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

Objective

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

Background

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

Methods

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

Results

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

Conclusion

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

     

The impact of successful revascularization of coronary chronic total occlusions on long‐term clinical outcomes in patients with non‐ST‐segment elevation myocardial infarction

Objectives

The purpose of this study was to assess the long‐term clinical impact of revascularization of coronary concomitant coronary chronic total occlusion (CTO) in patients with Non‐ST‐segment elevation myocardial infarction (NSTEMI).

Background

CTO is associated with poorer prognosis in patients with NSTEMI. The evidence of revascularization of CTO in patients with NSTEMI is still conflicting.

Methods

Consecutive patients with NSTEMI and CTO who underwent percutaneous coronary intervention (PCI) within 72 h of admission from 2006 to 2015 were retrospectively recruited and analyzed. A total of 967 patients underwent PCI for NSTEMI. Among them, 106 (11%) patients had concomitant CTO and were recruited for analysis. CTO lesions were revascularized successfully in 67 (63.2%) patients (successful CTO PCI group), while the CTO in the remaining 39 patients were either not attempted or failed (No/failed CTO PCI group).

Results

The 30‐day cardiac death and major adverse cardiac events (MACE) were significantly lower in the successful CTO PCI group (both cardiac death and MACE were 3% vs 30%, P < 0.001, respectively). A landmark analysis set at 30th day for 30‐day survivals was performed. After a mean of 2.5‐year follow‐up, the long‐term cardiac death was still significantly lower (16.9% vs 42.3%, P < 0.001), whereas the MACE showed a trend toward lower incidence (26.2% vs 40.7%, P = 0.051) in the successful CTO PCI group. In multivariate Cox regression analysis, successful revascularization of CTO is an independent protective predictor for long‐term cardiac death (HR 0.310, 95% CI, 0.109‐0.881, P = 0.028) in all population and in propensity‐score matched cohort (P = 0.007).

Conclusions

Successful revascularization of CTO was associated with reduced risk of long‐term cardiac death in patients with NSTEMI and concomitant CTO.

     

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)

     

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.

     

A Randomized Trial of Complete Versus Culprit‐Only Revascularization During Primary Percutaneous Coronary Intervention in Diabetic Patients With Acute ST Elevation Myocardial Infarction and Multi Vessel Disease

Background

Recent randomized trials and meta‐analyses demonstrated that a complete revascularization of significant non culprit lesions in patients with ST elevation myocardial infarction (STEMI) is superior to a culprit only revascularization approach in reducing major adverse cardiac events (MACE), however the proportion of diabetic patients was low in these trials.

Objectives

To investigate whether a complete revascularization approach is associated with better outcomes in diabetic patients with STEMI and multi‐vessel disease.

Methods

One hundred diabetic patients with acute STEMI with at least one non‐culprit lesion were randomized to either complete revascularization (n = 50) or culprit‐only treatment (n = 50). Complete revascularization was performed either at the time of primary percutaneous coronary intervention (PCI) or within 72 hours during hospitalization. The primary endpoint was the composite of all‐cause mortality, recurrent MI, and ischemia‐driven revascularization at 6 months.

Results

A complete revascularization approach was significantly associated with a reduction in the primary outcome (6% vs. 24%, P = 0.01), primarily due to reduction in ischemia driven revascularization in the complete revascularization group (2% vs. 12%; P = 0.047). There was no significant reduction in death or MI (2% vs. 8%; P = 0.17) and (2% vs. 4%; P = 0.56) respectively, or in the safety endpoints of major or minor bleeding, contrast‐induced nephropathy, or stroke between the groups.

Conclusions

In diabetic patients with multi‐vessel coronary artery disease undergoing PPCI, complete revascularization is associated with significantly reduced risk of adverse cardiovascular events, as compared with culprit vessel only PCI. (J Interven Cardiol 2016;29:241–247)

     

GuideLiner Mother‐and‐Child Guide Catheter Extension: A Simple Adjunctive Tool in PCI for Balloon Uncrossable Chronic Total Occlusions

Objectives

To investigate the use of the GuideLiner “mother‐and‐child” guide catheter extension system as a simple solution to facilitate initial device delivery in balloon uncrossable chronic total occlusions (CTOs) undergoing percutaneous coronary intervention (PCI).

Background

During PCIs for CTO lesions, an important reason for procedural failure is the inability to deliver a balloon or microcatheter across the lesion.

