Mean Minimal Lumen Diameter Research Articles

Quantitative Coronary Angiography vs Intravascular Ultrasonography to Guide Drug-Eluting Stent Implantation

Although intravascular ultrasonography (IVUS) guidance promotes favorable outcomes after percutaneous coronary intervention (PCI), many catheterization laboratories worldwide lack access. To investigate whether systematic implementation of quantitative coronary angiography (QCA) to assist angiography-guided PCI could be an alternative strategy to IVUS guidance during stent implantation. This randomized, open-label, noninferiority clinical trial enrolled adults (aged ≥18 years) with chronic or acute coronary syndrome and angiographically confirmed native coronary artery stenosis requiring PCI. Patients were enrolled in 6 cardiac centers in Korea from February 23, 2017, to August 23, 2021, and follow-up occurred through August 25, 2022. All principal analyses were performed according to the intention-to-treat principle. After successful guidewire crossing of the first target lesion, patients were randomized in a 1:1 ratio to receive either QCA- or IVUS-guided PCI. The primary outcome was target lesion failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The trial was designed assuming an event rate of 8%, with the upper limit of the 1-sided 97.5% CI of the absolute difference in 12-month target lesion failure (QCA-guided PCI minus IVUS-guided PCI) to be less than 3.5 percentage points for noninferiority. The trial included 1528 patients who underwent PCI with QCA guidance (763; mean [SD] age, 64.1 [9.9] years; 574 males [75.2%]) or IVUS guidance (765; mean [SD] age, 64.6 [9.5] years; 622 males [81.3%]). The post-PCI mean (SD) minimum lumen diameter was similar between the QCA- and IVUS-guided PCI groups (2.57 [0.55] vs 2.60 [0.58] mm, P = .26). Target lesion failure at 12 months occurred in 29 of 763 patients (3.81%) in the QCA-guided PCI group and 29 of 765 patients (3.80%) in the IVUS-guided PCI group (absolute risk difference, 0.01 percentage points [95% CI, -1.91 to 1.93 percentage points]; hazard ratio, 1.00 [95% CI, 0.60-1.68]; P = .99). There was no difference in the rates of stent edge dissection (1.2% vs 0.7%, P = .25), coronary perforation (0.2% vs 0.4%, P = .41), or stent thrombosis (0.53% vs 0.66%, P = .74) between the QCA- and IVUS-guided PCI groups. The risk of the primary end point was consistent regardless of subgroup, with no significant interaction. Findings of this randomized clinical trial indicate that QCA and IVUS guidance during PCI showed similar rates of target lesion failure at 12 months. However, due to the lower-than-expected rates of target lesion failure in this trial, the findings should be interpreted with caution. ClinicalTrials.gov Identifier: NCT02978456.

Propensity-score-matched comparison of safety, efficacy, and outcome of intravascular lithotripsy versus high-pressure PTCA in coronary calcified lesions

Data regarding safety, efficacy, and outcome of intravascular lithotripsy (IVL) in comparison to standard techniques are lacking. This study sought to compare IVL with non-compliant high-pressure balloon percutaneous coronary angioplasty (PTCA).We performed a retrospective propensity-score-matched study to compare procedural success in 57 consecutive patients who received IVL-guided PCI in calcified coronary lesions with 171 matched patients who were treated with high-pressure PTCA with a non-compliant (NC)-balloon. The mean minimal lumen diameter (MLD) for the IVL group was 1.08 ± 0.51 mm, and the median percent diameter stenosis on quantitative angiography was 70.2% (interquartile range, 60.2-78.6%). MLD in the high-pressure dilatation group was 0.97 ± 0.43 mm, and the median percent diameter stenosis was 71.5% (interquartile range, 58.5-77.0%). IVL-guided PCI reduced median stenosis to 17.5% (interquartile range, 9.3-19.8%) with an acute gain of 0.93 ± 0.7 mm. High-pressure dilatation resulted in a final median stenosis of 19.3% (interquartile range, 13.33-28.5%). Procedural success was significantly higher (82.5% vs. 61.4%; p: 0.0035) in the IVL group. MACE through 12 months occurred in 10.5% of cases in the IVL group and in 11.1% of the high-pressure group (p = 0.22). Angiographic complications (coronary dissection, slow or no reflow, new coronary thrombus formation, abrupt vessel closure) were very low (0.2% vs. 0.12%).IVL resulted in a significantly higher rate of procedural success compared to high- pressure NC-balloon dilatation in patients with calcified coronary lesions. The rate of MACE through 12 months was similar to the standard therapy.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Prospective, Observational, Multicenter Registry.

