Influence of the amount of myocardium subtended by a stenosis on fractional flow reserve.

BACKGROUND: Fractional flow reserve (FFR) specifically relates to the severity of a stenosis to the mass of tissue to be perfused. Accordingly, the larger the territory to be perfused, the greater the flow and the pressure gradient induced by maximal hyperemia. Although this notion may be considered intuitive, its unequivocal demonstration is still lacking. The aim of our study was to evaluate the influence of the amount of myocardium subtended to an intermediate stenosis on FFR, especially in relation to quantitative coronary angiography. METHODS AND RESULTS: The severity of each lesion was assessed by FFR and 2-dimensional quantitative coronary angiography. The amount of jeopardized myocardium was evaluated using 3 validated scores specifically adapted to this aim: the Duke Jeopardy Score (DJS), the Myocardial Jeopardy Index (MJI), and the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease (APPROACH) Lesion Score (ALS). The presence of a concomitant collateralized chronic total occlusion was also reported. A total of 213 intermediate coronary stenoses in 184 patients were enrolled. FFR values were correlated to minimal lumen diameter (r=0.34; P<0.0001) and diameter stenosis (r=-0.28; P<0.0001). FFR was inversely correlated with DJS, MJI, and ALS (r=-0.28, P<0.0001; r=-0.40, P<0.0001; and r=-0.34, P<0.0001). Lesions localized on proximal left anterior descending were related to significantly lower FFR values and to a higher rate of a positive FFR compared with those in distal left anterior descending, left circumflex, and right coronary arteries (0.80±0.09 versus 0.84±0.08 versus 0.88±0.09 versus 0.91±0.04; P<0.0001). The presence of a collateralized chronic total occlusion was associated with significantly lower FFR values (0.80±0.07 versus 0.85±0.09; P<0.005). At multivariate analysis MJI, minimal lumen diameter, and presence of a collateralized chronic total occlusion were confirmed as significant predictors of FFR. CONCLUSIONS: A larger amount of perfused myocardium subtended by a stenosis is associated with a higher probability that an angiographically intermediate coronary stenosis is functionally significant.

Management and timing of access-site vascular complications occurring after trans-radial percutaneous coronary procedures.

BACKGROUND: Access-site vascular complications (ASVC) in patients undergoing trans-radial coronary procedures are rare but may have relevant clinical consequences. Data regarding the optimal management of radial-access-related ASVC are lacking. METHODS: During a period of 6 years we prospectively collected ASVC. ASVC were defined as any complication requiring ultrasound examination or upper limb angiography. ASVC were categorized according to the timing of diagnosis: "very early" (in the cath lab), "early" (after cath lab discharge, but during the hospital stay) and "late" (after hospital discharge). The need of surgery (primary end-point) and the development of neurological hand deficit (secondary end-point) were assessed. RESULTS: Fifty-seven radial-artery related ASVC were collected. ASVC diagnosis was obtained by upper limb angiography in 25 patients (44%) and by Doppler in 32 patients (56%). Surgery was required in 6 cases (11%), the remaining patients receiving successful conservative management (which included prolonged local compression). Three patients (who received surgery) exhibited a mild neurological hand deficit in the follow-up. Need for surgery differed significantly according to timing of diagnosis as it occurred in 1 of 26 patients (3.8%) with "very early" diagnosis, in 1 of 21 patients (4.8%) with "early" diagnosis, and in 4 of 10 patients (40%) with "late" diagnosis (p=0.026). CONCLUSIONS: ASVC are diagnosed with different timing after trans-radial procedures. Conservative management including local compression allows successful management in the majority of ASVC. Prompt recognition is pivotal as late diagnosis is associated to the need for surgery.

Baseline inflammatory status and long-term changes in renal function after percutaneous renal artery stenting: a prospective study.

