Determinants of radiation dose during right transradial access: Insights from the RAD-MATRIX study.

BACKGROUND: The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. METHODS: Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. RESULTS: Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 µSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 µSv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 µSv, interquartile range 71.5-146.5 µSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 µSv, 31.3-56.8 µSv, P = .02). This difference persisted after normalization by dose-area product (P = .028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 µSv, respectively, P = .016). CONCLUSIONS: In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access.

Antiplatelet therapy and outcome in patients undergoing surgery following coronary stenting: Results of the surgery after stenting registry.

OBJECTIVES: The aim of the present study was to define the feasibility and clinical impact of complying with national consensus recommendations on perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. BACKGROUND: There are limited evidence-based recommendations on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. METHODS: The recommendations provided by the national consensus document were applied in a multicenter, prospective registry of consecutive patients with prior coronary stenting undergoing any type of surgery at 19 hospitals in Italy. The primary end-point was in-hospital net adverse clinical events (NACE) represented by the composite of all-cause death, myocardial infarction, probable/definite stent thrombosis and Bleeding Academic Research Consortium (BARC) grade ≥3 bleeding. Patients were followed for 30 days. RESULTS: A total of 1,082 patients were enrolled. Adherence to consensus recommendations occurred in 85% of the cases. Perioperative aspirin and dual antiplatelet therapy were maintained in 69.7 and 10.5% of the cases, respectively. In-hospital NACE rate was 12.7%, being significantly higher in patients undergoing cardiac surgery (36.3% vs. 7.3%, P < 0.01), mainly due to BARC 3 bleeding events (32.3%). At 30 days, MACE rates were similar (3.5% vs. 3.5%, P = NS) in patients undergoing cardiac and noncardiac surgery, whereas BARC ≥3 bleeding events were significantly higher with cardiac surgery (36.3% vs. 5.6%, P < 0.01). CONCLUSIONS: The results of this registry demonstrate the safety and feasibility of applying a national consensus document on the perioperative management of antiplatelet therapy in stented patients undergoing surgery. © 2016 Wiley Periodicals, Inc.

Double Reducer implantation in the coronary venous system for treatment of refractory angina: a case report.

Background: The coronary sinus (CS) Reducer can be considered for the treatment of refractory angina in patients unsuitable for coronary revascularization, but its effect can be influenced by the significant heterogeneity in the anatomy of the cardiac venous system. Case summary: We report the case of a 70-year-old woman with recurrent episodes of rest angina refractory to optimal medical therapy [Canadian Cardiovascular Society (CCS) Class IV] and inducible ischaemia in a large myocardial territory. Given the diffuse and peripheral nature of the coronary disease, the patient was considered ineligible for percutaneous or surgical revascularization and she was regarded as a good candidate for a CS occluder. Since coronary venous angiography showed the middle cardiac vein (MCV) to be at least as relevant as the CS, successful implantation of two devices, one in the CS and the second in the MCV, was performed. At 6-month follow-up, the patient reported a significant improvement in angina, resulting in a reduction of the CCS class from Grades IV to III. Discussion: In patients affected by refractory angina and regarded as good candidates for Reducer implantation, a thorough comprehension of the cardiac venous pathway drainage is of pivotal importance to guarantee the therapeutic success of the procedure. In this patient, since the CS and the MCV seemed to contribute equally to coronary venous drainage, Reducer implantation in both vessels allowed to obtain a significant improvement of symptoms. The clinical effectiveness of this strategy needs to be validated in randomized clinical trials.

Adherence of ticagrelOr in real world patients with aCute coronary syndrome: The AD-HOC study.

