Optimal duration of dual antiplatelet therapy after second-generation drug-eluting stent implantation in patients with diabetes: The SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed By Six- Versus Twelve-Month Dual Antiplatelet Therapy)-diabetes substudy.

BACKGROUND/OBJECTIVES: The randomized SECURITY (Second-Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial showed the non-inferiority of 6 vs. 12-month DAPT after percutaneous coronary intervention (PCI) with second-generation DES in a low-risk population. Nevertheless, diabetes mellitus (DM) remained a major predictor of adverse cardiovascular events. We aimed to assess the interaction between DAPT duration and outcome in DM patients. METHODS: All diabetic patients included in the SECURITY trial treated by second-generation DES PCI were analyzed. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable ST, or BARC type 2, 3, or 5 bleeding at 24months. RESULTS: Four hundred-twenty nine DM patients received either 6 (n=206) or 12 (n=223) months of DAPT. The primary endpoint occurred in 3.9% and 5.4% of patients in the 6 and 12-month DAPT group, respectively (log-rank test p=0.83). Similarly, no statistically significant difference in the secondary endpoint was observed between the two study groups (5.4% vs. 7.6%, p=0.620). Stent thrombosis rate was low irrespective of DAPT duration at both 12 (0.5% vs. 0.4%; p=0.804) and between 12 and 24months of follow-up (0.5% vs. 0%, p=0.291). At multivariable analysis, female gender (HR: 3.42; 95% CI 1.32-8.85; p=0.011 and HR 2.28; 95% CI 1.09-4.75; p=0.027) and insulin-treated diabetes mellitus (HR: 2.62; 95% CI 1.15-6.75; p=0.004 and HR: 2.23; 95% CI 1.09-6.33; p=0.003) were independent predictors of both primary and secondary endpoint. CONCLUSIONS: In diabetic patients treated by second-generation DES PCI, we failed to find any additional benefit of prolonging DAPT beyond 6months, regardless of insulin-requiring status.

First optical coherence tomography follow-up of coronary bifurcation lesions treated by drug-eluting balloons.

BACKGROUND: A strategy of percutaneous bifurcation intervention with provisional bare-metal stent (BMS) implantation followed by drug-eluting balloon (DEB) treatment represents a valuable opportunity in patients not compliant with long-duration dual-antiplatelet therapy. We used optical coherence tomography (OCT) to assess coronary bifurcation lesions treated by BMS and DEB, and secondarily, to better explore the association between stent geometry and tissue coverage. METHODS: Twelve patients underwent frequency-domain OCT 6 months after undergoing percutaneous bifurcation intervention with BMS implantation followed by kissing DEB. The same type of BMS was correspondingly implanted in silicone bifurcation models and scanned by microcomputed tomography. RESULTS: Overall, a total 2914 struts were analyzed, revealing 0.6% malapposed struts and 3.1% uncovered struts, with neointimal thickness of covered struts measured at 0.19 ± 0.13 mm. Findings were homogeneous among patients with the exception of one outlier who presented a significant distortion of the stent geometry, suggesting proximal cell rewiring prior to kissing DEB, as supported by the microcomputed tomography model. This pattern was not present in the other cases, which showed struts optimally apposed and nicely scaffolding the side-branch ostium. CONCLUSION: This is the first study describing the effects of DEB in percutaneous bifurcation interventions according to OCT parameters. The results show that a strategy of kissing DEB following BMS is associated with low neointimal thickness and high rate of covered stent struts. Moreover, these results appear to be dependent on the quality of bifurcation intervention, with distal cell rewiring more favorable than proximal cell rewiring.

One-year follow-up of patients treated with new-generation polymer-based 38 mm everolimus-eluting stent: the P38 study.

OBJECTIVES: To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES). BACKGROUND: Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents. METHODS: Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria. RESULTS: Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one. CONCLUSIONS: The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial.

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) following second-generation drug-eluting stent (DES) implantation is still debated. OBJECTIVES: The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES. METHODS: The SECURITY (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy) trial was a 1:1 randomized, multicenter, international, investigator-driven, noninferiority study conducted from July 2009 to June 2014. Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible. The primary endpoint was a composite of cardiac death, myocardial infarction (MI), stroke, definite or probable stent thrombosis, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 12 months. The main secondary endpoint was a composite of cardiac death, MI, stroke, definite or probable stent thrombosis, or BARC type 2, 3, or 5 bleeding at 12 and 24 months. RESULTS: Overall, 1,399 patients were enrolled in the study and randomized to receive 6 months (n = 682) versus 12 months (n = 717) DAPT. The primary composite endpoint occurred, respectively, in 4.5% versus 3.7% (risk difference 0.8%; 95% confidence interval [CI]: -2.4% to 1.7%; p = 0.469) at 12 months. The upper 95% CI limit was lower than the pre-set margin of 2%, confirming the noninferiority hypothesis (p < 0.05). Moreover, no differences were observed in the occurrence of the secondary endpoint at 12 months (5.3% vs. 4.0%, difference: 1.2%; 95% CI: -1.0 to 3.4; p = 0.273) and between 12 and 24 months (1.5% vs. 2.2%, difference: -0.7%; 95% CI: -2.1 to 0.6; p = 0.289). Finally, no differences were observed in definite or probable stent thrombosis at 12 months (0.3% vs. 0.4%; difference: -0.1%; 95% CI: -0.7 to 0.4; p = 0.694) and between 12 and 24 months of follow-up (0.1% vs. 0%; difference: 0.1%; 95% CI: -0.1 to 0.4; p = 0.305). CONCLUSIONS: In a low-risk population, the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death, MI, stroke, definite/probable stent thrombosis, and BARC type 3 or 5 bleeding at 12 months. (Second Generation Drug-Eluting Stent Implantation Followed by Six- Versus Twelve-Month Dual Antiplatelet Therapy; NCT00944333).

