‘Rota Regret’ Makes Training in High-Speed Rotablation A Necessity, for Interventionalists Dealing with Heavily Calcified Coronary Lesions High-Speed Rotational Atherectomy Versus Modified Balloons Before Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial. 

The results of PREPARE-CALC trial, presented at TCT 2018, have shown that among patients with severely calcified coronary lesions, the routine use of upfront high-speed rotational atherectomy (RA) increases stent deliverability compared with the use of balloon modification techniques such as scoring or cutting balloons (MB), with similar rates of angiographic late lumen loss and other clinical outcomes at 9 months. In his presentation in San Diego, the author, Dr. Gert Richardt emphasized that a strategy of provisional MB remained feasible, safe, and effective as long as bailout RA was readily available and offered the advantages of compatibility with smaller sized catheters and less irradiation.

Heavily calcified de novo coronary lesions are difficult lesions that need to be prepared using well-established techniques such as balloon dilatation or debulking, which are essential to allow successful stent implantation. Compared with standard balloon pre-dilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined. Keeping this in mind, Richardt and his colleagues aimed to assess the safety and efficacy of rotational atherectomy vs. cutting balloon angioplasty prior to stent implantation among patients with calcified coronary lesions.

A total of 200 German patients with documented myocardial ischemia and severely calcified native coronary lesions were randomized in a 1:1 ratio to either rotational atherectomy or balloon modification using either a scoring or a cutting balloon. This was followed by the implantation of the Orsiro sirolimus-eluting stent. The co-primary endpoints of the trial included strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). The total duration of follow-up was 9 months.

In this study, the investigators reported that the primary endpoint, strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3–39.7; P=0.0001). Additionally, at 9 months, 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). Lastly, secondary outcomes including target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups.

Richardt et al. concluded that among patients with severely calcified coronary lesions, the routine use of rotational atherectomy increased stent deliverability compared with the use of balloon modification techniques, but angiographic late lumen loss and other clinical outcomes were similar at 9 months. Highlighting the take-home message for practicing doctors, Dr. Gert Richardt remarked, “Depending on your experience and preference, you can do the heavily calcified lesions either with upfront rotablation electively or you can start with a balloon. But if you start with the latter, you have to be prepared for a crossover or a bailout situation (Rota regret). Either way, you have to be trained in the technique of rotational atherectomy.”

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