Impact of stent deformity induced by the kissing balloon technique for bifurcating lesions on in‐stent restenosis after coronary intervention

Objectives

To investigate the impact of stent deformity induced by final kissing balloon technique (KBT) for coronary bifurcation lesions on in‐stent restenosis (ISR).

Background

In experimental models, the detrimental effects of KBT have been clearly demonstrated, but few data exists regarding the impact of proximal stent deformity induced by KBT on clinical outcomes.

Methods

We examined 370 coronary lesions where intravascular ultrasound (IVUS)‐guided second‐generation drug‐eluting stent (DES) implantation for coronary bifurcation lesions was performed. Based on IVUS analysis, the stent symmetry index (minimum/maximum stent diameter) and stent overstretch index (the mean of stent diameter/the mean of reference diameter) were calculated in the proximal main vessel.

Results

The stent symmetry index was significantly lower (0.75 ± 0.07 vs 0.88 ± 0.06, P < 0.0001) and the stent overstretch index was significantly higher (1.04 ± 0.08 vs 1.01 ± 0.06, P = 0.0007) in lesions with KBT (n = 174) compared to those without KBT (n = 196). The number of two‐stent technique in lesions with KBT was 31 (18%). In multivariate analysis, the degree of stent deformity indices was not associated with ISR in lesions with KBT; however, two‐stent technique use was the only independent predictor of ISR at 8 months (hazard ratio: 3.96, 95% confidence interval: 1.25‐12.5, P = 0.01).

Conclusions

Second‐generation DES deformity induced by KBT was not associated with mid‐term ISR.

     

Impact of Diabetes Mellitus on Intravascular Ultrasound‐Guided Provisional Stenting in Coronary Bifurcation Lesions J‐REVERSE Sub‐Study

Objective

To investigate the impact of diabetes mellitus (DM) on provisional coronary bifurcation stenting under the complete guidance of intravascular‐ultrasound (IVUS).

Background

The efficacy of such intervention has not yet been fully elucidated in the DM patients.

Methods

A total of 100 DM and 139 non‐DM patients in a prospective multi‐center registry of IVUS‐guided bifurcation stenting were compared in angiographic results at 9 months. Vessel and luminal changes during the intervention were analyzed using the IVUS. Vascular healing at the follow‐up was also investigated in 23 lesions in each group using optical coherence tomography (OCT).

Results

No difference was detected regarding baseline reference vessel diameter and minimum lumen diameter in proximal main vessel (MV), distal MV, and side branch (SB). The rate of everolimus‐eluting stent use (78.4% vs. 78.3%), final kissing inflation (60.1% vs. 49.0%), and conversion to 2‐stent strategy (2.9% vs. 2.8%) were also similar. In the DM group, late loss was greater in proximal MV (DM 0.23 ± 0.29 vs. non‐DM 0.16 ± 0.24 mm, P < 0.05) and SB (0.04 ± 0.49 vs. ?0.08 ± 0.35 mm, P < 0.05). Smaller vessel area restricted stent expansion in the proximal MV (6.18 ± 1.67 vs. 6.72 ± 2.07 mm², P < 0.05). More inhomogeneous neointimal coverage (unevenness score, 1.90 ± 0.33 vs. 1.72 ± 0.29, P < 0.05) and more frequent thrombus attachment (26% vs. 4%, P < 0.05) were documented in the proximal MV at 9‐month follow‐up OCT.

Conclusions

Despite IVUS optimization for coronary bifurcation, DM is potentially associated with smaller luminal gain, higher late‐loss, and inhomogeneous vascular healing with frequent thrombus attachment in the proximal MV.

     

Long‐Term Clinical Outcomes of the One‐Stent Technique versus the Two‐Stent Technique for Non‐Left Main True Coronary Bifurcation Disease in the Era of Drug‐Eluting Stents

Background

Few studies have compared the long‐term major adverse cardiac events (MACEs) between the one‐stent technique (stenting only the main branch) and the two‐stent technique (stenting of both the main and side branches) for the treatment of true coronary bifurcation lesions in the drug‐eluting stent era. Therefore, we investigated this issue using the large nationwide coronary bifurcation registry.