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.

P973Intravascular lithotripsy for lesion preparation in calcified coronary lesions: a prospective, observational, two-center registry

Abstract 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.

Coronary artery size in North Indian population – Intravascular ultrasound-based study

ObjectiveThe coronary artery dimensions have important diagnostic and therapeutic implications in management of coronary artery disease (CAD). There is paucity of data on the coronary artery size in the Indian population as measured by intravascular ultrasound (IVUS). MethodsA total of 303 patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with intravascular ultrasound underwent analysis along with quantitative coronary angiography (QCA). Of the 492 proximal coronary segments; 221 relating to left main (LM), 164 to left anterior descending artery (LAD), 45 to left circumflex artery (LCX), and 62 to right coronary artery (RCA) were considered. ResultsPatient's mean age was 53.37 ± 3.5 years; men 80%; hypertension 35% and diabetes 24.8%. On IVUS, mean minimal lumen diameter as compared to QCA in LM (4.60 mm versus 4.50 mm, p < 0.001), LAD (3.71 mm versus 3.45 mm, p < 0.001), LCX (3.55 mm versus 3.16 mm, p < 0.001) and RCA (3.85 mm versus 3.27 mm, p < 0.001) were significantly larger. Lumen and external elastic membrane (EEM) cross-sectional area (CSA) were larger in males as compared to females with statistical significance for lumen CSA in LM (p = 0.04); RCA (p = 0.02) and EEM CSA in LM (p = 0.03); RCA (p = 0.006) but no significance for adjusted body surface area (BSA). In multivariate models, BSA and age were independent predictors of LM and LAD diameters and areas, but age was an independent predictor indexed to BSA. ConclusionThe coronary artery dimensions by IVUS are significantly larger than QCA. No gender difference in coronary artery size. Age was an independent predictor of coronary artery size in left main and LAD. The coronary artery size may not be a risk factor for acute coronary syndrome.

Systematic Transfemoral Transarterial Transcatheter Aortic Valve Replacement in Hostile Vascular Access

ABSTRACT Background: Traditionally, hostile peripheral access patients undergo TAVR via alternative access. We describe the “transfemoral-first” (TF-1) approach in patients with hostile peripheral access. Methods: Clinical and procedural data were obtained for all TAVR cases performed from August 2016 to July 2017. Computed tomography was used to assess iliofemoral arteries. Patients were divided into three femoral access groups: routine, hostile, and prohibitive. We attempted TF access in all patients with routine and hostile access. Hostile access was defined as: (1) arterial segments with diameter <5.0 mm; or (2) <5.5 mm with severe calcification (270–360° arc of calcification) or severe tortuosity; or (3) severe tortuosity along with severe calcification. Outcomes of the hostile access group patients who underwent TF-1 are described. The primary endpoint was successful completion of the procedure without major complications by the intended route. The secondary endpoints were procedural complications as defined by the VARC-2 criteria. Results: Of 377 consecutive patients, 99.5% underwent TF-1 TAVR; two patients (0.4%) had prohibitive access. Twenty-eight (7.4%) patients had hostile access with access side mean minimal lumen diameter of 4.7 mm (range 3.8–5.4 mm). Twenty-six (92.8%) were successfully treated with TF-1 strategy. Twelve (42.8%) of the 26 patients underwent preparatory endovascular treatment prior to TAVR during the same operating room visit. There was 1 (3.5%) major or life-threatening bleeding complication and 2 (7.1%) major vascular complications. There were no deaths or strokes. Conclusion: Using the safe and effective endovascular approach, TF-1 TAVR is feasible for all-comers—including those with hostile access—with low complication rate. Larger studies are warranted to validate this approach.

