[Bioresorbable vascular scaffolds: clinical experience of the Emilia-Romagna Region, Italy]. / Scaffold bioriassorbibile: l'esperienza clinica della Regione Emilia-Romagna.

BACKGROUND: The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection. METHODS: This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database. RESULTS: In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed. CONCLUSIONS: BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.

Twelve-month outcome of patients with an established indication for oral anticoagulation undergoing coronary artery stenting and stratified by the baseline risk of bleeding: Insights from the Warfarin and Coronary Stenting (War-Stent) Registry.

PURPOSE: To evaluate the outcome of patients with an established indication for oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S) and stratified by the baseline risk of bleeding. MATERIAL AND METHODS: The database of the prospective, multicentre, observational WAR-STENT registry (ClinicalTrials.gov identifier NCT00722319) was analyzed and patients with atrial fibrillation and CHA2DS2-VASc score ≥2, mechanical heart valve, prior cardiac embolism, intra-cardiac thrombus and recent venous thromboembolism who were treated with either triple (warfarin, aspirin and clopidogrel) or dual (warfarin and clopidogrel) or dual antiplatelet (aspirin and clopidogrel) therapy, identified. Patients were then sorted into two groups at non-low and low risk of bleeding, as defined by an ATRIA score >3 and ≤3 respectively, and compared regarding major adverse cardiac and vascular events (MACVE) and bleeding. RESULTS: At 12-month follow up, MACVE were comparable in the two groups, whereas total, major and minor bleeding, as well as combined MACVE and total bleeding, were significantly more frequent in the non-low bleeding risk group. Upon Cox univariate and multivariable analysis, non-low bleeding risk category confirmed as an independent predictor of major bleeding. The choice of antithrombotic therapy however, appeared not to be influenced by the bleeding risk category at baseline. CONCLUSIONS: In patients with an established indication for OAC undergoing PCI-S, non-low bleeding risk category is the most potent independent predictor of major bleeding. Stratification of the bleeding risk at baseline should therefore be regarded as an indispensable process to be carried out before selection of the antithrombotic therapy.

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.

Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry.

OBJECTIVES: To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S). BACKGROUND: The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined. METHODS: We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period. RESULTS: Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases. CONCLUSION: In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.

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).

[Percutaneous coronary interventions in elderly patients: clinical indications and adjunctive medical treatment. The Italian Drug Evaluation in Angioplasty (IDEA) study]. / Procedure interventistiche coronariche percutanee in pazienti anziani: indicazioni cliniche e terapie farmacologiche concomitanti. Lo studio Italian Drug Evaluation in Angioplasty (IDEA).

BACKGROUND: Specific guidelines for interventional cardiology in elderly patients are not available, and it appears that aged patients are treated more conservatively. Nevertheless data on the real clinical practice are lacking. The aim of the study was to describe different therapeutic strategies in elderly patients enrolled in the Italian Drug Evaluation in Angioplasty (IDEA) study. METHODS: The IDEA study is a registry of consecutive percutaneous coronary interventions (PCI) performed from September 15 to 29, 2003, at 79 Italian cath-labs. RESULTS: Out of 1517 consecutive PCI patients, 491 (32%) were aged > or = 70 years. Compared to younger patients, those > or = 70 years old showed more frequently (p < 0.001) renal insufficiency (10.4 vs 4.4%), peripheral vasculopathy (18 vs 6.9%), history of stroke (7.3 vs 3.3%) or previous surgical coronary revascularization (15 vs 7.5%) and multivessel disease (61 vs 49%). In patients aged > or = 70 years, acute coronary syndrome was the more frequent clinical indication for PCI (54 vs 49% in patients < 70 years, p = 0.05). Globally, stent use was 89% with no differences related to the patients' age. Drug-eluting stents were used in 21% of the procedures in elderly patients and in 22% in younger patients. Use of glycoprotein IIb/IIIa receptor antagonists in acute coronary syndrome was not correlated with the patients' age; nevertheless in elderly patients with acute myocardial infarction these drugs were less used during primary angioplasty compared to younger patients (48 vs 72%, p = 0.001). In-hospital mortality was higher in patients aged > or = 70 years (2.9 vs 0.9%, p = 0.004), particularly in patients treated for acute coronary syndromes (5.5 vs 1.4%, p = 0.002). In these patients, more bleeding complications (7.1 vs 3.9%, p < 0.001) and heart failure (5.5 vs 1.6%, p = 0.004) were observed. CONCLUSIONS: Compared to younger patients, elderly patients enrolled in the IDEA study had a higher risk profile and higher in-hospital morbidity and mortality. Except for a lower use of glycoprotein IIb/IIIa receptor antagonists for acute myocardial infarction, no discriminations were observed in elderly patients in terms of clinical indications, antiplatelet therapy and drug-eluting stent use.