Long‐term outcome after drug‐eluting stent implantation in unselected population: ROME and UDINE Experience (The RUDI Registry)

Objectives : The aim of our study is to evaluate the safety and efficacy of DES implantation in an unselected, “real world,” high‐risk population. Background : Several clinical trials showed that drug‐eluting stents (DESs) implantation is safe and effective in selected population. In spite of these encouraging results, there are some concerns about “real world” utilization of these stents. Methods : One thousand four hundred and fifty‐five off‐label patients have been included in our registry. Primary end‐points were: long‐term clinical incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombosis (ST). We detected the difference between uniDES vs. multiDES implantation in terms of MACCE, death, nonfatal‐MI, the composite of death/nonfatal‐MI and target lesion revascularization (TLR) and the difference between DES type in term of MACCE. Results : At 36 months follow‐up we found: cardiac death occurred in 20 patients (1.6%); 33 patients (2.6%) had a nonfatal MI and 81 patients (6.3%) had a TLR. We observed one (0.1%) acute, 9 subacute (0.6%), 6 late (0.6%), and 1 (0.5%) very late definite ST. No difference were found in terms of overall MACCE, MI, death and composite of death/nonfatal‐MI between uni‐ and multiDES implantation but multiDES group had a higher incidence of TLR. No difference between DES type in term of MACCE was detected. Conclusions : DES utilization shows their safety and efficacy in off‐label patients with complex clinical and angiographic profile in terms of long‐term incidence of MACCE. MultiDES implantation is associated with a higher risk of long‐term TLR. No difference between DES type was found. © 2011 Wiley Periodicals, Inc.     

Long‐term clinical outcomes after drug‐eluting stent implantation in unprotected left main coronary artery disease

Objective: To investigate long‐term outcomes of unprotected left main coronary artery (ULMCA) disease treatment using drug‐eluting stents (DES). Background: In several studies, DES implantation in ULMCA appeared safe and effective at mid‐term; however, to date, there is limited long‐term data. Methods : All consecutive patients undergoing sirolimus‐ or paclitaxel‐eluting stent implantation in ULMCA disease at a single institution were evaluated. The primary endpoint was long‐term major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization (TLR). Stent thrombosis (ST), according to Academic Research Consortium definitions, was also evaluated. Results: A total of 210 patients were assessed. In‐hospital MACE rate was 1%. During a mean follow‐up of 28.0 ± 14.5 months, MACE occurred in 26 patients (12.5%): cardiac death in nine patients (4.3%) and TLR in 17 patients (8.2%). The cumulative MACE‐free survival rate was 89.0, 87.4, and 85.4% at 1, 2, and 3 years, respectively. ST occurred in three patients (1.4%): one case was definite and the other two were probable/possible ST; there were no cases of very late ST. Binary restenosis occurred in 8.3%. The EuroScore >6 was the only independent predictor of MACE [hazard ratio (HR) 2.24, 95% confidence interval (CI) 1.05–4.77, P = 0.04]. There was a trend toward an increased risk of MACE associated with distal ULMCA location (HR 2.14, 95% CI 0.87–5.29, P = 0.10). Conclusions: Our study showed DES implantation in ULMCA to be feasible, safe, and effective at long term. Randomized trials comparing percutaneous versus surgical revascularization are warranted to define the treatment of choice for ULMCA disease. © 2009 Wiley‐Liss, Inc.     

Does stent design affect the long‐term outcome after coronary stenting?

The purpose of our study was to determine the clinical, angiographic, and procedural variables that predict the risk for 2-year target lesion revascularization (TLR) and other clinical events in a large cohort of patients treated with coronary stenting. Between March 1996 and March 1999, 1,340 patients were prospectively enrolled. They underwent at least one stenting procedure with one of the four coronary stent types used during this time period in our institution: Wiktor-I, Nir, Bard XT, or Tenax. Clinical follow-up was obtained for 99.1% of eligible patients (mean, 19.38 +/- 4.97 months). The overall TLR rate was 10.7% at 24 months. Two variables were independently associated with the long-term outcome: MLD post stenting and stent type. Implantation of silicon carbide-coated stents was associated with a twofold decrease in 24-month TLR (P < 0.01). The major adverse cardiac event rate at 2 years was 20.8%. Multivariate analysis showed that three parameters were predictive: diabetes (P < 0.002), recent onset of symptoms (P < 0.03), and high diffusion of coronary atherosclerosis as assessed by Gensini score (P < 0.0069). In conclusion, stent type, and particularly passive silicon carbide coating, appears to affect the 24-month TLR rate but not other major cardiac events.     