Early Recoil After Balloon Angioplasty of Erection-Related Arteries in Patients With Arteriogenic Erectile Dysfunction

Purpose: To evaluate the incidence of elastic recoil in patients presenting with erectile dysfunction (ED) undergoing endovascular revascularization of the pudendal or penile arteries. Methods: A consecutive series of 21 ED patients (mean age 58.3±9.3 years) undergoing minimally invasive revascularization of 31 arteries was analyzed. ED lesions included the pudendal arteries (n=27) and the penile artery (n=4). Mean lesion length was 20.6±13.9 mm. Minimal lumen diameter (MLD) measurements were assessed at baseline, immediately after balloon angioplasty, and 10 minutes thereafter. Early recoil was defined as an MLD reduction >10%. Elastic recoil with >10% lumen compromise was treated with drug-coated balloons, while severe elastic recoil (>30%) required drug-eluting stents (DES). The International Index of Erectile Function (IIEF-15) score was obtained prior to and 3 months after the procedure to obtain information on functional outcomes subsequent to angioplasty. Results: Mean MLD at baseline was 0.9±0.6 mm, which improved to 2.0±0.9 mm immediately after balloon dilation. At 10 minutes after dilation, the MLD was 1.7±1.0 mm. Elastic recoil was observed in all 31 lesions and resulted in a mean lumen compromise of 21.2%. Severe (>30%) recoil was observed in 14 arteries, which underwent DES therapy. The IIEF-15 score improved from 31.3±11.2 at baseline to 49.8±16.8 (p<0.001) at the 3-month follow-up. Conclusion: Endovascular revascularization constitutes a safe and feasible treatment modality to restore erectile function in patients with arteriogenic ED and ineffective conservative management. Early elastic recoil is very frequent subsequent to balloon dilation of small-caliber erection-related arteries. Thus, mechanical scaffolding with DES is required in a high subset of ED patients to provide favorable early angiographic and clinical results.

Intra-arterial injection of iloprost reduces the risk of early recoil after balloon angioplasty of below-the-knee vessels in patients with critical limb ischemia.

Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

A pan-coronary artery angiographic study of the association between diabetes mellitus and progression or regression of coronary atherosclerosis.

The frequency and pattern of progression or regression of coronary atherosclerosis in contemporary patients with diabetes remain unknown. This study included 605 patients with coronary artery disease (CAD). Two coronary angiographic examinations at baseline and after 2years were performed. The analysis focused on non-stented segments with diameter stenosis ≥25%. Atherosclerosis progression (or regression) was defined as a decrease (or increase) in the mean minimal lumen diameter (MLD) in the 2-year angiogram compared to mean MLD in the baseline angiogram of >0.2mm. Statins were prescribed in 576 patients (95.2%). The primary outcome was atherosclerosis progression or regression in the 2-year angiogram. One hundred sixty-nine patients (28%) had diabetes. Diabetic patients had greater reduction of mean MLD in the 24 angiogram compared to baseline angiogram than nondiabetic patients (0.11±0.18 vs. -0.08±0.15mm, P<0.001). Atherosclerosis progression was observed in 37 patients with diabetes and 16 nondiabetic patients (21.9 vs. 3.7%; P<0.001). Atherosclerosis regression was observed in two diabetic patients and 78 nondiabetic patients (1.2 vs. 17.9%; P<0.001). A progression pattern across all coronary segments was observed in 70 patients (41.4%) with diabetes and 60 patients (13.8%) without diabetes (P<0.001). Diabetic patients with a low-density lipoprotein cholesterol ≥70mg/dl showed more atherosclerosis progression than diabetic patients with LDL cholesterol <70mg/dl (delta-MLD: 0.12±0.19 vs. 0.08±0.16mm; P=0.04). In conclusion, in contemporary patients with CAD treated with moderate-intensity statin therapy, diabetes is associated with the increased risk of progression and decreased probability of regression of coronary atherosclerosis.

