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Background: In provisional technique, main vessel (MV) drug-eluting stent (DES) diameter is usually selected according to distal MV to reduce carina shift. Proximal optimization technique (POT) is used to expand the DES in the proximal MV. Occasionally, the size discrepancy between left main (LM) and left anterior descending artery (LAD) may be huge and this may cause stent malapposition and poor vessel wall coverage in large-sized LM. Recently, some manufactures designed extra-large DES to treat large vessels., Methods: We developed an "adapted" provisional strategy based on under-deployment of extra-large DES in case of major size mismatch between LM and proximal LAD. Bench tests were realized in appropriately designed LM bifurcation model using an extra-large DES (Onyx XL, Medtronic, Santa Rosa, CA, USA). This technique was adopted when such "rare" anatomy was found in our clinical practice., Results: At bench test, Onyx XL 4.5 mm stent reaches 3.8 mm at 5-6 atmospheres, with favorable stent deformation achieved after POT, kissing balloon and re-POT. This technique was performed in 10 patients undergoing unprotected LM stenting with large LM and major mismatch toward LAD. Angiographic success was achieved in all cases and optical coherence tomography assessment was performed in 5 patients revealing optimal stent result. After a follow-up of 557 days (range: 90-1369 days), clinical course was uneventful in all treated patients., Conclusions: Under-deployment of extra-large DES is a technical option that can be considered to optimize the provisional stenting technique in selected patients with major diameter mismatch between large-sized LM and LAD.

Aim: To assess the impact of lesion predilation with kissing inflation using under-sized balloons (pre-kissing [PK]) on the procedural outcome of percutaneous intervention (PCI) on coronary bifurcation lesions (CBLs)., Methods: Patients who underwent PCI with second-generation drug-eluting stenting on a complex CBL (Medina 1,1,1 or 1,0,1 or 0,1,1) were selected. The study population was divided according to the lesion preparation into the PK group and the control group. To adjust for higher anatomic complexity of PK patients, a 2:1 propensity-matched (PM)-control group was selected. The PCI procedural details were assessed to evaluate occurrence of "side-branch trouble" (primary procedural endpoint) after main-vessel (MV) stenting. Angiographic characteristics, including side-branch TIMI flow during PCI, were also systematically evaluated., Results: A total of 538 patients were identified, with 66 patients in the PK group, 472 patients in the control group, and 126 patients in the PM-control group. Side-branch trouble was less common in side-branch PK patients vs the PM-control patients (7.5% vs 18.0%, respectively; P=.03). In multivariable analysis, the absence of PK independently predicted side-branch trouble. Among selected patients with a long side-branch lesion (122 patients), the PK technique improved post-MV stenting side-branch TIMI flow., Conclusions: Use of PK with under-sized balloons may facilitate side-branch management after MV stenting in patients with complex CBL undergoing provisional stenting.

Unlabelled: The efficacy of DEB in modifying the high restenosis risk associated with BMS implantation is doubtful. Optical coherence tomography (OCT) may allow precise assessment of neointimal formation after stent implantation. We performed a single-center, prospective, 1:2 randomized trial comparing BMS implantation alone (BMS group) vs. additional DEB (DEB group). DEB patients were further randomized 1:1 to DEB before stenting (pre-DEB group), or after stenting (post-DEB group). Primary endpoint was OCT-assessed neointimal hyperplasia (expressed both as mean in-stent neointimal area and as percentage obstruction of the mean stent area) at 6 months. Secondary endpoints were the percentage of uncovered and malapposed stent struts. Thirty patients were enrolled and randomized to BMS (n = 10), pre-DEB (n = 10), post-DEB (n = 10). At 6-month OCT follow-up, DEB significantly reduced neointimal area compared with BMS: mean neointimal area 2.01 ± 0.89 vs. 3.03 ± 1.07 mm(2) (p = 0.02), percentage area obstruction 24.56 ± 12.50 vs. 37.51 ± 12.26 % (p = 0.02). The percentage of uncovered and malapposed stent struts did not differ significantly between BMS and DEB. In the comparison between pre-DEB and post-DEB, no significant difference was observed for both primary and secondary endpoints. In de novo coronary lesions treated with BMS, DEB use could be associated with a mild reduction in neointimal hyperplasia at 6 months; this effect could be unrelated to the timing of DEB dilation (pre- or post-stenting)., Clinical Trial Registration Information: http://www.clinicaltrials.gov . Identifier: NCT01057563.

A series of scientific evidence supports the concept that provisional side-branch stenting should be the preferred strategy for percutaneous coronary intervention of bifurcation coronary lesions. However, to date, many interventional cardiologists still consider this technique unsuitable for complex bifurcation lesions. This is mainly due to the fact that provisional stenting may be performed in different ways and several technical refinements may influence the procedural outcome. We here systematically overviewed the arguments which should be considered during the following steps of the provisional strategy: branch wiring, side-branch predilation, "crossover" stenting, proximal optimization, kissing balloon and the side-branch rescue techniques. We suggest that provisional stenting should be regarded as a highly flexible technique which, with specific technical tricks, may allow us to safely treat patients with wide spectrum of bifurcated lesion complexity.

