Rotablation & Recent Clinical Trials: Key Findings in the DES Era

Johnson Francis | June 1, 2026 | General Cardiology | No Comments

Rotational atherectomy (RA), commonly known as rotablation, is a percutaneous coronary intervention (PCI) technique used to modify heavily calcified coronary lesions prior to balloon angioplasty and stent placement. Introduced in the late 1980s, it has remained a vital tool in the drug-eluting stent (DES) era for lesions that are undilatable or uncrossable with conventional balloons.

Mechanism of Action

Rotablation works on the principle of differential cutting. A diamond-coated, olive-shaped burr is advanced over a dedicated 0.009-inch guidewire and rotated at high speeds (typically 135,000 to 180,000 rpm) by a gas-driven turbine.

Because the burr is abrasive rather than a sharp blade, it selectively pulverizes inelastic, calcified atherosclerotic plaque into microparticles (smaller than red blood cells) that are washed away harmlessly by the microcirculation. It leaves adjacent elastic, healthy tissue unaffected because normal tissue deflects away from the spinning burr.

Indications and Current Practice

While early trials (like COBRA and STRATAS) evaluated RA as a primary “debulking” strategy, its modern role is strictly for plaque modification to facilitate optimal stent expansion. It is indicated for:

Heavily calcified lesions that cannot be crossed with a balloon or microcatheter.
Undilatable lesions where high-pressure balloon inflations fail to expand the vessel.
Ostial lesions or severely angulated segments with significant calcium burden.
Stent underexpansion (in specific off-label scenarios where conventional methods fail).

Recent Clinical Trials in the DES Era

Recent randomized controlled trials have focused on how best to use RA alongside modern drug-eluting stents and specialized balloons.

ROTAXUS Trial (2013)

Randomized 240 patients with complex calcified lesions to standard balloon predilatation versus RA followed by stenting. The trial found that RA resulted in higher acute procedural success (92.5% vs. 83.3%). However, it did not show a long-term reduction in clinical events and was associated with slightly higher late lumen loss at 9 months.

PREPARE-CALC Trial (2018)

Compared lesion preparation using modified balloons (cutting/scoring) versus upfront RA in 200 patients with severely calcified lesions. RA demonstrated superior strategy success (98% vs. 81%), primarily because 16% of the modified balloon group required crossover to RA due to uncrossable or undilatable lesions. Both strategies yielded comparable final stent expansion on Optical Coherence Tomography (OCT).

ROTA-CUT Trial (2024)

Investigated whether combining RA with cutting balloon angioplasty (RA+CBA) would yield better stent expansion than RA followed by non-compliant balloon angioplasty (RA+NCBA). Randomizing 60 patients, the trial found no significant difference in the primary endpoint of minimum stent area (MSA) by intravascular ultrasound (6.7 mm² for RA+CBA vs. 6.9 mm² for RA+NCBA). Both strategies proved safe and effective with minimal 30-day complications.

Technical Considerations and Safety

Operators generally utilize a “pecking” motion (gentle advancement and retraction) to prevent the burr from lodging and to allow continuous blood flow, which cools the device. A continuous flush solution containing lubricants, vasodilators (like nitroglycerin), and sometimes verapamil is used to prevent vasospasm and clear debris.

Potential complications include:

Slow-flow or no-reflow phenomenon: Caused by microvascular obstruction from calcific debris or thermal injury.
Vessel dissection or perforation: Risk increases with oversized burrs (the recommended burr-to-artery ratio is ≤ 0.6).
Transient AV block: Common during ablation of the right coronary or dominant circumflex arteries; temporary pacing may be required.
Burr entrapment: A rare but severe complication requiring surgical retrieval if it cannot be freed.

References

Abdel-Wahab, M., Toelg, R., Byrne, R. A., Geist, V., El-Mawardy, M., Allali, A., … & Richardt, G. (2018). High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions. Circulation: Cardiovascular Interventions, 11. https://doi.org/10.1161/circinterventions.118.007415 PREPARE-CALC Trial.
Allali, A., Abdel-Wahab, M., Elbasha, K., Mankerious, N., Traboulsi, H., Kastrati, A., … & Richardt, G. (2022). Rotational atherectomy of calcified coronary lesions: current practice and insights from two randomized trials. Clinical Research in Cardiology, 112, 1143-1163.
Barbato, E., Carrié, D., Dardas, P., Fajadet, J., Gaul, G., Haude, M., … & Latib, A. (2015). European expert consensus on rotational atherectomy. EuroIntervention, 11, 30-36.
Sharma, S. K., Mehran, R., Vogel, B., Hooda, A., Sartori, S., Hanstein, R., … & Moses, J. W. (2024). Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial. EuroIntervention, 20, 75-84.