Association of progression or regression of coronary artery atherosclerosis with long-term prognosis

The association between coronary atherosclerosis progression or regression and long-term prognosis remains poorly defined. We assessed the association of atherosclerosis progression or regression with long-term mortality and factors that promote angiographic progression or regression of coronary atherosclerosis in patients with angiographically proven coronary artery disease. The study included 605 patients with coronary artery disease who underwent coronary angiography at baseline and at 2 years later. Pan-coronary artery tree quantitative coronary angiography was performed. Of 6259 coronary segments (10.3 lesions per patient) analyzed, 1790 non-stented segments with ≥25% diameter stenosis at baseline were included. Atherosclerosis progression or regression was defined as a decrease or increase in the mean minimal lumen diameter (MLD) of the non-stented segments of ≥0.2 mm in the 2-year angiography compared to baseline angiography. The primary outcome was all-cause mortality. Based on the change in mean MLD between baseline and 2-year angiography, patients were divided into 3 groups: the group with progression of atherosclerosis (n=53; 8.8%), the group with no progression or regression of atherosclerosis (n=472; 78.0%) and the group with regression of atherosclerosis (n=80; 13.2%). There were 126 deaths over 8-year follow-up: 17 deaths among patients with progression, 103 deaths among patients with no progression/regression and 6 deaths among patients with regression (Kaplan-Meier estimates of mortality, 37.5%, 25.2% and 8.9%, respectively; adjusted hazard ratio=1.16, 95% confidence interval 1.05 to 1.29, P=.004 for 0.1 mm reduction in mean MLD). Progression or regression of coronary atherosclerosis in non-treated coronary segments was significantly associated with 8-year mortality.

Impact of Insulin Resistance on Neointimal Tissue Proliferation after 2nd-Generation Drug-Eluting Stent Implantation.

Percutaneous coronary intervention is established as an effective treatment for patients with ischemic heart disease; in particular, drug-eluting stent implantation is known to suppress in-stent restenosis. Diabetes mellitus is an independent risk factor for restenosis, so reducing insulin resistance is being studied as a new treatment approach. In this prospective study, we sought to clarify the factors associated with in-stent restenosis after percutaneous coronary intervention, and we evaluated the homeostasis model assessment of insulin resistance (HOMA-IR) index as a predictor of restenosis. We enrolled 136 consecutive patients who underwent elective percutaneous coronary intervention at our hospital from February 2010 through April 2013. All were implanted with a 2nd-generation drug-eluting stent. We distributed the patients in accordance with their HOMA-IR index values into insulin-resistant Group P (HOMA-IR, ≥2.5; n=77) and noninsulin-resistant Group N (HOMA-IR, <2.5; n=59). Before and immediately after stenting, we measured reference diameter, minimal lumen diameter, and percentage of stenosis, and after 8 months we measured the last 2 factors and late lumen loss, all by means of quantitative coronary angiography. After 8 months, the mean minimal lumen diameter was smaller in Group P than that in Group N (1.85 ± 1.02 vs 2.37 ± 0.66 mm; P=0.037), and the mean late lumen loss was larger (0.4 ± 0.48 vs 0.16 ± 0.21 mm; P=0.025). These results suggest that insulin resistance affects neointimal tissue proliferation after 2nd-generation drug-eluting stent implantation.

Efficacy and safety of percutaneous transluminal balloon dilation to prevent progression of banding site stenosis after bilateral pulmonary artery banding.

