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.

     

Very Late Hazard with Stenting versus Balloon Angioplasty for ST‐Elevation Myocardial Infarction: A 16‐Year Single‐Center Experience

Objectives

This study compares very late outcomes following primary percutaneous coronary intervention for ST‐elevation myocardial infarction (STEMI) with stenting versus balloon angioplasty (BA).

Background

Stenting compared with BA for STEMI improves outcomes at 6–12 months, but comparisons beyond 6–12 months have not been studied. Recent studies have shown that stent thrombosis (ST) continues to increase beyond 3–5 years and may be higher with drug‐eluting stents (DES) than bare metal stents (BMS). We hypothesized that there may be a very late hazard with stenting versus BA due to very late ST.

Methods

From 1994 to 2010 consecutive patients with STEMI treated with BA (n = 601) or stenting (n = 1,594) were prospectively enrolled in our registry and followed for 1–16 years.

Results

Patients treated with BA were older, were more often female, had more three‐vessel disease, and had smaller vessels. Stented patients had trends for less stent/lesion thrombosis (ST/LT) and target vessel (TV) reinfarction at 1 year. In landmark analyses >1 year, stented patients had more very late ST/LT (6.1% vs. 2.9%, P = 0.002) and more TV reinfarction (7.9% vs. 3.1%, P < 0.001) which remained significant after adjusting for baseline risk. The greatest differences in very late outcomes were between DES and BA, but there were also significant differences between BMS and BA.

Conclusions

There appears to be a very late hazard with stenting versus BA for STEMI. These data should encourage new strategies for prevention of very late ST with both BMS and DES including the development of bio‐absorbable polymers and stent platforms. (J Interven Cardiol 2014;27:21–28)

     

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)

     

Outcome of Early Revascularization Surgery in Patients with ST‐Elevation Myocardial Infarction

Objectives

To compare morbidity and mortality of patients with ST‐elevation myocardial infarction (MI) undergoing coronary artery bypass graft (CABG) surgery within 24 hours with those who had surgery delayed >24 hours.

Background

Patients with ST‐elevation MI are currently managed by emergency percutaneous coronary intervention (PCI). If PCI is unsuccessful, or if there is severe coronary artery disease not amenable to PCI, CABG is considered. If the patient is clinically stable, surgeons wait several days before performing surgery, as very early surgery carries a prohibitive risk.

Methods

One hundred and eighty‐four patients with acute ST elevation MI (STEMI) who had undergone CABG were divided into two groups based on their surgery timing (<24 hours vs. >24 hours). Mortality and complication rates were studied between the two groups by Fischer test. Time‐to‐event analyses were performed for five primary variables: all‐cause mortality, cardiac events, congestive heart failure, stroke, and renal failure.

Results

At one month post‐CABC, all‐cause mortality was noted in 10.6% of patients who had CABG within 24 hours of STEMI diagnosis, compared with 8.9% in patients who had CABG after 24 hours (P = 0.3). Cardiac events including re‐exploration, atrial fibrillation, graft occlusion, and arrhythmias requiring shock occurred in 17.1% versus 13.9% between the two groups, respectively (P = 0.68). One year post‐coronary artery bypass surgery, there was no difference in individual or combined events between the two groups.

Conclusions

In patients with ST‐elevation myocardial infarction who required emergency coronary artery bypass surgery, there was no difference in procedure complications or mortality between early (within 24 hours) or later (more than 24 hours). That was noted at one month and one year after the index myocardial infarction. (J Interven Cardiol 2015;28:14–23)

     

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.

     

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.

     

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)

     

Long‐Term Outcomes of Drug‐Eluting Stent Therapy for In‐Stent Restenosis Versus De Novo Lesions

Background

Drug‐eluting stents (DES) are currently the most popular treatment modality for restenosis in bare metal stents and DES. This study compares risks of adverse cardiovascular events between DES‐treated in‐stent restenosis (ISR) and de novo lesions, an area that has not been systematically studied thus far.

