Search

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world’s leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.

Supplemental Digital Content is available in the text., Background: The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear. Methods: In the investigator-initiated, randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. Results: Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio [HR], 0.83 [95% CI, 0.60–1.15]; and HR, 0.88 [95% CI, 0.60–1.30], respectively) or without OAC indication (n=2913; HR, 1.01 [95% CI, 0.77–1.33]; or HR, 1.06 [95% CI, 0.79–1.44]; Pinteraction=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 [95% CI, 0.62–1.12]) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 [95% CI, 0.41–0.74]; Pinteraction=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 [95% CI, 0.33–0.69]; Pinteraction=0.021). Conclusions: Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.

Background: Ten-year all-cause death according to incomplete (IR) versus complete revascularization (CR) has not been fully investigated in patients with 3-vessel disease and left main coronary artery disease undergoing percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). Methods: The SYNTAX Extended Survival study (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]) evaluated vital status up to 10 years in patients who were originally enrolled in the SYNTAX trial. In the present substudy, outcomes of the CABG CR group were compared with the CABG IR, PCI CR, and PCI IR groups. In addition, in the PCI cohort, the residual SYNTAX score (rSS) was used to quantify the extent of IR and to assess its association with fatal late outcome. The rSS of 0 suggests CR, whereas a rSS>0 identifies the degree of IR. Results: IR was more frequently observed in patients with PCI versus CABG (56.6% versus 36.8%) and more common in those with 3-vessel disease than left main coronary artery disease in both the PCI arm (58.5% versus 53.8%) and the CABG arm (42.8% versus 27.5%). Patients undergoing PCI with CR had no significant difference in 10-year all-cause death compared with those undergoing CABG (22.2% for PCI with CR versus 24.3% for CABG with IR versus 23.8% for CABG with CR). In contrast, those with PCI and IR had a significantly higher risk of all-cause death at 10 years compared with CABG and CR (33.5% versus 23.7%; adjusted hazard ratio, 1.48 [95% CI, 1.15–1.91]). When patients with PCI were stratified according to the rSS, those with a rSS≤8 had no significant difference in all-cause death at 10 years as the other terciles (22.2% for rSS=0 versus 23.9% for rSS>0–4 versus 28.9% for rSS>4–8), whereas a rSS>8 had a significantly higher risk of 10-year all-cause death than those undergoing PCI with CR (50.1% versus 22.2%; adjusted hazard ratio, 3.40 [95% CI, 2.13–5.43]). Conclusions: IR is common after PCI, and the degree of incompleteness was associated with 10-year mortality. If it is unlikely that complete (or nearly complete; rSS Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT00114972. URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03417050.

Background— There is a paucity of data on the use of optimal medical therapy (OMT) in patients with complex coronary artery disease undergoing revascularization with percutaneous coronary intervention or coronary artery bypass grafting (CABG) and its long-term prognostic significance. Methods and Results— The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial is a multicenter, randomized, clinical trial of patients (n=1800) with complex coronary disease randomized to revascularization with percutaneous coronary intervention or CABG. Detailed drug history was collected for all patients at discharge and at the 1-month, 6-month, 1-year, 3-year, and 5-year follow-ups. OMT was defined as the combination of at least 1 antiplatelet drug, statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker. Five-year clinical outcomes were stratified by OMT and non-OMT. OMT was underused in patients treated with coronary revascularization, especially CABG. OMT was an independent predictor of survival. OMT was associated with a significant reduction in mortality (hazard ratio, 0.64; 95% confidence interval, 0.48–0.85; P =0.002) and composite end point of death/myocardial infarction/stroke (hazard ratio, 0.73; 95% confidence interval, 0.58–0.92; P =0.007) at the 5-year follow-up. The treatment effect with OMT (36% relative reduction in mortality over 5 years) was greater than the treatment effect of revascularization strategy (26% relative reduction in mortality with CABG versus percutaneous coronary intervention over 5 years). On stratified analysis, all the components of OMT were important for reducing adverse outcomes regardless of revascularization strategy. Conclusions— The use of OMT remains low in patients with complex coronary disease requiring coronary intervention with percutaneous coronary intervention and even lower in patients treated with CABG. Lack of OMT is associated with adverse clinical outcomes. Targeted strategies to improve OMT use in postrevascularization patients are warranted. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00114972.

