High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial.
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ABSTRACT:
SUBMITTER: Allali A
PROVIDER: S-EPMC10068860 | biostudies-literature | 2023 Apr
REPOSITORIES: biostudies-literature
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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.
Allali Abdelhakim A Richardt Gert G Toelg Ralph R Elbasha Karim K Sulimov Dmitriy S DS Kastrati Adnan A Geist Volker V El-Mawardy Mohamed M Rheude Tobias T Abdel-Wahab Mohamed M
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20230403 16
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Project description:BackgroundEvidence on the optimal timing of RA is scarce, although increased periprocedural complications for unplanned procedures have been reported.AimsTo compare planned versus unplanned use of rotational atherectomy (RA) for plaque modification in patients with severely calcified coronary lesions.MethodsProcedural and 1-year follow-up data of planned (n = 562 lesions in 448 vessels of 416 patients) and unplanned (n = 490 lesions in 435 vessels of 403 patients) RA between 2008 and 2020 were analyzed using the propensity score methods. The primary composite endpoint was target lesion failure (TLF), defined as cardiovascular death (CVD), target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR).ResultsAngiographic success was > 99% in both groups. Fluoroscopy time and contrast volume were significantly lower in planned RA (p < 0.001). Periprocedural complications including slow-flow, coronary dissection, and MI occurred in 4.8% after planned, and in 5.7% after unplanned RA. TLF occurred in 18.5% after planned, and in 14.7% after unplanned RA. Weighted subdistribution hazard ratios for TLFs revealed an unfavorable 1-year outcome for planned RA (sHR 1.62 [1.07-2.45], p = 0.023), which was driven by TLR (sHR 2.01 [1.18-3.46], p = 0.011), but not by CVD, or TVMI. No differences were observed in all-cause mortality.ConclusionsUnplanned RA was associated with favorable outcome when compared to planned RA. Thus, RA can safely be reserved for lesions that prove untreatable by conventional means. Randomized and prospective trials are needed to evaluate a predominant use of rotational atherectomy as a bailout strategy in the future.
| S-EPMC10449691 | biostudies-literature
Project description:BackgroundCalcified coronary lesions present therapeutic challenges for the interventional cardiologist, often requiring rotational atherectomy (RA).AimsThis study aimed to develop an angiographic scoring tool to predict the need for a priori RA.MethodsA pooled analysis of the randomised ROTAXUS and PREPARE-CALC studies was carried out, (N=220 patients, N=313 lesions), by virtue of the fact that both studies made provision for crossover to RA (from balloon dilatation or modified balloon dilatation, respectively). Logistical regression techniques were employed to assess for the presence of patient- or lesion-specific factors leading to a necessity for RA. External validation was performed though retrospective calculation of the score for 192 patients who underwent bail-out RA in a single centre.ResultsLesion length (odds ratio [OR] 1.02, 95% confidence interval [CI]: 1.00-1.04 per mm, p=0.04), bifurcation lesion (OR 2.60, 95% CI: 1.27-5.30, p=0.009), vessel tortuosity >45° (OR 3.49, 95% CI: 1.73-7.03, p<0.001) and severe vessel calcification (OR 11.60, 95% CI: 3.40-39.64, p<0.001) were predictive of the need for RA in multivariate analysis. Based on the regression coefficients, a scoring system was devised. The greater the score, the more likely a lesion required RA. The scoring system performed well in the external validation cohort, with 78% of patients crossing over having a score of greater than the proposed cut-off of 3.ConclusionsWe provide an angiographic scoring tool to support the expeditious use of time and resources, allowing assessment of the likelihood of success of a balloon-based strategy, or the necessity for RA.