Methods and Results

One thousand three hundred consecutive ISR patients were compared with 27,211 patients with de novo lesions who underwent DES treatment during the same period at the Fu Wai Hospital in Beijing. Angiographic success rate was similar between the ISR and de novo groups (98.0% vs. 98.2%; P = 0.61). Using logistic regression to derive the propensity score model, 1,266 matched patient pairs were compared. In this adjusted model, the rate of target lesion revascularization (TLR) was significantly higher in the ISR group (19.19% vs. 2.37%; P < 0.01) during an average 17‐month follow‐up, while rates of cardiac death and myocardial infarction (MI) were similar (0.71% vs. 0.79%; P = 0.93 and 3.48% vs. 1.26%; P = 0.13, respectively) between groups. In multivariate regression analysis, ISR was predictive of TLR, but not of cardiac death and MI.

Conclusion

Compared with those with de novo lesions, patients with ISR had a higher revascularization rate after DES treatment but no significant difference in rates of cardiac death and MI.

     

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.

     

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)

     

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in‐stent restenosis

Objectives

The objective of this study was to assess the 12‐month clinical outcomes in patients with drug‐eluting stent in‐stent restenosis (DES‐ISR) who were either pre‐dilated with non‐compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty.

Methods

This monocentric, retrospective study included patients with DES‐ISR who were routinely treated over a 2‐year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES‐ISR lesion were analyzed. The primary endpoint was the clinically driven target‐lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post‐interventional lumen gain and late lumen loss (LLL) at 6 months.

Results

The 12‐month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468).

Conclusions

Scoring Balloon Angioplasty can safely and effectively prepare DES‐ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

     

Risk of Long‐Term Dual Antiplatelet Therapy Following Drug‐Eluting Stent Implantation in Octogenarians

Objectives

To evaluate the risk of long‐term dual antiplatelet therapy (DAT) following drug‐eluting stent (DES) implantation in octogenarians.

Background

DES implantation requires DAT; however, DAT‐associated risk in octogenarians remains unclear.

Methods

Two‐hundred and six consecutive octogenarians (130 men, 83.3 ± 3.4 years) underwent stent implantation (104 bare metal stents [BMSs] and 102 DESs) and 38.0 ± 13.2 months of follow‐up.

Results

Significantly more DES patients received DAT. The incidence of bleeding events was similar in the DES and BMS groups for 1 year (total: 10.8% vs 5.8%, P = 0.19; major: 4.9% vs 2.9%, P = 0.70). However, after 2 years, significantly more bleeding events occurred in the DES group than the BMS group (total: 2 years, 21.6% vs 9.6%, P = 0.02; 3 years, 29.4% vs 11.5%, P = 0.001; 4 years, 31.4% vs 15.4%, P = 0.007; major: 2 years, 12.7% vs 3.8%, P = 0.04; 3 years, 18.6% vs 5.8%, P = 0.005; 4 years, 19.6% vs 6.7%, P = 0.006). Overall, significantly more total bleeding events (31.4% vs 15.4%, P = 0.007) and major bleeding events (19.2% vs 6.7%, P = 0.006) were observed in the DES group than in the BMS group. The adjusted hazard ratios and 95% confidence intervals (CI) were as follows: total bleeding events, 2.203 (95% CI: 1.065–4.556; P = 0.033); major bleeding events, 4.324 (1.506–12.414; P = 0.007).

Conclusions

DAT was associated with an increased risk of bleeding events in octogenarians after 2 years. DAT discontinuation should be considered for octogenarians 1‐year post‐DES implantation. (J Interven Cardiol 2013;26:114–122)

     

Drug‐Coated Balloons: A Safe and Effective Alternative to Drug‐Eluting Stents in Small Vessel Coronary Artery Disease

Background

Drug‐coated balloons (DCB) have been used to treat de novo small vessel coronary disease (SVD), with promising results and shorter dual antiplatelet therapy (DAPT) duration compared to drug‐eluting stents (DES). We compared safety and effectiveness of the two treatments at 1 year.

Methods

We reviewed 3,613 angioplasty cases retrospectively from 2011 to 2013 and identified 335 patients with SVD treated with device diameter of ≤2.5 mm. DCB‐only angioplasty was performed in 172 patients, whereas 163 patients were treated with second‐generation DES.

