Robert F. Bonvini

Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction: the COMFORTABLE AMI randomized trial

CONTEXT The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). OBJECTIVE To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI. DESIGN, SETTING, AND PATIENTS A prospective, randomized, single-blinded, controlled trial of 1161 patients presenting with STEMI at 11 sites in Europe and Israel between September 19, 2009, and January 25, 2011. Clinical follow-up was performed at 1 and 12 months. INTERVENTION Patients were randomized 1:1 to receive the biolimus-eluting stent (n = 575) or the bare-metal stent (n = 582). MAIN OUTCOME MEASURES Primary end point was the rate of major adverse cardiac events, a composite of cardiac death, target vessel-related reinfarction, and ischemia-driven target-lesion revascularization at 1 year. RESULTS Major adverse cardiac events at 1 year occurred in 24 patients (4.3%) receiving biolimus-eluting stents with biodegradable polymer and 49 patients (8.7%) receiving bare-metal stents (hazard ratio [HR], 0.49; 95% CI, 0.30-0.80; P = .004). The difference was driven by a lower risk of target vessel-related reinfarction (3 [0.5%] vs 15 [2.7%]; HR, 0.20; 95% CI, 0.06-0.69; P = .01) and ischemia-driven target-lesion revascularization (9 [1.6%] vs 32 [5.7%]; HR, 0.28; 95% CI, 0.13-0.59; P < .001) in patients receiving biolimus-eluting stents compared with those receiving bare-metal stents. Rates of cardiac death were not significantly different (16 [2.9%] vs 20 [3.5%], P = .53). Definite stent thrombosis occurred in 5 patients (0.9%) treated with biolimus-eluting stents and 12 patients (2.1%; HR, 0.42; 95% CI, 0.15-1.19; P = .10) treated with bare-metal stents. CONCLUSION Compared with a bare-metal stent, the use of biolimus-eluting stents with a biodegradable polymer resulted in a lower rate of the composite of major adverse cardiac events at 1 year among patients with STEMI undergoing primary PCI. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00962416.

Endovascular treatment of common femoral artery disease: medium-term outcomes of 360 consecutive procedures.

OBJECTIVES The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions. BACKGROUND Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options. METHODS Using a prospectively maintained single-center database, we retrospectively analyzed the outcomes of 360 consecutive percutaneous interventions of the CFA for atherosclerotic disease and assessed procedural success, in-hospital complications, and 1-year patency and target lesion revascularization rates. RESULTS Ninety-seven procedures (26.9%) were isolated CFA interventions, whereas 157 (43.6%) and 152 (42.2%) also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in 140 cases (38.9%), and concomitant treatment of the profunda femoral artery was performed on 93 occasions (25.8%). Chronic total CFA occlusions were recanalized in 60 cases (16.7%). Balloon angioplasty was performed as the primary intervention in virtually all cases (98.6%), whereas stenting was needed for suboptimal angioplasty results in 133 procedures (36.9%). Failures-defined as a final angiographic result with a >30% residual stenosis-were observed on 26 occasions (7.2%). In-hospital major (i.e., requiring surgery) and minor (i.e., treated percutaneously or conservatively) complications occurred in 5 (1.4%) and 18 (5.0%) procedures, respectively. One-year follow-up data were available for 281 patients (87.5%). Restenosis >50% by duplex scanning and target lesion revascularization were observed in 74 of 268 (27.6%) and 64 of 322 (19.9%) procedures, respectively. CONCLUSIONS This large series suggests that the percutaneous approach may be a valid alternative to surgery for CFA atherosclerotic obstructions.

COLOR-CODED DUPLEX ULTRASOUND FOR DIAGNOSIS OF RENAL ARTERY STENOSIS AND AS FOLLOW-UP EXAMINATION AFTER REVASCULARIZATION

Currently, angiography is still considered to be the gold standard for the diagnosis of a renal artery stenosis (RAS). However, angiography is invasive and carries the potential risk of haematoma, pseudoaneurysm, contrast agent induced nephropathy, and athermanous embolization. Color‐coded duplex ultrasound is a noninvasive frequently repeatable bed‐side examination and is currently the only diagnostic method to reliably differentiate between a hemodynamically relevant or irrelevant stenosis using the side‐to‐side difference of the intrarenal resistance index (RI). There is a highly specific correlation between a side difference of the RI of >0.05 and an at least 70% angiographic diameter stenosis. All other duplex parameters like a peak systolic flow velocity >200 cm/sec or a renal aortic flow velocity ratio >3.5 are correlated to a 50 or 60% angiographic diameter stenosis and offer therefore indeed a high sensitivity in terms of detecting a RAS; however, the specificity detecting a hemodynamically relevant RAS is low. Provided that duplex ultrasound is performed by an experienced physician with an adequate machine it should be the preferred imaging method. The present article gives an overview about the literature related to duplex based diagnosis of RAS and as a follow‐up diagnostic procedure following RAS revascularization.

