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)

     

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.

     

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

Objectives

We evaluated and compared the incidence and characteristics of late catch‐up phenomenon (LCU) between everolimus‐eluting stent (EES) and sirolimus‐eluting stent (SES) implantations.

Background

Late catch‐up phenomenon after everolimus‐eluting stent (EES) implantation has not yet been evaluated sufficiently.

Methods

Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES‐treated patients and 495 ESS‐treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1–3 years]) were compared.

Results

The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different.

Conclusions

EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation. (J Interven Cardiol 2015;28:551–562)

     

Comparison of 4.5‐Year Outcomes of Bare‐Metal and Zotarolimus‐Eluting Stents in New York

Background

Both bare‐metal stents (BMS; the first‐generation coronary stent) and zotarolimus‐eluting stents (ZES; a second‐generation drug‐eluting stent [DES]) have been widely utilized to treat coronary heart disease. However, the long‐term comparative effectiveness of BMS and ZES remains unclear. The purpose of this study was to evaluate long‐term comparative effectiveness of BMS versus ZES.

Methods

We created a longitudinal database by linking the New York State (NYS) cardiac registries, statewide hospital discharge data, the National Death Index (NDI), and the U.S. Census file (2010) for patients receiving either BMS or ZES during the 2008–2009 period. We examined the rates of all‐cause mortality, acute myocardial infarction (AMI), target‐lesion PCI (TLPCI), and target‐vessel coronary artery bypass graft (TVCABG) surgery for a follow‐up period of 4.5 years. A total of 10,443 propensity score matched pairs were compared using the Kaplan–Meier method and Cox proportional hazards regression adjusting for patient risk factors.

Results

We found that patients receiving ZES had a lower rate of 4.5‐year mortality (adjusted hazard ratio AHR: 0.68, 95% confidence interval CI: 0.63–0.73), AMI (AHR: 0.89, 95% CI: 0.80–0.98), and TVCABG (AHR: 0.84, 95% CI: 0.71–0.99) but a similar rate of TLPCI (AHR: 1.02, 95% CI: 0.93–1.12). For “off‐label” and “high‐risk” subgroups, ZES was associated with improved mortality and generally better or non‐inferior AMI, TLPCI, and TVCABG outcomes relative to BMS.

Conclusions

Compared with BMS, ZES was associated with lower long‐term mortality, AMI and TVCABG. (J Interven Cardiol 2016;29:265–274)

     

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 Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study

Objectives

to assess performance of new, bioresorbable polymer sirolimus‐eluting stent (BP‐SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus‐eluting stent (PP‐EES).

Background

LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear.

Methods

In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP‐SES (101) or PP‐EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee.

Results

The baseline patient and lesion characteristics were similar in the 2 study arms. At 9‐months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP‐SES and PP‐EES, respectively. There was no stent thrombosis (ST) in BP‐SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP‐EES group (P = 0.44).

Conclusions

Patients with LL showed similar clinical outcomes when treated with Ultimaster BP‐SES and Xience PP‐EES. (J Interven Cardiol 2016;29:47–56)

     

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)

     

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)

     

Risk Factors and Clinical Impacts of Peri‐Stent Contrast Staining After Second‐Generation Drug‐Eluting Stent Implantation

Background

Peri‐stent contrast staining (PSS) after sirolimus‐eluting stent implantation is associated with target lesion revascularization (TLR) and very late stent thrombosis. However, the risk factors and clinical sequelae of PSS after second‐generation DES implantation remain unclear.

Methods and Results

This study comprised 2,090 patients with 2,883 lesions treated with second‐generation DES from April 2009 to February 2013. Angiographic findings and clinical outcomes were compared between PSS and non‐PSS groups. Follow‐up angiography was available for 2,411 lesions. PSS was observed in 23 lesions: 4 in biolimus‐eluting stents, 4 in zotarolimus‐eluting stents (ZES), and 15 in everolimus‐eluting stents (EES). Right coronary artery lesions, chronic total occlusion (CTO), and lesions with severe angulation (>90°) were more frequent in the PSS group compared with the non‐PSS group. Lesions were longer and the cumulative TLR incidence at 3 years was higher in the PSS group than those in the non‐PSS group (27.9 mm vs. 19.4 mm, P < 0.0001; 27.4% vs. 8.6%, P = 0.0002). There was no significant difference in stent thrombosis between the two groups. Multivariable analysis identified CTO [odds ratio (OR) 3.75, 95%CI 1.52–8.88, P = 0.005] as an independent predictor of PSS.

