Balloon aortic valvuloplasty: current status and future prospects.

INTRODUCTION: Balloon aortic valvuloplasty (BAV) improves hemodynamic and clinical status of patients with severe aortic stenosis (AS) for a limited period of 6-12 months. However, there is a high number of procedures performed worldwide and an upward trend over the last decades. AREAS COVERED: Epidemiology of AS and the advent of transcatheter aortic valve implantation (TAVI) contribute to the extensive referral of patients. The expansion of recommendations for TAVI has occasionally led to financial reimbursement-related problems that do not exist for BAV. BAV is indicated as a bridge to valve replacement, to decision in complex cases, and to extracardiac surgery. BAV may play a role in preparing for TAVI and optimizing procedural results. The minimalist approach and reduced complication rate make it applicable in fragile patients. EXPERT OPINION: In the near future, BAV will continue to be a useful asset in managing patients with AS given the multiple indications, broad applicability, safety profile, low cost, and repeatability. Specific studies are necessary to explore technical solutions, stronger indications, the finest technique, and to standardize the procedural result. Pending the development of potential competitive devices, the role that BAV plays will remain closely intertwined with the one played by TAVI.

Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

BACKGROUND: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors-ticagrelor and prasugrel-currently recommended by the guidelines. STUDY DESIGN: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. CONCLUSIONS: The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02618837 . Registered on 1 December 2015.

Timing of Oral P2Y12 Inhibitor Administration in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.

BACKGROUND: Although oral P2Y12 inhibitors are key in the management of patients with non-ST-segment elevation acute coronary syndrome, the optimal timing of their administration is not well defined. OBJECTIVES: The purpose of this study was to compare downstream and upstream oral P2Y12 inhibitors administration strategies in patients with non-ST-segment elevation acute coronary syndrome undergoing invasive treatment. METHODS: We performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit). RESULTS: We randomized 1,449 patients to downstream or upstream oral P2Y12 inhibitor administration. A pre-specified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes; nonfatal myocardial infarction or nonfatal stroke; and Bleeding Academic Research Consortium type 3, 4, and 5 bleeding through day 30, did not differ significantly between the downstream and upstream groups (percent absolute risk reduction: -0.46; 95% repeated confidence interval: -2.90 to 1.90). These results were confirmed among patients undergoing percutaneous coronary intervention (72% of population) and regardless of the timing of coronary angiography (within or after 24 h from enrollment). CONCLUSIONS: Downstream and upstream oral P2Y12 inhibitor administration strategies were associated with low incidence of ischemic and bleeding events and minimal numeric difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of 1 strategy over the other. (Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers In Non-ST Elevated Acute Coronary Syndromes With Initial Invasive Indication [DUBIUS]; NCT02618837).

Multimodality Imaging of Purulent Pericarditis: Hints to Speed up Diagnosis and Promote Healing.

Purulent pericarditis is rare and usually associated with pneumonia, bacteremia, immunosuppression, and thoracic surgery. A timely diagnostic pericardiocentesis with dedicated maneuvers to improve the effectiveness of drainage and pericardial fibrinolytic rinsing can improve prognosis and prevent a surgical pericardiectomy. Imaging offers useful clues for a more aggressive approach.

No-Reflow Complicating Chronic Total Occlusion Coronary Revascularization.

OBJECTIVES: To assess the incidence of no-reflow in patients undergoing chronic total occlusion (CTO) percutaneous coronary intervention (PCI), analyze possible causes and differential diagnoses, and identify useful management approaches. METHODS: In this multicenter observational study, all CTO-PCIs performed between January 2018 and April 2019 were reviewed to collect no-reflow complications, defined as Thrombolysis in Myocardial Infarction (TIMI) flow ≤1 in a patent epicardial artery. Patient clinical, anatomical, and procedural characteristics were analyzed. RESULTS: Out of 461 PCIs, two (0.43%) were complicated by no-reflow. In 1 case, PCI was performed on a long segment of the right coronary artery, after use of a dissection-re-entry technique by knuckle wiring. In the second patient, no-reflow developed after proximal left anterior descending coronary artery stenting, with a short subintimal tracking. Intravascular ultrasound was used to exclude complications in the epicardial vessel in both cases. Distal embolization seems the most plausible cause, and intracoronary adenosine effectively improved flow. Both patients had a type 4a myocardial infarction, asymptomatic in the first case, and associated with chest pain, electrocardiographic changes, and new regional wall-motion abnormality at echocardiography in the second case. CONCLUSIONS: No-reflow in CTO recanalization is rare, but associated with a high risk of periprocedural myocardial infarction, with incomplete protection from ischemia offered by the pre-existing collateral network.