Platypnea–orthodeoxia syndrome in the elderly treated by percutaneous patent foramen ovale closure: A case series and literature review

BACKGROUND Platypnea-orthodeoxia syndrome (POS) is a rare clinical phenomenon, associating normal oxygen saturation in a supine position and arterial hypoxemia in an upright position. This pathology can be secondary to an intracardiac shunt, a pulmonary vascular shunt or a ventilation-perfusion mismatch. Cardiac POS occurs in the presence of a right-to-left cardiac shunt, most commonly through a patent foramen ovale (PFO). METHODS AND RESULTS From our single-center prospective database of percutaneous PFO closure we identified five patients (4 females, mean age: 77 ± 11 years) out of 224 (2.2%) patients with a PFO who presented with a POS of cardiac origin. Transthoracic and transoesophageal echocardiographic examinations revealed the underlying mechanisms of POS and the diagnosis was confirmed by right-and-left cardiac catheterization (RLC) and by measuring serial blood oxygen saturation in the pulmonary veins and left atrium in supine and upright positions. PFO was associated with atrial septal aneurysm and a persistent prominent Eustachian valve in 3 patients. All patients underwent a successful percutaneous PFO closure without any immediate or subsequent complications (mean follow-up of 24 ± 18 months). Immediately after the procedure, mean arterial oxygen saturation improved from 83% ± 3 to 93% ± 2 in an upright position and symptoms disappeared. CONCLUSION POS is a rare and under-diagnosed pathology that must be actively investigated in the presence of position-dependent hypoxemia. The diagnostic work-up must exclude other causes of hypoxemia and confirm the intracardiac shunt using either contrast echocardiography or RLC. For cardiac POS, percutaneous PFO closure is a safe and effective technique that immediately relieves orthodeoxia and patient symptoms.

Recanalization of chronic occlusions of the superficial femoral artery using the outback™ re-entry catheter: A single centre experience†

Purpose: To report our experience with a catheter system (The Outback™ catheter) designed to allow fluoroscopically controlled re‐entry after subintimal guide wire passage during recanalization of chronically occluded femoro‐popliteal arteries. Methods: Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49–98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques. Results: Median lesion length was 200 ± 102 mm. Recanalization of the arterial occlusion was successful in 57 of 65 treated lesions (88%). One patient died of myocardial infarction after delayed femoral bleeding possibly due to extensive recanalization attempts. There were no further procedure‐related complications. Conclusion: Use of the Outback™ re‐entry catheter system is a valuable option for interventional therapy of chronically occluded femoro‐popliteal arteries following failed standard antegrade recanalization attempt.

Angioplasty and provisional stent treatment of common femoral artery lesions.

PURPOSE Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment. MATERIALS AND METHODS A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007. In all cases, the intended strategy was balloon angioplasty with provisional stent placement in case of poor angioplasty results. Among 516 consecutive procedures involving the CFA, 419 were excluded because of nonatherosclerotic disease (n = 156) or treatment of additional vascular segments during the same procedure (n = 263). Procedural success (ie,<30% residual stenosis), in-hospital vascular complications (major [requiring surgical or percutaneous treatment] or minor [treated conservatively]), and 12-month restenosis and target lesion revascularization (TLR) rates were assessed for the remaining 97 interventions. RESULTS CFA bifurcation lesions were present in 40 cases (41.2%) and required treatment of the deep femoral artery in 25 (25.8%). Chronic total CFA occlusions accounted for 11 cases (11.3%). Balloon angioplasty was performed in 96 cases (98.9%), and provisional stent placement was necessary in 37 (38.1%). The procedure was successful in 89 cases (91.8%). Minor and major vascular complications at 30 days occurred in three (3.1%) and four (4.1%) cases, respectively. At 12 months, restenosis greater than 50% and TLR were observed in 19.5% and 14.1% of procedures, respectively. CONCLUSIONS This series shows that isolated CFA lesions may be safely and efficaciously treated with angioplasty and provisional stent placement.

Impact of non-inhibited platelet supplementation on platelet reactivity in patients treated with prasugrel or ticagrelor for an acute coronary syndrome: An ex vivo study.

