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)

     

Cryoplasty for the Treatment of Coronary Bifurcation Stenoses Following Main Vessel Stenting

Objectives

This retrospective study sought to assess the safety and clinical efficacy of cryoplasty for treatment of side‐branch stenoses following main vessel stenting in coronary bifurcation lesions.

Background

Cryoplasty prevents restenosis by reducing smooth muscle proliferation and extracellular matrix synthesis. Clinical effectiveness has been demonstrated in the peripheral circulation. Treatment of coronary bifurcation lesions remains a challenge. We used a novel strategy of main vessel stenting combined with side‐branch cryoplasty to treat high‐grade stenoses following main vessel stenting.

Methods

Eighteen patients with bifurcation lesions had significant plaque shift into a side branch after main vessel intervention. Drug‐eluting stents were placed in the main vessel and cryoplasty was performed on the side‐branch vessel. Quantitative coronary analysis was performed on all side‐branch vessels both pre– and post–main vessel stenting. All patients had clinical follow‐up 3 months or more after cryoplasty including either nuclear stress testing or diagnostic coronary angiogram.

Results

Mean percent stenosis decreased from 80.6% post main vessel stenting to 24.8% following cryoplasty (P < 0.0001). Of the 17 patients who had pre‐cryoplasty nuclear stress testing 1 patient had ischemia identified in the distribution of the treated vessel at follow‐up. Five patients had follow up angiography. One patient had restenosis, the other 2 were unchanged. There was a low incidence of MACE.

Conclusions

In this first report of its use in the coronary circulation, cryoplasty for bifurcation side‐branch disease was safe and associated with a low rate of clinical recurrence in carefully selected patients. (J Interven Cardiol 2013;26:239–244)

     

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.

     

Drug‐Eluting vs. Conventional Balloon for Side Branch Dilation in Coronary Bifurcations Treated by Provisional T Stenting

Objective

The origin of the side branch (SB) is the most common site for restenosis in coronary bifurcations. The end‐point is to compare the results of SB dilation with drug‐eluting balloon (DEB group) versus conventional balloon (BAL group) in bifurcations treated with provisional T stenting.

Methods and Results

Each group included 50 patients. In DEB, the origin of SB was dilated with a Sequent^® Please balloon. In both groups, a Taxus Liberté^® stent was implanted in the main vessel, with kissing balloon postdilation. If the outcome for the SB was suboptimal, a Taxus stent was implanted in BAL and a bare stent in DEB group. An angiographic follow‐up and IVUS were scheduled for 12 months later. Adverse events (MACE) were 24% in BAL versus 11% in DEB (P = 0.11), with greater revascularization (TLR) in the BAL group (22% vs. 12%, P = 0.16). At angiographic follow‐up, there was a lower percentage of SB restenosis in the DEB group (20% vs. 7%, P = 0.08), with less late loss (0.40 mm vs. 0.09 mm, P = 0.01).

Conclusion

Side branch dilation with a drug‐eluting balloon resulted in better angiographic outcomes than with a conventional balloon, with less late loss and restenosis at the 12‐month follow‐up. (J Interven Cardiol 2013;26:454‐462)

     

Edge‐to‐Edge Technique to Minimize Ovelapping of Multiple Bioresorbable Scaffolds Plus Drug Eluting Stents in Revascularization of Long Diffuse Left Anterior Descending Coronary Artery Disease

Background

Implantation of Drug Eluting Stents (DES) plus bioresorbable scaffolds (BVS) in very long diffuse left anterior descending coronary artery (LAD) disease may be problematic because of multiple devices overlapping. We sought to assess the short and mid‐tern outcomes of combined implantation of DES and BVS using a novel “edge‐to‐edge” technique in patients with diffuse LAD disease.

Methods

Patients with long diffuse LAD disease were enrolled in a prospective registry from 1st August 2014 to 1st August 2015 and treated with IVUS‐aided percutaneous coronary intervention using a DES plus a single or multiple BVS using a novel “edge‐to‐edge” technique. Clinical follow up and invasive follow up driven by clinical justification was performed.

