Second‐Generation Drug‐Eluting Balloon for Ostial Side Branch Lesions (001‐Bifurcations): Mid‐Term Clinical and Angiographic Results

Background

In the drug‐eluting stent era, the best strategy to treat Medina 001 lesion remains unestablished. This is the first prospective registry assessing the efficacy and safety of the second‐generation drug‐coated balloon in patients with side‐branch ostial lesion.

Methods

Forty‐nine patients with de novo Medina 001 lesion and associated myocardial ischemia were treated with second‐generation drug‐coated balloon—Dior balloon catheter (Eurocor GmbH, Bonn Germany), and prospectively included in this study. After mandatory pre‐dilatation, a paclitaxel‐eluting balloon was inflated for a minimum of 45 seconds. Left main bifurcation, severely calcified lesions and cardiogenic shock, were the only exclusion criteria.

Results

The inclusion period was 2.7 years. Mean age was 62 ± 12 years old, 41% diabetic, 65% presented with acute coronary syndrome. The most common vessel treated was the first diagonal (50%). Pre‐dilatation with a cutting balloon was used in 59%. Angiographic success was 86% (in 14% a bare metal stent was implanted because of acute recoil [n = 5] or coronary dissection more than type B [n = 2]). At a mean of 12.2 ± 2.2 months, major cardiac adverse events rate was 14.3% (1 myocardial infarction, 0 cardiac deaths, 7 target lesion revascularization). There was no thrombosis or occlusion. At a mean of 7.2 ± 1.1 months, binary restenosis was 22.5% (n = 7) with a late loss of 0.32 ± 0.73 mm.

Conclusion

Medina 001 lesion is an infrequent type of coronary lesion. Drug‐coated balloon—Dior is a safe and technically easy therapeutic option, associated with acceptable mid‐term clinical outcomes. (J Interven Cardiol 2016;29:285–292)

     

Evaluation of a Bifurcation Drug‐Eluting Stent System versus Provisional T‐Stenting in a Perfused Synthetic Coronary Artery Model

Background: Provisional T‐stenting is a widely used strategy for the treatment of coronary artery bifurcation lesions. However, the use of conventional stents in this setting is limited by multiple factors; this includes technical considerations such as wire wrap when accessing the involved vessel, and stent overlap at or near the carina of the lesion. In addition, current slotted tube stent technology tends to be associated with gaps in the coverage of the side branch ostium, which may result in restenosis in that segment of the lesion. The Pathfinder device, now more commonly referred to as the Xience Side Branch Access System (Xience SBA) is a drug‐eluting stent (DES) designed specifically to assist in the treatment of bifurcation lesions by allowing wire access into the side branch, irrespective of the treatment strategy to be employed. Methods: The Xience SBA drug‐eluting stent was compared with the standard Vision coronary stent system using a provisional T‐stenting strategy in a perfused synthetic model of the coronary vasculature with side branch angulations of 30°, 50°, 70°, and 90°. Stent delivery was performed under fluoroscopic guidance. Following the procedure, high‐resolution 2D Faxitron imaging was used to evaluate deployment accuracy of the side branch stent relative to the main branch stent. Results: Deployment of the Xience SBA was accomplished in the same total time as the standard stents in a provisional T‐stenting approach (14.9 vs. 14.6 minutes). However, the time required to achieve stent deployment in the main branch was less with the Xience SBA (4.0 vs. 6.6 minutes), and as a result, total contrast usage (49.4 vs. 69.4 cm³) and fluoroscopy time (5.1 vs. 6.2 minutes) was lower. Additionally, the Xience SBA had a lower incidence of wire wrap (22% vs. 89%) and less distal protrusion of the side branch stent into the main branch (0.54 vs. 1.21 mm). Significant gaps in ostial side branch coverage were not seen in either group. Conclusions: The Xience Side Branch Access DES is a viable device for consistently accessing coronary bifurcation lesions; it allows for easy wire access into the side branch. This may assist the operator in overcoming those well‐recognized limitations associated with use of standard one‐ or two‐stent strategies. In this perfused synthetic coronary model, Xience SBA deployment required less contrast usage and shorter fluoroscopy times. Further testing of this device is warranted.     