Methods

The 1,147 patients with non‐left main coronary true bifurcation lesions underwent percutaneous coronary intervention in the Korea Coronary Bifurcation Stent (COBIS) registry. All patients were stratified based on the stent placement technique: one stent (n = 898) versus two stents (n = 249). MACE, including death, nonfatal myocardial infarction (MI), and repeat vessel and lesion revascularization (TVR and TLR), were evaluated.

Results

The median follow‐up duration was 20 months. The MACEs did not differ between the 2 groups. Findings from the one‐stent group were similar to those of the two‐stent group in composite of death, MI, or TVR, based on analysis by crude, multivariate Cox hazard regression model, inverse‐probability‐of‐treatment weighting (hazard ratio [HR] 0.911, 95% confidence interval (CI) 0.614–1.351; HR 0.685 95% CI 0.381–1.232; HR 1.235, 95% CI 0.331–4.605, respectively). In further analysis with propensity score matching, the overall findings were consistent.

Conclusions

The findings of the present study indicate that the one‐stent technique was not inferior to the two‐stent technique for the treatment of non‐left main true coronary bifurcation lesions in terms of long‐term MACEs. (J Interven Cardiol 2013;26:245–253)

     

Real‐life experience of a stent‐less revascularization strategy using a combination of excimer laser and drug‐coated balloon for patients with acute coronary syndrome

Objectives

We aimed to test a novel stent‐less revascularization strategy using a combination of excimer laser coronary angioplasty (ELCA) and drug‐coated balloon (DCB) for patients with acute coronary syndrome (ACS).

Background

Percutaneous coronary intervention with drug eluting stents is a standard invasive treatment for ACS. Some unsolved issues however remain, such as stent thrombosis and bleeding risks associated with dual antiplatelet therapy.

Methods

Consecutive ACS patients were planned to receive either a DCB application following ELCA without a stent implantation or conventional revascularization with a coronary stent. The endpoints were (i) major cardiac adverse events (MACEs), defined as the composite of cardiac death, myocardial infarctions, and target lesion revascularization; (ii) target vessel revascularization (TVR); and (iii) angiographic outcome.

Results

Since a greater than expected number of patients allocated to the stent‐less treatment arm eventually received a bailout stenting, the following 3 as‐treated groups were compared; DCB with ELCA group (N = 60), Stent with ELCA group (N = 23), and Stent without ELCA group (N = 85). During a mean follow‐up period of 420 ± 137 days, and with angiographic 6‐ and 12‐month‐follow‐up rates of 96.7%, 87%, and 81.2%, and 50%, 65.2%, and 45.9%, respectively, the MACE rate did not differ across the groups (10%, 4.3%, and 3.5%; P = 0.22) while an incidence of TVR was more common (15%, 0, and 4.7%; P = 0.02) and the diameter stenosis at 6‐months of follow‐up was greater (25.7 ± 18.2, 14.9 ± 13.1 and 16.2 ± 15.4%; P = 0.002) in the DCB with ELCA group.

Conclusions

The stent‐less revascularization strategy with DCB and ELCA was associated with a higher occurrence of restenosis in ACS patients.

     

Comparison of 3‐Year Clinical Outcomes Between Resolute™ Zotarolimus‐ and Sirolimus‐Eluting Stents for Long Coronary Artery Stenosis

Objectives

Long‐term clinical outcomes were evaluated in long coronary artery stenosis treated with different types of drug‐eluting stents.

Background

Long‐term follow‐up data to compare clinical outcomes between Resolute? zotarolimus‐eluting stent (R‐ZES) versus sirolimus‐eluting stent (SES) implantation for long coronary artery stenosis is insufficient.

Methods

A total of 254 patients (307 lesions) treated with R‐ZES and 265 patients (303 lesions) treated with SES for long coronary lesions (total stent length ≥30 mm) were enrolled, and long‐term (3 years) clinical outcomes were compared between the 2 groups. Efficacy (target lesion revascularization [TLR]) and safety (the composite occurrence of cardiovascular death, target lesion–related myocardial infarction, or target lesion–related definite stent thrombosis) were assessed.

