Clinical outcomes of real-world patients treated with an amphilimus polymer-free stent versus new generation everolimus-eluting stents.

OBJECTIVES/BACKGROUND: To compare the 1-year clinical outcomes after implantation of the amphilimus, polymer-free stent (Cre8) versus new generation everolimus-eluting stents (EESs) in a real-world patient registry. METHODS: A total of 187 consecutive patients treated with Cre8 between January 2011 and August 2013 in four Italian centers were included. These were propensity matched with 150 patients treated with new generation EES during the same period. Primary outcome was 1-year major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: Both groups had similar baseline characteristics, including diabetes (28% Cre8 vs. 27.3% EES, P = 0.972) and previous percutaneous coronary intervention (56% Cre8 vs. 58% EES, P = 0.726). There was a higher prevalence of B2/C lesions in the EES group (70.1% vs. 83.8%, P < 0.001). Total stent length per patient was similar. There were no significant differences in 1-year estimated MACE (7.4% Cre8 vs. 10.2% EES, P = 0.261), all-cause mortality (1.3% Cre8 vs. 1.4% EES, P = 0.823), target vessel revascularization (5.2% Cre8 vs. 8.8% EES, P = 0.169), and target lesion revascularization (3% Cre8 vs. 7.4% EES, P = 0.108) between the two groups. When adjusting for differences in baseline lesion characteristics, hazard ratio(Cre8/EES) for MACE was not significantly different between the two groups (0.75, 95% confidence interval 0.37-1.53, P(noninferiority) = 0.001, P(superiority) = 0.432). In patients with diabetes (Cre8, n = 42; EEE, n = 41), 1-year target lesion revascularization was 2.5% in the Cre8 group versus 14.6% in the EES group (P = 0.056). CONCLUSIONS: In a "real-world" patient registry, the Cre8 stent is associated with noninferior 1-year MACE rates compared with that of new generation EES. Trends of superior efficacy in patients with diabetes treated with Cre8 require further investigation.

EFFECTS OF PREOPERATIVE ENOXAPARIN ON BLEEDING AFTER CORONARY ARTERY BYPASS SURGERY.

BACKGROUND: Low molecular weight heparins are replacing unfractionated heparin in practice prior to cardiac surgery. This study examines postoperative (post-op) bleeding indicators in patients who received enoxaparin and underwent elective isolated first time coronary artery bypass graft. METHODS: A total of 125 consecutive patients who underwent this procedure between 2009 and 2011 at one tertiary center were reviewed and divided into three groups: Group A (n = 50) received the last dose of enoxaparin between 12 and 24 hours before surgery, Group B (n = 25) received the last dose before 24 hours and Group C (n = 50) did not receive enoxaparin. Perioperative bleeding indicators and transfusion rates were compared. RESULTS: Preoperative patients' characteristics were comparable between the three groups. There were no perioperative deaths, return to the operating room for any reason, nor major bleeding. Post-op bleeding indicators were similar in the three groups. The average chest tube drainage at 24 hours post-op was 880 mL, 695 mL and 830 mL in Group A, B and C respectively (p = 0.71). Transfusion rates of red blood cells were not statistically different (Group A 56%, B 64% & C 62%; p = 0.747). In multivariate analysis, female gender, older age, and preoperative clopidogrel intake (stopped 5 days prior to surgery) were associated with higher transfusion rates. CONCLUSION: In elective first time coronary artery bypass graft patients who had no aspirin or clopidogrel intake 5 days prior to surgery, the use of enoxaparin up to 12 hours prior to skin incision does not increase the risk of post-op bleeding.

Characterization of right ventricular remodeling and failure in a chronic pulmonary hypertension model.

In pulmonary hypertension (PH), right ventricular (RV) dysfunction and failure is the main determinant of a poor prognosis. We aimed to characterize RV structural and functional differences during adaptive RV remodeling and progression to RV failure in a large animal model of chronic PH. Postcapillary PH was created surgically in swine (n = 21). After an 8- to 14-wk follow-up, two groups were identified based on the development of overt heart failure (HF): PH-NF (nonfailing, n = 12) and PH-HF (n = 8). In both groups, invasive hemodynamics, pressure-volume relationships, and echocardiography confirmed a significant increase in pulmonary pressures and vascular resistance consistent with PH. Histological analysis also demonstrated distal pulmonary arterial (PA) remodeling in both groups. Diastolic dysfunction, defined by a steeper RV end-diastolic pressure-volume relationship and longitudinal strain, was found in the absence of HF as an early marker of RV remodeling. RV contractility was increased in both groups, and RV-PA coupling was preserved in PH-NF animals but impaired in the PH-HF group. RV hypertrophy was present in PH-HF, although there was evidence of increased RV fibrosis in both PH groups. In the PH-HF group, RV sarcoplasmic reticulum Ca(2+)-ATPase2a expression was decreased, and endoplasmic reticulum stress was increased. Aldosterone levels were also elevated in PH-HF. Thus, in the swine pulmonary vein banding model of chronic postcapillary PH, RV remodeling occurs at the structural, histological, and molecular level. Diastolic dysfunction and fibrosis are present in adaptive RV remodeling, whereas the onset of RV failure is associated with RV-PA uncoupling, defective calcium handling, and hyperaldosteronism.