Background: The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions., Methods/design: Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale., Discussion: The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques., Trial Registration: Clinicaltrials.gov NCT01824030.

Laser atherectomy might decrease procedural complications during percutaneous coronary intervention (PCI) of degenerated saphenous vein grafts (SVGs) in case of unstable or thrombotic lesions because of its ability to debulk and vaporize thrombus. We aimed at prospectively evaluating the safety and efficacy of excimer laser coronary angioplasty (ELCA) as a primary treatment strategy in consecutively unstable patients undergoing PCI of degenerated SVG lesions. Seventy-one consecutive patients with non-ST elevation acute coronary syndrome (mean age 69 ± 10 years, 66 men [89%]) undergoing PCI of degenerated SVG were enrolled in a prospective case-control registry, using 2 different distal protection devices (DPDs; FilterWire EZ [Boston Scientific, Natick, Massachusetts; n = 24] and SpiderRX [Ev3, Plymouth, Minnesota; n = 23]) or ELCA (n = 24). Primary end points of the study were incidence of angiographic microvascular obstruction (Thrombolysis In Myocardial Infarction flow grade of <3 or Thrombolysis In Myocardial Infraction flow grade of 3 with myocardial blush grade 1 to 2) and incidence of type IVa myocardial infarction. Angiographic microvascular obstruction incidence tended to be less in ELCA-treated patients compared with DPD-treated patients (3 [13%] vs 15 [32%], p = 0.09). Type IVa myocardial infarction incidence was more in DPD-treated patients compared with ELCA-treated patients (23 [49%] vs 5 [21%], p = 0.04). In conclusion, in patients with non-ST elevation acute coronary syndrome undergoing PCI of degenerated SVG, ELCA compared with DPD, is associated with a trend for better myocardial reperfusion and a lesser incidence of periprocedural necrosis. Controlled randomized trials are warranted to confirm these early observations., (Copyright © 2013 Elsevier Inc. All rights reserved.)

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., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

The glycoprotein (GP) IIb/IIIa receptor is critical to the process of platelet aggregation and thrombus formation as it serves as the final common pathway for platelet aggregation. For this reason, the development of GP IIb/IIIa inhibitors that block fibrinogen binding to the receptor has become an attractive strategy for antiplatelet therapy with an expected strong and specific effect. Presently, there are three commercially available GP IIb/IIIa inhibitors: abciximab, eptifibatide and tirofiban. All three drugs are commonly administered intravenously, and large-scale clinical trials have demonstrated a clear clinical benefit and good safety profile in patients at high risk, especially those undergoing percutaneous coronary interventions (PCI). Recently, several studies tested the intracoronary (IC) route for GP IIb/IIIa inhibitors in order to verify its safety and its possible superiority as compared to the intravenous (IV) route. The majority of the studies testing the IC route were conducted using abciximab and in patients with STEMI with better results in terms of myocardial reperfusion and infarct size and also promising results in terms of clinical outcome. On the IC administration of eptifibatide and tirofiban only some, even if promising, data are available. Larger and randomized studies are warranted to confirm the superiority of the IC route of administration of the GP IIb/IIIa inhibitors to the IV one in patients with coronary artery disease undergoing PCI.

Background: Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies., Methods/design: We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months., Discussion: Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia., Trial Registration: Clinicaltrials.gov NCT01057563.

Objectives: To prospectively assess the impact of post-procedural side-branch (SB) stenosis on inducible myocardial ischemia in patients with bifurcated lesions undergoing percutaneous interventions., Background: Provisional-stenting with drug-eluting stents (DES) is the recommended strategy to treat percutaneously bifurcated lesions but is associated to variable degrees of residual SB stenosis. The role of SB residual stenosis on post-procedural myocardial ischemia is uncertain., Methods: Patients with bifurcations treated by DES according to provisional-stenting technique were enrolled in the study if they had no other untreated lesion. Patients were divided into two groups according to post-procedural 3D-quantitative coronary analysis (3DQCA): group OR (optimal result: stenosis < 50% of SB lumen area at 3DQCA) and group SR, suboptimal result: (stenosis ≥ 50% of SB lumen area at 3DQCA). Treadmill exercise stress test (EST) was performed within 1 week from PCI. The primary study endpoint was myocardial ischemia (≥1 mm ST-segment depression at EST)., Results: Sixty patients were enrolled: 49 (81.7%) comprised group OR and 11 (18.3%) group SR. Post-PCI myocardial ischemia at EST was inducible in 17 (34.7%) patients of group OR versus 10 (90.9%) patients of group SR (P = 0.0007). During the follow-up, patients of Group SR (vs. Group OR) had a significantly higher occurrence of inducible myocardial ischemia during late (>8 weeks) stress tests (P < 0.001)., Conclusions: In patients with bifurcated lesions treated by a provisional-stenting technique, residual SB stenosis ≥ 50% at 3DQCA is associated with post-procedural inducible myocardial ischemia at EST., (Copyright © 2011 Wiley Periodicals, Inc.)

