Clinical and Angiographic Outcomes with Everolimus Eluting Stents for the Treatment of Cardiac Allograft Vasculopathy

Objectives

This study aimed to examine clinical efficacy, safety, and intermediate clinical outcomes with everolimus‐eluting stents (EESs) in patients with transplant coronary artery disease (TCAD).

Background

TCAD is a major cause of mortality in patients following orthotopic heart transplantation (OHT). Systemic everolimus in OHT patients has been shown to reduce TCAD. The safety and efficacy of an EES, the Xience V, have not been evaluated in this population.

Methods

Patients post‐OHT with hemodynamically significant CAD who underwent percutaneous coronary intervention (PCI) with EES were included. Participants were maintained on dual antiplatelet therapy for 1‐year post‐PCI. We examined procedural success, in‐hospital and 1‐year mortality, stent thrombosis, angiographic restenosis, and myocardial infarction rates. All patients had follow‐up angiography 1‐year after PCI. Target vessel revascularization (TVR), target lesion revascularization (TLR), in‐segment restenosis, target vessel failure (TVF), and lumen late loss were noted.

Results

PCI was performed in 34 de novo lesions in 21 patients, and 40 EES were placed. Procedural success rate was 100%. Average stent was 16.5 ± 5.1 mm long and 3.0 ± 0.6 mm in diameter. All patients had angiographic follow‐up (409 ± 201 days). There was no stent thrombosis, deaths, or myocardial infarctions during follow‐up. Two patients had focal in‐stent restenosis. TLR rate was 5.9% (2/34), and TVR rate was 11.1% (3/27). Quantitative coronary angiography (QCA) showed stenosis diameter to be 19.98 ± 17.57%.

Conclusions

Use of an EES is associated with a low incidence of TVR and TLR in patients with TCAD. Further studies are needed to determine whether PCI with EES changes long‐term outcomes. (J Interven Cardiol 2014;27:73–79)

     

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)

     

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)

     

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.

     

Identification of Intrastent Pathology Associated With Late Stent Thrombosis Using Optical Coherence Tomography

Objective

To better characterize intrastent pathology using optical coherence tomography (OCT) in patients presenting with late and very late stent thrombosis (LST/VLST).

Background

The contribution of specific intrastent pathologies to the development of LST/VLST is not well understood.

Methods

In this single‐center, retrospective, observational study of 796 consecutive patients treated for ST‐segment elevation myocardial infarction (STEMI) with primary PCI we identified 57 patients (7.2%) in whom STEMI resulted from LST/VLST. Of the patients with LST/VLST, 21 patients (37%) had OCT performed at the discretion of the operator during PCI for LST/VLST. Independent reviewers performed qualitative offline analysis of OCT images to determine the cause of stent thrombosis defined as the specific intrastent pathology associated with thrombus deposition.

Results

The principal intrastent pathology causing LST/VLST was determined to be stent malapposition in 11 patients (55%), of which 5 (25% of all LST/VLST patents) had findings suggestive of positive vessel remodeling. Neoatherosclerosis was determined to be the cause of LST/VLST in 7 patients (35%). LST/VLST resulted from uncovered stent struts in 2 patients (10%). Among all LST/VLST patients, in‐hospital mortality (12.3%) and post‐hospital target vessel failure (TVF) or cardiac death (21.7%, median follow‐up 1.6 years) remained high. There was a trend towards decreased TVF or cardiac death (7.7% vs. 27.3% P = 0.24) in patients who underwent OCT‐guided therapy.

Conclusions

LST/VLST remains a significant cause of STEMI and is associated with considerable morbidity and mortality. OCT use at the time of PCI consistently identifies significant intrastent pathology with potentially meaningful clinical impact. (J Interven Cardiol 2015;28:439–448)

     

Complete versus incomplete revascularization with drug‐eluting stents for multi‐vessel disease in stable,unstable angina or non‐ST‐segment elevation myocardial infarction: A meta‐analysis

Objectives

To determine whether drug‐eluting stent (DES) coronary complete revascularization (CR) confers clinical benefit over incomplete revascularization (IR) in patients with multivessel coronary artery disease (MVD).

Background

Clinical benefit of CR over IR in patients with MVD with angina (both stable and unstable) and non‐ST‐segment elevation myocardial infarction (NSTEMI) in DES has not been well studied.

Methods

We conducted a systematic online literature search of PUBMED and EMBASE. Literatures that compared the clinical outcomes between CR and IR with exclusively or majority (>80%) using DES in patients without or included only small portion (<20%) of ST‐segment elevation myocardial infarction or single‐vessel coronary artery disease were included. Hazards ratio (HR) with 95% confidence interval (CI) was calculated with random‐effects model.