To investigate the efficacy and safety of percutaneous transluminal balloon dilation (PTBD) for the treatment of bilateral pulmonary artery banding (bil-PAB) site stenosis. Although bil-PAB is an alternative initial treatment for high-risk neonates with hypoplastic left heart syndrome (HLHS) or critical aortic stenosis (cAS), those patients often suffer from desaturation because of progressive stenosis of the bil-PAB sites during the interstage period. We retrospectively evaluated the efficacy and safety of 11 consecutive PTBD procedures performed between 2006 and 2012 to treat bil-PAB site stenosis in four high-risk infants (three females) with HLHS or cAS. PTBD was repeated twice in two patients and three times in one patient over intervals. The mean balloon diameter (BD) and BD-to-band circumference (BC) ratio were 3.1 ± 0.5 mm and 0.31 ± 0.06, respectively. After the procedures, the mean minimum lumen diameter was dilated significantly from 1.1 ± 0.1 mm to 1.7 ± 0.3 mm (P < 0.01), and the mean peripheral oxygen saturation increased significantly from 75 ± 8% to 85 ± 4% (P < 0.01). All patients reached the next stage operation involving the Norwood & bidirectional Glenn or Ross procedure, after growth. No complications such as band rupture occurred. For progressive stenosis of bil-PAB sites, PTBD using a balloon size that did not exceed the BC (BD around 30% of the BC) was an effective and safe procedure.

Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents

Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents Introduction: Restenosis after stent implantation is one of the major limitations of percutaneous coronary intervention (PCI). Compared to bare metal stents (BMS), drug-eluting stents (DES) have a reduced incidence of restenosis. However, the temporal pattern of restenosis development in patients implanted with DES has not been clearly defined. Aim: This study aims to compare the efficacy of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), and everolimus eluting stents (EES) via sequential angiographic follow-up and to reveal the development of restenosis over time. Material and methods: Patients were randomized to receive SES, PES, ZES, or EES, and follow-up angiography was performed at 6, 12 and 24months after percutaneous coronary intervention. We analyzed late loss (LL) at each time point and defined 2 time periods: “early” (within first year of follow-up) and “late” (after the first year). Results: In all groups, mean minimal lumen diameter decreased slightly during the 2-year period after the procedure. Compared with the SES group, the PES and the ZES groups showed significantly greater late loss (LL) within 1 year. However, the SES group showed significantly greater LL compared with the other drug-eluting stents (DES) between 1 and 2 years. Conclusions: Serial angiographic analysis revealed differences in the rate of restenosis development over time for various DES. Of the studied DES, EES showed the best results in both early and late LL.

Abstract 11491: Differences in the Development of Restenosis Over Time for Various Drug-Eluting Stents

Objective: This study aims to compare the efficacy of sirolimus-eluting stents (SES), paclitaxel-eluting stents (PES), zotarolimus-eluting stents (ZES), and everolimus eluting stents (EES) via sequential angiographic follow-up and to reveal the development of restenosis over time. Methods: Patients were randomized to receive SES, PES, ZES, or EES, and follow-up angiography was performed at 6, 12 and 24months after percutaneous coronary intervention. Results: The baseline clinical characteristics of the patients and the coronary lesions are shown in (Table 1). In all groups, mean minimal lumen diameter decreased slightly during the 2-year period after the procedure (Figure 1). Compared with the SES group, the PES and the ZES groups showed greater late loss (LL) within 1 year. However, the SES group showed significantly greater LL compared with the other drug-eluting stents (DES) between 1 and 2 years (Figure 2). Conclusion: Serial angiographic analysis revealed differences in the rate of restenosis development over time for various DES. As DES are comprised of many components (metallic platform, alloy, drug and polymer), the progression of LL can be complex and affected by different factors.

Direct Drug-Eluting Stenting to Reduce Stent Restenosis: A Randomized Comparison of Direct Stent Implantation to Conventional Stenting With Pre-Dilation or Provisional Stenting in Elective PCI Patients