Retrograde Deep Femoral Artery Access as Bailout Technique to Rescue Unexpected Ostial Occlusion during Antegrade Superficial Femoral Artery Recanalization.

We report a case of deep femoral artery (DFA) retrograde access for recanalization of an accidental ostial occlusion complicating an antegrade-retrograde superficial femoral artery (SFA) procedure. A 77-year-old man with chronic limb-threatening ischemia of the right lower limb was submitted to a duplex ultrasound that showed a heavy calcified SFA chronic total occlusion. During antegrade and retrograde attempts to cross the SFA obstruction, a control angiogram unexpectedly showed the ostial occlusion of the DFA. Several antegrade attempts to cross the DFA occlusion with various guidewires and catheters were unsuccessfully made. Retrograde access was achieved by direct puncture of the DFA distally to the first perforating artery. With sheathless approach, the occlusion was crossed, the retrograde guidewire was externalized through the femoral sheath, and the balloon angioplasty was then performed antegradely. The SFA recanalization was interrupted because of patient discomfort. The patient had an uncomplicated recovery, with immediate resolution of rest pain probably because of the resolution of the underestimated DFA stenosis. The retrograde DFA access is a useful bailout technique in case of accidental ostial occlusion of the DFA.

Arteriovenous Fistula of the Peroneal Artery Complicating a Retrograde Access: Successful Endovascular Treatment with Covered Stent Implantation.

An 80-year-old woman developed a recurrent chronic limb-threatening ischemia of the right lower limb after a popliteal artery (PA) recanalization with retrograde puncture of the peroneal artery (PR). The angiography showed the PA restenosis and an arteriovenous fistula (AVF) at the previous peroneal retrograde access site. After the PA angioplasty, the AVF was identified through selective contrast injections in multiple projections. A coronary balloon-expandable covered stent was deployed at the AVF site with complete resolution of the AVF. The final angiography demonstrated the patency of PA and PR with complete resolution of the AVF. The patient was discharged without complications, with regression of rest pain. The foot lesion healed within 2 months.

[SICI-GISE Position paper: Enhancing radiation safety in the catheterization laboratory]. / Position paper SICI-GISE: Miglioramento della radioprotezione nel laboratorio di Emodinamica.

The radiation dose received by interventional cardiologists during their activity in the catheterization laboratory is a matter of concern in terms of possible deterministic and stochastic risk. At the same time, very often, the knowledge of the effect and consequences of radiation exposure in the interventional cardiology community is limited. This document endorsed by the Italian Society of Interventional Cardiology (SICI-GISE) provides recommendations for cardiologists' radiation protection. Radiation safety considerations dedicated to women and other staff personnel working in the catheterization laboratory are also discussed.

Substent Anchor Technique for Recanalisation of a Full Metal Jacket Femoropopliteal In-Stent Occlusion.

PURPOSE: To report the endovascular treatment of a full metal jacket (FMJ) femoropopliteal chronic total occlusion (CTO) using a new ancillary retrograde technique. CASE REPORT: An 80 year old woman with type 2 diabetes presented to the Diabetic Foot Clinic with critical limb ischaemia with tissue loss in the right leg. Her comorbidities included coronary artery disease, morbid obesity, hypertension, dyslipidaemia, and active smoking habit. The patient had been treated at another hospital by femoropopliteal FMJ stenting six years before this presentation. The duplex ultrasound showed a full length in-stent re-occlusion. An antegrade recanalisation was attempted via contralateral femoral access, but was unsuccessful. An ultrasound guided retrograde puncture of the popliteal artery in the P2 segment was performed very close to the distal occluded stent. A 0.018 guidewire was pushed in the substent plane, functioning as an anchor to achieve a stable system. The FMJ was then retrogradely recanalised with a second guidewire. The procedure was completed by antegrade angioplasty with drug coated balloons. CONCLUSION: The substent anchor technique can help to achieve stability even if close to the occluded stents, and spares the distal landing zone for surgical revascularisation if the endovascular approach fails. This technique could be useful in retrograde treatment of long in-stent CTO.