Results

The 2 groups had similar baseline characteristics except for the duration of dual antiplatelet therapy (23.4 ± 11.2 months in R‐ZES‐treated patients vs. 27.4 ± 13.9 months in SES‐treated patients, P < 0.001). Total stent length was similar in R‐ZES‐treated patients (45.0 ± 19.0 mm) and SES‐treated patients (45.4 ± 18.6 mm) (P = 0.464). The cumulative TLR rate was 4.6% in R‐ZES‐treated patients versus 4.6% in SES‐treated patients (P = 0.911). For safety parameters, R‐ZES‐treated patients showed a significantly lower rate of the composite occurrence of cardiovascular death, target lesion–related myocardial infarction, or target lesion–related definite stent thrombosis than SES‐treated patients (0.4% vs. 2.4%, P = 0.042). Particularly, the occurrence of target lesion–related definite stent thrombosis was significantly lower in R‐ZES‐treated patients than in SES‐treated patients (0.0% vs. 2.0%, P = 0.028).

Conclusions

R‐ZES stents showed superior long‐term safety than SES for treating long coronary lesions, while maintaining a similar clinical efficacy.

     

A Novel‐Modified Provisional Bifurcation Stenting Technique: Jailed Semi‐Inflated Balloon Technique

Objective

We proposed a new technique for the treatment of coronary bifurcation lesions, called jailed semi‐inflated balloon technique (JSBT).

Background

Currently, provisional approach is recommended to treat most of coronary bifurcation lesions. However, it is associated with the risk of side branch (SB) occlusion after main vessel (MV) stenting due to plaque or carina shift into the SB. The SB occlusion may cause peri‐procedural myonecrosis or hemodynamic compromise. Therefore, strategies are needed to reduce the SB occlusion during provisional approach.

Methods

Between September 2014 and April 2015, we selected 137 patients (104 male, 33 female; mean age 63.6 ± 11.7 years) with 148 distinct coronary bifurcation lesions underwent percutaneous coronary intervention using JSBT. All patients were followed with hospital visits or telephone contact up to 1 month.

Results

The majority of the patients had acute coronary syndrome (64.2%) and Medina 1.1.1. bifurcation lesions (62.8%). The lesion localization was distal left main (LM) coronary artery in 28 patients. After the MV stenting, thrombolysis in myocardial infarction (TIMI) 3 flow was established in 100% of both MV and SB. There was no SB occlusion in any patient. There was no major adverse cardiac event during in‐hospital stay and 1 month follow‐up.

Conclusions

The JSBT technique can be successfully performed in both LM and non‐LM bifurcation lesion. This technique provides high rate of procedural success, excellent SB protection during MV stenting and excellent immediate clinical outcome. (J Interven Cardiol 2015;28:420–429)

     

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)

     

Effectiveness of the proximal optimization technique for longitudinal stent elongation caused by post‐balloon dilatation

Objectives

To evaluate the effectiveness of the proximal optimization technique (POT) to prevent longitudinal stent elongation.

Background

The mechanism of stent elongation, which occurs after post‐balloon dilation, is still unclear.

Methods

A total of 103 lesions treated with optical coherence tomography guided coronary intervention between May 2013 and November 2017 were retrospectively analyzed. Lesions were divided according to the circumferential degree of malapposition at the stent edge immediately after deployment into well‐apposed group (<180°) and malapposed group (≥180°). Post‐dilation was performed from distal to proximal within the stent until August 2016 (non‐POT cohort), and POT was applied thereafter (POT cohort). In the POT cohort, post‐dilation was done at the proximal portion of the stent with sufficiently large balloon to minimize malapposition followed by distal dilatations. Stent elongation length was defined as the change in stent length from stent deployment to after post‐dilatation.

Results

In the non‐POT cohort, 72 lesions, including 54 lesions in the well‐apposed group and 18 in the malapposed group were analyzed. Stent elongation length was significantly longer in the malapposed group than in the well‐apposed group (1.51 ± 1.34 mm vs 0.13 ± 0.84 mm, P < 0.01). In the POT cohort, 31 lesions including 21 in the well‐apposed group and 10 in the malapposed group were analyzed. Stent elongation length was not significantly different between the groups (?0.09 ± 0.91 mm vs 0.30 ± 0.99 mm, P = 0.29).

Conclusions

Malapposition of the stent edge is responsible for longitudinal stent elongation caused by post‐dilatation. POT appeared to effectively prevent longitudinal stent elongation.

     

Combined Paclitaxel‐Eluting Balloon and Genous Cobalt–Chromium Alloy Stent Utilization in De Novo Coronary Stenoses (PEGASUS)

Objectives

The aim of this study was to examine the angiographic result and its outcome predictors using the combination of paclitaxel‐eluting balloon (PEB) and Genous stent.