Conclusions

PSS after second‐generation DES implantation was associated with an increased risk of subsequent TLR. CTO was the independent predictor of PSS. (J Interven Cardiol 2016;29:179–187)

     

Real‐life data regarding acute procedural success and 1‐year clinical outcome of desolve bioresorbable scaffolds

Objectives

We aimed to evaluate the peri‐procedural success of DESolve bio‐resorbable scaffolds (BRSs) and analyzed real‐life data about major cardiac events during 1‐year follow‐up.

Background

There is little information about real‐life data of DESolve BRS which is a novel stent technology offering various advantages over drug eluting stents and commonly used in daily cardiology practice.

Methods

We conducted this single‐center and non‐randomized cross‐sectional study from June 2015 through August 2016 in Medipol University Department of Cardiology and included 117 patients undergoing single or multivessel percutaneous coronary interventions (PCI) with novolimus‐eluting BRS devices (152 scaffolds) (Elixir Medical Corporation). Study end points were acute device and procedural success, scaffold thrombosis and major adverse cardiac event (MACE) rates of DESolve BRS.

Results

Device success was 96.7% and procedural success was 99.3%. We detected MACE rate as 0.9% while clinical‐driven target lesion revascularization was performed in one patient. None of the patients experienced scaffold thrombosis or death. Peri‐procedural complications were reported in three patients.

Conclusions

High rates of successful scaffold implantations, low rates of peri‐procedural complications, and major cardiac events in long‐term suggest that DESolve scaffolds can safely and effectively be used in daily intervention practice by particularly experienced operators.

     

Bioresorbable vascular scaffold to treat in‐stent restenosis: Single‐center experience

Aims

The management of patients with in‐stent restenosis (ISR) is still a major clinical challenge even in the era of drug‐eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus‐eluting bioresorbable vascular scaffold (BVS) ABSORB? in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long‐term results of our preliminary experience with this novel approach at our institution.

Methods and Results

We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow‐up was available in 91.9% of the patients. Mean follow‐up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow‐up (16.2%).

Conclusions

These real‐world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB? BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis‐generating for larger randomized controlled studies.

     

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)

     

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.

     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

Everolimus‐eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease,single‐center initial experience

Aims

Recent studies have shown favorable outcomes with everolimus‐eluting bioresorbable vascular scaffold (BVS) in patients with stable coronary artery disease. Data on the use of BVS in saphenous vein graft disease (SVG) is currently lacking.

Methods and Results

A total of 10 consecutive patients (13 lesions, including 6 in‐stent restenosis) who underwent BVS for SVG disease between May 2013 and June 2015 at a tertiary care institution were included. Median follow‐up period was 874 (720‐926) days. One patient had scaffold thrombosis (ScT) 15 months after implantation, which was treated medically. Another patient had target lesion revascularization (TLR) in two different lesions, where BVS was used to treat in‐stent restenosis. The composite endpoint of TLR, ScT, target vessel myocardial infarction, and cardiac death, was reached in two patients

Conclusions

This first real‐world data on the use of the ABSORB? BVS in patients with SVG disease shows that its implantation is technically feasible. The observed rate of target lesion revascularization was similar to those observed with drug‐eluting stents in similar settings. Larger studies are required to better define the optimal use of BVS to treat SVG disease.

     

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)

     

MGuard Mesh‐Covered Stent for Treatment of ST‐Segment Elevation Myocardial Infarction with High Thrombus Burden Despite Manual Aspiration

Objectives

To assess the usefulness of the MGuard stent in patients with ST‐segment elevation myocardial infarction (STEMI) in whom a high thrombus burden persists after manual aspiration.

Background

In some patients with STEMI, a high thrombus burden may persist after manual aspiration. These patients may be at high risk of distal embolization and therefore impaired myocardial reperfusion. The MGuard is a novel mesh‐covered stent designed to minimize thrombus embolization.