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.

     

Long‐term cardiovascular outcome of Williams syndrome

Objective: Cardiovascular lesions are the leading cause of morbidity and mortality in patients with Williams syndrome. Recent studies have rebutted conventional reports about the natural course of cardiovascular anomalies in Williams syndrome.
Design: Retrospective study.
Setting: Single tertiary center.
Patients: Eighty patients with Williams syndrome followed up for more than 5 years.
Interventions: Not applicable.
Outcome Measures: Long‐term outcome of cardiovascular lesions, peak velocity change in obstructive cardiovascular lesions over time, post‐interventional courses of disease‐specific intervention, and intervention‐free survival of obstructive cardio‐ vascular lesions.
Results: The median follow‐up duration was 11.0 (5.1‐28.3) years. Among 80 pa‐ tients, supravalvular aortic stenosis (87.5%) was the most common cardiovascular lesion, followed by branch pulmonary stenosis (53.8%), mitral valve prolapse (22.5%), and aortic arch hypoplasia/coarctation (5.0%). During the follow‐up period, the peak flow velocity of supravalvular aortic stenosis did not change on peak Doppler echo‐ cardiography. Initially, severe supravalvular aortic stenosis was aggravated (P < .027). Conversely, the peak velocity of branch pulmonary stenosis decreased (from 3.08 to 1.65 m/s; P < .001) within age 3.2 (0.4‐6.9) years. Even the group with severe branch PS improved over time. Twenty‐two patients (27.5%) with Williams syndrome under‐ went disease‐specific interventions without mortality, mostly for supravalvular aortic stenosis or mitral valve prolapse. No patient in the late‐onset and initially mild sup‐ ravalvular aortic stenosis group needed intervention and 37.5%, 48.4%, and 65.1% in initially moderate and severe supravalvular aortic stenosis groups needed inter‐ vention at age 5, 10, and 20 years, respectively. Unlike the conventional therapeutic concept, the intervention for branch pulmonary stenosis was almost unnecessary.
Conclusions: In Williams syndrome, initially severe supravalvular aortic stenosis worsened over time and most branch pulmonary stenoses, including those in the severe group, improved spontaneously. Most patients with branch pulmonary ste‐ nosis did not require disease‐specific intervention. Surgical repairs for cardiovascular abnormalities in Williams syndrome showed favorable results.     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

Sirolimus-eluting stent implantation for treatment of proximal left anterior descending coronary artery lesions: long-term outcome and predictors of adverse cardiac events.

OBJECTIVES: Acute and long-term results after sirolimus-eluting stent (SES) implantation of proximal left anterior descending coronary artery (LAD) disease were evaluated. BACKGROUND: Although SES has been used increasingly for the treatment of LAD disease, data regarding their safety and efficacy in a real-world population are limited. METHODS: We investigate the short- and long-term results in 966 patients who underwent SES implantation for stenosis of proximal LAD. RESULTS: The procedural success rate was 97.6%, and procedural non-Q-wave myocardial infarction (MI) rate was 14.5%. In-hospital major complications occurred in five patients (0.5%), including three deaths and two Q-wave MIs. During follow-up (20.4 +/- 8.9 months), there were 16 deaths (1.7%; 10 cardiac, 6 noncardiac), 2 Q-wave MIs, and 22 target lesion revascularizations (2.3%). Late stent thrombosis occurred in two patients (0.2%), 14 and 23 months after the procedure. The event-free survival rates for cardiac death/Q-wave MI were 98.6% +/- 0.4% at 1 year and 97.8% +/- 0.6% at 2 years. The cumulative probabilities of survival without major adverse cardiac events (MACE) were 96.7% +/- 0.6% at 1 year and 95.4% +/- 0.8% at 2 years. In multivariate analysis, stented length (HR 1.04, 95%CI 1.01-1.07, P = 0.009) and infarct-related artery (HR 5.18, 95%CI 1.09-24.64, P = 0.039) were independently related to cardiac death/Q-wave MI. In addition, stented length (HR 1.04, 95%CI 1.02-1.06, P < 0.001) and left ventricular dysfunction (HR 2.66, 95%CI 1.07-6.63, P = 0.036) were significant independent predictors of MACE. CONCLUSIONS: SES implantation for proximal LAD disease appears safe and effective in a real-world population, and the independent predictors of MACE included stented length and left ventricular dysfunction.