A Prospective Randomized Trial of Sirolimus-Eluting Stents Compared to Balloon Angioplasty for Restenosis of Drug-Eluting Coronary Stents - CRISTAL

Sep 25, 2010
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Cordis Clinical Research, Waterloo, Belgium
Date Presented:
01/01/2010
Date Updated:
09/25/2010
Original Posted Date:
09/25/2010
References

Description:

Although the incidence of in-stent restenosis (ISR) has been significantly reduced with drug-eluting stents (DES), the optimal strategy for treating DES-ISR is unclear. The CRISTAL trial sought to compare outcomes after repeat DES implantation versus balloon angioplasty alone in the treatment of DES-ISR.

Hypothesis:

Repeat DES implantation for DES-ISR would be superior to percutaneous transluminal coronary angioplasty (PTCA) alone in the treatment of DES-ISR.

Study Design

  • Blinded
  • Parallel
  • Randomized

Patient Populations:

  • ISR in previously placed PES or SES

    Number of enrollees: 197
    Duration of follow-up: 12 months
    Mean patient age: 68 years
    Percentage female: 29%

Primary Endpoints:

  • In-stent late luminal loss at 9 months

Secondary Endpoints:

  • Angiographic: MLD pre, MLD post, acute gain, MLD at follow-up, net gain (acute gain–late loss)
  • Clinical: death (cardiac, noncardiac)
  • MI (Q, non-Q)
  • TLR, target vessel revascularization (clinically driven)
  • Stent thrombosis
  • Procedural success rates

Drug/Procedures Used:

In a stratified analysis, patients presenting with restenosis within previously placed sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) were randomized to either implantation of a Cypher Select SES or repeat PTCA alone in a 2:1 fashion. Patients presenting with bare-metal stent (BMS) ISR received an SES only, and were also included in the analysis.

Principal Findings:

A total of 197 patients were randomized, 136 to DES (SES and PES) and 61 to PTCA. Baseline characteristics were fairly similar between the two arms. About 39% had diabetes mellitus, 24% had a history of myocardial infarction (MI), and 9% had undergone prior coronary artery bypass grafting (CABG). The mean reference vessel diameter was 2.5 mm, with a mean lesion length of 14 mm. About 10% of these lesions were bifurcation lesions. Preprocedural minimal in-segment luminal diameter (MLD) at baseline was 1.1 mm.

Post-procedure MLD was significantly higher in the DES arm (2.5 vs. 2.1 mm, p < 0.0001). This was sustained at 9-12 months of follow-up (2.1 vs. 1.7 mm, p < 0.0001). Acute gain was higher in the DES arm (1.4 vs. 0.9 mm, p < 0.0001), as was net gain at the end of follow-up (1.1 vs. 0.5 mm, p < 0.0001). Clinical endpoints at the end of 1 year were similar, including cardiac death (0.7% vs. 1.6%, p = 0.52), Q-wave MI (0.7% vs. 0%, p = 1.0), clinically driven target lesion revascularization (TLR) (5.9% vs. 13.1%, p = 0.10), and stent thrombosis (0.7% vs. 0%, p = 1.0).

Interpretation:

The results of the CRISTAL trial indicate that DES implantation is superior to PTCA alone in the treatment of DES and BMS-ISR for angiographic outcomes; clinical outcomes at 12 months were similar. SES reimplantation seems to be effective in both SES- and PES-ISR. These results are in some ways similar to those noted in the ISAR-DESIRE 2 trial, in which SES and PES implantation showed similar outcomes after SES-ISR.

Trials such as PEPCAD II have compared PES implantation to the use of paclitaxel-coated balloons in the treatment of BMS-ISR, and demonstrated superior angiographic, but similar clinical outcomes. Further trials comparing second-generation DES to second-generation drug-coated angioplasty balloons for DES-ISR are awaited.

References:

Presented by Dr. Bernard Chevalier at the Transcatheter Cardiovascular Therapeutics Meeting (TCT 2010), Washington, DC, September 25, 2010.

Keywords: Paclitaxel, Myocardial Infarction, Follow-Up Studies, Metals, Thrombosis, Drug-Eluting Stents, Replantation, Sirolimus, Coronary Artery Bypass, Angioplasty, Balloon, Coronary, Diabetes Mellitus


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