Methods

We retrospectively accessed our interventional registry for 07/01/2010 to 03/21/2012 and extracted data on all CTO lesions involving GuideLiner catheter use. Cine review was performed to identify cases where a guidewire had crossed the CTO and the use of a GuideLiner catheter facilitated initial device delivery.

Results

We identified 28 patients that underwent PCI for CTO with a GuideLiner catheter used to assist initial balloon or microcatheter advancement across the culprit lesion. Mean overall CTO length was 26.3 ± 18.1 mm. The GuideLiner catheter was successful in delivering a small balloon to the CTO lesion in 85.7% of cases (24/28). A single CTO PCI resulted in a distal guidewire perforation, but there was no hemodynamic compromise or pericardial effusion and the patient was discharged the next day. Overall procedural success in these selected cases (where a guidewire had already crossed the CTO) was 89.3% (25/28).

Conclusions

The GuideLiner mother‐and‐child catheter is a simple, safe and efficacious adjunctive device for difficult CTO PCIs where despite standard measures it is not possible to deliver an initial balloon or microcatheter across the occluded segment.

     

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)

     

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‐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)

     

First‐in‐Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions

Objectives

To describe the first‐in‐man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.

Background

Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.

Methods

Prospective, single‐centre, non‐randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria—TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST‐resolution >70% at 90 minutes after vessel reperfusion—was also evaluated.

Results

Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre‐specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.

Conclusions

This first‐in‐man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155–161)

     

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)

     

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)

     

Bioresorbable Vascular Scaffolds in a Real‐World Patient Population‐Results From a Mid‐Term Angiographic Follow‐Up

Aim

We aimed to investigate the safety and efficacy of bioresorbable vascular scaffolds (BVS) in daily use in a real‐world patient population.

Methods and Results

Between March 2013 and September 2014, 224 patients (233 lesions) were treated with BVS at a tertiary care center. Patients underwent follow‐up coronary angiography 3–6 months after implantation. Clinical presentations were stable angina in 101 patients (45.1%), unstable angina in 47 (21.0%), NSTEMI in 38 (17.0%), and STEMI in 38 (17.0%) patients. Twenty‐two patients (27 lesions) had chronic total occlusion (CTO). Procedural success was achieved in all patients. Two patients died in the follow‐up period due to BVS thrombosis (0.9%). In‐hospital death occurred in further 3 patients (1.3%) due to other causes not related to the BVS implantation. Total BVS thrombosis was 3.1% (7 patients) and there was only 1 case of relevant restenosis on angiographic follow‐up. The overall incidence of major adverse cardiac events was 11 (4.9%).

Conclusions

Mid‐term follow‐up after implantation of BVS suggests a satisfactory safety profile and low restenosis rate in routine daily practice involving a large range of complex lesions.

     

Comparison between imported versus domestic drug‐eluting stents in China: A large single‐center data

Background

In recent years, most drug‐eluting stents (DESs) were domestically produced in China, but how domestic DESs perform compared to imported DESs was still unknown.

Methods

A total of 9011 consecutive cases with DESs implantation in a single center throughout 2013 were prospectively collected. Two‐year clinical outcomes were evaluated between patients implanted with imported and domestic DESs.

Results

During 2‐year follow‐up, the rates of all‐cause death, cardiac death, myocardial infarction, stroke, and stent thrombosis were not significantly different between two groups. However, the rate of revascularization was significantly higher in domestic DES group, shown as higher rates of overall revascularization, target vessel revascularization (TVR), and target lesion revascularization (TLR) (9.7% vs 6.4%, P < 0.001; 5.6% vs 3.2%, P < 0.001; 4.5% vs 2.2%, P < 0.001, respectively). Accordingly, major adverse cardiac events (MACE) rate was significantly higher in domestic DES group (12.1% vs 8.5%, P < 0.001). Multivariable Cox regression analysis indicated that domestic DES was an independent risk factor of MACE (HR [95%CI]: 1.22 [1.05‐1.41]), overall revascularization (HR [95%CI]: 1.29 [1.09‐1.53]), TVR (HR [95%CI]: 1.54 [1.22‐1.94]), and TLR (HR [95%CI]: 1.85 [1.41‐2.42]). After propensity score matching, the rates of overall revascularization, TVR, and TLR were still significantly higher in domestic DES group, and domestic DES was still predictive of overall revascularization, TVR, and TLR in multivariate Cox regression analysis.