Results

No randomized clinical trials were identified. A total of 14 observational studies with total of 41 687 patients (CR 39.6% and IR 60.4%) were included in this meta‐analysis. CR was associated with lower incident of all‐cause mortality (HR 0.71, P = 0.001), major adverse events (HR 0.75, P < 0.001), cardiovascular mortality (HR 0.39, P < 0.001). Meta‐regression analysis showed that CR significantly reduced the risk of all‐cause mortality in advanced age, triple vessel disease and male sub‐groups.

Conclusions

CR with DES conferred favorable outcomes compared to IR in MVD patients with stable, unstable angina or NTEMI. Further research to achieve higher CR in MVD patients may lead to improvement in prognosis in these cohorts.

     

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.

     

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Coronary Lesions Complicated by Coronary Artery Dissection (RAISE)

Objectives

To examine the safety and efficacy of immediate rotational atherectomy (RA) in nondilatable calcified coronary lesions complicated by coronary dissection during percutaneous coronary intervention (PCI).

Background

In the presence of coronary dissection in nondilatable calcified coronary lesions, conservative management is suggested to permit the dissection to heal prior to treatment with RA. However, many patients have frequent angina attacks and some patients develop serious complications during this period.

Methods

One hundred and nighty‐eight patients with severe coronary calcification underwent PCI, and were randomized into immediate (n = 105) or delayed RA group (n = 93) when coronary dissections occur. The primary endpoint of the present study was all‐cause death including cardiac and non‐cardiac death in 4 years follow‐up. Non‐fatal myocardial infarction, stent thrombosis, cardiac tamponade, stroke, target lesion revascularization, New York Heart Association (NYHA) class IV heart failure were analyzed as secondary end points.

Results

At a follow‐up of 4 years, event‐free survival rates were not statistically different between the immediate and delayed RA group (81.9% vs 80.6%, P = 0.820). Rates of PCI‐ and RA‐related major adverse cardiac events (MACE) and severe RA‐related complications were not statistically different between groups. Luminal loss was not significantly different between the immediate and delayed RA group as evaluated by Intravascular ultrasound (IVUS). Two cases in the delayed RA group experienced myocardial infarction during the 4‐week waiting.

Conclusion

This study indicates that immediate RA during PCI is safe and effective in patients with coronary artery dissection. (J Interven Cardiol 2015;28:456–463)

     

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)

     

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.

     

Bivalirudin versus heparin and provisional GP IIb/IIIa inhibitors in patients treated for ST‐segment elevation myocardial infarctions: Comparison of outcomes in a “real‐world” setting

Introduction

The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a “real‐world” study.

Methods

From 05/2013 until 11/2014, the STEMI‐patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs.

Results

In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35‐0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30‐1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1‐year follow‐up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock).

Conclusions

In this “real‐world” cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long‐term course.

     

Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new‐generation covered stents

Objectives

To compare outcomes in patients receiving polytetrafluoroethylene (PTFE) and polyurethane (PL) covered stents (CS) after coronary artery perforation (CAP).

Background

The prognosis of CAP has improved with the advent of CSs. Information is scarce about the outcomes of new‐generation CSs.

Methods

Sixty‐one patients were treated with CSs in a 5‐years period (age = 77 ± 8.75% males). Procedural and clinical data were retrospectively collected. The primary endpoint was procedural success. Secondary endpoints included death and major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, target vessel, and lesion revascularization and need for surgical repair).

Results

Twenty‐two (36%) received PL‐CSs and 39 (65%) PTFE‐CSs. There were no differences in procedural success (86% vs 69%, P = 0.216). Time to deliver was shorter with PL‐CS despite larger length of stents (8[11] vs 15[16] min, P = 0.001; 20[5] vs 16[3] mm, P < 0.001). This group had lower rate of pericardial effusion and cardiac arrest (41% vs 72%, P = 0.028; 5% vs 26%, P = 0.045). At 1‐year follow‐up, MACE rates were similar (58% vs 56%, P = 1.000) with atrend toward TVR in the PL‐CS arm (21% vs 5%, P = 0.083). No differences were found in mortality (26% vs 41%, P = 0.385). Each group had 1 stent thrombosis and in‐stent restenosis trended higher in the PL‐CS group (12% vs 3%, P = 0.223).

Conclusions

Time to deliver was shorter with the PL‐CS and resulted in lower rate of pericardial effusion and cardiac arrest. However, there were no significant differences in procedural success and 1‐year follow‐up MACE in patients treated with PL‐CS or PTFE‐CS.