Results

DCB patients had smaller reference vessel diameter (2.22 ± 0.30 vs. 2.44 ± 0.19 mm, P < 0.001) and received smaller devices (median diameter 2.25 vs. 2.50 mm, P < 0.001) compared to the DES group. DES‐treated vessels had larger acute lumen gain (1.71 ± 0.48 mm) than DCB (1.00 ± 0.53 mm, P < 0.001). Half the patients had diabetes mellitus. While there were more patients presenting with acute coronary syndrome (ACS) in the DCB group (77.9% vs. 62.2%, P = 0.013), they received shorter DAPT (7.4 ± 4.7 vs. 11.8 ± 1.4 months, P < 0.001) than the DES group. The 1‐year composite major adverse cardiac event rate was 11.6% in the DCB arm and 11.7% in the DES arm (P = 1.000), with target lesion revascularization rate of 5.2% and 3.7%, respectively, (P = 0.601).

Conclusions

In this high‐risk cohort of patients, DCB‐only angioplasty delivered good clinical outcome at 1 year. The results were comparable with DES‐treated patients, but had the added benefit of a shorter DAPT regime.

     

Drug eluting stents are superior to bare metal stents to reduce clinical outcome and stent‐related complications in CKD patients,a systematic review,meta‐analysis and network meta‐analysis

Aims

To compare clinical outcome in Chronic kidney disease (CKD) patients receiving coronary stents according to stent type BMS versus DES and 1st generation versus 2nd generation DES.

Methods and Results

PubMed, Cinhal, Cochrane, Embase, and Web of Science were searched for studies including CKD patients. CKD was defined as eGFR < 60 mL/min. We selected n = 35 articles leading to 376 169 patients, of which 76 557 CKD patients receiving BMS n = 35,807, 1st generation DES n = 37,650, or 2nd generation DES n = 3100. Patient receiving DES, compared to BMS, had a 18% lower all‐cause mortality (RR 0.82, 95%CI 0.71‐0.94). The composite of death or myocardial infarction (MI) was lower in DES patients (RR 0.78, 95%CI 0.67‐0.91), as was stent thrombosis (ST) (RR 0.57, 95%CI 0.34‐0.95), target vessel/lesion revascularization (TVR/TLR) (RR 0.69, 95%CI 0.57‐0.84) and death for cardiovascular cause (RR 0.43, 95%CI 0.25‐0.74). We also found a gradient between 1st and 2nd generation DES, through BMS. Second, compared to 1st generation DES, were associated with further relative risk (RR) reduction of ?18% in of all‐cause death, and lower incidence of stent‐related clinical events: ?39% RR of ST risk; ?27 RR of TVR/TLR risk.

Conclusions

DES in CKD patients undergoing PCI were superior to BMS in reducing major adverse clinical events. This was possibly explained, by a lower risk of stent‐related events as ST and TVR or TLR. Second, compared to 1st generation DES may furtherly reduce clinical events.

     

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

Objectives

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

Background

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

Methods

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

Results

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

Conclusions

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

     

Comparison of three treatment strategies for patients with triple‐vessel coronary disease and left ventricular dysfunction

Introduction

Current guidelines recommend coronary artery bypass grafting (CABG) for patients with multivessel coronary disease and left ventricular (LV) dysfunction. However, some patients undergo percutaneous coronary intervention (PCI) or solely medical therapy (MT) in actual practice. The comparison of long‐term outcomes of these three treatment strategies in real world is unclear.

Methods

A total of 699 consecutive patients in a single centre from 2004 to 2011 who had TVD and LV ejection fraction ≤40%, no prior PCI or CABG and had completed a median 6.2‐year follow‐up were evaluated. The primary endpoint was all‐cause death. The secondary endpoints included cardiac death, major adverse cardiovascular and cerebrovascular events (MACCE; composite of all‐cause death, myocardial infarction, repeat revascularization, or stroke), and the individual components of the composite endpoint.