Background: Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor antagonist is the cornerstone of therapy in patients with acute coronary syndrome (ACS). Adherence to medical therapy is an important issue, as premature DAPT discontinuation increases the risk of new ischemic events. The aim of the present observational prospective multicenter study was to evaluate in the real-world incidence and discontinuation patterns of ticagrelor during the first 12 months after ACS. Methods: We analyzed 431 ACS patients, discharged with ticagrelor, by 7 Italian centers. The primary end-point was the incidence of cessation of ticagrelor up to 12 months from the index event. Results: Definitive ticagrelor cessations occurred in 52 patients (12.1%), of which 35 were discontinuations (clinically driven) and 17 disruptions (due to acute events). Temporary cessation occurred in 14 cases (3.3%). Age ≥ 80 years and anticoagulant therapy were independent predictors of premature discontinuation. Bleeding occurred in 74 patients, of which 25 suffered a BARC ≥ 2 bleeding event. Bleeding were more frequent in female sex (27.0% vs 17.2%, p-value 0.049) and in patients with a history of bleeding (8.1% vs 2.9%, p-value 0.035). Conclusions: Our study found that the adherence to DAPT with ticagrelor after an ACS is still an important issue, premature discontinuation occurred mainly in fragile patients, like elderly, who suffered a previous bleeding or underwent previous percutaneous coronary intervention.

[Balloon aortic valvuloplasty and transcatheter valve implantation in a patient with unicuspid aortic valve and cardiogenic shock due to severe aortic stenosis]. / Un raro caso di stenosi aortica severa su valvola monocuspide trattato in emergenza con valvuloplastica e impianto transcatetere di protesi valvolare aortica.

We report a case of cardiogenic shock due to severe aortic stenosis in a 55-year-old patient with a congenital unicuspid aortic valve (UAV). An emergent aortic valvuloplasty was performed in the spoke catheterization laboratory which allowed to achieve transient stabilization of the hemodynamic parameters and to move the patient to the nearest hub hospital with on-site cardiac surgery. Since the surgical risk of an aortic valve replacement was deemed too high, a transcatheter procedure was performed with implantation of a self-expandable prosthesis. The final result was suboptimal due to a moderate residual paravalvular leak, but the patient experienced rapid recovery and was discharged 10 days after the procedure. Just a few cases of transcatheter aortic valve replacement due to severe aortic stenosis in UAV have been described but, to the best of our knowledge, this is the first one in a clinical setting of cardiogenic shock. Although the gold standard treatment for UAV is surgical intervention, this case demonstrates that the transcatheter procedure is feasible and may play a role as a bridge to definitive surgical replacement.

One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study).

BACKGROUND: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI). METHODS: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year. RESULTS: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel). CONCLUSIONS: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781).

Two-year clinical outcomes of the "Italian diffuse/multivessel disease absorb prospective registry" (IT-DISAPPEARS).

BACKGROUND: Large prospective studies on the use of bioresorbable vascular scaffolds (BVS) for diffuse coronary artery disease are lacking. IT DISAPPEARS is a large multicentre prospective registry investigating the short and long-term outcomes of everolimus-eluting BVS in patients with long coronary lesions and/or multivessel coronary artery disease (ClinicalTrials.gov: NCT02004730). We hereby report the 2-year outcomes of the registry. METHODS: We enrolled 1002 patients with complex lesions undergoing implantation of 2040 BVS with a prespecified technique including predilation, correct sizing, and postdilation with non-compliant balloons. The primary endpoint was the rate of device-oriented composite endpoint (DOCE), consisting of cardiac death, target vessel-related myocardial infarction (MI), and ischaemia-driven target lesion revascularization (TLR). Secondary endpoints included: 1) patient-oriented composite endpoint (POCE), consisting of all-cause mortality, all infarctions and all revascularisations; 2) definite/probable scaffold thrombosis. RESULTS: Clinical presentation was an acute coronary syndrome in 59.8% of patients. Total BVS length implanted was 47 ±â€¯22 mm. Postdilation of all scaffolds per patient was performed in 96.8%, while optimal implantation as per study guidelines was applied in 71.4%. Through 2-year follow-up, DOCE occurred in 9.5% of patients (cardiac death 0.6%, target vessel-related MI 5.3%, TLR 6.6%). The rate of POCE was 16.6% and of scaffold thrombosis 1.1%. Female gender, total length of coronary lesions, treatment of bifurcation lesions and use of 2.5 mm scaffolds were independent predictors of DOCE. CONCLUSIONS: The 2-year results of IT-DISAPPEARS show that BVS may yield acceptable clinical outcomes in patients with complex coronary lesions when the implantation technique is appropriate.

[Left main stent avulsion during percutaneous coronary intervention for chronic total occlusion]. / Avulsione di stent dal tronco comune in corso di disostruzione di occlusione totale cronica.

We report the case of a chronic total occlusion in the left circumflex coronary artery due to the struts of a stent previously placed on the left main artery. The procedure was complicated by detachment of the stent advanced into the culprit lesion within the struts of the previously implanted stent in the left main artery. The extraction of the lost stent was performed using the twisting wire technique, but this operation resulted in a further complication, i.e. avulsion of the previously implanted stent on the left main artery. The case was resolved favorably with the implantation of a new stent on the left main artery and surgical extraction of the retracted stent from the brachial artery.

[Treatment of mucous and haemorrhoidal prolapse with circular stapler according to Longo: personal experience]. / Il trattamento del prolasso muco-emorroidario con suturatrice circolare secondo Longo. Esperienza personale.

The authors present their experience with the treatment of haemorrhoidal prolapse using the Longo technique. From March 2005 to February 2006, 56 patients underwent the above-mentioned procedure, 49 of them (87.5%) suffering from third-degree and 7 (12.5%) from fourth-degree prolapse. The most common symptom, present in all patients, was rectal bleeding. Fifty patients (89.3%) were treated as one-day surgery cases. All patients were monitored at 1 week and1 month after the operation, 29 patients (51.8%) were monitored for 6 months postoperatively and 4 patients (7.1%) for 1 year. The mean follow-up was 5.6 months (range: 1 week-1 year). In our experience, the most important clinical evidence consisted in very low postoperative pain intensity, early return to work, a low rate of minor complications and the absence of major complications. It is necessary to ensure that both the details of technique and the indications for the procedure are fully considered and complied with and that an effective learning curve is implemented in order to achieve good postoperative results. We suggest the adoption of an eclectic approach that does not preclude more traditional operative techniques for the treatment of fourth-degree prolapse and prolapse with large external haemorrhoids. We consider this to be a sine qua non for an appropriate surgical approach to the disease.

Outcome of coronary lesions with deferred revascularization due to negative fractional flow reserve in subjects with acute coronary syndrome.

OBJECTIVE: Revascularization of functionally non-significant stenoses in patients with stable coronary artery disease can safely be deferred as rate of adverse cardiovascular events is low. It is not clear whether fractional flow reserve (FFR) is just as accurate in acute coronary syndromes (ACS). The aim of this study is to assess the outcome of coronary lesions whose revascularization was deferred based on negative FFR values in subjects with ACS. METHODS: Patients with acute coronary syndrome and showing at least one coronary stenosis whose revascularization was deferred based on FFR value >0.80 were included in the study. The primary endpoint of the study was the rate of target lesion failure (TLF), a composite of cardiac events (cardiac death, myocardial infarction and any coronary revascularization) related to the initially deferred stenosis at three-year follow-up. RESULTS: A total of 319 patients (237 male), mean age 68 [59-74] years and 355 coronary lesions with deferred revascularization based on negative FFR values (0.88±0.05) were selected. The rate of TLF was 6% at 1-year, 9% at 2-year and 12% at 3-year follow-up. TLF was driven by a new acute coronary syndrome in 75% of cases. The median time interval from FFR assessment to TLF was 457 [138-868] days. CONCLUSIONS: In patients with acute coronary syndrome, the rate of TLF of the initially deferred coronary stenoses is 12% at 3-year follow-up and TLF occurred because of a new ACS in three quarters of cases.

One-year clinical results of the Italian diffuse/multivessel disease ABSORB prospective registry (IT-DISAPPEARS).

AIMS: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study. METHODS AND RESULTS: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%. CONCLUSIONS: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.

Radiation Exposure and Vascular Access in Acute Coronary Syndromes: The RAD-Matrix Trial.