OBJECTIVES: To investigate a possible independent predictive role of systemic inflammation markers on renal function after renal artery stenting. BACKGROUND: An elevated baseline serum creatinine has previously been shown to be the strongest predictor of improved renal function after percutaneous renal artery stenting. The inflammatory system is implicated in every stage of chronic kidney disease, and we hypothesized an additional value of markers of systemic inflammation in predicting response after renal artery stenting. METHODS: This single center, prospective study includes 62 consecutive patients with chronic kidney disease at stage ≥ 3 or resistant hypertension who underwent stent placement for 74 angiographically significant atherosclerotic renal lesions. Inflammatory markers, including serum C-reactive protein (CRP), erythrocyte sedimentation rate, and white blood cell count were determined prior to renal angioplasty and related to changes in renal function at follow-up. RESULTS: Six-month clinical follow up was completed in 57 patients. Overall, median serum creatinine concentration exhibited a non significant reduction from 1.40 mg/dl (quartiles: 1.20, 1.75 mg/dl) at baseline to 1.30 mg/dl (quartiles: 1.1, 1.55 mg/dl) at 6 months (p=0.17). Significant multivariate independent predictors of decreased creatinine included higher baseline serum creatinine levels (adjusted OR per quartile increment, 2.5 [1.3 to 4.7], p=0.004) and lower C-reactive protein levels (adjusted OR per quartile increment 0.39 [0.19 to 0.82], p=0.013). CONCLUSIONS: Patients with higher serum creatinine and lower CRP derive the most benefit from renal artery stenting.

Sodium bicarbonate plus N-acetylcysteine to prevent contrast-induced nephropathy in primary and rescue percutaneous coronary interventions: the BINARIO (BIcarbonato e N-Acetil-cisteina nell'infaRto mIocardico acutO) study.

AIMS: Contrast-induced nephropathy (CIN) is a frequent and potentially harmful complication of percutaneous coronary interventions (PCI), especially in the setting of ST-elevation myocardial infarction (STEMI). We tested the efficacy of a sodium bicarbonate (SB)-based hydration in urgent PCI for STEMI. METHODS AND RESULTS: From June 2009 to September 2010, 262 consecutive STEMI patients undergoing urgent PCI were prospectively enrolled and treated by SB-based hydration (154 mEq/L at 3 ml Kg-1 for one hour followed by 1 ml Kg-1 for six hours) (group A). As controls, 262 consecutive STEMI patients receiving 0.9% saline hydration (1 ml Kg-1 for 24 hours) before June 2009 were retrospectively enrolled (group B). Both groups received high-dose N-acetylcysteine (NAC). The primary endpoint was the composite of in-hospital death, need for dialysis and CIN (≥25% increase in serum creatinine at 48 hours). The two groups were comparable for baseline clinical and procedural characteristics, for Mehran risk score and baseline estimated glomerular filtration rate. The primary combined endpoint was significantly reduced in group A as compared to group B (9.2 vs. 18.7%, p=0.023) with a number needed to treat (NNT) of 11. Specifically, a significant reduction of both in-hospital death (2.3 vs. 6.1%, p=0.049, NNT 27) and CIN (8.0 vs. 14.1%, p=0.03, NNT 17) was observed, with no difference in the need for dialysis. CONCLUSIONS: Our data indicate that hydration with sodium bicarbonate in addition to high-dose NAC in the setting of urgent PCI for STEMI is associated with a net clinical benefit.

Maximal hyperemia in the assessment of fractional flow reserve: intracoronary adenosine versus intracoronary sodium nitroprusside versus intravenous adenosine: the NASCI (Nitroprussiato versus Adenosina nelle Stenosi Coronariche Intermedie) study.

OBJECTIVES: This study sought to compare increasing doses of intracoronary (i.c.) adenosine or i.c. sodium nitroprusside versus intravenous (i.v.) adenosine for fractional flow reserve (FFR) assessment. BACKGROUND: Maximal hyperemia is the critical prerequisite for FFR assessment. Despite i.v. adenosine currently representing the recommended approach, i.c. administration of adenosine or other coronary vasodilators constitutes a valuable alternative in everyday practice. However, it is surprisingly unclear which i.c. strategy allows the achievement of FFR values comparable to i.v. adenosine. METHODS: Fifty intermediate coronary stenoses (n = 45) undergoing FFR measurement were prospectively and consecutively enrolled. Hyperemia was sequentially induced by incremental boli of i.c. adenosine (ADN) (60 µg ADN60, 300 µg ADN300, 600 µg ADN600), by i.c. sodium nitroprusside (NTP) (0.6 µg/kg bolus) and by i.v. adenosine infusion (IVADN) (140 µg/kg/min). FFR values, symptoms, and development of atrioventricular block were recorded. RESULTS: Incremental doses of i.c. adenosine and NTP were well tolerated and associated with fewer symptoms than IVADN. Intracoronary adenosine doses (0.881 ± 0.067, 0.871 ± 0.068, and 0.868 ± 0.070 with ADN60, ADN300, and ADN600, respectively) and NTP (0.892 ± 0.072) induced a significant decrease of FFR compared with baseline levels (p < 0.001). Notably, ADN600 only was associated with FFR values similar to IVADN (0.867 ± 0.072, p = 0.28). Among the 10 patients with FFR values ≤0.80 with IVADN, 5 were correctly identified also by ADN60, 6 by ADN300, 7 by ADN600, and 6 by NTP. CONCLUSIONS: Intracoronary adenosine, at doses higher than currently suggested, allows obtaining FFR values similar to i.v. adenosine. Intravenous adenosine, which remains the gold standard, might thus be reserved for those lesions with equivocal FFR values after high (up to 600 µg) i.c. adenosine doses.