Comparison of abluminal biodegradable polymer biolimus-eluting stents and durable polymer everolimus-eluting stents in the treatment of coronary bifurcations.

OBJECTIVES: To compare biodegradable polymer biolimus-eluting (BES) with abluminal drug elution and durable polymer everolimus-eluting (EES) stents in the treatment of bifurcation lesions. BACKGROUND: The persistence of a polymer in drug-eluting stents (DES) following drug elution has been viewed as a possible culprit for restenosis. DES with biodegradable polymer may thus be associated with improved clinical outcomes, especially in high-risk lesions such as those at bifurcation sites. METHODS: We performed a retrospective study of consecutive de novo bifurcation lesions treated with EES between October 2006 and October 2011 and BES between February 2008 and March 2012. Study endpoints included major adverse cardiac events (MACE) defined as all-cause death, myocardial infarction (MI), including peri-procedural MI, and target vessel revascularization (TVR) as well as target lesion revascularization (TLR) separately. RESULTS: We analyzed 236 bifurcation lesions treated with either BES (79 lesions in 69 patients) or EES (157 lesions in 154 patients). Patient and procedural characteristics were broadly similar between the two groups. Estimated MACE and TVR rates at 2-year follow-up were similar between the BES and EES groups (MACE = 13.6 ± 4.6% vs. 14.6 ± 3.2% (P = 0.871); TVR = 6.9 ± 3.5% vs. 8.0 ± 2.7% (P = 0.889). No significant differences were noted between the two groups following propensity-score matched analysis. There was no probable or definite stent thrombosis. CONCLUSION: BES use in the treatment of bifurcation lesions appears to be associated with good clinical outcomes, comparable to those seen with EES, at long-term follow-up. These results are hypothesis-generating and need to be validated with larger studies.

Gene therapy for heart failure: where do we stand?

Advances in understanding of the molecular basis of myocardial dysfunction, together with the development of increasingly efficient gene transfer technology, has placed heart failure within reach of gene-based therapy. Multiple components of cardiac contractility, including the Beta-adrenergic system, the calcium channel cycling pathway, and cytokine mediated cell proliferation, have been identified as appropriate targets for gene therapy. The development of efficient and safe vectors such as adeno-associated viruses and polymer nanoparticles has provided an opportunity for clinical application for gene therapy. The recent successful and safe completion of a phase 2 trial targeting the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) has the potential to open a new era for gene therapy in the treatment of heart failure.

Coronary bioresorbable stents: Non-invasive quantitative evaluation of intra- and juxta-stent plaque composition-A computed tomography longitudinal study.

PURPOSE: Coronary bioresorbable stents (BRS) do not produce blooming artifacts on computed tomography (CT), in contrast to metallic stents, as they are made of a bioresorbable polymer and are radiolucent. They allow to evaluate the coronary plaque beneath. The low-attenuation plaque (LAP) suggests plaque vulnerability and is CT assessable. The aim of our study was to show the possibility of a non-invasive CT evaluation of the volume and the LAP composition of the intra- and juxta-stent plaque. METHODOLOGY: In our prospective longitudinal study, we recruited 27 consecutive patients (35 BRS stents total; mean age 60 +/- 9 years) with bioresorbable stents for a 256-slice ECG-synchronized CT evaluation at 1- and 12-months post stent implantation. Total plaque volume (mm3), absolute and relative (%) LAP volume per block in the pre- intra- and post-stent zones were analyzed; comparison 1- and 12-months post-implantation of BRS. Changes in the previously mentioned variables were assessed by the mixed effects models with and without spline, which also accounted for the correlation between repeated measurements. RESULTS: Our block or spline model analysis has shown no significant difference in plaque or absolute LAP volumes in pre- intra- and post-stent zones between 1 and 12 months. Interestingly, % LAP volume increases near-significantly in the distal block of the intrastent at 12-mo follow-up (from 23.38 ± 1.80% to 26.90 ± 2.22% (increase of 15%), p = 0.052). CONCLUSION: Our study demonstrates the feasibility of the repeated non-invasive quantitative analysis of the intrastent coronary plaque and of the in-stent lumen by CT scan.

