Stent sub-expansion in coronary territory has been identified as one of the major predictors of stent failure at followup, which is why improving stent expansion will improve clinical and imaging outcomes.
In percutaneous coronary interventions (PCI) of severely calcified lesions, calcified lesions present a major challenge since they impede stent delivery, causing stent under-expansion or mal apposition.
Among treatment options, there is rotational atherectomy (RA). There are also those depending on barometric pleasure (high pressure balloons) and also mechanical methods for plaque rupture, such as modified balloons, among them scoring or cutting balloons, or fragmentation methods with ultrasound such as Shockwave.
The combination of two techniques with different plaque modifying mechanisms might have synergic effect and improve patency outcomes.
The aim of this study called PREPARE-CALC-COMBO, was the angiographic and OCT assessment of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut) prior stenting.
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This is a prospective single arm study carried out in a high-volume center in Germany including patients with documented ischemia and severely calcified lesions.
Primary end point was in-stent acute lumen gain (ALG) by quantitative angiographic analysis and co-primary end point was stent expansion (SE) on optical coherence tomography.
Mean age of patients receiving Rota-Cut was 74.9±8.2 years. 78.2% were men and 30.9% were diabetic. 91% of patients had acute coronary syndrome, with good ejection fraction in most cases.
Primary end point of ALG was significantly higher with Rota-Cut (1.92±0.45mm) compared against the control group with MB (1.74±0.45mm; p=0.001) and RA (1.70±0.42mm; p<0.001).
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OCT data were obtained from 69% of procedures, and the co-primary end point was comparable between patients receiving Rota-Cut and individual procedures (75.1±13.8% vs 73.5±13 with MB and 73.1±12.2 with RA). However, when looking at other measurements, Rota-Cut rendered a significantly larger minimal stent area (7.1±2.2 vs 6.1±1.7mm; p=0.003).
When looking at procedure safety, there was longer fluoroscopy time and more contrast, higher >5mm dissection rate, with no increase in events such as perforation or pericardial effusion.
Conclusions
Primary end point of ALG was higher among the Rota-Cut patients vs RA or MB alone. Also, there was increased MSA, with no significant difference in stent expansion.
This lumen gain supports the idea of a synergic effect of two combined strategies, independent of the observed magnitude that might have been modest. These data help take into account this combination as a viable and safe alternative.
Dr. Omar Tupayachi.
Member of the editorial board of SOLACI.org.
Reference: Allali, Abdelhakim et al. “Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.” Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions vol. 100,6 (2022): 979-989. doi:10.1002/ccd.30423.
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