Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial

Objectives: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions.Background: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications.Methods: Patients with calcified lesions (more than 100°of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment.Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events.Results: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable.Conclusions: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB.

Section: Discussioncontrasting

confidence: 71%

Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial

Mangieri

Nerla

Castriota

et al. 2023

“…1,4,8,11,14 Use of adjunctive devices such as specialized dedicated balloons (noncompliant, very high-pressure, scoring, or cutting balloons), rotational and orbital atherectomy, and excimer laser catheters do aid in adequate lesion preparation and stent expansion, but this is at the expense of an increased risk of coronary perforation and dissection, which can be catastrophic. 5,7,[15][16][17][18][19][20][21][22] Rotational and orbital atherectomy selectively ablate superficial calcium, which facilitates stent delivery.…”

Section: Introductionmentioning

confidence: 99%

Long‐term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real‐World Multicenter European Study

Basavarajaiah

Ielasi

Raja

et al. 2022

Objectives: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population.Background: IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients. Methods: This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed.Results: In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was

“…In the randomized ISAR-CALC trial, although super high-pressure balloon increased minimum lumen diameter (2.83 ± 0.34 mm vs. 2.65 ± 0.36 mm; p = 0.03) and reduced diameter stenosis (11.6 ± 4.8% vs. 14.4 ± 5.6%; p = 0.02) compared to scoring balloon, there was no significant difference in terms of ALG between both techniques (1.89 ± 0.42 mm vs. 1.83 ± 0.45 mm; p = 0.60). 17 The Disrupt CAD III trial was a prospective single arm multicenter trial designed for regulatory approval of intravascular lithotripsy. In terms of angiographic performance ALG was 1.7 ± 0.5 mm.…”

Section: Discussionmentioning

confidence: 99%

Combined rotational atherectomy and cutting balloon angioplasty prior to drug‐eluting stent implantation in severely calcified coronary lesions: The PREPARE‐CALC‐COMBO study

Allali

Abdel‐Wahab

Hemetsberger

et al. 2022

Self Cite

Objectives: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut).Background: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown.Methods: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimuseluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography.Results: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm 2 vs. 6.1 ± 1.7mm 2 with MB vs. 6.2 ± 1.9mm 2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient.Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively).