Correction: Optimal stent expansion indices for predicting outcomes in PCI of calcified coronary lesions.

TCT-156 Optimal Stent Expansion Indices for Predicting Outcomes in PCI of Calcified Coronary Lesions

CALCIFIED CORONARY LESION: IS IT STILL THE ACHILLES’ HEAL OF PERCUTANEOUS CORONARY INTERVENTIONS?

ObjectiveTo evaluate the factors affecting optimal stent expansion in calcified lesions treated by aggressive plaque modification with rotational atherectomy (RA) and a cutting balloon (CB).MethodsFrom January 2014 to May 2015, 92 patients with moderate to severe coronary calcified lesions underwent rotational atherectomy and intravascular ultrasound imaging at Chinese PLA General Hospital (Beijing, China) were included in this study. They were divided into a rotational artherectomy combined with cutting balloon (RACB) group (46 patients treated with RA followed by CB angioplasty) and an RA group (46 patients treated with RA followed by plain balloon angioplasty). Another 40 patients with similar severity of their calcified lesions treated with plain old balloon angioplasty (POBA) were demographically matched to the other groups and defined as the POBA group. All patients received a drug-eluting stent after plaque preparation. Lumen diameter and lumen diameter stenosis (LDS) were measured by quantitative coronary angiography at baseline, after RA, after dilatation, and after stenting. Optimal stent expansion was defined as the final LDS < 10%.ResultsThe initial and post-RA LDS values were similar among the three groups. However, after dilatation, the LDS significantly decreased in the RACB group (from 54.5% ± 8.9% to 36.1% ± 7.1%) but only moderately decreased (from 55.7% ± 7.8% to 46.9% ± 9.4%) in the RA group (time × group, P < 0.001). After stenting, there was a higher rate of optimal stent expansion in the RACB group (71.7% in the RACB group, 54.5% in the RA group, and 15% in the POBA group, P < 0.001), and the final LDS was significantly diminished in the RACB group compared to the other two groups (6.0% ± 2.3%, 10.8% ± 3.3%, 12.7% ± 2.1%, P < 0.001). Moreover, an LDS ≤ 40% after plaque preparation (OR = 2.994, 95% CI: 1.297–6.911) was associated with optimal stent expansion, which also had a positive correlation with the appearance of a calcified ring split (r = 0.581, P < 0.001).ConclusionsAggressive plaque modification with RA and CB achieve more optimal stent expansion. An LDS ≤ 40% after plaque modification was a predictive factor for optimal stent expansion in calcified lesions. This parameter was also associated with the presence of calcified ring split.

We sought to assess plaque modification and stent expansion following orbital atherectomy (OA) for calcified lesions using optical coherence tomography (OCT). The efficacy of OA for treating calcified lesions is not well studied, especially using intravascular imaging in vivo. OCT was performed preprocedure, post-OA, and post-stent (n = 58). Calcium modification after OA was defined as a round, concave, polished calcium surface. Calcium fracture was complete discontinuity of calcium. Comparing pre- vs post-OA OCT (n = 29), calcium area was significantly decreased post-OA (from 3.4 mm2 [2.4-4.7] to 2.9 mm2 [1.9-3.9], P < 0.001). Poststent percent calcium fracture (calcium fracture length/calcium length) correlated with post-OA percent calcium modification (calcium modification length/calcium length) (r = 0.31, P = 0.01). Among 75 calcium fractures in 35 lesions, maximum calcium thickness at the fracture site was greater with vs without calcium modification (0.58 mm [0.50-0.66] vs 0.45 mm [0.38-0.52], P = 0.003). Final optimal stent expansion, defined as minimum stent area ≥6.1 mm2 or stent expansion ≥90% (medians of this cohort) at the maximum calcium angle site, was observed in 41 lesions. Larger post-OA lumen area (odds ratio 2.64; 95% CI 1.21-5.76; P = 0.02) and the presence of calcium fracture (odds ratio 6.77; 95% CI 1.25-36.6; P = 0.03) were independent predictors for optimal stent expansion. Calcium modification by OA facilitates poststent calcium fracture even in thick calcium. Greater calcium modification correlated with greater calcium fracture, in turn resulting in better stent expansion.

Background: Calcified coronary lesions are challenging to the interventional cardiologists to manage. Debulking the calcified lesions with Rotablation is a well known strategy. Shockwave intravascular lithotripsy (IVL) is the newer novel therapeutic procedure found to be very effective in PCI of calcified lesions. Aims and Objectives: To assess the clinical utility of Shockwave IVL in densly calcified coronary lesions. Materials and Methods: Four patients underwent PCI with Shockwave IVL for densly calcified lesions between Febraury and March of 2020 and were followed up clinically in our centre. Results: All patients are doing well clinically without any coronary events. Conclusion: Shockwave IVL is safe and accepted modality of debulking the densly calcified coronary lesions and prepare the bed for optimal stent deployment.

Assessment of Post-Dilatation Strategies for Optimal Stent Expansion in Calcified Coronary Lesions: Ex Vivo Analysis With Optical Coherence Tomography

Background Intravascular coronary lithotripsy (IVL) is a novel alternative treatment for heavily calcified lesions. This study sought to determine the strategy success and safety of IVL on calcified lesions in an all-comers cohort of patients. Methods Patients with moderate and severely calcified coronary lesions were screened in two centers in Spain and Germany starting April 2018. Until February 2019, 61 patients with 67 lesions were eligible for IVL. Patients were assigned to the following groups: A) Primary IVL therapy for patients with circumferential calcified de-novo coronary lesions (n=32), B) Secondary IVL therapy for patients with moderate or severe calcified coronary lesions in which conventional non-compliant balloon dilatation failed (n=18) and C) Tertiary IVL therapy in patients with in-stent stenosis due to stent underexpansion after previous stenting (n=17). Primary endpoint was strategy success and safety outcome. Strategy success was defined as successful stent delivery and expansion with attainment of &lt;20% in-stent residual stenosis of the target lesion. Safety outcome were procedural complication, defined as coronary dissection, slow or no-reflow phenomenon, new coronary thrombus formation during PCI, abrupt vessel closure and device failure (inability to place the balloon, malfunction, or burst) and in hospital MACE. Results 61 patients with 67 calcified lesions were treated with IVL. Mean diameter of calcified stenosis on quantitative coronary angiography was 72.02±13.8% at baseline and decreased to 17.7±15.84% (p-value: &lt;0.01) after IVL with an acute gain of 1.9±0.63 mm. Mean minimal lumen diameter was 1.0±0.5 mm at baseline and increased after IVL to 2.9±0.6 mm. The overall average of applied pulses was 63±22. The primary endpoint of strategy success was reached overall in 85.2% of patients. 4 type b dissections (3 in group A, 1 in group B) were observed without further sequelae. There were no in-hospital MACE. In one patient (1.6%) non-ischemia driven target lesion failure was observed in routine follow up coronary angiography and was in need for revascularization. According to the subgroups, strategy success in primary IVL treatment (group A) and secondary IVL treatment (group B) was reached in 81.3% and 83.3% of cases, respectively. In tertiary IVL therapy (group C), the primary study endpoint was reached in 64.7% of cases. Device delivery and IVL treatment of target lesion could be performed in all lesions without vessel complications. 7 IVL balloons ruptured during treatment without any sequelae. Rupture was observed in most cases after repositioning of the balloon within the calcified lesion. Conclusions IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions, with high success rate, and low procedural complication and MACE rates. Longitudinal studies will confirm if these favourable initial results of IVL-supported PCI are followed by good long-term results.

There isa lack of established stent expansion criteria to predict long-term outcomes following percutaneous coronary intervention (PCI) in calcified coronary lesions. The aim of this study was to evaluate the relationship between various stent expansion indices and clinical outcomes including target lesion failure (TLF) following PCI in patients with calcified coronary lesions. This study was a retrospective single-center study. Patients with nativecalcified coronary arterylesions treated with imaging guided PCI and the availability of final intravascular ultrasound or optical coherence tomography images were included. The association between eight stent expansion indices and long-term TLF was evaluated. A total of 280 lesions from 221 patients were analyzed. The median patient age was 71years (Interquartile Range: 63-77), and 155 (70.1%) were male. Of the eight stent expansion indices, only the minimum stent area (MSA) > 100% of distal reference lumen area (HR 0.29; 95% CI 0.13-0.65; p = 0.003), MSA > 90% of distal reference area (HR 0.45; 95% CI 0.25-0.84; p = 0.012) and MSA > 5.0 mm2 or > 90% of distal reference lumen area criteria (HR 0.41; 95% CI 0.22-0.75; p = 0.004) demonstrated a significant association with lower risk of long-term TLF. In the present retrospective analysis, a final MSA > 100% relative to the distal reference lumen area and MSA > 5.0 mm2 or > 90% of distal reference lumen area criteria were most accurate in predicting TLF after PCI of calcified coronary lesions.

Optimal plaque preparation of calcified coronary lesions is key to prevent stent failure. The purpose of this study was to determine the strategy success and safety of intravascular lithotripsy (IVL) in calcified lesions of an all-comers cohort. Patients with calcified coronary lesions were screened in 3 centers. Seventy-one patients were eligible for IVL. Patients were assigned to (group A) primary IVL therapy for patients with calcified de-novo lesions (n=39 lesions), (group B) secondary IVL therapy for patients with calcified lesions in which noncompliant balloon dilatation failed (n=22 lesions), and (group C) tertiary IVL therapy in patients with stent underexpansion after previous stenting (n=17 lesions). Primary end point was strategy success (stent expansion with <20% in-stent residual stenosis) and safety outcomes (procedural complications, in-hospital major adverse cardiovascular event). Seventy-eight calcified lesions were treated using the Shockwave C2 balloon. Mean diameter stenosis of calcified lesions was 71.8±13.1% at baseline, decreased to 45.1±17.4% immediately after IVL, and to 17.5±15.2% after stenting. Mean minimal lumen diameter was 1.01±0.49 mm at baseline and increased to 1.90±0.61 after IVL, and to 2.88±0.56 mm after stenting. The primary end point of strategy success was reached in 84.6% (group A), 77.3% (group B), and 64.7% (group C). Device delivery and IVL treatment were possible in all lesions. Four type b dissections were observed without further sequelae. No patient suffered from in-hospital major adverse cardiovascular event. Seven Shockwave balloons ruptured during treatment without any sequelae. IVL provides a valid strategy for lesion preparation in severely calcified coronary lesions with high success rate, low procedural complications, and low major adverse cardiovascular event rates.

Several stent expansion criteria derived from the intravascular ultrasound (IVUS) evaluation have been proposed to predict future clinical outcomes, but optimal stent expansion criteria as a guide during percutaneous coronary intervention (PCI) are still controversial. There are no studies evaluating the utility of stent expansion criteria along with the clinical and procedural factors in predicting target lesion revascularization (TLR) after contemporary IVUS-guided PCI. OPTIVUS-Complex PCI study (Optimal Intravascular Ultrasound Guided Complex Percutaneous Coronary Intervention) multivessel cohort was a prospective multicenter study enrolling 961 patients undergoing multivessel PCI including left anterior descending coronary artery using IVUS with an intention to meet the prespecified criteria for optimal stent expansion. We compared several stent expansion criteria (minimum stent area [MSA], MSA/distal or average reference lumen area, MSA/distal or average reference vessel area, OPTIVUS criteria, IVUS-XPL [Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions] criteria, ULTIMATE [Intravascular Ultrasound Guided Drug Eluting Stents Implantation in "All-Comers" Coronary Lesions] criteria, and modified MUSIC [Multicenter Ultrasound Stenting in Coronaries Study] criteria) as well as clinical, angiographic, and procedural characteristics between lesions with and without TLR. Among 1957 lesions, the cumulative 1-year incidence of lesion-based TLR was 1.6% (30 lesions). Hemodialysis, treatment of proximal left anterior descending coronary artery lesions, calcified lesions, small proximal reference lumen area, and small MSA had univariate associations with TLR, while all of the stent expansion criteria except for MSA were not associated with TLR. The independent risk factors of TLR were calcified lesions (hazard ratio, 2.34 [95% CI, 1.03-5.32]; P=0.04) and small proximal reference lumen area (Tertile 1: hazard ratio, 7.01 [95% CI, 1.45-33.93]; P=0.02; and Tertile 2: hazard ratio, 5.40 [95% CI, 1.17-24.90]; P=0.03). In contemporary IVUS-guided PCI practice, the 1-year incidence of TLR was very low. MSA, but not other stent expansion criteria, had univariate association with TLR. Independent risk factors of TLR were calcified lesions and small proximal reference lumen area, although the findings should be interpreted with caution due to small number of TLR events, limited lesion complexity, and short duration of follow-up.

ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions: Design and rationale of the SONAR trial

Coronary lithoplasty for calcified lesions: real-world multicenter registry

Intravascular Ultrasound-Derived Criteria for Optimal Stent Expansion and Preprocedural Prediction of Stent Underexpansion.

BackgroundCalcified coronary artery disease presents a significant challenge during percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL) emerges as a ground-breaking modality for the modification of calcific plaques, thereby enhancing stent...

Comparison of drug-eluting versus bare-metal stents after rotational atherectomy for the treatment of calcified coronary lesions