BACKGROUND: It remains unclear whether radial access increases the risk of operator or patient radiation exposure compared to transfemoral access when performed by expert operators. OBJECTIVES: This study sought to determine whether radial access increases radiation exposure. METHODS: A total of 8,404 patients, with or without ST-segment elevation acute coronary syndrome, were randomly assigned to radial or femoral access for coronary angiography and percutaneous intervention, and collected fluoroscopy time and dose-area product (DAP). RAD-MATRIX is a radiation sub-study of the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) trial. We anticipated that 13 or more operators, each wearing a thorax (primary endpoint), wrist, and head (secondary endpoints) lithium fluoride thermoluminescent dosimeter, and randomizing at least 13 patients per access site, were needed to establish noninferiority of radial versus femoral access. RESULTS: Among 18 operators, performing 777 procedures in 767 patients, the noninferiority primary endpoint was not achieved (p value for noninferiority = 0.843). Operator equivalent dose at the thorax (77 µSv) was significantly higher with radial than femoral access (41 µSv; p = 0.02). After normalization of operator radiation dose by fluoroscopy time or DAP, the difference remained significant. Radiation dose at wrist or head did not differ between radial and femoral access. Thorax operator dose did not differ for right radial (84 µSv) compared to left radial access (52 µSv; p = 0.15). In the overall MATRIX population, fluoroscopy time and DAP were higher with radial compared to femoral access: 10 min versus 9 min (p < 0.0001) and 65 Gy·cm2 versus 59 Gy·cm2 (p = 0.0001), respectively. CONCLUSIONS: Compared to femoral access, radial access is associated with greater operator and patient radiation exposure when performed by expert operators in current practice. Radial operators and institutions should be sensitized towards radiation risks and adopt adjunctive radioprotective measures. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX; NCT101433627).

[Myocardial infarction as the first manifestation of an atrial myxoma: the bomb in the heart. Case report and literature review]. / Infarto miocardico come prima manifestazione di un mixoma atriale: la bomba nel cuore. Caso clinico e revisione della letteratura.

Atrial myxoma is a cardiac tumor often histologically benign but very insidious for its mechanical complications. Among these, myocardial infarction can be an expression of coronary embolism. Imaging techniques are essential for the diagnosis and the therapeutic steps. We describe the clinical case of a 52-year-old woman with acute myocardial infarction and normal coronary arteries with left atrial myxoma. We conducted a review of published case reports over the last 45 years on the rare association between atrial myxoma and acute myocardial infarction, to obtain pathogenic and epidemiological information from the real world.

Relation of plasma brain natriuretic peptide levels in non-ST-elevation coronary disease and preserved systolic function to number of narrowed coronary arteries.

Elevated plasma brain natriuretic peptide (BNP) levels have been described in patients with acute myocardial infarction and left ventricular dysfunction. The aim of the present study was to evaluate circulating BNP levels in patients with coronary artery disease without ST-segment elevation acute myocardial infarction and preserved systolic function and to evaluate the BNP levels in relation to the number of involved coronary vessels. We studied 88 patients with coronary artery disease: group 1 had stable angina, group 2 had unstable angina (UA), group 3 had non-Q-wave myocardial infarction (NSTEMI), and group 0 consisted of 15 healthy subjects. All recruited subjects underwent angiographic examination and echocardiographic evaluation. No patients had heart failure, previous myocardial infarction, or electrocardiographic ST elevation. A significant increase in BNP levels was observed in the UA and NSTEMI groups compared with the stable angina group (stable angina 31.3 pg/ml, UA 147.3 pg/ml, NSTEMI, 165.8 pg/ml, p <0.01), and no differences were found between the UA and NSTEMI groups. Analysis of BNP in relation to the number of involved vessels showed significantly higher BNP levels in patients with 3- than in those with 1- or 2-vessel disease (1 to 45.2, 2 to 127.3, and 3 to 220.8 pg/ml, respectively, p <0.05 and p <0.0001, 3 vs 1- and 2-vessel disease, p = 0.01, respectively). Patients with left anterior descending stenosis had higher BNP levels than those with stenosis in other areas (150.8 vs 52.2 pg/ml, p <0.01). In conclusion, circulating BNP levels appeared elevated in patients with acute coronary syndromes with diffuse coronary involvement, even in the absence of systolic dysfunction or heart failure. BNP was also associated with multivessel disease and left anterior descending involvement.