[Rescue thrombolytic therapy for the treatment of ST-elevation myocardial infarction after unsuccessful primary percutaneous coronary intervention in a patient with coronary artery aneurysm]. / Infarto miocardico acuto trattato con trombolisi di salvataggio dopo inefficace angioplastica coronarica primaria in paziente con aneurismi coronarici.

The recommended treatment for ST-segment elevation myocardial infarction (STEMI) is primary percutaneous coronary intervention (pPCI). However, in a non-negligible proportion of patients, pPCI is ineffective and the cardiologist must face the decision of how to achieve optimal myocardial reperfusion. Although the possibility of a rescue fibrinolytic strategy has not been evaluated yet in this clinical setting, it is a viable alternative to emergency cardiac surgery. We here report the case of a 60-year-old STEMI patient presenting with a coronary anatomy unsuitable for percutaneous mechanical revascularization, characterized by marked dilation and tortuosity of the proximal and middle epicardial segments. After pPCI failure, the administration of recombinant tissue-type plasminogen activator allowed us to obtain reperfusion as shown by clinical outcome, ST-segment resolution and subsequent angiographic study. No indication was given to further percutaneous or surgical revascularization. The long-term pharmacological management of these patients represents a challenge for the clinician, also considering the available data on the use of new antiplatelet and anticoagulant molecules and their possible associations.

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

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

[Transcatheter mitral valve repair for patients not amenable to surgical correction: epidemiology, diagnosis, equiti of access, and economic impact]. / Trattamento transcatetere dell'insufficienza mitralica per i pazienti non eleggibili all'intervento chirurgico: epidemiologia, diagnosi, equità di accesso ed impatto economico.

Mitral regurgitation is the most common valvular heart disease in western world, with moderate to severe mitral regurgitation having a deep impact on prognosis, mortality and rehospitalizations. Advanced congestive heart failure is frequently complicated by mitral regurgitation, a pathologic condition that is often under-diagnosed. A significant proportion of patients with severe mitral regurgitation is not eligible for surgery (mitral valve repair or replacement) because of contraindications or excessive surgical risk. Therefore, the need for a less invasive treatment has led to the development of endovascular techniques; among them the MitraClip system, which mimics Alfieri's edge-to-edge surgical technique introduced in 2003, has gained widespread acceptance. More than 35 000 patients have been treated using this technique. Evidence from clinical studies suggests that the MitraClip system is effective in improving survival and quality of life in patients with severe mitral regurgitation, also reducing rehospitalization rates with substantial social and economic advantages. At present, in Italy, undertreatment of patients with severe mitral regurgitation not amenable to surgical correction is still significantly high, and remarkable inhomogeneity among regions is observed in the availability of the MitraClip procedure.

[SICI-GISE Position paper: Use of Absorb BVS in clinical practice]. / Documento di posizione SICI-GISE: Utilizzo di Absorb BVS nella pratica clinica.

Drug-eluting stents (DES) are the current gold standard for percutaneous treatment of coronary artery disease. However, DES are associated with a non-negligible risk of long-term adverse events related to persistence of foreign material in the coronary artery wall. In addition, DES implantation causes permanent caging of the native vessel, thus impairing normal vasomotricity and the possibility of using non-invasive coronary imaging or preforming subsequent bypass surgery. On the contrary, coronary bioresorbable stents (BRS) may provide temporary mechanical support to coronary wall without compromising the subsequent recovery of normal vascular physiology, and have the potential to prevent late adverse events related to permanent elements. Several types of BRS have been introduced into clinical practice in Europe or are being tested. However, most of available clinical data relate to a single BRS, the Absorb bioresorbable Vascular Scaffold (Absorb BVS) (Abbott Vascular, Santa Clara, CA). Despite encouraging clinical results, no societal guidelines are available on the use of BRS in clinical practice.A panel of Italian expert cardiologists assembled under the auspices of the Italian Society of Interventional Cardiology (SICI-GISE) for comprehensive discussion and consensus development, with the aim to provide recommendations on the use of bioresorbable stents in terms of clinical indications, procedural aspects, post-percutaneous coronary angioplasty pharmacologic treatment and follow-up. Based on current evidence and BRS availability in Italian cath-labs, the panel decided unanimously to provide specific recommendations for the Absorb BVS device. These recommendations do not necessarily extend to other BRS, unless specified, although significant overlap may exist with Absorb BVS, particularly in terms of clinical rationale.

