Edoardo Pucci

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.

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).

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.

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

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).

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.

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.

TCT-204 Optimal duration of dual antiplatelet therapy (DAPT) after second generation drug-eluting stent (DES) implantation in elderly patients: the SECURITY-ELDERLY substudy

The randomized SECURITY trial ([NCT00944333][1]) showed non-inferiority of 6 vs 12 month DAPT after DES implantation in a low-risk population treated with percutaneous coronary intervention (PCI). We aim to assess the outcome of elderly (≥75 year old) in comparison to younger patients (<75 year

A classification of bifurcation restenosis

Fig. 3. (A) Endothelial dysfunctionwas investigated in rabbits by vascular ultrasound in vivo by infusion of increasing doses of acetylcholine. The effect of Ad-ADAM15, AdADAM15 prot neg and control adenovirus (AdGFP) was compared in atherosclerotic rabbits. The relative change of the diameter of the carotid artery compared to the baseline diameter (in %) is demonstrated (* indicates pb0.05 significance compared to AdGFP). (B) The effect of Ad-ADAM15 and Ad-ADAM15 prot neg on endothelial function was also investigated in healthy rabbits without any sign of atherosclerosis. Both AdADAM 15 and Ad-ADAM15 prot neg significantly impaired acetylcholine induced, endothelium-dependent vasoreactivity in healthy rabbits. (* indicates pb0.05 significance compared to AdGFP healthy). The means±SEM of 7 animals are shown. [16] Garton KJ, Gough PJ, Philalay J, et al. Stimulated shedding of vascular cell adhesion molecule 1 (VCAM-1) is mediated by tumor necrosis factor-alpha-converting enzyme (ADAM 17). J Biol Chem 2003;278:37459–64. [17] Furchgott RF, Zawadzki JV. The obligatory role of endothelial cells in the relaxation of arterial smooth muscle by acetylcholine. Nature 1980;288:373–6. [18] Moncada S, Higgs A. The L-arginine-nitric oxide pathway. N Engl J Med 1993;329:2002–12. [19] Loscalzo J. Nitric oxide insufficiency, platelet activation, and arterial thrombosis. Circ Res 2001;88:756–62.