Comparison of Strategies to Prepare Severely Calcified Coronary Lesions - PREPARE-CALC

Sep 24, 2018
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Presenter/Author:
Gert Richardt, MD
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany
Date Presented:
09/24/2018
Date Published:
09/24/2018
Date Updated:
09/24/2018
Original Posted Date:
09/24/2018
References

Contribution To Literature:

The PREPARE-CALC trial showed that, among patients with severely calcified coronary lesions, the routine use of rotational atherectomy increases stent deliverability compared with the use of balloon modification techniques, but angiographic late lumen loss and other clinical outcomes were similar at 9 months.

Description:

The goal of the trial was to assess the safety and efficacy of rotational atherectomy vs. cutting balloon angioplasty prior to stent implantation among patients with calcified coronary lesions.


Study Design

Patients with severely calcified coronary lesions were randomized in a 1:1 fashion to either rotational atherectomy (n = 100) or balloon modification using either a scoring or a cutting balloon (n = 100). All patients received the Orsiro sirolimus-eluting stent.

  • Total number of enrollees: 200
  • Duration of follow-up: 9 months
  • Mean patient age: 75 years
  • Percentage female: 24%
  • Percentage with diabetes: 33.5%

Inclusion criteria:

  • Anginal symptoms and/or evidence of ischemia
  • De novo lesion in native coronary artery
  • Reference vessel diameter 2.25-4.0 mm
  • Luminal diameter reduction of 50-100%
  • Severe calcification of the target lesion

Exclusion criteria:

  • Myocardial infarction (MI) within 1 week
  • Decompensated heart failure
  • Target lesion in a coronary bypass
  • Target lesion in an in-stent restenosis
  • Thrombus in the target vessel

Other salient features:

  • Chronic kidney disease: 24%
  • Left main disease: 30%, multivessel disease: 72%
  • Left ventricular ejection fraction: 56%
  • Lesion length: 21 mm
  • Reference vessel diameter: 3.1 mm
  • Maximum burr size: 1.5 mm
  • Balloon predilation: 84.4% for rotational atherectomy vs. 75.2% for balloon modification

Principal Findings:

The primary endpoint, strategy success at the end of the procedure, for rotational atherectomy vs. balloon modification, was 98% vs. 81%, p = 0.0001, driven mostly by crossovers (0% vs. 16%, p < 0.0001).

The co-primary endpoint, late lumen loss at 9 months, was 0.22 vs. 0.16 mm, for rotational atherectomy vs. balloon modification (p = 0.01 for noninferiority, p = 0.21 for superiority).

Secondary outcomes for rotational atherectomy vs. balloon modification:

  • Procedural duration: 88.2 vs. 78.5 mm, p = 0.07; fluoroscopy time: 23.9 vs. 19.6 minutes, p = 0.03
  • In-stent restenosis at 9 months: 2.1% vs. 5.3%, p = 0.3
  • Target vessel revascularization: 3% vs. 8%, p = 0.21
  • All-cause mortality: 2% vs. 2%, p = 1.0
  • All MI: 2% vs. 3%, p = 1.0
  • Stent thrombosis: 0%

Interpretation:

The results of this trial indicate that, among patients with severely calcified coronary lesions, the routine use of rotational atherectomy increases stent deliverability compared with the use of balloon modification techniques, but angiographic late lumen loss and other clinical outcomes were similar at 9 months. Of note, unlike the older rotational atherectomy trials, the burr size was sized for lesion modification alone (not 1:1), thus dissections and perforations were lower than reported in those trials.

References:

Abdel-Wahab M, Toelg R, Byrne RA, et al. High-Speed Rotational Atherectomy Versus Modified Balloons Before Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial. Circ Cardiovasc Interv 2018;Sep 24:[Epub ahead of print].

Presented by Dr. Gert Richardt at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 24, 2018.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Stable Ischemic Heart Disease, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and Imaging, Angiography, Nuclear Imaging, Chronic Angina

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angina Pectoris, Angiography, Angioplasty, Balloon, Coronary, Atherectomy, Coronary, Coronary Angiography, Coronary Restenosis, Drug-Eluting Stents, Geriatrics, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Stents, Thrombosis


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