Background

This approach to treat coronary stenoses is a logical strategy to strike a balance between minimizing restenosis and stent thrombosis.

Methods

From November 2010 to June 2012, 40 symptomatic patients with 44 de novo coronary lesions of diameter stenosis ≥50% were treated with the combination of PEB and Genous stents. Angiographic and clinical follow‐up were intended at 6 and 9 months, respectively.

Results

The mean age of patients was 61 ± 11 years, with male predominance (83%). Diabetes mellitus and end‐stage renal failure on peritoneal dialysis were found in 15 (38%) and 10 (25%) patients, respectively. Patients received dual antiplatelet therapy for 5.1 ± 1.5 months post procedure. The size and length of PEB used was larger than the stents (3.13 ± 0.46 mm and 28 ± 9 mm vs. 2.98 ± 0.36 mm and 23 ± 7 mm). Restudy angiography was performed on 41 (95%) lesions in 37 (93%) patients at 5.9 ± 1.7 months. Angiographic restenosis was seen in 5 (12%) lesions, and significantly associated with diabetes mellitus and dialysis dependency; the late lumen loss was 0.38 ± 0.37 mm. At 9‐month follow‐up, no stent thrombosis was observed.

Conclusions

The use of PEB combined with Genous stent is associated with a reasonably low restenosis and late lumen loss, whereas diabetes mellitus and renal failure with dialysis are poor predictors of angiographic restenosis.

     

Long‐Term Clinical Follow‐Up after Drug‐Eluting Stent Implantation for Bare Metal In‐Stent Restenosis

Objectives

We aimed to evaluate the long‐term safety and efficacy of drug‐eluting stent (DES) implantation in the treatment of diffuse bare metal stent (BMS) restenosis as compared to the treatment of de novo coronary lesions in high restenosis risk patient population.

Background

To date limited long‐term data are available about the treatment of BMS restenosis with DES.

Methods

Five hundred and fourteen consecutive patients who underwent DES implantation between January 2003 and October 2006 at our institute were studied: 201 patients received DES for treatment of BMS restenosis and 313 patients received DES for high restenosis risk de novo lesions. Outcomes were calculated using propensity score adjustment. Mean follow‐up length was 45.6 ± 21.5 months.

Results

The rates of acute coronary syndrome, three‐vessel disease, and diabetes were high in both restenosis and de novo groups: 44.8% versus 46.3%, 20.9% versus 28.7%, and 34.3% versus 38.9%, respectively. The incidence of ischemia‐driven target lesion revascularization (TLR) yielded similar results in the restenosis group and de novo group at 4 years (10.4% vs 12.4%, P = 0.490). All‐cause mortality was lower in the restenosis group at 4 years (7.4% vs 14.7%, P = 0.032); however, the incidence of definite and probable stent thrombosis did not differ (1.9% vs 1.6%, P = 0.708) between the 2 groups.

Conclusions

DESs are safe in the treatment of diffuse BMS restenosis and the rate of additional TLR is acceptable as compared to the use of DES in de novo lesions. (J Interven Cardiol 2013;26:271–277)

     

Real‐World Safety and Effectiveness Outcomes of a Zotarolimus‐Eluting Stent: Final 3‐Year Report of the RESOLUTE International Study

Objectives

We evaluated the safety and effectiveness of the Resolute? zotarolimus‐eluting stent (R‐ZES) in real‐world clinical practice through 3 years.

Background

A randomized comparison of the R‐ZES and the XIENCE V? everolimus‐eluting stent showed no difference in any outcomes through 3‐year follow‐up in high‐volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R‐ZES in real‐world clinical practice.

Methods

RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end‐point was the composite of cardiac death and target vessel myocardial infarction (TV‐MI) at 1 year. Secondary end‐points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).

Results

At 3 years 97.2% of patients completed clinical follow‐up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV‐MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.

Conclusions

The safety and effectiveness of the R‐ZES through 3 years in this real‐world all‐comer study was consistent with previously reported all‐comer trials. (J Interven Cardiol 2013;26:515‐523)

     

Feasibility and clinical outcomes of rotational atherectomy for heavily‐calcified side branches of complex coronary bifurcation lesions in the real‐world practice of the drug‐eluting stent era

Objectives

To evaluate the outcomes of rotational atherectomy for heavily‐calcified side branches of coronary bifurcation lesions.