Sustained Performance of a "Physicianless" System of Automated Prehospital STEMI Diagnosis and Catheterization Laboratory Activation.

BACKGROUND: Treatment times for primary percutaneous coronary intervention frequently exceed the recommended maximum delay. Automated "physicianless" systems of prehospital cardiac catheterization laboratory (CCL) activation show promise, but have been met with resistance over concerns regarding the potential for false positive and inappropriate activations (IAs). METHODS: From 2010 to 2015, first responders performed electrocardiograms (ECGs) in the field for all patients with a complaint of chest pain or dyspnea. An automated machine diagnosis of "acute myocardial infarction" resulted in immediate CCL activation and direct transfer without transmission or human reinterpretation of the ECG prior to patient arrival. Any activation resulting from a nondiagnostic ECG (no ST-elevation) was deemed an IA, whereas activations resulting from ECG's compatible with ST-elevation myocardial infarction but without angiographic evidence of a coronary event were deemed false positive. In 2012, the referral algorithm was modified to exclude supraventricular tachycardia and left bundle branch block. RESULTS: There were 155 activations in the early cohort (2010-2012; prior to algorithm modification) and 313 in the late cohort (2012-2015). Algorithm modification resulted in a 42% relative decrease in the rate of IAs (12% vs 7%; P < 0.01) without a significant effect on treatment delay. CONCLUSIONS: A combination of prehospital automated ST-elevation myocardial infarction diagnosis and "physicianless" CCL activation is safe and effective in improving treatment delay and these results are sustainable over time. The performance of the referral algorithm in terms of IA and false positive is at least on par with systems that ensure real-time human oversight.

Drug-eluting balloon versus second-generation drug-eluting stent for the treatment of restenotic lesions involving coronary bifurcations.

AIMS: To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion. METHODS AND RESULTS: Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second-generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001). CONCLUSIONS: DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis.

Transcatheter Left Atrial Appendage Closure Using Intracardiac Echocardiographic Guidance From the Left Atrium.

BACKGROUND: Most commonly, left atrial appendage (LAA) occlusion procedures are performed using transesophageal echocardiography (TEE) guidance and general anaesthesia. Intracardiac echocardiography (ICE) offers potential advantages over TEE, however, ICE-guided LAA occlusion experience is limited and has been typically performed from a right-sided location where LAA visualization might be suboptimal. We sought to evaluate the efficacy and safety of percutaneous LAA occlusion using ICE guidance performed from the left atrium. METHODS: Thirty-seven patients with atrial fibrillation, significant risk for stroke, and long-term contraindication to anticoagulation underwent LAA closure with the Amplatzer Cardiac Plug (St Jude Medical, Inc, St Paul, MN) with mild sedation and ICE guidance. The ICE catheter was introduced in the left atrium through a second transseptal puncture. Patients underwent preprocedural TEE to rule out thrombus and 3-month follow-up TEE to assess occlusion grade. Patient characteristics, procedural data, effectiveness of ICE imaging, quality of occlusion, and complications were prospectively recorded. RESULTS: Procedural success was achieved in 36 of 37 patients (97%). Closure was complete or near complete (grade ≥3 according to ICE and angiography) in all cases where the device was released. In all cases, ICE imaging yielded good LAA and surrounding structure visualization and adequate procedural guidance. Three major procedural or in-hospital complications occurred. Median length of stay was 1 day. Follow-up TEE documented the absence of any residual peri-device leak in all but 1 (29 of 30) case. CONCLUSION: Initial experience suggests LAA occlusion with the Amplatzer Cardiac Plug using ICE guidance from the left atrium is feasible, reproducible, and safe.

Impact and natural history of postprocedural aortic regurgitation on early and midterm mortality following transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis.