Vascular complications and access crossover in 10,676 transradial percutaneous coronary procedures.

BACKGROUND: Randomized trials have shown that transradial approach, compared with transfemoral, reduces vascular complications (VCs) of coronary procedures in selected patients. Yet, radial approach is associated to a variety of access-site VC as well as to a higher failure rate compared with femoral access. METHODS: At our institution, from May 2005 to May 2010, we prospectively assessed the occurrence and outcome of VC in consecutive patients undergoing transradial percutaneous coronary procedures performed by trained radial operators. The need of access crossover to complete the procedure was also prospectively investigated. Vascular complications were classified as "radial related" or "nonradial related" (in the case of access crossover). Vascular complications were also classified "major" if requiring surgery and/or blood transfusions or causing hemoglobin drop >3 g/dL. RESULTS: Ten thousand six hundred seventy-six procedures were performed using a right radial (87.5%), left radial (12.4%), or ulnar (0.1%) artery as primary access. A total of 53 VCs (0.5%) were observed: 44 (83%) radial related and 9 (17%) nonradial related. Major VCs occurred in 16 patients only (0.2%) and were radial related in 10 (62.5%) and nonradial related in 6 (37.5%) patients. Vascular complications rate was stable during the study and independent of operator's experience. Access crossover rate was 4.9%, differed according to the operator radial experience and significantly decreased over time. CONCLUSIONS: The present study, conducted in a center with high volume of radial procedures, shows that transradial approach is associated with a very low rate of VC, which is stable over time. On the contrary, access crossover rate decreased over time and differed according to operator (radial) experience.

The HEART study: a real-world experience using the CID Chrono Carbostent in primary and rescue PCI.

BACKGROUND: Chrono Carbostent (CID, Saluggia, Italy) is characterized by a peculiar coating with Carbofilm which could reduce the risk of thrombosis as compared to other bare metal stents (BMS). This feature should be particularly useful in the setting of primary or rescue percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS: We tested the efficacy and safety of this stent in patients with STEMI undergoing primary or rescue PCI. Inclusion criteria included the diagnosis of STEMI, a coronary anatomy suitable for stenting and no contraindications to dual antiplatelet therapy for at least 1 month. The primary endpoint was the composite of the following major adverse cardiac events (MACEs) at 12 months: death, recurrence of myocardial infarction and target vessel revascularization. RESULTS: One hundred and seven STEMI patients treated with Chrono Carbostent implantation were enrolled. Eighty-three (77%) patients underwent primary and 24 (23%) rescue PCI. A total of 148 stents were successfully implanted. Cardiogenic shock was present in 12 (11%) patients and in-hospital mortality was 6.5%. Cumulatively, the rate of MACEs at 12 months was 17.7% (deaths 7.4%, target lesion revascularization 9.3%). CONCLUSIONS: In unselected patients with STEMI treated by urgent PCI, the Chrono Carbostent showed a low rate of events in those patients surviving the acute phase of myocardial infarction. Unfortunately, and especially for patients in cardiogenic shock, survival continued to be relatively independent of interventional treatment, even when successfully completed, thus strictly linking prognosis of STEMI to severity of clinical presentation.

Prospective randomized comparison of sirolimus- or everolimus-eluting stent to treat bifurcated lesions by provisional approach.

OBJECTIVES: This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions. BACKGROUND: Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI. METHODS: Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure. RESULTS: A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57). CONCLUSIONS: In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Procedural and clinical evaluation of the novel zotarolimus-eluting resolute stent in patients with unselected bifurcated coronary stenosis treated by provisional approach: a multicenter registry.

