Maura Giammarinaro

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).

Transradial approach to treat superficial femoral artery in-stent restenosis†

Transradial access reduces the incidence of access site complications of percutaneous revascularization procedures. However, in patients with peripheral vascular disease, the adoption of transradial approach for superficial femoral artery (SFA) angioplasty is usually prevented by the distance between the vascular access and the target lesions; thus, SFA angioplasty is commonly performed by transfemoral approach. Recently, low‐profile balloons with extended shaft length became available, allowing to potentially address SFA lesions by transradial approach. As plain balloon angioplasty represents a valuable option for SFA in‐stent restenosis treatment, we evaluated the feasibility of transradial approach in this clinical setting.

Feasibility of complex coronary and peripheral interventions by trans-radial approach using large sheaths

Background: Trans‐radial approach (TRA) reduces vascular access‐site complications but has some technical limitations. Usually, TRA procedures are performed using 5 Fr or 6 Fr sheaths, whereas complex interventions requiring larger sheaths are approached by trans‐femoral access. Methods: During 4 years, at two Institutions with high TRA use, we have attempted to perform selected complex coronary or peripheral interventions by TRA using sheaths larger than 6 Fr. Clinical and procedural data were prospectively collected. Attempt to place a 7 Fr or 8 Fr sheath (according to the planned strategy of the procedure) was performed after 5–6 Fr sheath insertion, administration of intra‐arterial nitrates and radial artery angiography. Late (>3 months) patency of the radial artery was checked (by angiography in the case of repeated procedures or by palpation + reverse Allen test). Results: We collected 60 patients in which TRA large sheath insertion was attempted. The large sheath (87% 7 Fr, 13% 8 Fr) was successfully placed in all cases. Most of the procedures were complex coronary interventions (bifurcated or highly thrombotic or calcific chronic total occlusive lesions), whereas 8.3% were carotid interventions. Procedural success rate was 98.3% (1 failure to reopen a chronic total occlusion). No access‐site related complication occurred. In 57 (95%) patients, late radial artery patency was assessed and showed patency in 90% of the cases, the remaining patients having asymptomatic collateralized occlusion. Conclusions: In selected patients, complex percutaneous interventions requiring 7–8 Fr sheaths can be successfully performed by RA approach without access‐site clinical consequences.

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 μg/kg per 3 min) of tirofiban was administered immediately before PCI followed by 8 h continuous infusion (0.15 μg/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.

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.

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≥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.

EuroSCORE predicts long-term mortality of unselected patients undergoing percutaneous coronary interventions

BACKGROUND The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a simple risk model able to predict early and late mortality after cardiac surgery. Recent data suggest that this score may also predict early clinical outcome after percutaneous coronary intervention (PCI). Data regarding EuroSCORE usefulness to predict late outcome after PCI in unselected patients are lacking. METHODS EuroSCORE was prospectively assessed in consecutive patients undergoing PCI during 18 months. The primary end-point was cardiac mortality during the follow-up after PCI. Total mortality was the secondary end-point. Kaplan-Meyer analyses were performed dividing the study population in three subgroups according to the additive EuroSCORE algorithm (low risk group: EuroSCORE 0-2; medium risk group: EuroSCORE 3-5; high-risk group: EuroSCORE ≥ 6). Receiver operating characteristics (ROC) curve and landmark analysis on cardiac mortality after 30 days were performed. RESULTS The study population comprised 1170 patients undergoing PCI. Mean follow-up duration was 633 days (range: 365-1000 days). Cardiac mortality was 2%; 2.4%; 13.2% in patients with low, medium and high EuroSCORE respectively. Kaplan-Meyer survival curves for cardiac death differed significantly between EuroSCORE groups (p<0.0001). The area under the ROC curve for the prediction of cardiac death was 0.77. Similar results were obtained for total mortality. At landmark analysis starting 30 days after PCI, EuroSCORE groups were significantly associated with different survival in the long term (P=0.014). CONCLUSION EuroSCORE risk model can be efficiently utilized to predict late mortality in consecutive, unselected, patients undergoing PCI.

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/1.73m2 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.

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.

Colon-like right coronary artery

Coronary aneurysmatic dilatation may be localized to a segment or may involve multiple segments. We herein report a case of a diffuse aneurysmatic dilatation of the right coronary artery.