[Sequential spontaneous coronary artery dissection in a female patient on oral ephedrine]. / Dissezione coronarica spontanea sequenziale in donna in terapia con efedrina.

Spontaneous coronary artery dissection (SCAD) is an infrequent, but not rare, cause of acute coronary syndrome. It mainly affects young women, often with few or no traditional cardiovascular risk factors. In the case described, a 57-year-old woman experienced a first episode of SCAD involving a distal branch of the circumflex coronary artery--treated conservatively--followed, after a few hours, by a second episode of SCAD involving the left anterior descending coronary artery, complicated by hemodynamic instability and treated with emergency angioplasty. During the previous months, the patient was taking a slimming drug containing ephedrine. Dual spontaneous coronary dissection of different type and involving two different vessels, which occurred in the same patient within a few hours, testifies the heterogeneity of the clinical picture of this syndrome and of the therapeutic approach.

[An unexpected culprit lesion: subclavian artery stenosis]. / Una inaspettata "culprit lesion" di infarto: la stenosi dell'arteria succlavia.

After non-ST-elevation myocardial infarction, a 61-year-old woman underwent coronary artery bypass grafting with left internal mammary artery (LIMA) to left anterior descending artery combined with saphenous vein grafts to the second obtuse marginal branch and the right coronary artery. At age 79, she was admitted for anterior non-ST-elevation myocardial infarction. Echocardiography showed hypokinesia of the left anterior descending territory. From the left radial approach the LIMA graft was patent, but a critical stenosis of the proximal subclavian artery was diagnosed and treated with stenting. The coronary subclavian steal syndrome usually presents with effort angina but has rarely been reported as a cause of myocardial infarction. A coronary steal syndrome should be suspected in patients with internal mammary artery bypass with recurrence of angina but also in case of acute coronary syndrome. When stable angina is present, a computed tomography scan of the bypass and subclavian artery may allow diagnosis before coronary angiography. In case of urgent coronary angiography and undetectable culprit lesions, selective angiography of the subclavian artery may confirm the suspicion of the coronary steal syndrome.

[A very rare coronary artery anomaly in a patient with corrected transposition of the great arteries]. / Una anomalia coronarica molto particolare in paziente con trasposizione corretta delle grandi arterie.

An 84-year-old male affected by correct transposition of the great arteries was admitted for an acute coronary syndrome, complicated by pulmonary edema. Coronary angiography showed a unique coronary anomaly: a common trunk, situated in the right sinus of Valsalva, gave rise to the left anterior descending coronary artery (LAD), the right coronary artery and an atrial branch; the circumflex coronary artery originated separately but close to the common trunk. A tight stenosis in the proximal LAD was successfully treated by percutaneous coronary intervention.

Comparison of Strut Coverage at 6 Months by Optical Coherence Tomography With Everolimus-Eluting Stenting of Bare-Metal Stent Restenosis Versus Stenosis of Nonstented Atherosclerotic Narrowing (from the DESERT Study).

Incomplete struts coverage is a predictor of late stent thrombosis after implantation of the drug-eluting stents (DES) in atherosclerotic lesions. The process of struts coverage in DES implanted for bare-metal stent (BMS) restenosis has never been described. Thirty-two patients with stable coronary artery disease were consecutively selected, 11 with BMS restenosis (group A) and 21 with de novo atherosclerotic lesions (group B). All patients underwent everolimus-eluting stent implantation; coronary angiography and optical coherence tomography were performed at 6 months follow-up. Percentage difference in struts coverage between the 2 groups was the primary end point. A total of 85,773 struts (17,891 in group A and 67,882 in group B) were analyzed: compared with group B, the percentage of uncovered stent struts was significantly lower in group A (2.6% vs 4.8%; p <0.0001). In group A, DES struts protruding out of BMS were more uncovered (5.0% vs 1.9%; p <0.0001) and malapposed (4.1% vs 2.1%; p <0.0001) compared with overlapping struts. In conclusion, when DES are implanted to treat BMS restenosis, struts coverage at 6 months follow-up is more complete compared with DES implanted in atherosclerotic lesions.

Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry.

The aim was to investigate the perioperative risk of ischaemic and bleeding events in patients with coronary stents undergoing cardiac and non-cardiac surgery and how these outcomes are affected by the perioperative use of oral antiplatelet therapy. This was a multicentre, retrospective, observational study conducted in patients with coronary stent(s) undergoing cardiac or non-cardiac surgery. The primary efficacy endpoint was the 30-day incidence of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI) or stroke. The primary safety endpoint was the 30-day incidence of Bleeding Academic Research Consortium (BARC) bleeding ≥ 2. A total of 666 patients were included. Of these, 371 (55.7 %) discontinued their antiplatelet medication(s) (all or partly) before undergoing surgery. At 30 days, patients with perioperative discontinuation of antiplatelet therapy experienced a significantly higher incidence of MACE (7.5 % vs 0.3 %, p< 0.001), cardiac death (2.7 % vs 0.3 %, p=0.027), and MI (4.0 % vs 0 %, p< 0.001). After adjustment, peri-operative antiplatelet discontinuation was the strongest independent predictor of 30-day MACE (odds ratio [OR]=25.8, confidence interval [CI]=3.37-198, p=0.002). Perioperative aspirin (adjusted OR 0.27, 95 % CI 0.11-0.71, p=0.008) was significantly associated with a lower risk of MACE. The overall incidence of BARC ≥ 2 bleeding events at 30-days was significantly higher in patients who discontinued oral antiplatelet therapy (25.6 % vs 13.9 %, p< 0.001). However, after adjustment, antiplatelet discontinuation was not independently associated with BARC ≥ 2 bleeding. In conclusion antiplatelet discontinuation increases the 30-day risk of MACE, in patients with coronary stents undergoing cardiac and non-cardiac surgery, while not offering significant protection from BARC≥ 2 bleeding.

One-year outcomes in unselected patients treated with a thin-strut, platinum-chromium, paclitaxel-eluting stent: primary endpoint results from the TAXUS Element European post-approval surveillance study (TE-PROVE).

AIMS: To evaluate clinical outcomes in patients receiving the next-generation, paclitaxel-eluting, platinum-chromium TAXUS Element stent in a real-world setting. The PERSEUS Workhorse and Small Vessel studies showed positive results with the TAXUS Element stent in a clinical trial setting. METHODS AND RESULTS: TE-PROVE was a prospective, open-label, multicentre, "all-comers" study which enrolled 1,014 patients at 37 European sites. Follow-up was at 30 days, six months and one year, and will continue annually up to five years. The primary endpoint was overall and stent-related target vessel failure (TVF), defined as cardiac death, target vessel-related myocardial infarction (MI) and target vessel revascularisation (TVR) at one year post implantation. Secondary endpoints included the components of TVF, all-cause mortality, and ARC definite/probable stent thrombosis. Follow-up was available in 97.3% (987/1,014) of patients. Patients were 75.0% male (760/1,014), mean age was 65.1±10.8 years, 25.5% had medically treated diabetes (259/1,014), and 10.7% (109/1,014) were treated for STEMI. At baseline, mean lesion length among 1,299 treated lesions was 19.8±12.0 mm and mean reference vessel diameter was 3.1±0.5 mm. At one year, the rate of TVF (primary endpoint) was 6.0% (59/987) overall; 3.7% (37/987) of TVF events were stent-related. Cardiac death was 0.7% (7/987), target vessel-related MI was 1.1% (11/987), and TVR was 4.7% (46/987). All-cause death occurred in 1.2% (12/987) of patients and ARC definite/probable ST was 0.5% (5/987). CONCLUSIONS: The primary endpoint results from the TE-PROVE registry demonstrate good performance and safety for the TAXUS Element paclitaxel-eluting stent at one year in everyday clinical practice. CLINICAL TRIAL REGISTRATION INFORMATION: NCT01242696.