Background

Side‐branch (SB) preservation is clinically important but technically challenging in heavily‐calcified non‐left main true bifurcation lesions. SB rotational atherectomy (SB RA) is sometimes mandatory but the clinical outcomes are not well studied.

Methods

We retrospectively studied the outcomes of patients who underwent RA at our institute for heavily calcified, balloon‐uncrossable or—undilatable SB lesions over an approximately 5‐year period (January 2011 to September 2016).

Results

Two hundred and forty‐four patients underwent main vessel only RA (SB?MV + RA group) and another 48 patients underwent SB RA (SB + MV ± RA group) for 49 side branches. The demographic variables were comparable between the two groups. However, patients underwent SB RA experienced more SB perforations and greater acute contrast‐induced nephropathy (CIN). Among the SB RA patients, 30 (62.5%) underwent RA for both SB and MV (SB + MV + RA subgroup), whereas the other 18 underwent SB only RA (SB + MV?RA subgroup). Patients in these two subgroups could be completed with similar procedural, fluoroscopic durations, and contrast doses. The long‐term MACE rate of SB RA was 27.1% over a mean follow‐up period of 25.1 months with no differences between the two subgroups.

Conclusions

RA for SB preservation in complex and heavily‐calcified bifurcation lesions was feasible with high success rate and quite favorable long‐term outcomes in the drug‐eluting stent (DES) era. Given the higher rates in SB perforation and acute CIN, we recommend that SB RA should be conducted by experienced operators.

     

Long‐Term Clinical Outcomes of a Biodegradable Polymer‐Based Biolimus‐Eluting Stent

Objectives

To investigate the long‐term clinical outcomes of biolimus‐eluting stents with biodegradable polymers in real‐world clinical practice.

Background

Long‐term clinical outcomes of biolimus‐eluting stents have not been clearly established.

Methods

A total of 824 all‐comer patients (971 lesions) treated with unrestricted implantation of a biolimus‐eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long‐term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion‐related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow‐up.

Results

The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5‐year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5‐year cumulative rate for a composite of cardiac death, target lesion‐related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5‐year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST).

Conclusions

Biodegradable polymer‐based biolimus‐eluting stents showed favorable efficacy and safety in all‐comer patients during 5 years of follow‐up. (J Interven Cardiol 2016;29:162–167)

     

Long‐Term Effects of Novel Combination Coating Anti‐CD34 Antibody Applied on Sirolimus‐Eluting Stents

Objectives

We investigated whether the combination coating of a novel “prohealing coating” hyaluronan‐chitosan (HC) and anti‐CD34 antibody applied on an SES (HCASES) can reduce neointimal formation while promoting endothelialization compared to either agent alone.

Background

Drug‐eluting stents have considerably reduced the incidence of in‐stent restenosis compared with bare metal stents. However, the beneficial effect of drug elution is overshadowed by delayed re‐endothelialization as well as later “catch‐up” proliferation related to the drug.

Methods

Three different stents: Sirolimus‐eluting stents (SES), Genous anti‐CD34 antibody stents (GS), and the combination of HC‐anti‐CD34 antibody with sirolimus‐eluting stents (HCASES) were deployed in 54 normal porcine coronary arteries and harvested for scanning electron microscopy (SEM) and histological analysis at 60, 90, and 120 days.

Results

At 60 and 90 days, SEM analysis showed stent surface endothelial coverage was nearly completed in the HCASES (87 ± 3%, 95 ± 3%) compared with that in the SES (68 ± 6%, 77 ± 8%, P = 0.03). Histological examination at 90 days showed that the HCASES group had less percentage of stenosis than the GS group (P < 0.05). At 120 days, SEM showed a significantly higher extent of endothelial coverage above struts in the HCASES (96 ± 2%) and the GS (95 ± 3%) as compared with the SES group (66 ± 3%; P = 0.02). The HCASES group showed less stenosis than that in the GS group (P < 0.05), but it was not significantly different from the SES group (P = 0.063).

Conclusions

Histological and SEM analyses demonstrate that the HCASES can reduce neointimal formation and inflammation while promoting endothelialization in the long term. (J Interven Cardiol 2015;28:257–263)

     

Valve‐in‐valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses

Objectives

We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow‐up in patients with degenerated bioprostheses.