Abstract Managing bleeding in patients receiving P2Y12 inhibitors is challenging. Few data are available regarding the efficacy of platelet transfusion in patients treated with prasugrel or ticagrelor. The aim of this study was to evaluate the minimal amount of platelet supplementation (in terms of ratio of non-inhibited platelets to inhibited platelets) necessary to restore platelet reactivity in platelet-rich plasma (PRP) of patients treated with aspirin and a prasugrel or ticagrelor loading dose for an acute coronary syndrome. PRP samples from patients were mixed ex vivo with increasing proportions of pooled PRP from healthy volunteers. Platelet reactivity was challenged with adenosine diphosphate (ADP), arachidonic acid, collagen or thrombin receptor activating peptide using light transmission aggregometry. The primary endpoint was the proportion of patient samples recovering an ADP-induced maximal aggregation (ADP-Aggmax) value above 40%. In patients treated with prasugrel (n = 32), ADP-Aggmax increased progressively with supplements of pooled PRP, with an average increase of 7.9% (95% CI [7.1; 8.8], p < 0.001) per each 20% increase in the ratio of non-inhibited platelets to inhibited platelets. A ratio of 60% was associated with 90% of patients reaching the primary endpoint. In patients treated with ticagrelor (n = 15), ADP-Aggmax did not significantly increase with any level of supplements. In conclusions, ex vivo addition of non-inhibited platelets significantly improved ADP-Aggmax in patients treated with prasugrel with a dose-dependent effect. There was no evidence of such a reversal in patients treated with ticagrelor. These results suggest that platelet transfusion may be more effective in blunting bleeding in patients treated with prasugrel, than those treated with ticagrelor.

Incidence of atrial fibrillation after percutaneous closure of patent foramen ovale and small atrial septal defects in patients presenting with cryptogenic stroke

Objective The occurrence of atrial fibrillation after percutaneous closure of a patent foramen ovale for cryptogenic stroke has been reported in a variable percentage of patients. However, its precise incidence and mechanism are presently unclear and remain to be elucidated. Design Prospective follow-up study. Patients Ninety-two patients undergoing a percutaneous patent foramen ovale closure procedure (closure group) for cryptogenic stroke were compared with a similar group of 51 patients, who were medically treated. Methods A systematic arrhythmia follow-up protocol to assess the incidence of AF was performed including a 7-day event-loop recording at day 1, after 6 and 12 months in patients of the closure group and compared with those of the medically treated group. Results The incidence of AF was similar in both study groups during a follow-up of 12 months, including 7·6% (95% CI: 3·1–15·0%) in the closure and 7·8% (95% CI: 2·18–18·9%) in the medically treated group (P = 1·0). The presence of a large patent foramen ovale was the only significant risk factor for the occurrence of AF as demonstrated by a multivariate Cox regression analysis (95% CI, 1·275–20·018; P = 0·021). Conclusions Our findings indicate that patients with cryptogenic stroke and patent foramen ovale have a rather high incidence of AF during a follow-up of 12 months. Atrial fibrillation occurred with a similar frequency whether the patent foramen ovale/atrial septal defect was successfully percutaneously closed or was medically managed. The presence of a large patent foramen ovale was the only significant predictor of AF occurrence during follow-up.

Percutaneous retrieval of intravascular and intracardiac foreign bodies with a dedicated three‐dimensional snare: A 3‐year single center experience

The presence of symptomatic or asymptomatic intravascular/intracardiac foreign body (FB) is under‐reported in the literature, but it is more commonly encountered in clinical practice. The implantation of long‐term venous catheters and the number of technical challenging endovascular procedures are both constantly increasing. Thus, the number of reported FBs will also increase, becoming a serious concern, especially once associated with a cardiovascular complication.

Acute Coronary Syndrome and its Antithrombotic Treatment: Focus on Aspirin and Clopidogrel Resistance

Cardiovascular diseases are the most common cause of mortality and morbidity accounting for more than 40% of total mortality in Western countries, most of which is due to acute coronary syndromes (ACS), including ST and non-ST elevation myocardial infarction. An optimal pharmacological approach in these patients is of major importance with a particular emphasis on the antiplatelet regimen, which remains the cornerstone of the initial ACS treatment at hospital admission and during percutaneous coronary interventions (PCI). This review briefly discusses the pathogenesis of ACS, and updates the available pharmacological antithrombotic strategies with a particular focus on aspirin and clopidogrel resistance, which has caused major concern, especially in the modern era of interventional cardiology. Persistent platelet reactivity despite aspirin or clopidogrel intake is probably a risk factor for the recurrence of ischemic events. Despite a lack of uniformly accepted definitions of aspirin and clopidogrel resistance, we provide an objective description of what is already proved and what remains to be established. In clopidogrel poor-responders, preliminary data suggest that increasing the loading dose might be beneficial prior to PCI, while trials on the potential benefit of an increased maintenance dose after PCI are ongoing. Overall, data on the mechanisms and the management of platelet hyperactivity or antiplatelet drug biological resistance are still scarce and further studies are needed.