| S-EPMC9896390 | biostudies-literature
Project description:Rotational atherectomy (RA) is technically more difficult in a diffuse calcified lesion than in a focal calcified lesion. We hypothesized that taking a halftime can be another option for RA to the diffuse calcified lesions. Halftime was defined as at least one long break during RA, in which an operator pulled out the Rotablator system from the guide catheter before crossing the lesion. This study aimed to compare the complications between RA with and without halftime. We included 177 diffuse long severely calcified lesions (lesion lengths ≥ 30 mm) that required RA, and divided those lesions into a halftime group (n = 29) and a no-halftime group (n = 148). The primary outcome was periprocedural myocardial infarction (MI). The reference diameter was smaller in the halftime group than in the no-halftime group [1.82 (1.70-2.06) mm versus 2.17 (1.89-2.59) mm, p = 0.002]. The total run time was longer in the halftime group than in the non-halftime group [133.0 (102.0-223.0) seconds versus 71.5 (42.0-108.0) seconds, p < 0.001]. Although creatinine kinase (CK) and CK-myocardial band (MB) was significantly higher in the halftime group than in the no-halftime group [CK: 156 (97-308) U/L versus 99 (59-216) U/L, p = 0.021; CK-MB: 15 (8-24) U/L versus 5 (3-15) U/L, p < 0.001], periprocedural MI was not observed in the halftime group. In conclusion, periprocedural MI was not observed in RA with halftime. This preliminary study suggests that halftime RA may be a safe option for diffuse severely calcified lesions.
| S-EPMC10764388 | biostudies-literature
Project description:Although endovascular therapy (EVT) is commonly used in treatment of peripheral artery disease (PAD), severely calcified lesions pose a challenge, in spite of the technical advancement. In this report, we discuss the case of a 74-year-old male with coronary artery disease and end-stage renal disease who presented at our institution with bilateral intermittent claudication. Angiography showed chronic total occlusion (CTO) of the right superficial femoral arteries (SFA). Because the bilateral external iliac arteries demonstrated moderate stenosis, we performed endovascular therapy on the right SFA-CTO using a contralateral approach. With the antegrade wire progressing into the subintimal space, direct distal-SFA puncture was performed and wire externalization was established. However, no devices (minimal balloon, microcatheter, or Crosser system) were able to pass the lesion in antegrade or retrograde manner, even though the child catheter support or needle cracking technique from outside/inside was applied. Therefore, we used a combination of an excimer laser and high-speed rotational atherectomy to overcome the severely calcified lesion. First, the excimer laser catheter (Turbo Elite 0.9 mm) ablated the entry to the CTO; however, it did not pass through completely. Thereafter, the thin microcatheter (Caravel) succeeded in crossing the CTO in an antegrade manner using the BAlloon Deployment using FORcible Manner (BADFORM) technique. After wire-exchange to the Rota-wire, rotational atherectomy (RotaLink Plus 1.5 mm) passed through the CTO. Subsequently, we could dilate the CTO lesion with a conventional balloon followed by bare metal stent deployment. The right ankle-brachial index of the patient improved from being unmeasurable to 0.79, and the intermittent claudication disappeared. This combination therapy, described as the "RASER" technique in coronary section, is accepted for reimbursement. However, these devices in EVT section are considered off-label use in Japan. Therefore, we have to refrain from frequent use of this strategy; however, this method provides an option for severely calcified lesions.
| S-EPMC6500656 | biostudies-literature
Project description:BackgroundThe comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied.AimsWe sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon.MethodsIn this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success.ResultsOCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon.ConclusionsIn patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.