The aim was to investigate whether a strategy of direct drug-eluting stent (DES) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting (PS). Previous studies were performed comparing direct stenting (DS) with conventional stenting (CS) after pre-dilation; however, none of these in the DES era. Therefore, the STRESSED (direct Stenting To reduce REStenosis in Stent Era with Drug elution) study was designed and carried out. A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS, CS, or PS strategy. The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography. Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events (MACE), and MACE at 9-month and 2-year follow-up. Stent implantation in the DS group was 98%, 99% in the CS group, and 77% in the PS group. Percutaneous coronary intervention success was 99% in all groups. The minimal lumen diameter at 9-month follow-up was 2.12 ± 0.58 mm (DS), 2.17 ± 0.67 mm (CS), and 1.99 ± 0.69 mm (PS), p= 0.556 for comparison of DS with CS, p= 0.073 for comparison of DS with PS. The absolute difference was-0.05 (DS to CS), 95% confidence interval:-0.19 to-0.09, p= 0.48 and 0.13 (DS to PS), confidence interval:-0.02 to-0.27, p= 0.087. Restenosis was found in 3.4% (DS), 6.7% (CS), and 11.5% (PS), p=0.025. At 9-month and 2-year follow-up, MACE occurred in 6.8% and 11.5% (DS), 4.6% and 10.3% (CS), and 7.6% and 13.8% (PS) (p= 0.439 and 0.536), respectively. Direct DES implantation compared with conventional DES implantation did not reduce restenosis. Provisional stenting, however, was associated with a higher rate of restenosis. This did not translate into a difference in the rate of MACE. (STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution; ISRCTN41213536).

Pivotal Trial to Evaluate the Safety and Efficacy of the Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

OCT Compared With IVUS in a Coronary Lesion Assessment: The OPUS-CLASS Study

The aim of this study was to investigate the reliability of frequency domain optical coherence tomography (FD-OCT) for coronary measurements compared with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS).Accurate luminal measurement is expected in FD-OCT because this technology offers high resolution and excellent contrast between lumen and vessel wall.In 5 medical centers, 100 patients with coronary artery disease were prospectively studied by using angiography, FD-OCT, and IVUS. In addition, 5 phantom models of known lumen dimensions (lumen diameter 3.08 mm; lumen area 7.45 mm(2)) were examined using FD-OCT and IVUS. Quantitative image analyses of the coronary arteries and phantom models were performed by an independent core laboratory.In the clinical study, the mean minimum lumen diameter measured by QCA was significantly smaller than that measured by FD-OCT (1.81 ± 0.72 mm vs. 1.91 ± 0.69 mm; p < 0.001) and the minimum lumen diameter measured by IVUS was significantly greater than that measured by FD-OCT (2.09 ± 0.60 mm vs. 1.91 ± 0.69 mm; p < 0.001). The minimum lumen area measured by IVUS was significantly greater than that by FD-OCT (3.68 ± 2.06 mm(2) vs. 3.27 ± 2.22 mm(2); p < 0.001), although a significant correlation was observed between the 2 imaging techniques (r = 0.95, p < 0.001; mean difference 0.41 mm(2)). Both FD-OCT and IVUS exhibited good interobserver reproducibility, but the root-mean-squared deviation between measurements was approximately twice as high for the IVUS measurements compared with the FD-OCT measurements (0.32 mm(2) vs. 0.16 mm(2)). In a phantom model, the mean lumen area according to FD-OCT was equal to the actual lumen area of the phantom model, with low SD; IVUS overestimated the lumen area and was less reproducible than FD-OCT (8.03 ± 0.58 mm(2) vs. 7.45 ± 0.17 mm(2); p < 0.001).The results of this prospective multicenter study demonstrate that FD-OCT provides accurate and reproducible quantitative measurements of coronary dimensions in the clinical setting.

Clinical and angiographic outcomes following first-in-man implantation of a novel thin-strut low-profile fixed-wire stent: the Svelte Coronary Stent Integrated Delivery System first-in-man trial