BACKGROUND: Post-procedural aortic regurgitation (AR) negatively impacts the prognosis after trans-catheter aortic valve implantation. However, data evaluating the impact of different post-procedural AR grades (particularly mild) on clinical outcomes are still important. AIM AND METHODS: A retrospective cohort analysis was performed on all consecutive patients with severe aortic stenosis who underwent trans-catheter aortic valve implantation between July 2008 and August 2011 in a single Institution. Aim of the study was to evaluate the impact of different post-procedural AR grades on early and mid-term clinical outcomes. RESULTS: 322 consecutive patients were evaluated. At post-procedural echocardiographic evaluation: 105 (32.6%) patients had no AR, 204 (63.4%) mild AR and 13 (4%) moderate/severe AR. In-hospital mortality was higher in patients with moderate/severe AR than in those with absent or mild AR (38.5% vs. 2.6%, P < 0.001). At a median clinical follow-up of 342 days [interquartile range 93-485] cardiovascular mortality was 2.9% in patients without AR; 13.2% in the mild AR group (P = 0.004 vs. absent AR) and 46.2% in the moderate/severe AR group (P < 0.001 vs. mild or absent AR). On multivariable analysis, post-procedural AR (hazard ratio = 2.65 absent vs. present any grade, 95% confidence interval = 1.11-6.29; P = 0.027) was an independent predictor of mid-term mortality. CONCLUSIONS: The impact of post-procedural AR on outcomes after trans-catheter aortic valve implantation is proportional with its grade even in case of mild post-procedural AR compared to absent. This study confirms that every effort should be made to reduce the grade of post-procedural AR after trans-catheter aortic valve implantation with current devices.

The role of intravascular ultrasound and quantitative angiography in the functional assessment of intermediate coronary lesions: correlation with fractional flow reserve.

BACKGROUND: The correlation between fractional flow reserve (FFR) and intravascular ultrasound (IVUS) metrics including minimal lumen area (MLA), plaque burden and morphology remain a matter of debate. METHODS: Between June 2008 and May 2013, 132 intermediate stenoses in 109 patients were assessed by FFR, IVUS and quantitative angiography. Receiver-operating characteristic (ROC) curve analyses were used to identify MLA/lesion length/plaque burden cut-off values predictive of FFR <0.80. RESULTS: FFR <0.80 was observed in 39 lesions. In the entire cohort, MLA value <2.70mm(2) had 79.5% sensitivity, 76.3% specificity, 0.822 area under curve (AUC), 58.5% positive predictive value, 89.9% negative predictive value and 77.3% accuracy in predicting a positive FFR. In lesions with reference diameter vessel (RVD) ≥3.0mm, the MLA cut-off value was 2.84mm(2) (sensitivity 72.2%, specificity 83.0%, AUC 0.842) whereas in lesions with RVD <3.0mm, 2.59mm(2) (sensitivity 90.5%, specificity 69.6%, AUC 0.823). A moderate correlation was observed between MLA and FFR (r=0.429, p<0.001). The cut-off lesion length predictive of FFR <0.80 was 11.0mm with a weak correlation between the two (r=-0.348, p<0.001). Plaque morphology did not significantly affect FFR (p=0.485). On multivariable analysis, MLA (OR: 0.15; 95% CI: 0.05-0.40; p<0.001) and plaque burden (OR: 1.11; 95% CI: 1.04-1.20; p<0.003) were independent predictors of FFR <0.80. CONCLUSION: A modest, yet significant correlation was observed between MLA and FFR. The high negative predictive value of large MLAs (using afore-mentioned cut-off values) may provide some degree of confidence that the lesion in question is not functionally significant.

Comparison of results of transcatheter aortic valve implantation in patients with severely stenotic bicuspid versus tricuspid or nonbicuspid valves.

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment.

Drug-coated balloons in interventional cardiology.

Over the last few years, drug-coated balloon (DCB) therapy has emerged as a promising therapeutic intervention for the management of obstructive cardiovascular disease. The dictum of this novel technology is that effective prevention of restenosis can be achieved by the short-term transfer of antiproliferative drug to local arterial tissue by means of a single prolonged balloon angioplasty dilatation. Its main attraction is that no foreign body is implanted eliminating thus the risk of late inflammatory response to device components without preventing positive remodeling. Here, we discuss the evidence regarding the effectiveness of DCB in different lesion types and clinical settings as well as the types of DCB commercially available or under development.

Percutaneous approaches for efficient cardiac gene delivery.