Methods

From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow‐up were entered into a dedicated database.

Results

Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1‐year follow‐up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013.

Conclusion

ViV‐TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.

     

Age is not a bar to PCI: Insights from the long‐term outcomes from off‐site PCI in a real‐world setting

Objectives

We sought to analyze the percutaneous coronary intervention (PCI) outcomes of very elderly patients (V. Eld. group, age >80 years) and compare their outcomes to a less elderly cohort (Eld. group, age 75‐80 years) traditionally reported in the literature.

Background

Limited data exist on peri‐procedural and long‐term outcomes following PCI in the V. Eld. (age >80 years), with under‐representation of this cohort in randomized controlled trials. These patients present with advanced complex coronary disease and multiple comorbidities.

Methods

All 580 consecutive patients aged ≥75 years (age 80 ± 4.9 years, 57.4% males) undergoing PCI between April 2006 and November 2011 were included. A total of 624 consecutive lesions were identified and analyzed. All V. Eld. patients (n = 253) were subsequently selected, and their outcomes compared to Eld. patients (n = 327). Mean follow‐up was 30.8 ± 2.7 months with 98% clinical follow‐up achieved.

Results

All comparative data are expressed as (V. Eld. vs Eld.) unless otherwise specified. All‐cause mortality was significantly higher in the V. Eld. group (11.9% vs 6.1%), although this did not translate into a significant difference in cardiac mortality (6.3% vs 3.7%) or major adverse cardiac and cerebrovascular events (16.2% vs 12.5%). The composite incidence of myocardial infarction (MI), stroke, definite/probable stent thrombosis, and TIMI major bleed was 4.7%, 1.4% 1.9%, and 6.4%, respectively with no significant difference between both cohorts.

Conclusions

This study demonstrates an acceptable occurrence of MI, death, repeat intervention, and stent thrombosis in a high‐risk group of V. Eld. patients with de novo lesions. Age alone in the absence of other non‐cardiac factors should not prohibit a patient from access to PCI.

     

A “Jail Escape Technique” (JET) for distal side branch wiring during provisional stenting: Feasibility and first‐in‐man study

Objective

To evaluate the feasibility of a novel technique for achieving distal SB access and improve strut apposition during provisional stenting.

Background

While distal rewiring and stent expansion toward the side branch (SB) are associated with better results during provisional stenting of coronary artery bifurcation lesions, these techniques are technically challenging and often leave unopposed struts near the carina.

Methods

The “Jail Escape Technique” (JET) is performed by passing the proximal tip of the SB wire between the main vessel (MV) stent struts and balloon before implantation, allowing the MV stent to push the SB wire against the distal part of the carina. The MV stent can then be deployed without jailing the SB wire. Distal SB access and strut distribution at the carina were tested in phantom and swine models. Stent distortion, dislodgement forces, and material damage were evaluated with tensile testing. Human feasibility was then tested on 32 patients.

Results

Preclinical testing demonstrated that the SB wire was located at the most distal part of the carina and no strut malapposition at the carina was present after balloon inflation. Stent distortion, dislodgement forces, or material damage were not affected. JET was successfully performed in 30 of 32 patients. No major adverse cardiovascular events occurred in any patient at 6‐month follow‐up.

Conclusion

The “JET” enables distal SB access and eliminates strut malapposition at the carina. Further studies with larger numbers of patients are needed to further investigate this technique.

     

Nine‐Month Angiographic and Intravascular Ultrasound Outcomes After Resolute Zotarolimus‐Eluting Stent Implantation for the Treatment of In‐Stent Restenosis

Objectives

We aimed to evaluate the mid‐term outcomes of resolute zotarolimus‐eluting stent (R‐ZES) implantation for in‐stent restenosis (ISR).

Background

There has been a paucity of data regarding the effects of new‐generation drug‐eluting stent to treat ISR.

Methods

From 2009 to 2010, a total of 98 patients with 98 ISR lesions were prospectively enrolled after R‐ZES implantation for the treatment of ISR. Among 98 patients, 73 patients underwent follow‐up angiography at 9 months. Serial intravascular ultrasound (IVUS) at both postprocedure and 9 months was evaluated in 55 patients. The overlapped segment of R‐ZES was defined as the portion of R‐ZES superimposed on previous stent.