The Svelte Stent Integrated Delivery System (IDS) is a novel fixed-wire thin-strut cobalt-chromium stent characterised by a very low entry profile. The aim of the present study is to evaluate the safety and the feasibility of the Svelte stent IDS implantation in humans. The present investigation is a prospective, multicentre non-randomised single-arm study. The primary endpoint was freedom from major adverse cardiac events (MACE) at 30 days post-procedure. Invasive follow-up was scheduled at six months post implantation. A total of 47 patients were enrolled and serial OCT imaging was performed in a subgroup of 18 patients. At the index procedure the lesion success rate was 97.9% (46 patients), the mean acute gain was 1.56 ± 0.43 mm with a mean minimum lumen diameter of 2.48 ± 0.43 mm. Post-implantation OCT imaging revealed a minimal mean prolapse area (0.10 ± 0.06 mm²), mean incomplete stent apposition area (0.12 ± 0.13 mm²) and mean intraluminal mass area (0.05 ± 0.03 mm²). Edge dissections were reported in eight cases (mean dissection width 0.17 ± 0.07 mm proximally and 0.25 ± 0.24 mm distally). At 30-day clinical follow-up, one case of myocardial infarction was reported. At six months, the angiographic mean in-stent late loss was 0.95 ± 0.76 mm. By OCT, a high percentage of struts was covered (97.6 ± 15.00 %) with a mean neointimal thickness of 0.31 ± 0.14 mm, all edge dissections were clinically silent and healed. Target lesion revascularisation (TLR) occurred in 11 patients (23.4%) and clinically driven TLR in three of these patients (6.4%). No cases of death or stent thrombosis were reported during the study. Implantation of the Svelte stent IDS was observed to be safe, feasible and associated with a low acute vascular injury and a high percentage of strut coverage at 6-month follow-up.

Effects of verbal suggestion on coronary arteries: Results of a randomized controlled experimental investigation during coronary angiography

Decrease of chest pain perception under placebo conditions has been frequently observed. The aim of this study was to examine whether placebo-induced chest pain improvement could be the result of changes in coronary blood flow. We, therefore, performed an experiment to investigate whether a verbal suggestion (VS) integrated in a cardiologic procedure has an impact on diameters of coronary arteries. A total of 30 chest pain patients with normal diagnostic angiograms were assigned to a VS or a control group (CG). Saline solution was administered intracoronarily to both groups. The VS group received a standardized VS, implying coronary vasodilation. The CG remained without VS. Coronary end points were the changes in percentage diameter stenosis, Minimal lumen diameter and reference diameter of the index coronary segment before and 60 seconds after the administration of saline. Furthermore, changes in hemodynamics, psychological distress, and chest pain perception were recorded. The VS led to coronary vasoconstriction in comparison with CG (change in mean percentage diameter stenosis ± SD 3.2% ± 6.3% vs -1.7% ± 6.8%, P = .062; change in mean minimal lumen diameter ± SD -0.18 ± 0.32 mm vs 0.06 ± 0.23 mm, P = .029, no relevant change in the reference diameter). At the same time, the degree of chest pain perception was significantly reduced in the VS group (-0.7 ± 1.3) compared with the CG (0.3 ± 1.3), P = .024. The findings of this study suggest that a VS results in a biological alteration within coronary arteries. Contrary to expectation, the VS led to vasoconstriction, whereas chest pain perception decreased.

Double stenting: a method for treating acute stent recoil and luminal filling defects

Acute stent recoil and luminal filling defects can result in a suboptimal angiographic result following stent deployment and are associated with an increased risk of adverse outcomes. We aimed to evaluate the effect of double stenting, deployment of a second stent within the first, in the treatment of these conditions and to review the literature on this procedure. Thirteen cases of double stenting performed by a single operator at the Manchester Royal Infirmary over a three year period were identified and quantitative coronary angiography was performed. The indication for double stenting was acute stent recoil in eight cases, luminal filling defects in three cases and a combination of recoil and filling defects in two cases. There was a high frequency of target vessel calcification (77%) and ostial lesions (23%). Following double stenting, mean minimum lumen diameter increased significantly from 2.5 mm to 3.5 mm (p <0.001). There were no procedural complications. At mean clinical follow-up of 19 months (range six to 37 months), there were no major adverse cardiac events. Double stenting can significantly improve angiographic outcome in cases of acute stent recoil and luminal filling defects, with excellent clinical results in the medium term.