| S-EPMC9724952 | biostudies-literature
Project description:Compared to rotational atherectomy (RA), orbital atherectomy (OA) has been shown to decrease procedure failure and reintervention rates in the treatment of severely calcified coronary artery lesions. Our objective was to explore the cost-effectiveness of OA compared to RA in the Japanese healthcare system. A decision-analytic model calculated reintervention rates and consequent total 1-year costs. Effectiveness inputs were therapy-specific target lesion revascularization (TLR) rates and all-cause mortality, pooled from clinical studies. Index and reintervention costs were determined based on claims data analysis of n = 33,628 subjects treated in 2014-2016. We computed incremental cost-effectiveness in Japanese Yen (JPY) per life year (LY) gained based on differences in 1-year cost and projected long-term survival, assuming OA device cost between JPY 350,000 and JPY 550,000. OA was found to be associated with improved clinical outcomes (12-month TLR rate 5.0 vs. 15.7%) and projected survival gain (8.34 vs. 8.16 LYs (+0.17), based on 1-year mortality of 5.5 vs. 6.8%). Total 1-year costs were lower for device cost of JPY 430,000 or less, and reached a maximum ICER of JPY 753,445 per LY at the highest assumed device cost, making OA dominant or cost-effective across the tested range, at ICERs substantially below the willingness-to-pay threshold. In conclusion, orbital atherectomy for the treatment of severely calcified coronary artery lesions, compared to rotational atherectomy, is a cost-effective treatment approach in the Japanese healthcare system due to improved clinical performance.
| S-EPMC6153894 | biostudies-literature
Project description:Background: Coronary vessels in women may have anatomical and histological particularities. The aim of this study was to investigate sex-specific characteristics and outcomes of patients with calcified coronary arteries in the Prepare-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) trial. Methods: The Prepare-CALC trial randomised patients with severe coronary calcification to coronary lesion preparation either using modified balloons (MB; cutting or scoring) or rotational atherectomy (RA). Results: Of 200 randomised patients, 24% were women. Strategy success in general was similar between women (93.8%) and men (88.2%; p=0.27). For men, strategy success was significantly more common with an RA-based strategy than an MB-based strategy (98.7% in the RA group versus 77.3% in the MB group, p<0.001), whereas for women there was no evidence of a significant difference in strategy success between RA and MB (95.7% in the RA group versus 92% in the MB group, p>0.99, p for interaction between sex and treatment strategy=0.03). Overall, significant complications such as death, MI, stent thrombosis, bypass operation and perforations were rare and did not differ significantly by gender or treatment strategy. Plaque rupture and disrupted calcified nodules were more common in women. Conclusion: In a well-defined patient population with severely calcified coronary arteries, lesion preparation with an RA-strategy was superior to an MB-strategy in men. For women, both RA and MB strategies appear to have a similar success rate, although definitive conclusions are limited due to the small number of women in the trial.
| S-EPMC9987508 | biostudies-literature
Project description: Not available
| S-EPMC8525725 | biostudies-literature
Project description: Not available
| S-EPMC10015487 | biostudies-literature
Project description:BackgroundThe incidence of severe complications such as burr entrapment or perforation is considerable with rotational atherectomy (RA). Halfway RA is a novel strategy, in which an operator does not advance the burr to the end of a continuous calcified lesion, and performs balloon dilatation to treat the remaining part of the calcified lesion. The purpose of this study was to compare complications after halfway and conventional RA.MethodsWe included 307 consecutive lesions that were divided into a conventional RA group (n = 244) and halfway RA group (n = 63). In analysis 1, the incidence of complications was compared between the conventional RA and halfway RA groups. Propensity-score matching was used to match the intentional halfway RA and conventional RA. In analysis 2, the incidence of complications was compared between the matched conventional RA and intentional halfway RA groups.ResultsBurr entrapment (0.4%) and major perforation (0.8%) were observed in the conventional RA group, whereas there was no burr entrapment or perforation in the halfway RA group. The success rate of halfway RA was 90.5%, which required switching from halfway RA to conventional RA. The incidences of slow flow and periprocedural myocardial infarction with slow flow were similar between the intentional halfway RA and matched conventional RA groups.ConclusionsThere was no burr entrapment or vessel perforation following halfway RA. The incidences of slow flow and periprocedural myocardial infarction were similar between the intentional halfway RA and the matched conventional RA, indicating the safety of halfway RA.
| S-EPMC6611662 | biostudies-literature