Risk of Adverse Cardiac and Bleeding Events Following Cardiac and Noncardiac Surgery in Patients With Coronary Stent: How Important Is the Interplay Between Stent Type and Time From Stenting to Surgery?

BACKGROUND: Epidemiology and consequences of surgery in patients with coronary stents are not clearly defined, as well as the impact of different stent types in relationship with timing of surgery. METHODS AND RESULTS: Among 39 362 patients with previous coronary stenting enrolled in a multicenter prospective registry and followed for 5 years, 13 128 patients underwent 17 226 surgical procedures. The cumulative incidence of surgery at 30 days, 6 months, 1 year, and 5 years was 3.6%, 9.4%, 14.3%, and 40.0%, respectively, and of cardiac and noncardiac surgery was 0.8%, 2.1%, 2.6%, and 4.0% and 1.3%, 5.1%, 9.1%, and 31.7%, respectively. We assessed the incidence and the predictors of cardiac death, myocardial infarction, and serious bleeding event within 30 days from surgery. Cardiac death occurred in 438 patients (2.5%), myocardial infarction in 256 (1.5%), and serious bleeding event in 1099 (6.4%). Surgery increased 1.58× the risk of cardiac death during follow-up. Along with other risk factors, the interplay between stent type and time from percutaneous coronary intervention to surgery was independently associated with cardiac death/myocardial infarction. In comparison with bare-metal stent implanted >12 months before surgery, old-generation drug-eluting stent was associated with higher risk of events at any time point. Conversely, new-generation drug-eluting stent showed similar safety as bare-metal stent >12 months and between 6 and 12 months and appeared trendly safer between 0 and 6 months. CONCLUSIONS: Surgery is frequent in patients with coronary stents and carries a considerable risk of ischemic and bleeding events. Ischemic risk is inversely related with time from percutaneous coronary intervention to surgery and is influenced by stent type.

Open-label, randomized, placebo-controlled evaluation of intracoronary adenosine or nitroprusside after thrombus aspiration during primary percutaneous coronary intervention for the prevention of microvascular obstruction in acute myocardial infarction: the REOPEN-AMI study (Intracoronary Nitroprusside Versus Adenosine in Acute Myocardial Infarction).

OBJECTIVES: This study sought to assess whether intracoronary adenosine or nitroprusside following thrombus aspiration (TA) is superior to TA alone for the prevention of microvascular obstruction (MVO) in ST-segment elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: MVO, due to its multifactorial pathogenesis, still occurs after TA in a sizeable portion of patients. METHODS: We performed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial. A total of 240 STEMI patients with Thrombolysis In Myocardial Infarction (TIMI) flow grade 0/1 were randomly allocated 1:1:1 to receive adenosine (n = 80), nitroprusside (n = 80), or saline (n = 80) given distal to the occluded site after TA. The primary endpoint was the incidence of ST-segment resolution (STR) >70% on surface electrocardiogram at 90 min after PCI. Secondary endpoints were angiographic MVO incidence (TIMI flow grade ≤2 or 3 with a myocardial blush grade <2) and major adverse cardiac event (MACE) rate at 30 days as a composite of cardiac death, myocardial infarction, target lesion revascularization, and heart failure requiring hospitalization. RESULTS: STR >70% occurred in in 71% of adenosine-treated patients, in 54% of nitroprusside-treated patients, and in 51% of saline-treated patients (p = 0.009 and p = 0.75, respectively, vs. saline). Angiographic MVO occurred in 18% of adenosine-treated patients, in 24% of nitroprusside-treated patients, and in 30% of saline-treated patients (p = 0.06 and p = 0.37, respectively, vs. saline). MACE occurred in 10%, 14%, and 20% of patients, respectively (p = 0.08 and p = 0.29 vs. saline). CONCLUSIONS: In STEMI patients treated by PCI and TA, the additional intracoronary administration of adenosine, but not that of nitroprusside, results in a significant improvement of MVO, as assessed by STR.

Transradial versus transfemoral intervention for acute myocardial infarction: a propensity score-adjusted and -matched analysis from the REAL (REgistro regionale AngiopLastiche dell'Emilia-Romagna) multicenter registry.

OBJECTIVES: This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach. BACKGROUND: Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty. METHODS: We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching. RESULTS: A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052). CONCLUSIONS: In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

Comparison by meta-analysis of eptifibatide and tirofiban to abciximab in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Adjunctive therapy with abciximab during primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI) determines a better short-term outcome compared to placebo. Tirofiban and eptifibatide represent a valid option with lower cost, but these have been less studied. The aim of the present study was to combine all randomized trials and registries to demonstrate the noninferiority of tirofiban and eptifibatide compared to abciximab in patients with STEMI treated with PPCI. We identified 6 randomized trials and 4 registries. Overall, 4,653 received small molecules and 2,696 abciximab, and the rate of combined death and nonfatal reinfarction did not differ (4.6% vs 4.5%, odds ratio 0.99, 95% confidence interval [CI] 0.78 to 1.27, p = 0.95) up to 30 days of follow-up, with an absolute difference of 0.1% (95% CI -1.06 to 0.8). Because the noninferiority limit was set at +1.5%, and because the upper point estimate (0.8%) of the 95% CI did not cross the prespecified limit, the noninferiority of the small molecules was documented. In-hospital major bleeding was also similar (8.8% vs 6.1%, odds ratio 0.92, 95% CI 0.75 to 1.13, p = 0.43). Sensitivity analysis comparing randomized trials to registries and tirofiban or eptifibatide to abciximab did not show any significant differences. In conclusion, our results documented noninferiority of "small molecules" compared to abciximab and, therefore, support their alternative use as adjunctive therapy during PPCI for patients with STEMI.

Long-term outcome after drug eluting stenting in patients with ST-segment elevation myocardial infarction: data from the REAL registry.

BACKGROUND: The long-term safety and efficacy of drug eluting stents (DES) implanted during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is unclear. The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES vs. bare metal stent (BMS) implantation. METHODS: In the present analysis 4764 patients were enrolled (706, 15%, received DES). We assessed the cumulative incidence of major adverse cardiac events (MACE) and stent thrombosis (ST). RESULTS: Overall, no significant difference emerged for the rates of death and reinfarction. DES implantation was associated to a reduction of target vessel revascularization (TVR) (HR 0.65, 95%CI 0.47-0.91; p=0.01), leading to a MACE reduction (HR 0.7, 95%CI 0.56-0.86; p<0.01). In particular, during the first 2 years we observed less adverse events in the DES group, mainly because of a lower TVR rate (TVR: HR 0.56, 95%CI 0.37-0.83, p<0.01; MACE: HR 0.71, 95%CI 0.54-0.94, p=0.01). On the contrary, during the third year, adverse events tended to be higher in the DES group. ST did not differ between DES and BMS groups (p=0.6). No differences were observed between sirolimus eluting stents and paclitaxel eluting stents. CONCLUSIONS: DES implantation during primary PCI is safe and associated with a significant TVR and MACE reduction in the first two years, whereas a trend to have more adverse events in the third year is observed. More data about long-term follow-up are needed to better evaluate both safety and efficacy of DES in the setting of STEMI.

Randomized evaluation of intracoronary nitroprusside vs. adenosine after thrombus aspiration during primary percutaneous coronary intervention for the prevention of no-reflow in acute myocardial infarction: the REOPEN-AMI study protocol.

BACKGROUND: Thrombus aspiration improves microvascular obstruction in patients with acute myocardial infarction treated by percutaneous coronary intervention. However, drugs such as nitroprusside and adenosine have not yet been tested as adjuncts to thrombus aspiration. Therefore, we designed a placebo-controlled, randomized, open-label, blind-examination, multicenter trial assessing the effects of intracoronary nitroprusside or adenosine on microvascular obstruction in patients undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration. METHODS AND RESULTS: Six hospitals in Italy participate in the REOPEN-AMI study. Two hundred and forty consecutive patients with acute myocardial infarction undergoing primary or rescue percutaneous coronary intervention and thrombus aspiration are randomly allocated 1: 1: 1 to receive either intracoronary nitroprusside, adenosine or placebo. The primary end-point is the incidence of ST resolution greater than 70% on surface ECG at 90 min after the procedure. Secondary end-points are: incidence of angiographic no-reflow (thrombolysis in myocardial infarction flow < or =2 or 3 with a myocardial blush grade <2); changes of left ventricular volumes at follow-up (at bidimensional echocardiography); rate of major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization and heart failure requiring hospitalization). CONCLUSIONS: REOPEN-AMI will provide important data on the efficacy and safety of intracoronary nitroprusside and adenosine as an adjunctive treatment to percutaneous coronary intervention after thrombus aspiration for patients with acute myocardial infarction.