Results

Late loss and binary restenosis rate were 0.3 ± 0.5 mm and 5.5% at 9 months. On IVUS, the percentage of neointimal volume and maximum percentage of neointimal area were 3.9 ± 6.3% and 17.3 ± 15.5%, respectively. There was no significant change of vessel volume index between postprocedure and 9 months (16.9 ± 4.7 mm³/mm vs. 17.1 ± 4.6 mm³/mm, P = 0.251). Late‐acquired incomplete stent apposition was observed in 5 (5/55, 9.1%) cases. Compared with nonoverlapped segments of R‐ZES, the overlapped did not show larger neointimal volume index (0.3 ± 0.5 mm³/mm vs. 0.2 ± 0.3 mm³/mm, P = 0.187) on 9‐month IVUS. During follow‐up (median, 353 days), repeat target‐lesion revascularization was performed in four cases, but there were no death or stent thrombosis.

Conclusions

This study suggested that R‐ZES implantation for the treatment of ISR was effective up to 9 months and showed favorable vascular responses on serial IVUS assessment.

     

Same or Different Drug‐Eluting Stent Re‐Implantation for Drug‐Eluting Stent Restenosis: An Assessment Including Second‐Generation Drug‐Eluting Stents

Objectives

We examined the long‐term outcomes of implanting a different type of drug‐eluting stent (DES), including second‐generation DES, for treatment of DES‐in stent restenosis (ISR).

Background

Treatment for DES‐ISR has not been standardized.

Methods

The subjects were 80 patients with 89 lesions underwent DES implantation for DES‐ISR. The patients were divided into the group of patients receiving the same DES for DES‐ISR (Homo‐stent: 24 patients, 25 lesions) and a different DES for DES‐ISR (Hetero‐stent: 56 patients, 64 lesions). The primary endpoint was survival free of major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization (TVR). The secondary endpoint was late loss at 8–12 months follow‐up. In the subgroup of patients who were treated with second‐generation DES for DES‐ISR, we also assessed the survival free of MACE.

Results

During a mean follow‐up of 45.1 ± 21.2 months, 26 patients experienced MACE. There was no significant difference in the survival free of MACE (Log rank P = 0.17). In the sub‐analysis of second generation DES, MACE was significantly higher in the Homo‐stent group compared to the Hetero‐stent group (Log rank P = 0.04). Late loss was significantly higher in the Homo‐stent group than in the Hetero‐stent group (0.86 ± 1.03 vs. 0.38 ± 0.74 mm, P = 0.03). This trend was prominent in the first‐generation DES group.

Conclusions

Although there was no significant difference in MACE between the Hetero‐stent and the Homo‐stent groups including both first and second‐generation DES, the sub‐analysis demonstrated different DES implantation for DES‐ISR significantly improved the MACE rate among patients treated with second‐generation DES. (J Interven Cardiol 2016;29:311–318)

     

Percutaneous Coronary Intervention of Complex Calcified Lesions With Drug‐Coated Balloon After Rotational Atherectomy

Objectives

We investigated the safety and efficacy of PCI using drug‐coated balloon (DCB) after rotational atherectomy (rotablation) in a retrospective single center study in patients with calcified de novo coronary lesions. The majority of patients had an increased risk for bleeding.

Background

DCB has been effective in the treatment of in‐stent restenosis, small vessels, and bifurcations. DCB enables short one month dual antiplatelet treatment. No published data exist on the use of DCB after rotablation.

Methods

82 PCIs were performed in 65 patients (mean age 72 ± 10 years) using rotablation followed by DCB treatment. The median follow‐up time was 17 months. 82% of the patients had at least one risk factor for bleeding such as oral anticoagulation. 32% had an acute coronary syndrome. Median duration of dual antiplatelet treatment was 1 month.

Results

MACE (the composite of cardiovascular death, ischemia‐driven target‐lesion revascularization [TLR] or non‐fatal myocardial infarction) occurred in 14% and 20% of the patients at 12 and 24 months, respectively. The rate of ischemia‐driven TLR was 1.5% at 12 months and 3.0% at 24 months. No acute closure of the treated vessel occurred. Bailout stenting was needed in 10% of the PCIs. The incidence of significant bleeding was 9% at 12 months.

Conclusions

This is the first study to show that PCI using DCB after preparation of calcified lesions with rotablation is safe and effective. This novel strategy may be considered especially in patients with a bleeding risk such as those using an oral anticoagulant.