Results

One hundred forty‐two patients (20.3%) underwent PCI, 201 (28.8%) underwent CABG while 356 (50.9%) received MT alone. MT alone was associated with the worst survival (P < 0.001). Compared with PCI, CABG was associated with a similar risk of all‐cause death (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.52‐1.41; P = 0.54) but lower risks of cardiac death (HR, 0.47; 95%CI, 0.25‐0.91; P = 0.03), repeat revascularization (HR, 0.29; 95%CI, 0.10‐0.85; P = 0.02), and MACCE (HR, 0.63; 95%CI, 0.43‐0.93; P = 0.02).

Conclusions

For patients with TVD and LV dysfunction, both CABG and PCI were associated with a lower risk of mortality compared with MT alone. Compared with PCI, CABG has a lower risk of cardiac death, repeat revascularization, and MACCE.

     

Complications with Angio‐Seal™ Vascular Closure Devices Compared with Manual Compression after Diagnostic Cardiac Catheterization and Percutaneous Coronary Intervention

Objectives

This study assessed and compared vascular complications in CATHs and PCIs using an Angio‐Seal? vascular closure device (VCD) versus manual compression (MC).

Methods

Secondary data analysis of a population‐based multiyear cohort database was conducted to compare femoral access‐related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared.

Results

Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31–0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31–0.81).

Conclusions

A low incidence of vascular complications was observed with the use of an Angio‐Seal VCD relative to MC for both procedures.

     

Polymer‐free versus permanent polymer‐coated drug eluting stents for the treatment of coronary artery disease: A meta‐analysis of randomized trials

Background

Polymer‐free drug eluting stents (PF‐DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer‐coated DES (PP‐DES). However, trial results are inconsistent with longer‐term safety and efficacy of PF‐DES remaining unknown. We performed a meta‐analysis of randomized trials assessing outcomes of patients receiving PF‐DES versus PP‐DES for treatment of coronary artery disease (CAD).

Methods

Electronic searches were performed for randomized trials comparing outcomes between PF‐DES and PP‐DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all‐cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow‐up and landmarked beyond 1‐year.

Results

Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF‐DES and PP‐DES at longest follow‐up (Odds Ratio [OR] 0.96, 95%CI 0.85‐1.10, P = 0.59) or landmark analysis beyond 1‐year (OR 0.96, 95%CI 0.76‐1.20, P = 0.70). Although PF‐DES were associated with a significant reduction in all‐cause death (OR 0.85, 95%CI 0.72‐1.00, P < 0.05), this effect was not present on landmark analysis beyond 1‐year (OR 0.89, 95%CI 0.73‐1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77‐1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54‐1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91‐1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88‐1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI ?0.08 to 0.11, P = 0.76).

Conclusions

PF‐DES are as safe and efficacious as PP‐DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.

     

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)

     

Drug‐coated balloon: Long‐term outcome from a real world three‐center experience

Objectives

In‐stent restenosis (ISR) and diffuse small vessel disease still represent challenging subsets for percutaneous coronary interventions, also in the new‐generation DES era. We aim at reporting on the long‐term clinical outcome of drug‐coated balloons (DCB) in all‐comers population.

Methods

Consecutive patients treated with DCB between January 2011 and December 2014 were retrospectively studied in three centers of northern Italy. The measured end‐points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TLR.

Results

We included 143 patients. Of the 167 lesions treated, 41 (24.5%) were de novo lesions in small coronary vessels (<2.5 mm) and 126 (75.4%) were ISR. Among ISR lesions, 78.5% were DES‐ISR, 32.5% were focal, 15.8% multifocal, 30.1% diffuse, 18.2% proliferative, and 3.1% were total occlusions. Procedural success was achieved in 94.6% of cases. Overall survival free from MACEs was 91.6% at 12 months, and 75.3% at 48 months, with a total of 3 cardiac deaths, 8 MI, and 27 TLR. No thrombotic event occurred in the treated segments. There were no differences in MACESs between the ISR and de novo lesions groups. At multivariate analysis, acute coronary syndromes, previous MI, previous surgical revascularization, peripheral arterial disease and diabetes were independent predictors of MACEs at long‐term follow‐up.

Conclusions

DCB proved a valid revascularization strategy in an all‐comers population of patients with ISR and de novo lesions in small vessels, with an acceptable rate of cardiac events up to 48 months follow‐up.