Outcomes of Overlapping Heterogeneous Drug‐Eluting Stents Versus Homogeneous Drug‐Eluting Stents for Diffuse Lesions in Small Coronary Arteries

Objective

To investigate the outcomes of overlapping drug‐eluting stenting (DES) in small and diffuse lesions.

Background

Clinical outcomes of overlapping heterogeneous versus homogeneous DES of diffuse lesions (requiring ≥30 mm of length) in small coronary arteries (requiring ≤2.75 mm of diameter) are unknown.

Methods

From January 2005 to December 2009, there were 99 patients with diffuse lesions in small coronary arteries receiving overlapping heterogeneous DES, and 558 patients receiving overlapping homogeneous DES at our institution. The clinical end‐point of the study included in‐hospital and 12‐month major adverse cardiac events (death, nonfatal myocardial infarction, and target vessel revascularization (TVR).

Results

There were no statistically significant differences between overlapping heterogeneous and homogeneous DES groups in‐hospital (2.0% vs. 1.4%, respectively; P = 0.66) and 12‐month (9.1% vs. 9.3%, respectively; P = 0.94) major adverse cardiac events. After adjustment, no significant differences for major adverse cardiac events were noted, but the rate of nonfatal myocardial infarction was lower in overlapping homogeneous DES group (odds ratio: 4.20, P = 0.03).

Conclusion

In this analysis, there were no significant differences in major adverse cardiac events between the 2 types of overlapping DES for diffuse lesions in small coronary arteries, except for higher nonfatal myocardial infarction in overlapping heterogeneous DES. (J Interven Cardiol 2013;26:264–270)

     

One‐Year Results of the CRISTAL Trial,a Randomized Comparison of Cypher Sirolimus‐Eluting Coronary Stents versus Balloon Angioplasty for Restenosis of Drug‐Eluting Stents

Objectives: We compared the efficacy of the Cypher Select? (Cordis Corporation, Bridgewater, NJ, USA) sirolimus‐eluting stent (SES) versus balloon angioplasty (BA) in in‐stent restenosis (ISR) of Taxus? or Taxus Liberté? paclitaxel‐eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Background: Optimal treatment strategies have not been identified for drug‐eluting stent (DES) ISR. Methods: Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. Results: 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12‐month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end‐point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in‐stent binary restenosis (11.1% vs. 14%, P = 0.59). Target‐lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. Conclusions: In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed Abstract Optimal treatment strategies have not been identified for sirolimus‐ (SES) or paclitaxel‐eluting stent (PES) in‐stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end‐point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow‐up MLD and immediate and net gain favored SES. (J Interven Cardiol 2012;25:586–595)     

Crush Stenting With Drug‐Eluting Stents: Relevance of Coronary Bifurcation Lesion Location on Angiographic and Clinical Outcomes

Background

Data on the relevance of the location of coronary bifurcation lesions treated by crush stenting with outcomes were limited.

Hypothesis

We hypothesized that the location of the bifurcation lesion correlated with clinical outcome.

Method

A total of 212 patients with 230 true bifurcation lesions treated by crush stenting with drug‐eluting stents (DES) were assessed prospectively. Surveillance quantitative angiographies were indexed at 8 months after procedure. Primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).

Results

Patients in the distal right coronary artery (RCAd) group were characterized by higher proportions of prior myocardial infarction and very tortuous lesions. However, lesions in the RCAd group, compared to those of other groups, had the lowest late lumen loss, with resultant lowest incidence of MACE at a mean follow‐up of 268±35 days. Independent predictors of MACE included unsatisfied kissing (KUS; hazard ratio [HR]: 12.14, 95% confidence interval [CI]: 4.01–12.10, P = .001) and non‐RCA lesion (HR: 20.69, 95% CI: 5.05–22.38, P = .001), while those of TLR were KUS (HR: 10.21, 95% CI: 0.01–0.34, P = .002), bifurcation angle (HR: 4.728, 95% CI: 2.541–4.109, P = .001), and non‐RCA lesion (HR: 16.05, 95%CI: 1.01–4.83, P = .001).

Conclusions

Classical crush stenting with drug‐eluting stents is associated with significantly better outcomes in RCAd. Quality of kissing inflation is mandatory to improve outcome. Copyright © 2009 Wiley Periodicals, Inc.     