AIMS: As data on the use of the latest-generation drugeluting stents (DES) in bifurcation interventions are lacking, we realized a multicenter registry to assess the procedural and clinical results obtained in patients with unselected bifurcated lesions treated with the novel zotarolimus-eluting Resolute stent (ZRS). METHODS AND RESULTS: Three Italian centers participated in the study. Consecutive patients with significant stenosis of bifurcated lesions undergoing DES implantation were treated with ZRS. The recommended technique was the "provisional TAP approach" [main-vessel (MV) stent implantation eventually followed by kissing balloon and sidebranch (SB) stenting according to TAP technique]. Clinical characteristics, procedural details and clinical follow-up data were prospectively recorded. Procedural success was defined as post-percutaneous coronary intervention visual stenosis > 20% on MV and TIMI 3 flow on both MV and SB. Primary endpoint was major adverse coronary events (cardiac death, myocardial infarction and target vessel revascularization) at 9-month follow up. A total of 180 patients were enrolled. The target lesion was located in the distal left main in 16% and in the left anterior descending artery in 52%. All but 3 cases were treated according to the provisional TAP approach (kissing balloon rate, 69%; overall SB stenting rate, 10.6%). Procedural success was obtained in 98.3% (3 failures due to final SB TIMI flow < 3). At 9-month follow up, the survival free from MACE was 97.8% (1 cardiac death and 3 repeat revascularizations). CONCLUSION: The use of the latest-generation ZRS in unselected bifurcated lesions treated by a provisional approach is associated with excellent procedural results and with promising clinical outcomes.

Outcome of non-cardiac surgery after stent implantation in the DES era: results of the Surgery After Stent (SAS) registry.

BACKGROUND: Optimal management of patients needing non-cardiac surgery after coronary stenting has not been established. Objective. To assess the perioperative outcome of patients undergoing non-cardiac surgery after coronary bare-metal stent (BMS) or drug-eluting stent (DES) implantation. METHODS: We enrolled consecutive patients undergoing non-cardiac surgery (up to 2008) after coronary stenting in a single-center registry, prospectively registering clinical and procedural data about revascularization and retrospectively recording surgical details, perioperative therapy and in-hospital outcome after surgery. At our institution, we implant BMS for planned surgery at time of revascularization, and use antiplatelet therapy for surgery required within 1 month of BMS or within 12 months of DES implantation. The primary endpoint was defined as perioperative occurrence of major adverse events, both cardiovascular (death, myocardial infarction, stent thrombosis and repeated revascularization) and hemorrhagic (bleeding requiring transfusions or surgical hemostasis). RESULTS: We enrolled 101 patients: 70 treated with BMS (group 1) and 31 with DES (group 2). The mean interval between stenting and surgery was 288 days. The average number of antiplatelet drugs used during the operative period was higher in group 2 than group 1 (p = 0.02). Fifteen patients (15%) experienced major adverse events (5.9% had non-ST elevation myocardial infarction, 12% received blood transfusions), without a significant difference between the two groups (p = 0.72). At multivariate analysis, the predictor of primary endpoint was time interval between stenting and surgery (p = 0.022). CONCLUSION: We found similar outcomes for non-cardiac surgery after coronary stenting when BMS were selected for planned surgery and dual antiplatelet therapy was used, if indicated, during the operative period.

Comparative assessment of mammalian target of rapamycin inhibitor-eluting stents in the treatment of coronary artery bifurcation lesions: the CASTOR-Bifurcation registry.

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

Renal artery stenting in patients with chronic ischemic heart disease.