Conclusions

Domestic DESs showed the same safety as imported DESs in this real‐world cohort. But, patients implanted with domestic DESs had a higher risk of revascularization than imported DESs.

     

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.

     

Recurrent Myocardial Infarction After Primary Percutaneous Coronary Intervention in Multivessel Coronary Disease Is Primarily Related to Stent Failure

Objectives

Our aim was to investigate the risk of events related to non‐culprit lesions after primary percutaneous coronary intervention (PCI) in patients with multivessel coronary disease (MVD).

Background

In patients undergoing primary PCI for ST‐elevation myocardial infarction (STEMI) who are diagnosed with MVD, the optimal treatment strategy is currently under debate. Although observational data exposed an increased risk of multivessel PCI in the acute phase of STEMI, 2 recently published randomized controlled trials showed a reduction of death or recurrent myocardial infarction (MI) after preventive PCI of non‐culprit lesions when compared with culprit‐lesion PCI only.

Methods

We performed a post‐hoc analysis of 279 patients with MVD included in the Paclitaxel‐Eluting Stent versus Conventional Stent in Myocardial Infarction with ST‐Segment Elevation (PASSION) trial. We analyzed the incidence and cause of recurrent MI. Recurrent MI due to stent failure was assumed in the event of definite or probable stent thrombosis.

Results

After 5 years, 14 patients (5.7%) with MVD had a recurrent MI versus 17 (5.4%) patients with 1‐vessel disease (HR 1.06, 95%CI 0.52–2.15, P = 0.87). The majority of events was attributable to stent failure, while of the remaining 6 events, only 1 was proven to originate from a lesion that was judged significant at enrolment.

Conclusions

In this post‐hoc analysis of the PASSION trial, recurrent MI in patients with MVD was mainly related to stent failure rather than a new event originating from a significant stenosis in a non‐culprit coronary artery. (J Interven Cardiol 2015;28:523–530)

     

Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices

Objectives

To evaluate balloon‐expandable and self‐expanding third‐generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background

Two competing third‐generation TAVR technologies are currently commercially available in the US. There are no published head‐to‐head comparisons of the relative performance of these two devices.

Methods

257 consecutive patients undergoing TAVR with a third‐generation balloon‐expandable (Edwards Sapien 3) or self‐expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30‐day outcomes were prospectively collected.

Results

74 patients received a self‐expanding valve (SEV) and 183 received a balloon‐expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30‐day mortality was comparable (1.4% vs 1.6%, P = 1.00).

Conclusions

Short‐term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

     

Short‐term Effect of Upstream Administration in Comparison to Deferred Injection of Tirofiban on Patients with Acute ST‐Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Background

High bolus dose tirofiban has been demonstrated to provide greater inhibition of platelet aggregation, but the most appropriate timing of its administration remains unknown.

Objectives

To evaluate the efficacy of upstream vs. deferred administration of tirofiban in patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) on clinical outcomes.

Methods

The 660 patients with acute ST‐segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were divided into upstream (n = 330, administration of tirofiban to all patients in emergency room) and deferred groups (n = 330, treatment of patients with large thrombus burden or no‐reflow phenomenon in cardiac catheterization laboratory during PCI). The primary end‐points were death, nonfatal myocardial infarction (MI), stent thrombosis (ST), revascularization of targeted vessels (TVR) or major adverse cardiac events (MACE) at 1 month and 6 months following PCI, with safety end‐point at 7 days.

Results

Compared with that of the deferred group, there was a significant increase of left ventricular ejection fraction (LVEF) in the upstream group within 7 days (55.5 ± 6.6% vs. 54.6 ± 7.9%, P = 0.011). The rates of 7‐day and 1‐month MACE in the upstream group were lower than those in the deferred group (1.5% vs. 4.2%, 3.3% vs. 7.0%, P = 0.037 and 0.034, respectively). However, there were higher tendencies for major and minor bleedings in the upstream group (1.8% vs. 0.9%, 2.7% vs. 1.5%, P = 0.315 and 0.280, respectively).

Conclusion

To the Chinese patients with acute myocardial infarction undergoing primary PCI, upstream administration of tirofiban was slightly superior to deferred injection for short‐term clinical outcomes.

     

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.

     

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.