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

Objective

This study aimed to compare the safety and efficacy of everolimus‐eluting stents (EES) to first‐generation drug‐eluting stents (DES) in multivessel disease (MVD).

Background

Second‐generation EES have demonstrated superiority over first‐generation DES for single‐vessel disease, although the merits of EES in MVD are less established.

Methods

A cohort of 1,285 patients (3,124 lesions) with ≥2 diseased vessels were treated with either first‐generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non‐fatal myocardial infarction, were compared at 1 year.

Results

Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first‐generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38–0.87]; P = 0.009; 95% confidence interval).

Conclusions

The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first‐generation DES. Randomized trials comparing new‐generation DES to coronary artery bypass grafting surgery are warranted.

     

Drug‐Coated Balloons: A Safe and Effective Alternative to Drug‐Eluting Stents in Small Vessel Coronary Artery Disease

Background

Drug‐coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug‐eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year.

Methods

We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB‐only angioplasty was performed in 172 patients, whereas 163 patients were treated with second‐generation DES.

Results

DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES‐treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1‐year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601).

Conclusions

In this high‐risk cohort of patients, DCB‐only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES‐treated patients, but had the added benefit of a shorter DAPT regime.

     

The Impact of Side Branch Predilatation on Procedural and Long-term Clinical Outcomes in Coronary Bifurcation Lesions Treated by the Provisional Approach

Introduction and objectives

It is uncertain whether side branch predilatation before main vessel stenting is necessary. We evaluated the effect of side branch predilatation on outcomes in percutaneous coronary intervention for true nonleft main bifurcation determined by the Medina classification using the provisional approach.

Methods

Target vessel failures (composite of cardiac death, myocardial infarction, or target vessel revascularization) were compared between patients who underwent side branch predilatation (predilatation group, n = 175) and those who did not (nonpredilatation group, n = 662).

Results

Final kissing-balloon inflation (57.1% vs 35.8%; P < .001) was performed more frequently and the cross-over rate to a 2-stent technique (14.9% vs 5.1%; P < .001) was higher in the predilatation group. During a median follow-up of 21 months, the predilatation group had a higher incidence of target vessel failures (14.3% vs 6.8%; P = .002) and target vessel revascularization (12.0% vs 5.6%; P = .003), but not of cardiac death or myocardial infarction compared with the nonpredilatation group. On multivariate analysis, side branch predilatation was associated with a higher occurrence of target vessel failures (adjusted hazard ratio = 2.11; 95% confidence interval, 1.27-3.50; P = .004). These results remained consistent after a propensity score-matched population analysis (for target vessel failures, adjusted hazard ratio = 2.63; 95% confidence interval, 1.09-6.34; P = .0031) and they were also constant among the various subgroups, according to the bifurcation angle, calcification, and diameter stenosis of the side branch.

Conclusions

Side branch predilatation before main vessel stenting may be associated with an increased risk of repeat revascularization in patients with true nonleft main bifurcation treated by the provisional approach.Trial registration: ClinicalTrials.gov number: NCT00851526.     

Trends in In‐Hospital Outcome After Percutaneous Coronary Intervention in the Drug‐Eluting Stents Era

Background

The introduction of drug‐eluting stents (DES) dramatically changed the practice of percutaneous coronary intervention (PCI) in the 2000s. Little is known about trends in in‐hospital outcome after PCI in the DES era.

Hypothesis

The in‐hospital outcomes after PCI might be continuously improved over time.

Methods

We analyzed in‐hospital outcomes of 21 667 patients who underwent PCI at Fu Wai Hospital in the past 5 years. The patients were divided into 5 groups according to the time of their intervention: group 1 (June 2004 to May 2005), group 2 (June 2005 to May 2006), group 3 (June 2006 to May 2007), group 4 (June 2007 to May 2008), and group 5 (June 2008 to May 2009).

