • Late lumen loss at 6-8 months

Secondary Endpoints:

  • Binary restenosis at 6-8 months
  • TLR at 1 year
  • Death, MI, or stent thrombosis at 1 year

Drug/Procedures Used:

In an open-label fashion, patients meeting enrollment criteria were randomized to receive either SES or PES.

Concomitant Medications:

All patients received dual antiplatelet therapy for 12 months.

Principal Findings:

A total of 450 patients were enrolled, 225 to SES and 225 to PES. Baseline characteristics were fairly similar between the two groups. About 36% were diabetics, and the majority of patients presented with stable angina (82%). The mean lesion length was 12.6 mm, and the mean vessel size was 2.77 mm. The morphology of ISR was defined as: focal body (36%), diffuse/proliferative (33%), focal margin (20%), multifocal (7%), and occlusive (4.1%). Procedural success was noted in 99.8% of the patients.

The primary endpoint of late lumen loss at 6-8 months was similar between the SES and PES arms, respectively (0.40 vs. 0.38 mm, p = 0.75). Similarly, binary restenosis was similar (19.0% vs. 20.6%, p = 0.69), as was target lesion revascularization (TLR) (16.6% vs. 14.6%, p = 0.52). Clinical endpoints were similar between the SES and PES arms at 12 months, including major adverse cardiac events (MACE) (20.4% vs. 19.6%, p = 0.71) and death, myocardial infarction (MI), or stent thrombosis (0.4% vs. 0.4%, p = 0.67). There were no episodes of stent thrombosis at 30 days in either arm. One episode of stent thrombosis was noted in both arms after 30 days.

Interpretation:

The results of this trial indicate that there is no difference in clinical or angiographic outcomes up to 1 year between SES and PES when used for ISR secondary to SES. Whether second-generation DES such as everolimus-eluting stents, which have been shown to have lower late lumen loss compared with PES would result in superior outcomes is unknown. Also, it is unknown what the optimal strategy should be in situations with ISR secondary to PES, which have been demonstrated to have a higher late lumen loss as compared with SES.

References:

Mehilli J, Byrne RA, Tiroch K, et al., on behalf of the ISAR-DESIRE 2 Investigators. Randomized Trial of Paclitaxel- Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents: The ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) Study. J Am Coll Cardiol 2010;May 10:[Epub ahead of print].

Presented by Dr. Robert Bryne at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2009), San Francisco, CA, September 23, 2009.

Keywords: Paclitaxel, Myocardial Infarction, Coronary Restenosis, Angina, Stable, Thrombosis, Drug-Eluting Stents, Immunosuppressive Agents, Sirolimus, Diabetes Mellitus, Stents


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