Results

Twenty‐three patients (5 females, mean age 59.1± 9.1 years) were enrolled. Mean length of LAD disease was 73.1 ± 20.6 mm. Mean number of DES and BVS implanted was 1.2 ± 0.4 and 1.7 ± 1.3, respectively. At a mean follow‐up of 11.3 ± 3.8 months, no stent thrombosis or MACE were observed. Angiographic and IVUS follow‐up at a mean of 6.6 ± 0.7 months showed no significant angiographic restenosis and no appreciable stent gaps.

Conclusions

In revascularization of long diffuse disease of the LAD, the edge‐to‐edge implantation technique appears to be feasible resulting in no restenosis or thrombosis on the short‐term follow‐up. (J Interven Cardiol 2016;29:275–284)

     

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)

     

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

Objectives

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

Background

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

Methods

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

Results

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

Conclusions

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

     

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

Objectives

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

Background

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

Methods

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

Results

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

Conclusions

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

     

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)

     

Clinical and angiographic outcome of a single center,real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry

Objectives

With this prospective study we aim at investigating the long‐term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation.

Background

It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome.

Methods

Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow‐up. After a run‐in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high‐pressure post‐dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1‐year angiographic follow‐up and ischemia‐driven target‐lesion revascularization (ID‐TLR) at 2‐year clinical follow‐up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years.

Results

A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow‐up LLL was 0.38 ± 0.9. At 2‐year clinical follow‐up, ID‐TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR.

Conclusions

In a complex, all‐comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid‐term angiographic and long‐term clinical outcome.

     

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

Objective

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

Background

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

Methods

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

Results

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

Conclusions

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

     

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)

     

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.

     

Impact of Calcified Target Lesions on the Outcome of Percutaneous Coronary Intervention for Acute Coronary Syndrome: Insights From the BASE ACS Trial

Objectives

We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial.

Background

The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown.

Methods

The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium‐nitride‐oxide‐coated stents or everolimus‐eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non‐fatal myocardial infarction or ischemia‐driven target lesion revascularization. Follow‐up was planned at 12 months, and yearly thereafter for up to 7 years.

Results

Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow‐up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non‐fatal myocardial infarction events (P < 0.05, both). The rates of ischemia‐driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity‐score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions.

Conclusions

Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long‐term clinical outcome, compared with those treated for non‐calcified lesions, mainly due to more frequent safety events. In the propensity score‐matched analysis, the outcome was comparable.

     

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)

     

Clinical and angiographic outcomes of axial stent deformations in unrestricted real world patient population

Background

Prior reports have suggested that the design of the Promus Element stent is prone to longitudinal stent deformation (LSD). However, little is known about the clinical and angiographic outcomes of Promus Element stent axial deformations when implanted in unrestricted coronary lesions.

Method and Results

Two independent reviewers retrospectively evaluated the procedure steps of 961 Promus Element stent (833 de novo lesions in 494 consecutive patients) implanted in unrestricted coronary lesions, between February 2012 and March 2013, and compared the prevalence, predictors, and the mid‐term clinical and angiographic outcomes between lesions with and without stent deformation. Fifteen stents (1.56%) with LSD were observed (95% confidence interval [CI]: 0.78–2.34%). The proximal edge of the stent was deformed in 13 stents (86.6%). Ostial stenting (Adjusted Odds ratio [OR]: 9; 95%CI: 2.27–33.3; P = 0.002), and bifurcation lesions (Adjusted OR: 3; 95%CI: 1.03–8.8; P = 0.04) were independently associated with the occurrence of stent deformation. LSD led to unplanned stenting in (53%, 8 of 15) of the deformed stents, which consumed larger contrast volume and longer fluoroscopy time. At 8‐month follow‐up, there was no significant difference in binary restenosis rate and target lesions revascularization between both groups (P = 0.98, and P = 0.56, respectively), while death occurred in six patients of the non‐LSD group (1.36%, 6 of 440) and none in the LSD group. All patients of the LSD group had no major adverse clinical events at 8‐month follow‐up.

Conclusions

Axial stent deformation in Promus Element platform is an infrequent event, occurs following manipulation of the interventional tools. Other than unplanned stenting, the LSD was not associated with any adverse clinical events at 8‐month follow‐up.

     

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.

     

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.

     

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

Objectives

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

Background

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

Methods

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

Results

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

Conclusions

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