Results

Procedural success rates for the 5 groups were 93.6%, 95%, 94.4%, 94.2%, and 94.3%, respectively (P = 0.39). Significant reduction in in‐hospital major adverse cardiac events (3.1%, 3.4%, 2.8%, 1.6%, and 1.0%, P < 0.001) and need for target‐vessel revascularization (2.0%, 2.2%, 1.5%, 0.4%, and 0.2%, P < 0.001) was noted over time, which was associated with a significant increase in use of DES (from 56.6% to 97.0%, P < 0.001). On multivariate analysis, use of DES, dissection during procedure, left main lesion, prior myocardial infarction, and age ≥ 65 years were independent predictors of major adverse cardiovascular events.

Conclusions

There were substantial reductions in in‐hospital major adverse cardiac events and target‐vessel revascularization over the past 5 years. This reduction was associated with the concurrent increased use of DES. Copyright © 2010 Wiley Periodicals, Inc. This work was performed at the Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Impact of Acute Coronary Syndrome Classification and Procedural Technique on Clinical Outcomes in Patients With Coronary Bifurcation Lesions Treated With Drug‐Eluting Stents

Background:

We examined the impact of non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) on clinical outcomes in patients with bifurcation lesions treated with drug‐eluting stents.

Hypothesis:

We hypothesized that NSTE‐ACS would be attributable to the increased risk of major adverse cardiac events (MACE) in bifurcation percutaneous coronary intervention.

Methods:

We enrolled 1668 patients, using data from a multicenter real‐world bifurcation registry. The primary objective was to compare the 2‐year cumulative risk of MACE in patients with NSTE‐ACS to those with stable angina. Major adverse cardiac events were defined as the composite endpoint of cardiac death, myocardial infarction (MI), and target‐lesion revascularization.

Results:

Non–ST‐segment elevation acute coronary syndrome was seen in 969 (58.1%) patients and stable angina in 699. Major adverse cardiac events occurred in 7.3% of NSTE‐ACS patients and in 5.2% with stable angina (P = 0.042). However, cardiac death, MI, and target‐lesion revascularization were similar between the 2 groups. We stratified patients with NSTE‐ACS into those with non–ST‐segment elevation MI and those with unstable angina. Cumulative risks of 2‐year MACEs were 7.0% in non–ST‐segment elevation MI patients and 7.5% in unstable angina patients (P = 0.87). In the NSTE‐ACS cohort, the baseline lesion length in the side branch (adjusted hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01‐1.07, P = 0.022), paclitaxel‐eluting stents in the main vessel (adjusted HR: 2.02, 95% CI: 1.21‐3.40, P = 0.008), and final kissing ballooning (adjusted HR: 1.88, 95% CI: 1.10‐3.21, P = 0.021) were independent predictors of MACE.

Conclusions:

Compared with stable angina patients, the NSTE‐ACS patients who underwent bifurcation percutaneous coronary intervention had an increased risk of MACE during the 2‐year follow‐up. Clin. Cardiol. 2012 doi: 10.1002/clc.22020 Drs Pil Sang Song and Dong Ryeol Ryu contributed equally to this work. Coronary Bifurcation Stenting (COBIS) Registry in South Korea, US Department of Health and Human Services, US National Institutes of Health, ClinicalTrials.gov no. NCT00851526. This work was supported by the Korean Society of Interventional Cardiology, Seoul, South Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Aggressive Plaque Modification with Rotational Atherectomy and/or Cutting Balloon before Drug‐Eluting Stent Implantation for the Treatment of Calcified Coronary Lesions

Introduction: Calcified coronary lesions may be associated with stent underexpansion, malapposition, and high rates of restenosis. The use of drug‐eluting stents (DES) in such lesions has not been fully addressed in the major trials. We sought to examine the outcomes of patients who were treated with plaque modification (PM) to facilitate DES implantation. Methods: We analyzed 164 calcified coronary lesions in 145 consecutive patients who underwent aggressive PM with either rotational atherectomy (RA) and/or cutting balloon (CB) before DES implantation. CB was used in moderate calcified lesions and RA alone or followed by CB in severe calcified lesions. Results: Patients were 68.7 ± 10.1 years old, 47% were diabetic, 34% had left ventricular ejection fraction (LVEF) ≤50%, and 39% had 3‐vessel disease. Ninety‐five percent of lesions were classified as B2/C, 100% as moderately/severely calcified. PM was achieved by using CB in 57% and by RA alone or followed by CB in 43%. In 100%, a DES was implanted. There was no failure to deliver a stent. At 15 ± 11 months follow‐up, the overall major adverse cardiac events (MACE) rate was 9.6% (3.4% cardiac death, 2.3% myocardial infarction, and 3.4% target lesion revascularization [TLR]). The only independent predictor of MACE was LVEF ≤50% (odds ratio 3.88; 95% confidence interval: 1.15–13.1; P = 0.03). The incidence of stent thrombosis (ST) was 2.1%. There were no significant differences in MACE and TLR based on the type of PM used. Conclusions: In this population at high risk of restenosis, aggressive PM by CB and/or RA before DES implantation provides excellent mid‐term outcomes with only 3.4% TLR and 2.1% ST. (J Interven Cardiol 2010;23:240–248)     