     

Role of deferred stenting in patients with ST elevation myocardial infarction treated with primary percutaneous coronary intervention: A systematic review and meta‐analysis

Objectives

We conducted a meta‐analysis of studies comparing deferred stenting strategy versus the conventional approach with immediate stenting in patients with ST elevation myocardial infarction.

Background

Deferring stent after mechanical flow restoration has been proposed as a strategy to reduce the risk of “no reflow” in patients with STEMI undergoing primary percutaneous coronary intervention (pPCI). Conflicting evidence is available currently, especially after the recent publication of three randomized clinical trials.

Methods

Searches in electronic databases were performed. Comparisons between the two strategies were performed for both hard clinical endpoints (all cause‐mortality, cardiovascular mortality, unplanned revascularization, myocardial infarction and readmission for heart failure) and surrogate angiographic endpoints (TIMI flow < 3 and myocardial blush grade (MBG) < 2).

Results

Eight studies (three randomized and five non‐randomized) were deemed eligible, accounting for a total of 2101 patients. No difference in terms of hard clinical endpoints was observed between deferred and immediate stenting (OR [95% CI]: 0.79 [0.54‐1.15], for all‐cause mortality; odds ratio (OR) [95% CI]: 0.79 [0.47‐1.31] for cardiovascular mortality; OR [95% CI]: 0.95 [0.64‐1.41] for myocardial infarction; OR [95% CI]: 1.37 [0.87‐2.16], for unplanned revascularization and OR [95% CI]: 0.50 [0.21‐1.17] for readmission for heart failure). Notably, the deferred stenting approach was associated with improved outcome of the surrogate angiographic endpoints (OR [95% CI]: 0.43 [0.18‐0.99] of TIMI flow < 3 and OR [95% CI]: 0.25 [0.11‐0.57] for MBG < 2.

Conclusions

A deferred stenting strategy could be a feasible alternative to the conventional approach with immediate stenting in “selected” STEMI patients undergoing pPCI.

     

Comparison of Clinical Results Following the Use of Drug‐Eluting Balloons for a Bare‐Metal Stent and Drug‐Eluting Stent Instent Restenosis

Background

Drug‐eluting balloons (DEBs) have emerged as a potential alternative to current treatments of instent restenosis (ISR). The study aims to investigate the clinical outcomes of a DEB angioplasty to treat bare‐metal stent (BMS) ISR and drug‐eluting stent (DES) ISR at 1‐year clinical follow‐up period.

Methods

Between November 2011 and December 2014, 312 patients were diagnosed with coronary artery ISR at our hospital. A total of 426 coronary ISR lesions were treated with DEBs. The clinical outcomes, including target lesion revascularization (TLR), myocardial infarction, stroke, cardiovascular mortality, and all‐cause mortality were compared between the BMS‐ISR group and DES‐ISR group. Propensity score matched analysis was used to minimize bias.

Results

The average age of the patients was 64.99 ± 10.35 years, and 76.9% of the patients were male. After multivariate Cox regression analyses about 1‐year recurrent restenosis in DES‐ISR group, only end stage renal disease (ESRD) (P = 0.047) and previous DEB failure (P < 0.001) were identified with significant difference. After propensity score matched analysis, the bias of baseline characteristics showed no significant difference. The DES‐ISR group experienced more myocardial infarctions (2.8% vs 8.3%, P = 0.075), more TLR (8.1% vs 15.4%, P = 0.051), especially at nonostial lesion (5.7% vs 14.9%, P = 0.030) than the BMS‐ISR group. Higher incidence of major cardiac cerebral adverse events happened in the DES‐ISR group. (11.7% vs 22.1 %, P = 0.038)

Conclusion

During the 1‐year follow‐up period, DEBs angioplasty for BMS‐ISR had better clinical outcomes and less TLR than DES‐ISR. ESRD and previous DEB failure were associated to TLR in DES‐ISR group.

     

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)

     

A Comparative Study of Bivalirudin Plus Clopidogrel versus Bivalirudin Plus Prasugrel in Primary Angioplasty Using Propensity Score Matching

Introduction and Objectives

In primary angioplasty, bivalirudin is superior to treatment with heparin plus glycoprotein inhibitors for reducing cardiovascular events, although bivalirudin increases the risk of stent thrombosis. Our hypothesis is that the use of prasugrel plus bivalirudin in primary angioplasty would reduce stent thrombosis and cardiovascular events.