OBJECTIVES: To investigate the role of renal stenting in selected patients with chronic ischemic heart disease and renal artery stenosis. METHODS: Consecutive patients, with chronic ischemic heart disease and severe hypertension and/or impaired renal function undergoing renal stenting, were prospectively enrolled. Mid-term (at least 2 years) follow-up was performed to assess both changes in renal function [serum creatinine and estimated glomerular filtrate rate (eGFR)] and blood pressure (BP) control (number of required drugs) and to record the incidence of clinical major adverse events. Moreover, in the first consecutive 24 patients, out-of-range pressure values at 24-hr BP monitoring and GFR at renal scintigraphy were measured at baseline and 1 month after stenting. RESULTS: Seventy patients treated by stenting on 86 renal arteries entered the study. Procedural success rate was 99% and no major complication occurred. At 2-year follow-up, both mean serum creatinine (-0.1 +/- 0.7 mg/dl at follow-up compared to baseline, P = 0.6) and eGFR (+3.7 +/- 23.5 ml/min/1.73m(2) at follow-up compared to baseline, P = 0.2) did not significantly change while the number of drugs required to control BP significantly decreased (2.7 +/- 0.8 to 2.2 +/- 0.7, P < 0.0001). In the subset of 24 patients evaluated at 1 month, GFR significantly increased (62 +/- 20 ml/min to 67 +/- 21 ml/min; P = 0.008) and the rate of the out-of-range systolic pressure values at 24-hr monitoring significantly decreased (51-33%, P = 0.005). Elevated baseline creatinine values and the presence of global renal ischemia were identified as predictors of poor outcome at the multivariate analysis. CONCLUSIONS: In selected patients with chronic ischemic heart disease and hypertension and/or renal insufficiency, renal stenting may be performed with very low periprocedural complications and results in unchanged renal function and improved BP control.

Provisional TAP-stenting strategy to treat bifurcated lesions with drug-eluting stents: one-year clinical results of a prospective registry.

OBJECTIVE: To assess the clinical outcome of unselected patients undergoing drug-eluting stent (DES) implantation on bifurcated lesions using a "provisional T And small Protrusion (TAP)" stenting strategy. METHODS: Consecutive patients undergoing DES implantation on one major bifurcation lesion were treated by main-vessel (MV) stenting, followed (if needed) by side-branch (SB) rewiring (with a "pullback" technique) and kissing balloon. SB stenting was performed according to the TAP-technique in selected cases. The endpoint of the study was a 12-month incidence of major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction (MI), stent thrombosis and target vessel revascularization (TVR). RESULTS: The study population included 266 patients (9% unprotected left main). Only 19 patients (7.1%) (with more complex angiographic features) received stents in both the MV and SB using the TAP-technique. Overall, 22 (8.2%) patients had MACE at 1 year. Observed, non-hierarchical MACE were: 1 (0.4%) cardiac death, 11 (4.1%) MI, 2 probable stent thromboses and 12 (4.5%) TVRs. Postprocedural troponin T increase and adverse events up to 12 months were similar between patients treated by MV stenting only or double stenting. CONCLUSIONS: In unselected patients undergoing DES implantation on bifurcated lesions, a provisional TAP-stenting strategy (with a low rate of SB stenting) appears to be safe and effective.

Evaluation of a strategy for treating bifurcated lesions by single or double stenting based on the Medina classification.

INTRODUCTION AND OBJECTIVES: The Medina bifurcated lesion classification has been widely adopted because of its simplicity. However, no data are available on its use in helping select the best stenting technique for bifurcations. METHODS: Consecutive patients with bifurcated lesions (side branch >or=2.25 mm) were prospectively assessed using the Medina classification. The treatment strategy studied involved implanting two stents in lesions with a Medina classification of 1,1,1 (M3 group) and one stent in only the main vessel in lesions with other Medina classifications (OM group). Clinical endpoints were a major adverse cardiac event (MACE) and target lesion revascularization (TLR) during hospitalization and at 12-month follow-up. RESULTS: The study included 120 patients: 25 in the M3 group and 95 in the OM group. There was no difference in baseline characteristics between the groups. The treatment strategy was successfully implemented in 97% of the OM group and 68% of the M3 group (P< .001). No death or TLR was recorded during hospitalization, though three myocardial infarctions occurred postoperatively (2.1% in the OM group vs 4.0% in the M3 group; P=.6). At 12 months, there was no difference in clinical outcome between the two groups (MACE: 12.6% in the OM group vs 8% in the M3 group; P=.4; TLR: 13.7% in the OM group vs 8% in the M3 group; P=.5). Multivariate analysis showed that bare metal stent implantation (only in patients receiving a single stent) was the only independent predictor of TLR. CONCLUSIONS: The planned treatment strategy of implanting a single stent in patients with bifurcated lesions not classified as Medina 1,1,1 lesions was associated with a very low rate of second stent implantation. Moreover, bare metal stent use was a predictor of TLR, suggesting that drug-eluting stents should be used routinely to treat bifurcated lesions regardless of their angiographic complexity.