Long‐Term Follow‐Up of Coronary Venous Bypass Graft Lesions Treated with a New Generation Drug‐Eluting Stent with Bioabsorbable Polymer

Background

To date, no published data are available regarding long‐term follow‐up of new generation DES implanted in coronary artery bypass graft (CABG) lesions.

Objectives

To assess the long‐term clinical outcome of patients receiving the new generation Biolimus A9‐coated drug‐eluting stent (DES) with biodegradable polymer in saphenous vein grafts (SVG).

Methods

Three thousand sixty‐seven patients were included in the NOBORI 2 registry: 71 patients with a total of 117 lesions received at least 1 biolimus A9 DES in SVG lesions and 2,959 patients received percutaneous coronary intervention in other lesions. Clinical follow‐up was performed at 1, 6, and 12 months, and annually up to 3 years.

Results

Compared to the non‐CABG group, patients with CABG lesions were older (P < 0.001), had a higher Charlson Comorbidity Index (P = 0.004), and presented more often with acute coronary syndrome (P = 0.02). At 3‐year follow‐up, cardiac death occurred in 9.7% versus 2.1% (P < 0.001), myocardial infarction (MI) in 8.3% versus 3.0% (P = 0.02), target lesion failure in 13.9% versus 6.4% (P = 0.03), and major adverse cardiac event in 18.1% versus 8.6% (P = 0.01). No differences were observed in TV‐MI and TLR, nor stent thrombosis (ST) which was generally low in both groups (1.4% vs 0.8%, P = NS).

Conclusion

Albeit 3‐year outcomes were less favorable in the CABG group, the higher cardiac mortality was apparently not driven by ST, target vessel MI, or TLR, but is likely due to advanced disease and age as well as comorbidity. The low TLR rate as well as the absence of late and very late ST suggest that BES are safe and effective for the treatment of CABG lesions. (J Interven Cardiol 2013;26:425‐433)

     

Comparison between Plain Old Balloon Angioplasty and Drug‐Eluting Stent Implantation for the Treatment of Stent Fracture

Objectives

The aim of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) for stent fracture (SF).

Background

SF has been reported as a predictor of in‐stent restenosis (ISR) and stent thrombosis (ST).

Methods

Between January 2009 and December 2012, consecutive SF cases treated with either drug‐eluting stent (DES) or plain old balloon angioplasty (POBA) were retrospectively enrolled in this study. The study endpoints were all‐cause death, cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), ST, re‐stent fracture (re‐SF), and major adverse cardiac events (MACE) defined as the composite of cardiac death, MI, and TLR.

Results

Of 135 SF cases, 67 (49.6%) cases were treated with DES, whereas 68 (50.4%) cases with POBA. Median follow‐up period was 1,401 (IQR: 967–1,771) days. The estimated MACE rate at 3 years was significantly lower in the DES group as compared with the POBA group largely driven by less TLR (25.7 vs. 55.8%, P < 0.001). Moreover, 1‐year landmark analysis after PCI for SF revealed that MACE continued to occur even after 1 year irrespective of the treatment option (P = 0.47). On multivariable Cox regression analysis, POBA and large post‐procedure angle (Δ) defined as the degree difference between the end systolic and diastolic angle were identified as independent predictors for TLR.

Conclusions

DES implantation for SF is associated with better clinical outcomes as compared to POBA alone, due to a lower need for TLR. Large post‐procedural angle (Δ) appears to be an independent predictor of TLR.