Vascular imaging balloon with local drug delivery for the treatment of renal artery recurrent in-stent restenosis.

Renal artery stenosis is a common finding among patients with atherosclerotic disease and its percutaneous treatment with stent implantation is frequently performed by interventional cardiologists and vascular radiologists. However, renal artery in-stent restenosis is not a rare complication and its management is not straightforward. We describe and report angiographic follow-up of an innovative approach to renal artery in-stent restenosis based on combined intravascular ultrasound and drug-eluting balloon treatment.

[Intracardiac echography in interventional cardiology]. / L'ecografia intracardiaca in cardiologia interventistica.

Since its early development, interventional cardiology relies on radiological imaging to show and describe vascular structures involved in percutaneous treatment. However, the development of the transcatheter approach to structural heart disease has highlighted the limits of X-rays in guiding interventions targeting soft heart tissues because of their low radiological resolution. Transesophageal echocardiography has thus gained an important role in many catheterization laboratories that perform percutaneous structural heart disease interventions. The endorsement of this technique necessarily requires expertise of echocardiographers and anesthesiologists for endotracheal intubation, thus increasing the logistic complexity of the procedure. Hence, the idea to apply ultrasonography directly into the heart, thus the introduction of intracardiac echography. At present, there are two different technological implementations of intracardiac echography related to the use of an electronic or mechanical ultrasonic transducer placed at the tip of a catheter inserted into the cardiac chambers, most frequently via femoral venous vascular access. In this review, we describe the potentials, advantages and limits of intracardiac echography, as well as its operative function, current use, and future developments.

Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series.

Coronary bifurcation restenoses are especially challenging lesions to treat. In this report, four cases are described in which an innovative approach consisting of the simultaneous inflation of two drug-eluting balloons has been successfully applied to treat different kinds of bifurcation restenoses following both provisional and complex stenting strategies. These selected cases illustrate the concept and the advantages of a kissing drug-eluting balloon strategy for the treatment of virtually any kind of bifurcation restenosis.

IVUS rings mapping a patient's history.

We describe the case of a patient presenting with a stent thrombosis and an intravascular ultrasound image of three concentric strut layers of progressively worse expanded stents resembling a tree's growth rings.

Kissing inflation is feasible with all second-generation drug-eluting balloons.

OBJECTIVE: To assess the feasibility of kissing second-generation drug-eluting balloons (DEB), which have better mechanical properties than the first-generation DEB, in order to optimize provisional bare-metal stenting (BMS) when treating coronary bifurcation lesions in patients with contraindication to drug-eluting stents. METHODS: Consecutive patients with anticipated low compliance to dual antiplatelet therapy who are undergoing provisional stenting with an open-cell design BMS and final kissing balloon with second-generation DEB were enrolled in this feasibility study. Angiographic success and procedural success (i.e., angiographic success in absence of in hospital major cardiovascular events) were registered. Clinical follow-up was also attempted in all patients. RESULTS: A total of 14 patients (mean age 66±9 years, nine men) participated on the study. The DEB used were SeQuent Please (B. Braun Melsungen, Berlin, Germany) in six patients, In.Pact Falcon (Medtronic Invatec, Roncadelle, Italy) in four patients, New Dior (Eurocor, Bonn, Germany) in two patients and Pantera Lux (Biotronik, Berlin, Germany) in another two patients. All procedures, but one, were performed by transradial access through a 6-French high-flow guiding catheter. True bifurcation was present in 50% of the patients. Angiographic and procedural success was obtained in all patients. At a mean follow-up of 234±81 days, all contacted patients were asymptomatic and free from major adverse cardiac events (including cardiac death, nonfatal myocardial infarction and target bifurcation revascularization). CONCLUSION: At the advent of dedicated bifurcation stents, kissing DEB appears safe and effective and can be used to implement innovative, simpler, safer and possibly more effective bifurcation techniques. These remarkable results have laid the ground for an ongoing prospective registry of the kissing DEB technique (KISSING DEBBIE study, ClinicalTrials.gov NCT01009996).

Long-term outcome of transcatheter patent foramen ovale closure in patients with paradoxical embolism.