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., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Background: No reflow after primary percutaneous coronary intervention is a dynamic process and its reversibility may affect left ventricular (LV) remodeling. We aimed at assessing in-hospital evolution of angiographic no reflow, predictors of its reversibility, and its impact on LV function at follow-up (FU)., Methods: Fifty-three consecutive patients (age, 60±10 years; male sex, 79%) presenting with ST-elevation myocardial infarction and undergoing primary percutaneous coronary intervention within 12 h of symptom onset were enrolled. No reflow was defined as a final thrombolysis in myocardial infarction (TIMI) flow of 2 or final TIMI flow of 3 with myocardial blush grade (MBG) of less than 2. The evolution of angiographic no reflow was assessed by repeat in-hospital coronary angiography. Patients with no reflow found to have an improvement of TIMI and/or MBG leading to a final TIMI 3 and MBG of greater than or equal to 2 were classified as reversible no reflow; the remaining patients were classified as sustained no reflow. Variables predicting the patterns of no reflow, recorded on admission, were assessed among clinical, angiographic and laboratory data. FU echocardiographic data (at 6 months) were compared with those obtained in-hospital according to no reflow evolution., Results: Thirty-six patients (68%) exhibited myocardial reperfusion; 17 patients (32%) showed no reflow. Among these, six patients (age, 58±10 years; male sex, 83%) showed sustained no reflow, whereas 11 patients (age, 55±8 years; male sex, 82%) showed reversible no reflow. Patients with sustained no reflow had longer time to percutaneous coronary intervention (261±80 min) compared with those with myocardial reperfusion (216±94 min) or reversible no reflow (237±76 min; P=0.008 and 0.05, respectively). Moreover, patients with sustained no reflow had a higher peak troponin-T levels (14.5 ng/ml; range, 7.5-20.2 ng/ml) compared with those presenting with myocardial reperfusion (3.9 ng/ml; range, 3.3-9.1 ng/ml) and reversible no reflow (7.7 ng/ml; range, 3.6-29.9 ng/ml; P=0.03 and 0.07, respectively). At multivariate ordinal logistic regression, time pre-PCI retained its statistical significant association with angiographic no reflow evolution (odds ratio=2.54; 95% confidence interval: 1.45-6.53; P=0.04), with troponin T levels showing a borderline statistical significance (odds ratio=3.12; 95% confidence interval: 1.07-6.23; P=0.09). Finally, in patients with sustained no reflow only both end-diastolic and end-systolic volumes significantly increased at FU (P<0.001 and 0.001, respectively)., Conclusion: Sustained no reflow is associated with a longer ischemic time and predicts worse LV remodeling. No reflow, however, shows an in-hospital reversibility calling for therapeutic interventions when its prevention fails.

The transradial approach for percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or left radial approach (LRA) after an appropriate "learning curve." However, studies evaluating the "learning curve" for RRA and LRA are lacking. In the Transradial Approach (Left vs Right) and Procedural Times During Percutaneous Coronary Procedures (TALENT) study, which randomized 1,540 patients to the RRA or LRA, transradial procedures were performed by either seniors or fellows. Diagnostic procedures performed by fellows were divided into 3 stages: 0 to 100 procedures (stage 1), 101 to 200 procedures (stage 2), and >200 procedures (sage 3). The primary end point of the study was fluoroscopy time during the 3 stages. Six fellows performed 532 procedures, 260 through the RRA and 272 through the LRA. During the training period, fellows showed a progressive significant reduction in fluoroscopy time for the LRA over the 3 stages (stage 1: 258 seconds, interquartile range [IQR] 138 to 377; stage 2: 198 seconds, IQR 126.5 to 375; stage 3: 142 seconds, IQR 95 to 325; p = 0.003), whereas for the RRA, only a slight and nonsignificant reduction in fluoroscopy time was observed (stage 1: 271 seconds, IQR 186 to 364; stage 2: 240 seconds, IQR 156 to 395; stage 3: 218.5 seconds, IQR 145.5 to 300.5; p = 0.20). Cannulation time was progressively reduced over the time for the 2 radial approaches: during stage 1, <40% of procedures required ≤3 minutes for radial cannulation, whereas at stage 3, radial cannulation time was ≤3 minutes in >60% of procedures (p <0.0001). In conclusion, the LRA is associated with a shorter learning curve compared to the RRA., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Transradial percutaneous coronary procedures may be effectively performed through the right radial approach (RRA) or the left radial approach (LRA), but data on radiation dose absorbed by operators comparing the two approaches are lacking. The aim of the present study was to evaluate radiation dose absorbed by operators during coronary procedures through the RRA and LRA., Methods and Results: Three operators were equipped with 5 different dosimeters (left wrist, shoulder, thorax outside the lead apron, thorax under the lead apron, and thyroid) during RRA or LRA for coronary procedures. Each month, the dosimeters were analyzed to determine the radiation dose absorbed. From February to December 2009, 390 patients were randomly assigned to the RRA (185 patients; age, 66±11 years) or the LRA (185 patients; age, 66±11 years). There were no significant differences in fluoroscopy time (for RRA, 369 seconds; interquartile range, 134 to 857 seconds; for LRA, 362 seconds; interquartile range, 142 to 885 seconds; P=0.58) between the 2 groups. There were no significant differences in monthly radiation dose at the thorax (0.85±0.46 mSv for RRA and 1.12±0.78 mSv for LRA, P=0.33), at the thyroid (0.36±0.2 mSv for RRA and 0.34±0.3 mSv for LRA, P=0.87), and at the shoulder (0.73±0.44 mSv for RRA and 0.94±0.42 mSv for LRA, P=0.27). The dose at the wrist was significantly higher for the RRA (2.44±1.12 mSv) compared with the LRA (1±0.8 mSv, P=0.002). In both radial approaches, the thoracic radiation dose under the lead apron was undetectable., Conclusions: Compared with RRA, LRA for coronary procedures is associated with similar radiation dose for operators at the body, shoulder, or thyroid level, with a possible significant advantage at the wrist. The cumulative radiation dose for both approaches is well under to the annual dose-equivalent limit., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00282646.