Method

Consecutive patients with acute ST‐segment elevation myocardial infarction who were treated by primary angioplasty within 12 hours of the onset of symptoms received bivalirudin plus clopidogrel (Group A) or bivalirudin plus prasugrel (Group B). We compared the groups using propensity score matching. The combined end‐point was cardiac death, thrombosis, acute myocardial infarction, and cerebrovascular accident at 30 days.

Results

We assessed 168 patients. The approach was preferentially radial (95.7%). No differences in baseline characteristics were observed between Groups A (n = 70) and B (n = 70). The total mortality and rate of major bleeding complications at 30 days were 0% for both of the groups. The rate of acute and subacute thrombosis was 4.3% in Group A and 0% in Group B (P = 0.08). We observed an increased rate of events in Group A (5.7%) versus Group B (0%) (P = 0.042).

Conclusions

The administration of bivalirudin plus prasugrel in primary percutaneous coronary intervention reduces cardiovascular effects compared to bivalirudin plus clopidogrel without increasing major bleeding complications during the first 30 days following primary angioplasty performed with a preferentially radial approach. (J Interven Cardiol 2013;26:463‐469)

     

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.

     

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.

     

Rotational Atherectomy for Left Main Coronary Artery Disease in Octogenarians: Transradial Approach in a Tertiary Center and Literature Review

Objectives

The aim of this study was to appreciate the safety and effectiveness of transradial percutaneous coronary intervention (PCI) with rotational atherectomy for highly calcified left main coronary artery (LMCA) disease in octogenarians.

Background

Conventional surgery is still considered the preferred management for LMCA disease; but, when the lesion is severely calcified, and the patient is unsuitable for surgery, the interventional cardiologist faces a complex PCI traditionally approached by femoral access.

Methods

Between June 2004 and December 2010, octogenarians with calcified LMCA disease who were primary denied for surgical revascularization were enrolled. Procedural success and major adverse cerebral and cardiovascular events (MACCE) including death, nonfatal myocardial infarction, target lesion revascularization (TLR), or stroke during long‐term follow‐up were evaluated.

Results

Forty‐two consecutive patients≥80 years had undergone stenting for calcified LMCA disease (13 with rotational atherectomy, the “Rota” group, and 29 without rotational atherectomy, the “without Rota” group). Procedural success was good (92.3% vs. 96.6%, respectively, p = NS). Mean follow‐up time was 25.7 ± 21.4 and 28 ± 32.3 months, respectively. There was a TLR in 25% and 11.1%, respectively; p = NS. No difference was detected in terms of overall in‐hospital or long‐term mortality or MACCE.

Conclusion

Rotational atherectomy followed by stent implantation by transradial approach, when applied to heavily calcified lesions, appeared to be a safe and effective strategy for the treatment of LMCA disease in octogenarians who were refused for surgery. (J Interven Cardiol 2013;26:173–182)

     

Vascular Endothelial Growth Factor–Bound Stents: Application of In Situ Capture Technology of Circulating Endothelial Progenitor Cells in Porcine Coronary Model

Objectives

We evaluated the in vivo performance of a newly devised vascular endothelial growth factor (VEGF)‐bound stent in a porcine coronary model.

Background

An anti‐CD34 antibody‐bound stent, which captures endothelial progenitor cells (EPCs) to accelerate tissue formation, did not reduce intimal hyperplasia. By targeting the VEGF receptor, which is expressed on endothelial‐lineage cells, we developed VEGF‐bound stents that may enable selective capture of EPCs followed by rapid endothelialization.

Methods

Metallic stents were first coated with poly‐(ethylene‐co‐vinyl alcohol), and then chemically bound with either VEGF or anti‐CD34 antibody. These stents were placed in porcine coronary arteries for up to 14 days. Stent surface was evaluated by immunohistochemistry and by scanning electron microscope (SEM).

Results

After 2‐day stenting with VEGF‐bound stents, small populations of KDR (VEGF receptor‐2)‐positive cells adhered to the stent struts. After 7‐ and 14‐day stenting, struts were fully covered with newly regenerated tissue. SEM images showed that the uniform tissue formed on struts was morphologically similar to native endothelium and was continuously connected with adjacent native endothelium. On the other hand, for the anti‐CD34 antibody‐bound stents, stent struts were rapidly covered by newly generated tissue that consisted of multicellular aggregates.

Conclusions

Compared with anti‐CD34 antibody‐bound stents, VEGF‐bound stents provide highly selective capture of EPCs, followed by rapid formation of intact endothelium tissue at an early period of stenting. These results suggest that VEGF‐bound stents could represent a promising therapeutic option for cardiovascular stenting, although further long‐term follow‐up experiment with double‐blinded fashion is needed prior to clinical application. (J Interven Cardiol 2014;27:63–72)