BACKGROUND: Optimal management of patients with PFO and paradoxical embolic events is still debated. Moreover, data from long-term studies on large patient populations are lacking. Aim of the study is to assess immediate and long-term clinical outcome of patients with PFO and paradoxical thrombo-embolic events submitted to transcatheter PFO closure. METHODS: Only patients with PFO-related transient ischemic attack or stroke underwent PFO closure. Patients were evaluated clinically and echocardiographically at 1, 6 and 12 months after the procedure and yearly thereafter. Primary endpoints were death, recurrent stroke or TIA. Residual right-to left shunt (RLS) was monitored by transthoracic echocardiography (TTE) or transcranial Doppler (TCD) at 6 months'follow-up. RESULTS: 202 consecutive patients underwent percutaneous PFO closure for secondary prevention of TE. Device migration was observed in one patient 24 h after the procedure. No cases of procedure-related death or stroke occurred during a median follow-up of 3+/-1.3 years. Three recurrent TIAs were observed within the first 6 months of follow-up. The cumulative estimated probability of recurrent TE-free survival rate after PFO closure was 99% in patients 55 years (p<0.05) and 94% and 100% in patients with PFO, with or without atrial septal aneurysm (ASA), respectively (p<0.05). Of the 188 (93%) patients submitted to TTE or TCD at 6 months' follow-up, 8 (4%) presented a small RLS. CONCLUSION: Transcatheter PFO closure is associated with low incidence of in-hospital complications and low frequency of recurrent TE at long-term follow-up.

Clinical outcome of patients with chronic total occlusion treated with drug-eluting stents.

BACKGROUND: There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation. METHODS: We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents. RESULTS: During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002). CONCLUSIONS: During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.

Endovascular treatment of aortic coarctation: long-term effects on hypertension.

INTRODUCTION: Endovascular management of aortic coarctation (CoA) is safe but few data are available concerning the long-term cure of hypertension. Aim of this study was to evaluate immediate and long-term clinical and haemodynamic outcome in a consecutive series of adolescent and adult patients with CoA submitted to endovascular treatment. METHODS: A total of 21 adolescent and adult patients underwent successful transcatheter intervention of CoA. Follow-up comprised cardiological examination with special attention to blood pressure (BP), echocardiogram, 24/h ambulatory blood pressure monitoring (ABP), exercise test and spiral computed tomography. RESULTS: Pre-intervention CoA diameter and degree of stenosis were 4.8+/-2.1 mm and 73.7+/-9.8%, respectively, and 14.8+/-3.0 mm and 13.5+/-6.5% post-intervention (p<0.001). Systolic arterial hypertension persisted in 2 patients at rest (9.5%). Mean number of antihypertensive medications per patient was 1.5+/-1.1 and 0.5+/-0.9 at 1 year after treatment (p<0.05). At ABP 3 patients (14%) were hypertensive. The Doppler gradient across the coarctation site decreased from 58.8+/-16.9 to 10.5+/-4.9 mmHg (p<0.001) as well as left ventricular mass (199+/-14.6 and 189.3+/-9.1; p<0.001). Overall, 18 patients (86%) underwent a treadmill exercise test and 4 patients (22%), normotensive at rest, showed a pathological blood pressure response. Overall, 7/21 patients (33%) showed persistent hypertension. CONCLUSION: Endovascular treatment of native or recurrent CoA in adolescent and adult patients is safe but 33% of patients showed persistent hypertension. Meticulous clinical follow-up is mandatory, including an exercise test in order to monitor eventual blood pressure increase and to assess effort tolerance.

Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).

OBJECTIVES: To confirm whether sirolimus-eluting stents (SES) safely reduce the incidence of restenosis in patients with ST-segment elevation acute myocardial infarction compared with bare-metal stents (BMS). BACKGROUND: In the setting of primary angioplasty, stent restenosis occurs in up to 27% of patients. The introduction of drug-eluting stents has drastically reduced the incidence of restenosis in clinically stable patients. METHODS: We conducted a randomized trial of 320 patients with acute ST-segment elevation myocardial infarction assigned to receive SES or BMS. The primary end point was binary restenosis at 1-year angiographic follow-up. RESULTS: At 1 year, the incidence of binary restenosis was lower in the SES group than in the BMS group (9.3% vs. 21.3%, respectively; p = 0.032), as were the rates of target lesion revascularization (4.3% vs. 11.2%; p = 0.02), target vessel revascularization (5% vs. 13.1; p = 0.015), major adverse cardiac events (6.8% vs. 16.8%; p = 0.005), and target vessel failure (8.7% vs. 18.7%; p = 0.007). The incidence of angiographically documented stent thrombosis was 1.2% (n = 2) in the SES group and 0.6% (n = 1) in the BMS group. CONCLUSIONS: In patients with acute myocardial infarction, SES are superior to BMS, reducing the incidence of binary restenosis by 56%, target lesion revascularization by 61%, target vessel revascularization by 62%, adverse cardiac events by 59%, and target vessel failure by 53% at 1 year. (Sirolimus Eluting Stenting in Acute Myocardial Infarction; http://www.clinicaltrials.gov/ct/show/NCT00288210; NCT00288210).