Evaluación de una estrategia de implantación de stent único o doble para tratar lesiones bifurcadas basada en la clasificación de Medina / Evaluation of a Strategy for treating Bifurcated lesions by Single or Double Stenting Based on the Medina classification

Introducción y objetivos. La clasificación de Medina de las lesiones bifurcadas ha alcanzado gran difusión debido a su simplicidad. No hay datos sobre el uso de la clasificación de Medina para orientar la técnica de implantación de stents que utilizar en las bifurcaciones. Métodos. Se clasificó prospectivamente a pacientes consecutivos con lesiones bifurcadas (rama (..) (AU)

Introduction and objectives. The Medina bifurcated lesion classification has been widely adopted because of its simplicity. However, no data are available on its use in helping select the best stenting technique for bifurcations.Methods. Consecutive patients with bifurcated lesions (side branch (..) (AU)

Glycoprotein IIB/IIIA inhibitor to reduce postpercutaneous coronary intervention myonecrosis and improve coronary flow in diabetics: the 'OPTIMIZE-IT' pilot randomized study.

BACKGROUND: Subgroup analyses of trials enrolling acute coronary syndrome patients suggest that inhibition of glycoprotein IIb/IIIa can improve the outcome of diabetic patients undergoing percutaneous coronary interventions (PCIs), possibly by improving microvascular perfusion. However, the efficacy of small-molecule IIb/IIIa receptor inhibitors to improve microvascular perfusion in stable diabetic patients undergoing elective PCI has not been specifically investigated. METHODS: We randomized consecutive stable diabetic patients, undergoing elective PCI, to tirofiban or placebo groups along with double antiplatelet therapy. High-dose bolus (25 microg/kg per 3 min) of tirofiban was administered immediately before PCI followed by 8 h continuous infusion (0.15 microg/kg per min). Postprocedural myonecrosis was assessed prospectively by measurement of cardiac troponin T (cTnT) at 6 and 24 h after PCI. The primary end-points were post-PCI coronary flow estimated by corrected thrombolysis in myocardial infarction frame count and post-PCI myocardial infarction. Platelet aggregation was measured by platelet function analyser-100 values. RESULTS: Forty-six patients entered the study (22 randomized to placebo and 24 randomized to tirofiban). The study drug was associated with a significant increase of platelet function analyser-100 values that peaked immediately after PCI and was maintained at 6 h (pre-PCI: 131 +/- 65 s; post-PCI: 222 +/- 49 s; after 6 h: 219 +/- 55 s).Post-PCI corrected thrombolysis in myocardial infarction frame count was similar in tirofiban and in placebo groups (10.2 +/- 3.6 vs. 12.0 +/- 7.6, P = 0.30, respectively). The prevalence of raised cTnT levels was similar in the two groups (25 vs. 30%, P = 0.56, respectively). At multivariate analysis, direct stenting (associated with reduced myonecrosis) and postdilatation (associated with increased myonecrosis) predicted cTnT elevation. CONCLUSION: A high-dose bolus of tirofiban in stable diabetic patients undergoing elective PCI, along with double antiplatelet therapy, was associated with a significant further inhibition of platelet aggregation which, however, did not translate in a lower incidence of post-PCI distal embolization.

Outcome of patients treated by a novel thin-strut cobalt-chromium stent in the drug-eluting stent era: Results of the SKICE (Skylor in real world practice) registry.

OBJECTIVES: To investigate the outcome of patients undergoing percutaneous coronary interventions (PCI) with implantation of a new thin-strut cobalt-chromium bare-metal-stent (BMS) in the drug-eluting-stent (DES) era. BACKGROUND: Despite the contemporary penetration of DES in the clinical practice, a relevant percentage of patients are still treated by BMS. Data on clinical outcome of novel BMSs are lacking. METHODS: This is a single-centre-registry enrolling patients treated by Skylor stent implantation. During the study, the criteria for BMS selection adopted at our institution ("internal" criteria) were as follows: (1) limited compliance to prolonged double antiplatelet therapy, (2) ST-elevation myocardial infarction (STEMI) or saphenous vein grafts (SVG) interventions, and (3) in the absence of these conditions, noncomplex (no bifurcations, no chronic total occlusions) lesions considered at low restenosis risk on the basis of arbitrary angiographic criteria (short lesions, large vessels). Primary and secondary end-points were respectively major adverse cardiovascular events (MACE) and target vessel failure (TVF) up to 9-month. RESULTS: A total of 150 patients were treated with Skylor stent on 169 lesions. At 9-month follow-up, MACE occurred in 12 patients (8.0%) and TVF in 21 lesions (12.4%). By multivariable analysis, the predictors of MACE were Euroscore>or=9 and ejection fraction < 30% while the predictors of TVF were the absence of the angiographic criteria of low restenosis risk and ejection fraction < 30%. CONCLUSIONS: In the DES era, the use of a last-generation BMS in patients with limited compliance to double antiplatelet therapy, STEMI or SVG interventions, and noncomplex angiographic lesions may be associated with acceptable clinical outcome.

Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study.

OBJECTIVE: We evaluated the acute and long-term results of the use of a new intracardiac microaxial pump, the Impella Recover LP 2.5, during elective high-risk percutaneous coronary interventions in a two-centre registry. METHODS: Ten consecutive patients with poor left ventricular function and multivessel or left main coronary artery disease were considered at high risk of haemodynamic compromise and underwent percutaneous coronary interventions with preintervention Impella implantation. Procedural complications, 30-day and 12-month clinical outcome were recorded. Left ventricular ejection fraction was assessed by echocardiography before procedure and after at least 6 months. RESULTS: The Impella was implanted before percutaneous coronary interventions by femoral approach and percutaneous coronary interventions were successfully performed (by contra lateral femoral or radial approach) in all cases. After percutaneous coronary intervention, Impella was removed in all patients, and haemostasis was obtained by prolonged manual compression or by double suture device preimplantation technique. No access-site complication was observed and no patient required transfusions. One patient died after Impella removal due to acute stent thrombosis. The other patients had an uncomplicated in-hospital course and were discharged within 5 days. At 1-year follow-up, no patient died nor suffered acute myocardial infarction, whereas two patients underwent re-percutaneous coronary intervention. Left ventricular ejection fraction at follow-up increased significantly in this study population (from 31 +/- 7% to 41% +/- 13%, P = 0.02). CONCLUSION: Our results support the feasibility and safety of Impella-assisted percutaneous coronary intervention in high-risk patients. Prospective randomized trials are needed to test the clinical impact of such an innovative approach.

Outcomes of the tacrolimus drug-eluting Janus stent: a prospective two-centre registry in high-risk patients.

BACKGROUND: To date, only two drug-eluting stents (DES) have been extensively tested in both randomized controlled clinical trials and large 'real world' registries: sirolimus-DES (Cypher stent, Cordis, Miami Lakes, Florida, USA) and paclitaxel-DES (Taxus stent, Boston Scientific, Natick, Massachusetts, USA). Recently, a new polymer-free tacrolimus-eluting Carbofilm-coated stent, the Janus stent (Sorin Biomedica, Saluggia, Italy), has entered the market but only few clinical data testing its safety and efficacy in selected patients are available. Thus, we performed a prospective registry of consecutive, unselected patients receiving this new DES. METHODS: A total of 118 patients scheduled for percutaneous coronary intervention (PCI) with DES were enrolled in two separate centers. End-points were: (i) immediate angiographic failure; (ii) major adverse coronary events (MACE) defined as the composite of cardiovascular death, nonfatal myocardial infarction (MI) and target lesion revascularization (TLR); (iii) clinically driven TLR; (iv) and stent thrombosis at 6-month follow-up. RESULTS: A total of 192 Janus stents were successfully implanted during elective (36%) or urgent PCIs (64%), including patients with ST elevation MI (16%). Twenty-four percent of patients were diabetics and 27% underwent multivessel PCI. Target lesions were B2-C type in 54%, in-stent restenosis in 8%, and located in degenerated venous grafts in 9%. Angiographic failure was observed in five of the 147 (3.4%) lesions treated. Total MACE rate at 6-month follow-up was 22% and clinically-driven TLR was carried out in 14% of patients. Stent thrombosis occurred in 4% of cases. CONCLUSION: This registry of the new tacrolimus-eluting Carbofilm-coated Janus stent showed an incidence of MACE, TLR and stent thrombosis higher than that reported in previous similar studies on DES. Whether this risk is due to this specific device or to the unselected (i.e. high-risk) population warrants further research.