High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial

Allali, Abdelhakim; Richardt, Gert; Elbasha, Karim; Sulimov, Dmitriy S.; Kastrati, Adnan; Geist, Volker; El-Mawardy, Mohamed; Rheude, Tobias; Abdel‐Wahab, Mohamed

doi:10.4244/eij-d-22-00677

Cited by 5 publications

(4 citation statements)

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“…The 2-year outcome results of the randomized PREPARE-CALC revealed higher rates of TVR (TVR and target lesion failure) in patients treated with a cutting or scoring balloon compared with our findings (20% vs. 9%, respectively) (22). The rates of AMI were comparable (5% vs. 4%).…”

Section: Follow-up Analysescontrasting

confidence: 57%

“…Severe lesion calcification leads to stent underexpansion and has been reported as a predictor of worse outcome in patients with coronary artery calcification ( 5 – 7 , 20 ). Studies, particularly randomized trials, that compare the performance of devices in calcified lesions are scarce ( 11 , 21 , 22 ). The reported angiographic success rates vary widely and depend on the chosen strategy, which may include preparation of the lesion before stent implantation by super high-pressure balloon, MB, IVL, or rotational atherectomy devices; success rates between 78% and 99% have been reported ( 5 , 16 , 21 , 23 – 26 ).…”

Section: Discussionmentioning

confidence: 99%

“…Severe lesion calcification leads to stent underexpansion and has been reported as a predictor of worse outcome in patients with coronary artery calcification (5)(6)(7)20). Studies, particularly randomized trials, that compare the performance of devices in calcified lesions are scarce (11,21,22).…”

Section: Discussionmentioning

confidence: 99%

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Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

Leick

Rheude

Denne

et al. 2023

Front. Cardiovasc. Med.

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BackgroundThe aim of this two-center, all-comers registry was to compare the effectiveness and safety of intravascular lithotripsy (IVL) to that of modified balloon angioplasty (MB). MB angioplasty using a cutting or scoring balloon is commonly used in patients with calcified coronary arteries. IVL is a new technology for lesion preparation. This is the first study to compare MB with IVL.MethodsThe cohort included all patients treated by MB angioplasty or IVL between 2019 and 2021. The primary endpoint was strategy success (<20% residual stenosis). The secondary endpoint was long-term safety outcomes [cardiac death, acute myocardial infarction (AMI), target lesion failure/revascularization (TVR)]. Quantitative coronary angiography (QCA) was performed in all patients. Primary and secondary endpoints were compared using inverse probability of treatment weighting (IPTW) for treatment effect estimation.ResultsA total of n = 86 patients were treated by IVL and n = 92 patients by MB angioplasty. The primary endpoint was reached in 152 patients (85.4%). Patients in the IVL group had less residual stenosis (5.8% vs. 22.8%; p = 0.001) in QCA. Weighted multivariable regression analysis revealed that IVL had a significant positive effect on reaching the primary endpoint of strategy success [odds ratio (OR) 24.58; 95% confidence interval (95% CI) 7.40–101.86; p = 0.001]. In addition, severe calcification was shown to result in a lower probability of achieving the primary endpoint (OR 0.08; 95% CI 0.02–0.24; p = 0.001). During the follow-up period (450 days) there was no difference in cardiovascular mortality rate [IVL (n = 5) 2.8% vs. MB (n = 3) 1.7%; p = 0.129]. Patients with unstable angina at the time of the index procedure had the highest probability of cardiovascular death [hazard ratio (HR) 7.136; 95% CI 1.248–40.802; p = 0.027]. No differences were found in long-term rates of AMI (IVL 1.7% vs. MB 2.8%; p = 0.399; IVL HR 2.73; 95% CI 0.4–17.0; p = 0.281) or TVR (IVL 5.6% vs. MB 9%; p = 0.186; IVL HR 0.78; 95% CI 0.277–2.166; p = 0.626).ConclusionIVL leads to a significantly better angiographic intervention outcome compared to MB angioplasty in our cohort. During long-term follow-up, no differences in cardiovascular mortality, rate of acute myocardial infarction, or target lesion failure/revascularization were observed.

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Section: Follow-up Analysescontrasting

confidence: 57%

Section: Discussionmentioning

confidence: 99%

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Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

Leick

Rheude

Denne

et al. 2023

Front. Cardiovasc. Med.

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“…More recently, the PREPARE-CALC study randomized 200 patients with severely calcified lesions to RA vs. angioplasty with cutting/scoring balloon. The results demonstrate that RA is superior in terms of procedural success compared to the cutting/scoring balloon strategy (98% vs. 81%) with shorter fluoroscopy times, but both strategies guarantee an excellent result at 9 months in terms of angiographic late loss and new incidence of revascularizations [69] . These data were confirmed at 2-year follow-up [70] and underscored the importance of the combination of operators' experience, intravascular imaging guidance and excellent DES performance to obtain optimal long-term results in treating patients with severely calcified lesions.…”

Section: Randomized Evidence Supporting Rotational Atherectomymentioning

confidence: 93%

Severely calcified coronary artery lesions: focus on interventional management

Andò¹,

Alagna²,

Rosa³

et al. 2023

Vessel Plus

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Severe coronary artery calcifications remain a challenge for the contemporary interventional cardiologist in the light of the growing demand for diagnostic procedures and interventions in elderly patients; in addition, the general prognostic improvement after percutaneous coronary intervention (PCI) is expanding the indications to PCI to increasingly complex anatomies. In the last decade, a renewed interest in the treatment of calcific lesions has been observed, with the aim to optimize the mechanic effects of balloon angioplasty and the expansion and apposition of DES to the vessel wall. However, patients with calcific coronary artery disease represent a subset with a high risk of adverse outcomes, both intra-procedural and in the long-term. The need to guarantee a targeted and tailored treatment based on the coronary anatomy of any individual patient is a current priority of the interventional community. The efficacy of rotational atherectomy in improving procedural success for the treatment of calcified lesions has been widely demonstrated. The advent of new technologies -especially of intravascular lithotripsy (IVL)-, the application of techniques and materials initially developed for as complex procedures as chronic total occlusions (CTO), the increasing experience of contemporary operators and the introduction of latest generation drug-eluting stents (DES) with excellent technical and structural properties, are further contributing to improving outcomes of current PCI for calcific lesions.

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Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial

Mankerious,

Richardt,

Allali

et al. 2024

Clin Res Cardiol

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High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial

Cited by 5 publications

References 5 publications

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

Comparison of long-term outcome in patients with calcified stenosis treated with intravascular lithotripsy or with modified balloon angioplasty: a propensity score-adjusted study

Severely calcified coronary artery lesions: focus on interventional management

Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial

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