Methods

Single‐arm, prospective registry of patients with STEMI and high thrombus burden after aggressive thrombus aspiration treated with the MGuard stent. High thrombus burden was defined as thrombus burden grade 4 or 5 according to the TIMI score. Lesions with a side branch ≥2 mm and patients with cardiogenic shock were not included. The study end‐points were proportion of final TIMI 3 flow, normal myocardial blush, and complete ST‐segment resolution.

Results

Fifty‐six patients were included. After MGuard stent implantation >85% of cases had thrombus score = 0. Final TIMI 3 flow was achieved in 82% of cases, normal myocardial blush in 55%, and complete ST‐segment resolution in 59%. Occlusion of a side branch (<2 mm) occurred in 2 cases (3.5%), embolization to a distal branch in 5 cases (8.9%), and transient no‐reflow in 4 cases (7.1%). Major adverse cardiac events rate at 9 months was 3.6%, including 1 definite acute stent thrombosis and 1 target‐vessel revascularization.

Conclusions

The MGuard stent may be useful to prevent distal embolization in patients with STEMI and high thrombus burden despite mechanical aspiration.

     

Three‐months optical coherence tomography analysis of a biodegradable polymer,sirolimus‐eluting stent

Objective

We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus‐eluting stent with biodegradable polymer.

Background

New generations of drug‐eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers.

Methods

In this prospective, open‐label study, 34 patients received an Orsiro® sirolimus‐eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT‐examination at three months. The primary endpoint was 3‐month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months.

Results

At 3 months, NIH score was 13.7 (5.4‐22), covered struts per lesion were 90% (84‐97%), malapposed struts were 2.7% (0.8‐5.4%) and rate of mature tissue coverage was 47% (42‐53%). No target lesion failure occurred up to 12 months. Patients with OCT‐guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8‐26.4]; OCT‐guided: 9.8% [4.0‐15.5]; mean difference ?8, [95%CI: ?18.7‐2.9], P = 0.123). This group had significantly more covered struts per lesion (angio‐guided: 86% [82‐90]; 95% [92‐99]; mean difference 9% [95%CI: 3‐15], P = 0.001).

Conclusion

The Orsiro® sirolimus‐eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3‐month follow‐up. OCT guided stent implantation had a positive impact on early vascular healing.

     

Assessment of Efficacy and Safety of Combining “Paclitaxel” Eluting Balloon and “Limus” Eluting Stent in the Same Lesion

Objectives

To assess the safety and efficacy of combining drug‐eluting balloon (DEB) and drug‐eluting stents (DES) in the same coronary lesion.

Background

Use of DEB may not always produce optimal results or even result in dissection, compelling the operators to consider bailout stenting with bare metal stents (BMS). However, BMS may not be ideal in patients who have significant risk‐profile for restenosis. We have opted for DES over BMS in such situations and present our follow‐up data.

Methods

Between 2009 and 2011, 46 patients (57 lesions) requiring bailout stenting following DEB use were treated with second‐generation DES. All patients had at‐least one or more risk‐factors that made them vulnerable for restenosis (diabetes, chronic kidney disease, previous in‐stent restenosis [ISR], and/or long diffuse lesions ≥30 mm).

Results

Of the 57 lesions, 34 (60%) were previous ISR. The mean length of the DEB was: 36.2 ± 5.6 mm. All patients had TIMI‐3 flow post PCI with no in‐lab complications. At median follow‐up of 12.3 months (interquartile range [IQR]: 7.5–18.1), the rates target lesion revascularization (TLR) and target vessel revascularization (TVR) were 3 (5.3%) and 4 (7%), respectively. One patient had died 3 months following treatment. There were no episodes of myocardial infarction, definite or probable stent thrombosis. The major adverse cardiovascular events (MACE) rate defined as cardiac‐death, MI, and TVR occurred in 11% of patients.

Conclusion

The results from this novel strategy of combining “Paclitaxel” eluting balloon and “Limus” eluting stent in a same lesion are encouraging. Dual drug‐elution acting on two different pathways may provide potential synergy that may explain the favorable outcome. (J Interven Cardiol 2013;26:259–263)

     

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.