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)., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2010 Wiley-Liss, Inc.)

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.

Background: most of the studies assessing transradial approach for coronary angiography (CA) have been performed through right radial approach (RRA). Our aim was to evaluate the safety and efficacy of left radial approach (LRA) compared with RRA for coronary procedures., Methods: from January 2009 to December 2009, in 2 hospitals, 1,540 patients were randomized to RRA (770 patients) or LRA (770 patients) for percutaneous coronary procedures. The primary end point was fluoroscopy time for CA and for percutaneous coronary intervention (PCI) evaluated independently. Prespecified subgroup analyses according to patient age and operator experience were planned., Results: in 1,467 patients (732 RRA and 735 LRA), a CA (diagnostic group) was performed, and in 688 (344 each for RRA and LRA), a PCI. In the diagnostic group, LRA was associated with significantly lower fluoroscopy time (149 seconds, interquartile range [IQR] 95-270 seconds) and dose area product fluoroscopy (10.7 Gy cm(2), IQR 6-20.5 Gy cm(2)) compared with the RRA (168 seconds, IQR 110-277 seconds, P = .0025 and 12.1 Gy cm(2), IQR 7-23.8 Gy cm(2), P = .004, respectively). In the PCI group, there were no significant differences in fluoroscopy time (614 seconds, IQR 367-1,087 seconds for LRA and 695 seconds, IQR 415-1,235 seconds, P = .087 for RRA) and dose area product fluoroscopy (53.7 Gy cm(2), IQR 29-101 Gy cm(2) for LRA and 63.1 Gy cm(2), IQR 31-119 Gy cm(2), P = .17 for RRA). According to subgroup analyses, the differences between LRA and RRA were confined to older patients (≥ 70 years old) and to operators in training., Conclusions: left radial approach for coronary diagnostic procedures is associated with lower fluoroscopy time and radiation dose adsorbed by patients compared with the RRA, particularly in older patients and for operators in training.

Safe guidewire placement in the main vessel (MV) and in the side branch (SB) does represent the key point for successful percutaneous coronary interventions (PCI) in bifurcated lesions. During bifurcation PCI, SB wiring is systematically performed as a first step and is often repeated ("rewiring") during the procedure in order to treat the SB after MV stenting. Wiring and rewiring are crucial phases of bifurcation PCI which require, in the most complex cases, specific operator experience. In the present paper, the classic SB wiring techniques necessary for routine bifurcation interventions (antegrade and pullback wiring technique) as well as "advanced" wiring techniques ("reverse wire" technique, Venture-facilitate wiring, MV balloon predilation or debulking) are described. Moreover, the rewiring technique is discussed in detail, with particular attention on the tips and tricks which may facilitate the achievement of optimal result with provisional stenting (pullback rewiring) and help manage bail out situations like acute SB flow impairment after MV stenting.

Background: The use of thrombus aspiration during percutaneous coronary intervention (PCI) is recommended in patients with ST-elevation myocardial infarction (STEMI) undergoing mechanical revascularization. When thrombus aspiration is adopted, the standard technique includes, after mechanical thrombus extraction, angioplasty and/or stent implantation to eliminate residual stenosis. To date, no data are available concerning the use of thrombectomy alone without additional ballooning or stenting., Methods and Results: We report the angiographic and clinical outcome of a series of selected STEMI patients undergoing mechanical reperfusion by thrombus aspiration without additional ballooning or stenting. Four patients out of 316 consecutive STEMI patients were managed by thrombus aspiration alone (1.3%). All patients had angiographic documentation of an occlusive large intracoronary thrombus in the infarct-related artery before intervention and complete restoration of coronary flow in the absence of critical coronary stenosis after thrombus aspiration. Three of these patients had a clinical contraindication to dual antiplatelet therapy, thus suggesting that to avoid stent implantation would be advisable. Angiographic reevaluation was performed before discharge in 3 patients confirming persistent patency of the infarct-related artery (in 1 case the residual stenosis was judged to require intravascular ultrasound evaluation and subsequent elective PCI with stent implantation). The thirty-day clinical course was uneventful in all patients., Conclusions: In selected patients with STEMI undergoing mechanical reperfusion, thrombus aspiration without additional ballooning or stenting may be successfully performed. Further studies are needed to assess the clinical relevance of this novel approach.

Background: Restoration of myocardial perfusion is the goal of percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction. A major predictor of no-reflow is the increasing time to treatment (TTT). Thrombus aspiration (TA) is reported to improve myocardial reperfusion as compared with standard PCI (SP)., Objective: To investigate the influence of TTT on TA efficacy., Design: Pooled analysis of individual patients' data of three prospective randomised trials comparing TA and SP., Patients: A total of 299 patients (150 in TA group and 149 in SP group) entered the study. The study population was divided into three subgroups according to the TTT: < or = 3 h (short TTT subgroup), >3 h to < or = 6 h (intermediate TTT subgroup), >6 h to < or = 12 h (long TTT subgroup)., Main Outcome Measures: The goal of the study was the comparison of optimal myocardial reperfusion, defined as the combination of myocardial blush grade 2 or 3 at post-PCI angiography and ST resolution more than 70% at post-PCI ECG, between SP and TA according to TTT., Results: In the SP group, increasing TTT was associated with a decreased rate of optimal reperfusion (27.4% vs 17.9% vs 10%, p for trend=0.06), whereas in the TA group the same trend was not seen (40.9% vs 33.8% vs 50%, p for trend=0.93). In a multivariate logistic regression model, a significant interaction (p=0.04) between time to treatment and thrombus aspiration was observed., Conclusions: TA limits the adverse effects of TTT prolongation on myocardial reperfusion.

Stent thrombosis is a catastrophic occurrence burdened by a high mortality rate and a tendency to recur. We sought to evaluate the angiographic risk factors for recurrent stent thrombosis (rST) in a subpopulation of 91 Outcome of PCI for stent-ThrombosIs Multicenter STudy (OPTIMIST) patients who underwent quantitative angiographic evaluation by an independent core laboratory. The Academic Research Consortium criteria were used for rST adjudication. A multivariate Cox proportional hazards model was applied to estimate the hazard ratios and the corresponding 95% confidence intervals for the occurrence of Academic Research Consortium-defined, definite rST (primary end point), definite or probable rST (secondary end point), and definite or probable or possible rST (secondary end point). A total of 8 definite rST events occurred during a median follow-up of 244 days (range 165 to 396), of which 5 were early and 3 were late. In the multivariate model, a residual thrombus score of > or =3 (hazard ratio 6.5, 95% confidence interval 1.4 to 30.7, p = 0.017) and a larger postprocedural reference vessel diameter (hazard ratio 4.5, 95% confidence interval 1.5 to 13.3, p = 0.006) were significantly associated with the primary end point. When the same model was applied to the 15 definite and probable rST events, only a residual thrombus score of > or =3 (hazard ratio 7.8, 95% confidence interval 2.5 to 24.5, p <0.001) was significantly associated with rST. Finally, when possible rST events were included (18 patients), a residual thrombus score of > or =3 remained associated with the dependent variable (hazard ratio 6.1, 95% confidence interval 2.0 to 18.2, p = 0.001), along with a larger postprocedural reference vessel diameter. In conclusion, when performing percutaneous coronary intervention for stent thrombosis, the residual thrombus burden and larger reference vessel were potent risk factors for rST.

Background: In the treatment of coronary bifurcation lesions (CBL), with drug eluting stents (DES), we sought to compare angiographic and clinical outcomes of a simple strategy of stenting main vessel only with balloon dilatation of the side branch with a complex strategy of stenting both branches., Methods: We performed a meta-analysis of six studies, randomized (three) or prospective observational (three), including 963 patients, that directly compared the simple strategy to the complex strategy, in the treatment of CBL with DES., Results: Final minimal lumen diameter (MLD) of the side branch was significantly smaller in the simple strategy group [WMD -0.50 mm, 95% CI (-0.76, -0.24), p<0.00001]. The risk of main vessel restenosis [RR 0.66, 95% CI (0.38-1.17), p=0.16], side branch restenosis [RR 0.62, 95% CI (0.24-1.56), p=0.31], follow up death [RR 0.60, 95% CI (0.19-1.86), p=0.38], follow up myocardial infarction [RR 0.71, 95% CI (0.46-1.10), p=0.13], or target vessel revascularization [RR 0.90, 95% CI (0.56-1.46), p=0.67] was similar between the two strategies. The simple strategy showed a trend to a lower risk of early myocardial infarction [RR 0.65, 95% CI (0.41-1.05), p=0.08]., Conclusion: In the treatment of unselected CBL with DES, the complex strategy does not penalize angiographic and clinical outcomes compared to the simple strategy. Further randomized studies are needed to assess the benefit of simple or complex strategy in the treatment of specific subsets of bifurcated lesions., (Copyright 2008 Elsevier Ireland Ltd. All rights reserved.)

Aims: Provisional stenting with drug-eluting-stents is actually adopted to treat most of bifurcated lesions. A major drawback of this technique is the risk of side-branch (SB) closure after main vessel (MV) stenting., Methods and Results: We set-up, and bench tested, a novel technique for SB protection based on the placement of a balloon in the SB during MV stenting. The uninflated balloon, which remains jailed under the stent struts, serves to reduce both carina and plaque shifts due to its SB ostium spatial occupation. If SB flow is preserved after MV stenting, the jailed balloon is removed uninflated. If the SB becomes occluded after MV stenting, the jailed balloon may either be used as a marker and a favourable angle modifier to facilitate rewiring or can be dilated to try to restore SB flow. SB rewiring and kissing balloon inflation must be performed to correct stent deformation or malapposition. This novel technique has been successfully adopted in 20 patients with complex (55% unprotected left main, 85% Medina 1,1,1 lesions) true bifurcated lesions undergoing drug-eluting-stent implantation., Conclusions: The jailed balloon protection is a novel technique aimed at improving SB protection during provisional stenting of bifurcated lesions considered at high risk of SB compromise after MV stenting.

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.

Background: We speculated that elevated admission cardiac troponin T (cTnT) could predict worse microvascular function in patients with ST-elevation myocardial infarction who are managed with emergency percutaneous coronary intervention., Methods: In 27 patients with ST-elevation myocardial infarction, we obtained admission cTnT, angiography at the time of intervention, and cardiovascular magnetic resonance after 3 days., Results: Elevated admission cTnT was associated with a higher corrected Thrombolysis In Myocardial Infarction frame count (P = 0.04) and with a trend toward worse myocardial blush grade at the end of the procedure (P = 0.069), indicating a higher degree of microvascular obstruction. This was confirmed by its correlation with the size of perfusion defect seen at first-pass cardiovascular magnetic resonance (rho = 0.42, P = 0.028). In contrast, admission cTnT did not correlate with the amount of muscle necrosis as seen by delayed-enhancement cardiovascular magnetic resonance (rho = 0.12, P = 0.55)., Conclusion: Elevated admission cTnT predicts worse microvascular function in ST-elevation myocardial infarction patients managed with emergency percutaneous coronary intervention. Measuring admission cTnT might provide the interventionalist with useful information for selecting additional therapies that benefit coronary microcirculation.

Percutaneous coronary interventions (PCI) in patients with severely depressed left ventricular (LV) function and in those with chronic total occlusions are technically challenging and at high risk of complications. Here we report a case of successful retrograde transradial recanalization and stenting of a chronically occluded left main coronary artery (LMCA) from a saphenous vein graft supported by the Impella Recover LP 2.5 assist device.

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.

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., ((c) 2009 Wiley-Liss, Inc.)

Aims: Stent thrombosis (ST) is a major complication of percutaneous coronary interventions (PCIs). An invasive management by re-PCI is the commonly adopted treatment for ST, but data on outcome are limited., Methods and Results: We performed a 2-year multicentre registry enrolling consecutive patients with angiographically confirmed ST undergoing PCI. The primary angiographic endpoint was optimal angiographic reperfusion (TIMI 3 + blush grade 2 or 3). The primary clinical endpoints were death and major adverse coronary and cerebrovascular events (MACCEs) at 6 months. A total of 110 patients underwent 117 urgent PCI during the study. Patients with drug-eluting stent (DES) thrombosis, compared with those with bare metal stent (BMS) thrombosis, exhibited a higher rate of late or very late presentation and of anti-platelet therapy withdrawal. Optimal angiographic reperfusion was obtained in 64% of the patients. Death and MACCE rates at 6 months were 17 and 30%, respectively. Clinical outcome was similar for BMS and DES thrombosis. Very late ST, implantation of stent during PCI for ST, and failure to achieve optimal angiographic reperfusion were the independent predictors of 6-month mortality., Conclusion: DES and BMS thromboses have different clinical features, but a similar poor outcome. Indeed, PCI for ST is associated with a low rate of reperfusion and to a high rate of death and MACCE, calling for action in order to prevent its occurrence and to improve its management.

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.

Objectives: Stent thrombosis (ST) is a recognized complication of percutaneous coronary interventions (PCI). Due to the high thrombus burden present in ST, the use of thrombus aspiration (TA) may enhance the angiographic results by limiting distal embolization., Methods: Consecutive patients undergoing urgent PCI due to ST were studied, consisting of two groups according to the type of intervention (standard PCI [SP] or TA). TIMI flow, corrected TIMI frame count (cTFC), myocardial blush grade (MBG), thrombus score (TS), Yip's adverse thrombus burden features, occurrence of angiographically evident distal embolization (DE) were evaluated offline. In-hospital outcomes were also recorded., Results: Twenty-eight patients entered the study. Baseline clinical and angiographic features were similar between patients treated by SP (n = 12) and those treated by TA (n = 16). After PCI, a trend in favor of TA as compared to SP was observed for post-PCI TIMI 3 flow rate (67% vs. 89%; p = 0.10), final cTFC (31 +/- 35 vs. 17 +/- 21; p = 0.10) and MBG 2-3 rate (40% vs. 67%; p = 0.12). Accordingly, the rate of adverse angiographic outcome (post-PCI TIMI 0-1 flow and/or DE) was significantly lower in the TA as compared to SP: 5% (1 out of 18) vs. 33% (5 out of 15) respectively (p = 0.04). Throughout hospitalization, major adverse events occurred in 6% of TA patients vs. 33% of SP patients (p = 0.08)., Conclusions: TA in patients with ST is safe and is associated with better angiographic outcomes compared to standard PCI. Larger studies are warranted to confirm these early observations.

Objectives: To overview and summarize the results emerging from the studies on adjunctive devices (AD) with theoretical anti-embolic properties in patients with ST-elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary interventions (PCI)., Background: A series of small-to-medium size randomized studies have compared different AD with standard PCI (SP) in the setting of STEMI. The reported results are conflicting., Methods: Eighteen prospective randomized studies on 3180 STEMI patients comparing AD with SP were identified and entered the meta-analysis. Pre-specified angiographic, electrocardiographic (absence of ST-segment resolution, STR) and early (up to 30 days) clinical end-points were assessed., Results: AD were associated with lower rates of angiographically evident distal embolization: OR (95% CI): 0.54 (0.37-0.81). Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity among studies and an overall trend toward better results with AD: OR (95% CI) 0.76 (95% CI 0.51-1.12) for TIMI<3, 0.53 (0.37-0.76) for myocardial blush grade (MBG)<3, 0.60 (0.45-0.78) for absence of STR. Subgroup analysis according to the type of AD for the end-point of no STR showed concordant absence of benefit in studies testing distal protection devices, positive results being confined to the studies using thrombectomy devices (OR 0.46, 95% CI 0.32-0.66). However, the possibility of a "small study" bias within thrombectomy studies cannot be discharged (significant heterogeneity and positive Egger's test). Early major adverse cardiac events were not different between AD and SP., Conclusions: AD use may be associated with reduced rate of angiographic distal embolization, and improved MBG 3 and STR rates. However, efficacy might vary with the type of device employed. Moreover, early clinical outcome is not modified suggesting that further, larger, studies are needed to assess the clinical impact of AD., Condensed Abstract: We conducted a meta-analysis of 18 prospective randomized trials comparing adjunctive devices (AD) with standard PCI in the setting of STEMI. The use of AD was associated with lower rates of (angiographically evident) distal embolization. Analyses of angiographic and electrocardiographic reperfusion showed striking heterogeneity and an overall trend toward better results with AD. Subgroup analysis suggested that different types of device may have different effects. Early major adverse cardiac events were similar between AD and SP.

In order to avoid distal embolization in patients undergoing emergency percutaneous coronary intervention for ST-elevation myocardial infarction, both thrombectomy and distal protection devices have been evaluated with conflicting effects on myocardial perfusion. However, the removal of massive coronary thrombus is always problematic, and failure of standard approaches might result in severe microvascular damage. We report a case of the unusual use, in a "Fogarty-like" fashion, of the Spidertrade mark filter to trap and remove a large thrombus that was refractory to aspiration and balloon dilatation before stent implantation in a proximal, infarct-related coronary artery.

Background: A series of thrombectomy and distal filter devices have been developed to limit distal embolization during percutaneous coronary interventions (PCI)., Objective: To evaluate the feasibility of the combined use of thrombus-aspirating catheters and distal filter devices in patients at high risk of no-reflow., Methods: Thrombus aspiration (TA) and distal filter protection (DFP) were sequentially used in a series of patients undergoing urgent PCI within 48 hours of acute myocardial infarction (MI). Inclusion criteria were: (1) occlusion of the infarct-related artery; (2) at least 2 out of the 6 Yip's classification features of high thrombus burden. Coronary angiograms were evaluated off-line to assess thrombus score, coronary flow and distal embolization in different phases of the procedure., Results: TA followed by DFP prior to balloon dilatation or stent implantation was successfully performed in 20 patients with acute MI due to occlusion of de novo lesions (80%) or in-stent thrombosis (20%) located in a native coronary artery (90%) or a saphenous vein graft (10%). TA was associated with a significant acute reduction of TS and improvement of coronary flow (TIMI grade from 0.7 +/- 0.8 to 1.6 +/- 1.1; p = 0.004 and CTFC from 83 +/- 29 to 52 +/- 36; p = 0.006). This facilitated the deployment of DFP, which did not induce significant flow modification (TIMI grade: 2.3 +/- 0.9 pre-DFP placement vs. 2.2 +/- 1.0 post-DFP placement; p = 0.20; CTFC: 32 +/- 28 pre-DFP placement vs. 35 +/- 28 post-DFP placement; p = 0.47). Post-PCI angiography revealed a 90% TIMI 3 flow rate and 47% MBG 3 rate with only 1 case of angiographically evident distal embolization., Conclusions: Sequential use of TA and DFP may be successfully used during PCI in patients at very high risk of distal embolization. However, the possible benefits of such an approach should be weighted with the increased complexity of the procedure. Further evaluations of the clinical efficacy of this approach are needed.

Objectives: To describe a novel modification of the T-stenting technique and to report the bench test as well as the first clinical results obtained., Background: The best technique to treat bifurcated coronary lesions has not been defined., Methods: This novel modification of the T-stenting technique is based, after stenting of the main vessel (MV) and kissing balloon, on the intentional minimal protrusion of the side-branch (SB) stent within the MV. Final kissing balloon is performed using the balloon kept uninflated into the MV before SB stenting. The technique was tested in vitro and applied in two independent series of patients undergoing elective drug-eluting stent implantation on one bifurcated lesion. Bifurcated lesions were classified according to the Medina classification. Patients' outcome up to 9 month was prospectively assessed., Results: The bench test showed perfect coverage of the bifurcation with minimal stent's struts overlap at the proximal part of SB ostium and a small, single layer stent struts, neo-carina not affecting the MV patency. Seventy-three complex patients (67% of Medina 1,1,1 lesions; 44% of unprotected distal left main lesions) were treated with sirolimus-, paclitaxel-, or zotarolimus-eluting stents using the TAP technique. Procedural success was achieved in all cases and the clinical outcome up to 9 month was characterized by a low rate of clinically-driven target vessel revascularization (6.8%)., Conclusions: The TAP-stenting is a modification of the T-stenting technique which allows full coverage of bifurcated lesions and facilitates final kissing balloon. The first clinical experience suggests that this technique may be practical, thus calling for further evaluations of the technique., ((c) 2007 Wiley-Liss, Inc.)

Angiographic myocardial blush grade (MBG) is a potent predictor of long-term outcome after percutaneous treatment of myocardial infarction, yet little is known regarding the underlying pathophysiologic features. The relation between MBG and cardiovascular magnetic resonance (CMR)-defined amounts of necrosis and microvascular obstruction was examined in 27 patients. Another powerful prognostic indicator, ST-segment resolution>70%, was correlated with other predictors. Increasing MBG was associated (p=0.001) in a linear fashion (p<0.001) with less microvascular obstruction using CMR, whereas the inverse relation with amount of necrosis, although significant (p=0.043), was nonlinear (p=0.36). ST resolution was not correlated with either MBG or CMR parameters. In conclusion, MBG is mainly influenced by microvascular patency and is less dependent on the amount of muscle necrosis, and the common practice of including MBG 2 and 3 into a single "patent microcirculation" category might not be justified. Moreover, the mechanisms of ST resolution should be searched for at the cellular level.

Background: Systemic inflammation is involved in several pathological cardiovascular processes. However, whether it plays a role in the no-reflow phenomenon occurring in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI) is unknown., Methods: We studies 60 consecutive patients (59.5+/-12 years, 82% males) with a first ST-segment elevation AMI, treated by primary or rescue PCI within 6 h of symptom onset. Angiographic indexes of no-reflow, evaluated at the end of the procedure, included coronary TIMI flow grading, corrected TIMI frame count (c-TFC) and myocardial blush grade (MBG). ECG indexes of no-reflow included the lack of ST segment resolution (defined as a reduction <50% of the measured ST-segment elevation at 90 min, compared to the admission ECG), as analyzed both in the single lead with the maximal ST elevation and in all leads showing ST elevation on admission. Patients were divided into two groups according to baseline high-sensitivity C-reactive protein (CRP) serum levels measured on admission: high CRP group (CRP>5 mg/L) and low CRP group (CRP<5 mg/L)., Results: A similar prevalence of final TIMI flow<3 and MBG<3 was observed in patients with high and low CRP serum levels (30% vs. 12%, p=0.1, and 50% vs. 53%, p=1.0, respectively), and c-TFC was also similar in the two groups (26+/-4.5 vs. 24+/-6, p=0.5). Accordingly, the prevalence of lack of ST-segment resolution in the two groups was similar, both by the single-lead method (25% vs. 25%, p=1.0) and the multiple-lead method (29% vs. 19%, p=0.4)., Conclusion: In this study we failed to demonstrate any significant association between CRP serum levels on admission and coronary no-reflow, as assessed by both angiographic and ECG parameters in AMI patients treated by successful primary or rescue PCI within 6 h of chest pain onset.

Background: Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population., Methods: We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization)., Conclusions: The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.

Overlapping homogenous drug-eluting stents (DESs) may be used instead of overlapping bare metal stents (BMSs) to treat coronary lesions longer than available stents. Yet, no data are available on patients treated with overlapping heterogenous DESs or DESs and BMSs. We prospectively assessed 9-month clinical outcome and 6-month angiographic late loss (evaluated at 5 different lesion segments) in a consecutive series of 40 patients who received overlapping homogenous DESs (sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES]), heterogenous DESs (SES + PES), or overlapping DESs and BMSs. In 8 patients (7 with angiographic follow-up) with overlapping heterogenous DESs, no angiographic or clinical adverse event was observed. Moreover, in-segment late loss was similar to that of patients who received homogenous DESs. In 8 patients (7 with angiographic follow-up) with overlapping DESs and BMSs, there was a higher incidence of major adverse events (3 repeat percutaneous coronary interventions and 1 death, 50% adverse event rate) and worse in-segment binary restenosis rate compared with patients treated with homogenous or heterogenous DESs (p = 0.02 and 0.012, respectively). Late lumen loss at the site of stent overlap showed significant differences according to type of overlapped stent (1.00 +/- 0.76 mm in DES-BMS overlap, 0.32 +/- 0.55 mm in PES-PES overlap, 0.13 +/- 0.11 in SES-PES overlap, and 0.08 +/- 0.10 mm in SES-SES overlap, p = 0.005). In conclusion, the present study suggests that overlap of DESs and BMSs should be avoided because the antirestenotic effect of DESs is skewed by contiguous BMS implantation. Overlap between SESs and PESs in this very preliminary report was associated with no specific adverse event.