Gene therapy for heart failure treatment is currently being optimized and validated. The results to date are encouraging but challenges remain before it becomes a therapeutic approach in clinical cardiology. Much effort is dedicated to improve gene transduction efficiency by improving the vectors and the delivery methods. Successful translation from the benchtop to the bedside requires teams including biologists focusing on vector modification and cardiologists refining delivery methods. Two key components for translation to the clinic include safety and efficacy. Transduction efficiency is closely linked to invasiveness in most delivery methods. However, current candidates for cardiac gene therapy are patients without effective treatment option and are in advanced heart failure, thus a less invasive approach is preferred. This review focuses on injection methods of gene delivery with emphasis on percutaneous and endovascular approaches to summarize currently available percutaneous gene delivery methods and their features.

Comparison of first- and second-generation drug-eluting stents in saphenous vein grafts used as aorto-coronary conduits.

Saphenous vein grafts (SVGs) are prone to an aggressive atherosclerotic process, and the efficacy of drug-eluting stents (DES) in treating this is still debated. In recent years, second-generation DES have been increasingly used in SVG intervention. The main objective of this study was to compare midterm clinical outcomes between first- and second-generation DES in SVGs because data regarding the use of second-generation DES in SVG are lacking. Patients treated with first-generation DES (127 patients with 143 lesions) and those treated with second-generation DES (84 patients with 100 lesions) were included in the study. Major adverse cardiac events, defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization, as well as target vessel revascularization and target lesion revascularization separately, were evaluated at 30-day, 12-month, and 18-month follow-up. Baseline characteristics were similar between the 2 groups. Older grafts were treated with second-generation DES (11.6 ± 5.3 vs 14.3 ± 6.0 years, p = 0.001). Stent length was longer in the first-generation group (34.1 ± 25.1 vs 30.5 ± 19.4 mm, p = 0.006), and maximum balloon diameter was smaller in the second-generation group (3.42 ± 0.42 vs 3.30 ± 0.41 mm, p = 0.003). Embolic protection device use was higher in the second-generation DES group (55.2% vs 72.0%, p = 0.012). At 18-month follow-up, rates of major adverse cardiac events, target vessel revascularization, and target lesion revascularization for the first- and second-generation groups were 24.4% versus 20.2% (p = 0.479), 18.1% versus 14.2% (p = 0.465), and 15.0% versus 10.7% (p = 0.373), respectively. In conclusion, second-generation DES are at least comparable with first-generation DES with regard to clinical outcomes at midterm follow-up.

The role of everolimus-eluting and resolute zotarolimus-eluting stents in the treatment of coronary bifurcations.

OBJECTIVES: To compare the long-term clinical outcomes of everolimus-eluting (EES) and Resolute zotarolimus-eluting (R-ZES) stents in the treatment of coronary bifurcation lesions. BACKGROUND: Recent studies have suggested that the R-ZES is comparable to the EES in the treatment of de novo coronary artery disease. Available data on how these compare in the treatment of bifurcation lesions are limited. METHODS: We retrospectively analyzed consecutive de novo bifurcation lesions, including left main stem lesions, treated with either EES or R-ZES between October 2006 and October 2011. Study endpoints examined included major adverse cardiac events (MACEs), defined as the composite of all-cause death, myocardial infarction (MI), including periprocedural MI, and target vessel revascularization (TVR). Target lesion revascularization (TLR) per patient and per bifurcation as well as stent thrombosis (ST) were also analyzed. RESULTS: We identified 235 bifurcation lesions treated with either EES (157 lesions in 154 patients) or R-ZES (78 lesions in 73 patients). Baseline clinical and procedural characteristics were broadly similar between the two groups. No significant differences in MACE (14.6% vs 11.5%; P=.99) or TVR (8.0% vs 7.3%; P=.45) rates were noted between the two groups at 2-year follow-up. The incidence of ST was low and similar in both groups (0% vs 1.4%). CONCLUSIONS: EES and R-ZES are associated with acceptable and comparable long-term clinical outcomes when used in the treatment of bifurcation lesions. Further evaluation into the role of currently available drug-eluting stents in bifurcation percutaneous coronary intervention is required.

The role of drug-eluting balloons alone or in combination with drug-eluting stents in the treatment of de novo diffuse coronary disease.

OBJECTIVES: This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm). BACKGROUND: The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited. METHODS: We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone. RESULTS: A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84). CONCLUSIONS: DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease.

First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations.

BACKGROUND: Randomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions. METHODS AND MATERIALS: This was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients). RESULTS: Second-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p=0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p=0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p=0.02) and per bifurcation (11.8% vs. 7.0%, p=0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33-0.85; p=0.01) and TVR (HR, 0.44; 95% CI, 0.24-0.83; p=0.01). CONCLUSIONS: Our results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization.