Several multicenter studies have suggested that in the above patients, an initial management strategy of PCI+MT does not reduce the long-term risk of cardiovascular events more effectively than initial MT only.

We conducted a randomized comparative study (JSAP [Japanese Stable Angina Pectoris] study) in the previously mentioned patients.

The patients were randomized to PCI+MT (n = 192) or initial MT only group (n = 192), and the patient characteristics were very similar in the 2 groups. During the 3.3-year follow-up, there was no significant difference in the cumulative death rate between PCI+MT (2.9%) and MT (3.9%). However, the cumulative risk of death plus acute coronary syndrome was significantly smaller in PCI+MT.

In stable low-risk CAD, PCI+MT may improve long-term prognosis more effectively than MT.

It is uncertain whether percutaneous coronary interventions (PCI) or coronary artery bypass grafting (CABG) surgery provides better clinical outcomes among patients with single-vessel disease of the proximal LAD.

We searched relevant databases (MEDLINE, EMBASE, and Cochrane from 1966 to 2006) to identify randomized controlled trials that compared outcomes for patients with single-vessel proximal LAD assigned to either PCI or CABG.

We identified 9 randomized controlled trials that enrolled a total of 1,210 patients (633 received PCI and 577 received CABG). There were no differences in survival at 30 days, 1 year, or 5 years, nor were there differences in the rates of procedural strokes or myocardial infarctions, whereas the rate of repeat revascularization was significantly less after CABG than after PCI (at 1 year: 7.3% vs. 19.5%; at 5 years: 7.3% vs. 33.5%). Angina relief was significantly greater after CABG than after PCI (at 1 year: 95.5% vs. 84.6%; at 5 years: 84.2% vs. 75.6%). Patients undergoing CABG spent 3.2 more days in the hospital than those receiving PCI (95% confidence interval: 2.3 to 4.1 days, p < 0.0001), required more transfusions, and were more likely to have arrhythmias immediately post-procedure.

In patients with single-vessel, proximal LAD disease, survival was similar in CABG-assigned and PCI-assigned patients; CABG was significantly more effective in relieving angina and led to fewer repeat revascularizations.

Data are limited regarding uniform evaluation of ST and the influence of clopidogrel continuation beyond 12 months on late events after DES treatment.

We identified 7,221 patients who received DES implantation (n = 3,160) or bare-metal stent (BMS) implantation (n = 4,061), and compared long-term adverse outcomes. Additionally, 2,851 patients with DES surviving 12 months without major events were analyzed according to clopidogrel continuation.

The adjusted-risk of overall ST was similar in the 2 groups. After 1 year, however, DES patients showed a higher risk of ST; definite/probable (hazard ratio [HR]: 3.55, 95% confidence interval [CI]: 1.26 to 9.99). The adjusted-risk of death (HR: 0.60, 95% CI: 0.46 to 0.79), death/myocardial infarction (HR: 0.63, 95% CI: 0.49 to 0.81), and target lesion revascularization (HR: 0.32, 95% CI: 0.24 to 0.43) were significantly lower in the DES group than in the BMS group. Continuing clopidogrel beyond 12 months was not associated with a reduced risk for ST (HR: 0.54, 95% CI: 0.07 to 4.23), death (HR: 1.20, 95% CI: 0.55 to 2.66), or death/myocardial infarction (HR: 1.16, 95% CI: 0.56 to 2.42) after DES implantation.

As compared with BMS, DES showed a similar risk of overall ST, but a higher risk of very late ST. The rates of death, death/myocardial infarction, and target lesion revasuclarization were significantly lower in the DES group. Clopidogrel continuation beyond 1 year did not appear to reduce ST and clinical events after DES implantation.

Time to reperfusion is a major determinant of mortality among STEMI patients. Rapid initiation of fibrinolytic therapy can shorten time to reperfusion, and mechanical therapy of the culprit lesion is known to be beneficial.

Data from 2,869 STEMI patients treated in 5 high-volume percutaneous coronary intervention (PCI) centers were pooled for analysis. Mortality at 30 days was the primary end point. Death, reinfarction, and stroke were secondary end points, as were infarct-related artery TIMI (Thrombolysis In Myocardial Infarction) flow grade before PCI and shock on arrival to the catheterization laboratory.

Compared to PPCI, mortality at 30 days was significantly lower with FAST-PCI (3.8% vs. 6.4%, p = 0.002). The combined triple end point of death, reinfarction, or stroke was also less frequent (5.1% vs. 8.9%, p < 0.0001). The FAST-PCI patients had a lower incidence of Killip class IV (5.6% vs. 10.9%, p < 0.0001) and higher infarct-related artery TIMI flow grades (2.1 ± 1.2 vs. 1.1 ± 1.3, p < 0.0001) upon arrival in the catheterization laboratory. Stepwise logistic regression analysis demonstrated that FAST-PCI was an independent predictor of 30-day mortality (relative risk = 0.542, p = 0.0151).

The FAST-PCI strategy reduced the mortality and combined end point of death, reinfarction, and stroke among STEMI patients, without increasing the risk of stroke or bleeding, compared to PPCI. Fibrinolysis before hospital admission also increased the initial infarct-related artery patency and decreased the likelihood of shock at presentation.

Previous studies in patients with acute coronary syndromes suggest that the impact of infarct-related artery recanalization on clinical outcome is greatest in patients at highest risk.

Of 2,201 patients (age 58.6 ± 11.0 years) with infarct-related artery occlusion on days 3 to 28 after myocardial infarction in the OAT (Occluded Artery Trial) study, 1,101 were assigned to percutaneous coronary intervention (PCI) and 1,100 to medical therapy alone and followed for a mean of 3.2 years. The primary end point was a composite of death, reinfarction, or New York Heart Association functional class IV heart failure. Interaction of treatment effect with tertiles of predicted survival were examined using the Cox survival model.

The 5-year rate for the primary end point was 18.9% versus 16.1% for patients assigned to PCI and medical treatment alone, respectively (hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.92 to 1.43, p = 0.23). Lack of benefit of PCI was consistent across the risk spectrum for both the primary end point and total mortality, including for the highest tertile (33.9% PCI vs. 27.3% medical treatment alone, HR: 1.27, 99% CI: 0.87 to 1.85 primary end point and 23.5% PCI vs. 21.7% medical treatment alone, HR: 1.16, 99% CI: 0.73 to 1.85 mortality). The independent predictors of the composite outcome were history of heart failure (HR: 2.06, p < 0.001), peripheral vascular disease (HR: 1.93, p = 0.001), diabetes (HR: 1.49, p = 0.002), rales (HR: 1.88, p < 0.001), decreasing ejection fraction (HR: 1.48 per 10%, p < 0.001), decreasing days from myocardial infarction to randomization (HR: 1.04 per day, p < 0.001), and decreasing glomerular filtration rate (HR: 1.11 per 10 ml/min/1.73 m², p < 0.001).

In the OAT study, there was no variation in the effect of PCI on clinical outcomes at different levels of patient risk, including the subset with very high event rates. (Occluded Artery Trial [OAT]; NCT00004562)

The ZoMaxx stent system elutes 10 µg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.

Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.

After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 ± 0.57 mm vs. 0.45 ± 0.48 mm; p < 0.001; in-segment 0.43 ± 0.60 mm vs. 0.25 ± 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).

After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Inflammatory responses to polymers and delayed healing remain important safety issues associated with CDES. Whether nonpolymeric stents that elute sirolimus or sirolimus and estradiol provoke less inflammation and heal better is unknown.

Twenty-eight rabbits received 2 overlapping stents in each iliac artery: SES, SES+ED, BMS, or CDES, and vessels were harvested at 28 days for histology and scanning electron microscopy.

Although similar at nonoverlapping segments, neointimal thickness within the overlap site of CDES was significantly less than in SES, SES+ED, and BMS (0.07 ± 0.04 mm vs. 0.16 ± 0.03 mm, 0.14 ± 0.03 mm, and 0.15 ± 0.03 mm, p < 0.0001). Endothelialization was greater in SES, SES+ED, and BMS compared with CDES in nonoverlapping sections (80.0 ± 5.0% vs. 95.3 ± 5.0%, 97.5 ± 2.5%, and 96.7 ± 3.8%; p = 0.0028) and overlapping sections (85.8 ± 2.9% vs. 90.8 ± 6.3%, 89.2 ± 6.3%, and 48.3 ± 2.9%; p < 0.0001). The number of luminal eosinophils was also less in overlapping sections of SES, SES+ED, and BMS versus CDES but was similar in nonoverlapping sections.

Polymer-free stents coated with SES or SES+ED result in less robust neointimal suppression but markedly improved arterial healing compared with CDES in the rabbit model.

Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 µm).

In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and ≤14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up.

Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 ± 0.32 mm and 9.98 ± 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 ± 0.25 mm and percent of stent obstruction was 2.8 ± 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered.

The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

Septal ablation is an alternative therapy for patients with obstructive hypertrophic cardiomyopathy (HCM). However, its beneficial effect on diastolic function, by relieving the systolic contraction load, may be countered by adverse effects from the infarction on left ventricular mechanics.

Using high-fidelity, micromanometer-tipped catheters, we examined 40 HCM patients by taking direct measurements of the left ventricular outflow tract (LVOT) gradient, time constant of myocardial relaxation (tau), and left atrial pressure (LAP) before and after septal ablation.

Although there was an overall reduction in LVOT gradient, septal ablation resulted in variable changes in myocardial relaxation and left atrial pressure. In 20 patients (50%), LAP increased. The magnitude of LVOT gradient reduction directly correlated with the effects of septal ablation on LAP (R = 0.58; p < 0.0001). Those patients with a greater decrease in the LVOT gradient had better improvement in direct LAP. Furthermore, those patients with a larger decrease in left ventricular outflow tract gradient had a beneficial enhancement of ventricular relaxation, as measured by tau (R = 0.43; p = 0.006). Thus, the beneficial enhancement of relaxation was directly related to improvement in LAP (R = 0.75; p < 0.0001).

Septal ablation results in variable effects on left ventricular filling pressure, which are dependent upon the magnitude of reduction in the LVOT gradient. These effects are mediated in part by effects of ablation on myocardial relaxation. These findings shed insight into the pathophysiologic effects of septal reduction therapy in patients with HCM.

There are inadequate data on the long-term outcome of ASA for symptomatic hypertrophic obstructive cardiomyopathy (HOCM).

Six hundred and twenty-nine patients were enrolled consecutively (1996 to 2007) and 98.4% (n = 619) underwent ASA with 92% follow-up in 2007. Evaluation included deaths, procedural complications, pacemaker requirement, repeat ASA, and myectomy/valve surgery. Follow-up parameters included angina (Canadian Cardiovascular Society score), dyspnea (New York Heart Association functional class), exercise time, and echocardiographic indices (septal thickness, ejection fraction, resting and provoked gradients).

Ethanol (2.6 ± 1.0 ml) was injected into 1.3 ± 0.5 septal arteries, inducing a septal infarct. Complications included death 1% (n = 6), permanent pacemaker requirement 8.2% (n = 52), coronary dissection 1.3% (n = 8), and worsening mitral regurgitation 0.3% (n = 2). The mean follow-up was 4.6 ± 2.5 years (range: 3 months to 10.2 years). During follow-up, New York Heart Association functional class decreased from 2.8 ± 0.6 to 1.2 ± 0.5 (p < 0.001); Canadian Cardiovascular Society angina score decreased from 2.1 ± 0.9 to 1.0 ± 0 (p < 0.001); and exercise time increased from 4.8 ± 3.3 to 8.2 ± 1.0 (p < 0.001) min. The resting and provoked left ventricular outflow tract gradients decreased progressively (p < 0.001) and remained low during follow-up. The septal thickness decreased from 2.1 ± 0.5 cm to 1.0 ± 0.1 cm (p < 0.001) and the ejection fraction decreased from 68 ± 9% to 62 ± 3% (p < 0.001). The survival estimates at 1, 5, and 8 years were 97%, 92%, and 89%, respectively.

The initial benefits of ASA were maintained during follow-up.

Predominantly clinically silent cerebral ischemia has been observed in up to 50% of patients undergoing emboli-protected CAS. The timing and location of cerebral ischemia has not been sufficiently elucidated.

In 58 patients (69.6 ± 8.3 years) who underwent 59 procedures, diffusion-weighted magnetic resonance imaging (DWMRI) was performed before the intervention and at 2 time points (t ₁ and t ₂) after the intervention.

No patient showed recent cerebral injury before CAS. At t ₁ = 3.5 ± 1.8 h, new ischemic foci, all located in the ipsilateral hemisphere, were observed in 12 of 59 DWMRI studies (20.3%, 95% confidence interval: 11.0% to 32.8%). At t ₂ = 18.0 ± 3.1 h, 7 more DWMRI scans showed recent ischemic foci, and 3 scans in patients with positive scans at t ₁ showed additional foci, for a total of 10 scans (17.0%, 95% confidence interval: 8.4% to 29.0%) documenting late cerebral ischemia. In 4 of these (40%), ischemic foci were located contralaterally. Cerebral ischemia was not associated with overt neurological sequelae out to 30 days in any patient.

The incidence of late cerebral ischemia occurring between 3.5 and 18 h after emboli-protected CAS was 17%. It may occur with equal likelihood in either hemisphere. Preventive measures to possibly reduce the incidence of cerebral embolization should focus not only on the target lesion, but also on the access vasculature. Patients should be monitored and DWMRI delayed for at least 18 h after the intervention.

Despite clinicians' growing experience with THV procedures, the best method of annulus sizing remains unclear.

Twenty-three patients with aortic stenosis (<1.0 cm²) who were undergoing surgical valve replacement were enrolled. Pre-operative echocardiographic measurements of the annulus and computed tomography measurements of valve calcium were made. Intraoperatively, a valvuloplasty balloon of known size and inflatable pressure was inserted into the aortic valve and inflated. The development of intraballoon pressure in addition to the nominal inflation pressure (AIBP) reflected the apposition of balloon and valve. Surgical annulus was measured by cylindrical sizers.

In patients with tricuspid valves, AIBP was generated in 11 of 12 patients when the balloon diameter was greater than the surgically measured annulus, regardless of leaflet calcification (2 of 10 patients when balloon ≤ surgical annulus). In bicuspid valves, high AIBP (~1 atm) was encountered with balloons that were within 1 mm of annulus size, and leaflet dehiscence occurred with larger balloons (n = 2 patients). Annulus size was underestimated by transthoracic echocardiogram and transesophageal echocardiogram compared with surgery (p < 0.001): transthoracic echocardiogram = 21.5 ± 1.8 mm, transesophageal echocardiogram = 22.0 ± 1.6 mm and surgical = 23.2 ± 1.9 mm (range 20 to 27 mm, mode 22 mm).

These data suggest that measuring AIBP during balloon aortic valvuloplasty in tricuspid valves is an important adjunctive measurement of the aortic annulus and may help in determining the appropriate THV size.

Although the strategy of provisional side-branch stenting is widely accepted for suitable bifurcation lesions, there is no consensus on the best option for elective stenting with 2 stents. The crush technique has the potential to scaffold and apply the drug to the side-branch ostium where restenosis is most common.

Sequential steps of crush stent deployment and post-dilation were undertaken in silicone phantoms and recorded on cine angiography and microcomputed tomography. We assessed the effect of deployment strategies, post-dilation strategies, and cell size on side-branch ostial area.

Side-branch ostial coverage by metal struts was 53% (95% confidence interval [CI]: 46 to 59) after 1-step kissing post-dilation and was reduced by 2-step kissing post-dilation to 33% (95% CI: 28 to 37; p < 0.0001). Although the residual stenosis after the classical crush strategy was 47% (95% CI: 39 to 53), it was 36% (95% CI: 31 to 40; p = 0.002) after mini-crush deployment. Stents with larger cell size (>3.5 mm diameter) had a residual stenosis of 37% (95% CI: 32 to 42) after crush deployment that was less than the residual stenosis for stents with smaller cell size (52%; 95% CI: 44 to 60; p < 0.0001).

Side-branch ostial stenosis after crush stenting was minimized by mini-crush deployment, 2-step kissing post-dilation, and the use of stents with larger cell size. It is unknown if optimizing stent deployment at bifurcation lesions will reduce clinical stent thrombosis and restenosis.

In comparison with simple stenoses, successful percutaneous intervention for coronary bifurcation lesions is limited by a higher incidence of procedural complications and need for repeat revascularization. The ideal strategy to overcome these limitations remains to be demonstrated while recent controversy surrounds the long-term safety of DES in bifurcations.

Consecutive patients treated for bifurcation lesions using DES were studied in a prospective single-center registry. Between 2003 to 2005, 477 procedures were performed. The PTS strategy was used in 92%, with a side-branch stent in 28% and final kissing balloon inflation in 95%.

Angiographic success was achieved in 99% with 2.5% in-hospital major adverse cardiac events. The cumulative rate of major adverse cardiac events was 10.7% at 1 year and 13.6% at 2 years, including 6.9% and 8.9% target vessel revascularization. Deviation from the PTS strategy independently predicted 2-year mortality (odds ratio: 5.5 [95% confidence interval: 1.63 to 18.3], p < 0.01). The rate of definite or probable stent thrombosis at 2 years was 2.5% with half of all events occurring before hospital discharge.

The PTS strategy for the treatment of bifurcation lesions is applicable to over 90% of patients in the real world. With DES, both safety and efficacy have been demonstrated in the long-term with <10% need for repeat revascularization in the first 2 years and a low incidence of late stent thrombosis.

Practice guidelines recommend an early invasive management strategy for NSTE ACS, but revascularization procedures may not always be performed after early angiography, even when significant coronary artery disease is present.

We evaluated 8,225 intermediate- to high-risk NSTE ACS patients with at least 1 coronary lesion >50% stenosis on early angiography from the SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors) trial (2001 to 2003), comparing patients treated with conservative medical management with those who underwent in-hospital percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 7 days of randomization.

A total of 2,633 patients (32%) were medically managed, 4,294 (52%) underwent PCI, and 1,298 (16%) underwent CABG. The strongest independent predictors of conservative medical management versus any intervention were prior CABG, lower body weight, lack of a reinfarction between randomization and catheterization, and 3-vessel disease. With conservative medical management, the cumulative risk of 1-year mortality after discharge increased rapidly during the first 90 days and thereafter remained higher at 7.7% compared with that seen in patients treated with PCI (3.6%) or CABG (6.2%).

One-third of patients with NSTE ACS and significant coronary disease on early angiography were managed without in-hospital revascularization in the SYNERGY trial, and these patients had an increased risk of late mortality. These findings highlight the need for novel treatment approaches for NSTE ACS patients who are not candidates for revascularization. (SYNERGY trial; NCT00043784)

There are few current data on the use and outcomes of the radial approach to PCI (r-PCI) in clinical practice.

Data from 593,094 procedures in the National Cardiovascular Data Registry (606 sites; 2004 to 2007) were analyzed to evaluate trends in use and outcomes of r-PCI. Logistic regression was used to evaluate the adjusted association between r-PCI and procedural success, bleeding complications, and vascular complications. Outcomes in elderly patients, women, and patients with acute coronary syndrome were specifically examined.

Although the proportion of r-PCI procedures has recently increased, it only accounts for 1.32% of total procedures (n = 7,804). Compared with the femoral approach, the use of r-PCI was associated with a similar rate of procedural success (adjusted odds ratio: 1.02 [95% confidence interval: 0.93 to 1.12]) but a significantly lower risk for bleeding complications (odds ratio: 0.42 [95% confidence interval: 0.31 to 0.56]) after multivariable adjustment. The reduction in bleeding complications was more pronounced among patients <75 years old, women, and patients undergoing PCI for acute coronary syndrome.

The use of r-PCI is rare in contemporary clinical practice, but it is associated with a rate of procedural success similar to the femoral approach and with lower rates of bleeding and vascular complications, even among high-risk groups. These results suggest that wider adoption of r-PCI in clinical practice may improve the safety of PCI.

Percutaneous closure of PFO is usually aided by transesophageal echocardiography or ICE. This may be unnecessary where anatomical features are straightforward.

Patients were excluded from standby ICE if they had adverse anatomical features on their diagnostic transoesophageal echocardiogram, a device other than Amplatzer (AGA Medical, Plymouth, Minnesota), STARflex (NMT Medical, Boston, Massachusetts), or BioSTAR (NMT Medical) were to be used, or they were in a clinical trial demanding ICE/transesophageal echocardiography. Procedurally, defect diameter >15 mm on balloon sizing and tunnel length >12 mm warranted ICE guidance.

Between April 2006 and October 2007, 124 patients underwent PFO closure. Fifty-four were excluded from standby ICE due to trial protocols (n = 22), hybrid atrial septal defect/PFO (n = 6), additional defect (n = 4), exuberant aneurysm (n = 3), or other device (n = 19, all HELEX, Gore Medical, Flagstaff, Arizona). The remaining 70 patients were age 38.1 ± 6.4 years, 49% men. Primary indication for PFO closure was stroke (n = 46, 65%), transient ischemic attack (n = 22, 31%), or decompression illness (n = 2, 3%). Sixty-four (91%) underwent contrast fluoroscopic PFO closure alone. Six patients (9%) converted to ICE-controlled closure: PFO sized to >15 mm (n = 2); difficulties crossing PFO (n = 2), or long tunnel requiring transseptal puncture (n = 2). All 70 patients had procedural success without significant complications. Procedure duration and cost favored standby ICE.

PFO closure can, in the majority of cases, be performed safely using contrast media and fluoroscopy alone. Standby ICE facilitates closure in the remaining patients during the index procedure.

The optimal treatment for acute type B dissection is still a matter of debate.

Information on 290 clinical variables were compared, including demographics; medical history; clinical presentation; physical findings; imaging studies; details of medical, surgical, and endovascular management; in-hospital clinical events; and in-hospital mortality.

Of the 571 patients with acute type B aortic dissection, 390 (68.3%) were treated medically, 59 (10.3%) with standard open surgery and 66 (11.6%) with an endovascular approach. Patients who underwent emergency endovascular or open surgery were younger (mean age 58.8 years, p < 0.001) than their counterparts treated conservatively, and had male preponderance and hypertension in 76.9%. Patients submitted to surgery presented with a wider aortic diameter than patients treated by interventional techniques or by medical therapy (5.36 ± 1.7 cm vs. 4.62 ± 1.4 cm vs. 4.47 ± 1.4 cm, p = 0.003). In-hospital complications occurred in 20% of patients subjected to endovascular technique and in 40% of patients after open surgical repair. In-hospital mortality was significantly higher after open surgery (33.9%) than after endovascular treatment (10.6%, p = 0.002). After propensity and multivariable adjustment, open surgical repair was associated with an independent increased risk of in-hospital mortality (odds ratio: 3.41, 95% confidence interval: 1.00 to 11.67, p = 0.05).

In the International Registry of Acute Aortic Dissection, the less invasive nature of endovascular treatment seems to provide better in-hospital survival in patients with acute type B dissection; larger randomized trials or comprehensive registries are needed to access impact on outcomes.

Drug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied.

The STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses.

Drug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus "on-label" use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months.

Off-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients.

The cardiac biomarkers, creatine kinase (CK), CK-MB, and troponins T and I are routinely measured after myocardial infarction. However, their correlation with functional and clinical outcomes after PCI for STEMI is not well established.

In the EVOLVE (EValuation Of MCC-135 for Left VEntricular Salvage in Acute Myocardial Infarction) trial, patients were randomized to receive intracellular calcium modulator as adjunct to primary PCI for first large STEMI. Cardiac biomarker levels were determined in 378 patients before PCI and serially up to 72 h. Single-photon emission computed tomography was performed after 5 and 30 days, and patients were monitored up to 180 days.

All single time-point, peak, and area under time-concentration curve of CK, CK-MB, and troponins T and I after PCI significantly correlated with infarct size and LVEF. In particular, 72-h troponin I (TnI72h) correlated strongly with 5-day and 30-day infarct size (r > 0.70; p < 0.001). A TnI72h threshold >55 ng/ml was 90% sensitive for large infarct size (≥10%) and low LVEF (≤40%) with specificities of 70% and 52%, respectively (c = 0.88, 0.81; p < 0.001). The highest TnI72h tertile was associated with increased 180-day composite clinical events (23% vs. 23% vs. 42%; p = 0.001) and independently predicted adverse events (hazard ratio = 2.3; p = 0.01).

Assessing TnI72h after primary PCI is a simple, effective method to estimate infarct size, LVEF, and potentially useful for risk stratification.

Distal embolization during primary PCI results in reduced myocardial perfusion and poor clinical outcomes.

The VAMPIRE (VAcuuM asPIration thrombus REmoval) study was a prospective, randomized, controlled multicenter trial conducted in 23 institutions. Patients (N = 355) presenting within 24 h of STEMI symptoms onset were randomized to primary PCI with (n = 180) or without (n = 175) upfront thrombus aspiration using Nipro's TransVascular Aspiration Catheter (Osaka, Japan).

The TransVascular Aspiration Catheter reached the lesion in 100% of cases. It successfully crossed the target obstruction in 86% without any delay in procedure time or time to reperfusion; whereas macroscopic thrombi were removed in 75% of the cases. Procedure success was similar between groups (98.9% vs. 98.3%). There was a trend toward lower incidence of slow or no reflow (primary end point—defined as a Thrombolysis In Myocardial Infarction flow grade <3) in patients treated with aspiration versus conventional primary PCI (12.4% vs. 19.4%, p = 0.07). Rate of myocardial blush grade 3 was higher in the aspiration group (46.0% vs. 20.5%, p < 0.001). Aspiration was most effective in patients presenting after 6 h of symptoms onset (slow flow rate: 8.1% vs. 37.6%, p = 0.01).

This study suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI. The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.

Because surgical myectomy is the preferred treatment in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM) at our institution, we perform ASA in patients who are at high risk for surgery.

We studied 55 symptomatic HOCM patients (mean age 63 ± 13 years, 67% women, mean follow-up 8 ± 1 years), at high risk for surgery (as the result of age/comorbidities) who had ASA between 1997 and 2000. The following were recorded at baseline, 3 months, and 1 year: septal thickness, maximal (resting or provocable) left ventricular outflow tract gradient, Minnesota living with heart failure questionnaire score, and the presence of a permanent pacemaker. All-cause mortality was recorded.

No patients died at 48 h, 2 died at 1 year, 7 died at 5 years, and 13 died at 10 years. Only age >65 years at time of ASA predicted long-term mortality (log-rank p = 0.03). Mean maximal left ventricular outflow tract gradient (104 ± 35 mm Hg vs. 49 ± 28 mm Hg), septal thickness (2.4 ± 0.4 cm vs. 1.8 ± 0.6 cm), and Minnesota living with heart failure score (63 vs. 25) improved at 3 months, compared with baseline (all p < 0.001), with no significant changes at 1 year. New permanent pacemaker was present in 26% of patients.

In symptomatic HOCM patients who are at high risk for surgery, ASA is associated with symptomatic improvement and low short-term mortality; with long-term mortality only associated with older age at time of procedure. In symptomatic HOCM patients at high-risk for surgery, ASA is a viable option.

Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.

We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.

Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).

At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.

Pathophysiologic studies suggest that the use of DES for STEMI may be associated with stent thrombosis and increased clinical events. However, although short-term data exist, long-term follow-up is lacking.

Patients who presented with STEMI from January 2002 to May 2007 to our institution were included. In addition to multivariable adjusted analysis, propensity analysis for stent choice was performed. The primary end point was the composite of death or target lesion revascularization (TLR).

Of the 804 patients, 699 underwent stenting and met our study criteria. There were 152 composite events over a median follow-up of 1.7 years. In a multivariable Cox model, DES use was associated with a trend toward lower death or TLR compared with BMS (adjusted hazard ratio [HR] 0.72, 95% confidence interval [CI], 0.50 to 1.02, p = 0.06). However, this was mainly due to lower TLR (adjusted HR 0.60, 95% CI, 0.36 to 0.98, p = 0.043). Similarly, DES was associated with a trend toward lower death or TLR compared with BMS in the propensity-matched patients (adjusted HR 0.65, 95% CI 0.42 to 1.00, p = 0.05). This was mainly due to lower TLR in the DES patients (adjusted HR 0.52, 95% CI 0.28 to 0.96, p = 0.04).

Both DES and BMS are effective in the setting of STEMI; however, DES is associated with lower TLR without an increase in all-cause mortality.

Expert guidelines recommend coronary artery bypass graft (CABG) surgery for the treatment of significant stenosis of the unprotected left main coronary artery (ULMCA) if the patient is eligible for CABG; however, treatment by percutaneous coronary intervention (PCI) is common.

Details of patients (n = 343, ages 69.9 ± 11.9 years) undergoing coronary revascularization for ULMCA stenosis (April 2003 to January 2007) were recorded. A total of 223 patients were treated with CABG (mean [interquartile range]: follow-up 600 [226 to 977) days) and 120 by PCI (follow-up 362 [192 to 586) days). The hazard ratios (HRs) for death and major adverse cardiovascular and cerebrovascular events (MACCE) were calculated incorporating propensity score adjustment. Survival comparisons were conducted in propensity-matched subjects (n = 134), and in low- and high-risk subjects for CABG.

Patients treated by PCI were more likely to be ≥75 years of age (49% vs. 33%; p = 0.005), and of greater surgical risk (Parsonnet score 17.2 ± 11.2 vs. 13.0 ± 9.3; p < 0.001) than patients treated by CABG. Overall, the propensity-adjusted HR for death was not statistically different (HR 1.93, 95% confidence interval [CI] 0.89 to 4.19, p = 0.10), but MACCE was greater in the PCI group (HR 1.83, 95% CI 1.01 to 3.32, p = 0.05). In propensity-matched individuals, neither survival nor MACCE-free survival were different. Survival was equivalent among low-risk candidates, but PCI had a tendency to inferior survival in high-risk candidates (Ellis category IV, log-rank p = 0.05). Interaction testing, however, failed to demonstrate a difference in outcomes of the 2 revascularization techniques as a function of baseline risk assessment.

Overall, the propensity-adjusted risk of mortality for treatment of ULMCA disease does not differ between PCI- and CABG-treated groups. There appears to be sufficient equipoise that a randomized clinical trial to compare the techniques would not be ethically contraindicated.

Percutaneous coronary intervention of degenerative SVG is associated with embolization of atherothrombotic debris and subsequent myocardial infarction in a significant portion of patients. The use of distal embolic-protection devices has previously been demonstrated to reduce major adverse cardiovascular events associated with PCI in these patients.

In this multicenter, randomized noninferiority trial, 797 patients undergoing PCI with stenting of SVG stenoses (de novo or restenotic) with reference vessel diameter 2.5 mm to 5.25 mm were randomly assigned 2:1 to either the Interceptor PLUS (n = 533) or control distal-protection devices (GuardWire [n = 191], FilterWire EZ [n = 73]) at the physician's discretion.

The trial primary clinical end point (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was observed in 8% and 7.3% of Interceptor and control-treated patients, respectively (p = 0.025 for noninferiority; p = 0.77 for difference). Key secondary end points for device and procedural success were similar between randomly assigned treatment strategies.

The Interceptor PLUS Coronary Filter System is noninferior in safety and efficacy to 30 days when compared with the GuardWire and FilterWire EZ distal embolic protection devices.

Distal embolization is common during percutaneous coronary intervention in ST-segment elevation myocardial infarction and can induce impaired myocardial perfusion. Several aspiration thrombectomy devices have been introduced to prevent distal embolization, however, with conflicting clinical results. Currently, it is unclear to what extent this variance in outcome can be explained by device-related factors, such as internal lumen size.

We performed a prospective cohort study in which patients undergoing primary percutaneous coronary intervention were treated with a large-internal-lumen catheter (Diver, Invatec, Roncadelle, Italy). Outcomes were compared with a matched population of the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) trial, in which patients were treated with a medium-sized catheter (Export, Medtronic, Minneapolis, Minnesota). A histopathological analysis was performed of retrieved material.

A total of 160 patients, treated with the Diver (n = 80) or Export (n = 80) aspiration catheter, were enrolled. Effective thrombus aspiration was seen in 70.3% of the patients treated with the Diver catheter versus 81.8% with the Export catheter (p = 0.10) No significant difference was found in myocardial blush grade or electrocardiographic outcome between the 2 devices. Size distribution of retrieved thrombotic particles was similar per device. Erythrocyte-rich thrombi were found in 34.8% of the cases and were predominately seen in patients with low initial Thrombolysis In Myocardial Infarction flow grade (p = 0.008).

A larger internal lumen diameter does not result in retrieval of larger thrombotic particles, nor in improved angiographic or electrocardiographic outcomes.

Distal embolization is a major complication of PCI. The Doppler guidewire (DGW) can detect the embolic particles as high-intensity transient signals (HITS) during the PCI procedure.

We prospectively studied 37 patients with acute myocardial infarction (MI). Under monitoring with the DGW, we performed first and second balloon angioplasty, followed by stenting and post-high-pressure dilatation. Left ventricular ejection fraction (LVEF) (%) and regional wall motion (RWM) (standard deviation/chord) were measured on days 1 and 22.

The HITS were detected in 35 of 37 patients. The number of HITS was the greatest after stenting (16 ± 18) followed by first balloon inflation (5 ± 4). There was a significant correlation between the total number of HITS and the corrected Thrombolysis In Myocardial Infarction frame count (r = 0.52, p = 0.003) and a significant weak inverse correlation between the total number of HITS and changes in LVEF and RWM (r = 0.37, p = 0.03 and r = 0.35, p = 0.04, respectively).

Distal embolization is common during PCI in patients with acute MI, and the majority of HITS were observed after stenting. An increase in the total number of HITS is associated with reduced coronary blood flow, and is weakly associated with poor recovery of left ventricular function.