Background— The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. Methods and Results— Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained Conclusions— For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. Clinical Trial Registration— URL: www.clinicaltrials.gov . Unique identifier: NCT00114972.

Background— The residual Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) Score is an objective measure of the degree and complexity of residual stenosis after percutaneous coronary intervention (PCI). Methods and Results— In the randomized PCI cohort of the SYNTAX Trial (n=903), the baseline and residual SYNTAX Scores were calculated. Subjects with a residual SYNTAX Score of 0 were defined as having undergone complete revascularization (CR), and a residual SYNTAX Score >0 as incomplete revascularization (ICR). Five-year clinical outcomes were stratified by CR and ICR (tertiles of the residual SYNTAX Score: >0–4, >4–8, and >8). In the PCI cohort, the mean baseline and residual SYNTAX Scores were 28.4±11.5 and 4.5±6.9, respectively. The mean Δ SYNTAX Score (representative of the burden of disease removed by PCI) was 23.8±10.9. The residual SYNTAX Score was distributed as follows: CR, 0 (n=386, 42.7%); ICR, >0 to 4 (n=184, 20.4%), >4 to 8 (n=167, 18.5%), >8 (n=153, 16.9%). A progressively higher residual SYNTAX Score was shown to be a surrogate marker of increasing clinical comorbidity and anatomic complexity. Subjects with CR or residual SYNTAX Scores ≤8 had comparable 5-year mortality (CR, 8.5%; residual SYNTAX Score >0–4, 8.7%; >4–8, 11.4%; P =0.60). A residual SYNTAX Score >8 was associated with 35.3% all-cause mortality at 5-years ( P Conclusions— The residual SYNTAX Score was shown to be a powerful indicator of 5-year mortality in the SYNTAX Trial. The residual SYNTAX Score may aid in determining a reasonable level of revascularization. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00114972.

Background: Obesity is associated with increased cardiovascular risk. Paradoxically, however, patients with higher body mass index (BMI) might have better outcomes after acute coronary syndrome treated with percutaneous coronary intervention (PCI). The effect of different BMI categories on long-term cardiac outcomes in women receiving drug-eluting stents (DES) has not been well characterized. Methods: We pooled patient-level data for female participants from 26 randomized trials of DES in patients with coronary artery disease. Patients were stratified according to BMI category in BMI &lt 25 (normal weight), 25 to 30 (overweight), &gt 30 to 35 (obese) or &gt 35 (Morbidly obese). Primary endpoint was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction or target lesion revascularization. Secondary endpoint was all-cause mortality. Results: From 11,557 women included in the pooled database, 9,420 had received DES and had BMI data available. Patients with higher BMI were significantly younger and more likely to have hypertension, hyperlipidemia and diabetes mellitus. However, they exhibited lower anatomical and procedural complexity. There were no differences in crude 3-year MACE rates across the 4 groups (14.6% vs. 12.9% vs. 14% vs. 13.2%; p = 0.34) but normal BMI group was associated with increased all-cause mortality (5.9% vs. 4.0% vs. 4.2% vs. 4.5%; p = 0.01). Following multivariable adjustment the 3-year risk of MACE progressively decreased with increase in BMI category (HR: 0.76, 95% CI: 0.61 - 0.94; HR: 0.71, 95% CI: 0.54 - 0.92; HR: 0.52, 95% CI: 0.38 - 0.73; p &lt 0.001; for overweight, obese and severely obese, respectively). Similarly, risk of 3-year mortality independently decreased in all BMI categories compared with normal BMI (HR: 0.41, 95% CI: 0.28 - 0.61; HR: 0.51, 95% CI: 0.32 - 0.80; HR: 0.48, 95% CI: 0.28 - 0.81; for overweight, obese and severely obese, respectively, p &lt 0.001). Conclusion: Following PCI with DES, lower rather than higher BMI appears to be associated with higher risk of cardiac events and mortality. The reason for this paradoxical effect of obesity is not clear but may include unknown or unmeasured confounding variables or more aggressive therapies.

Background— The prospective, multinational, randomized Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial was designed to assess the optimal revascularization strategy between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), for patients with left main (LM) and/or 3-vessel coronary disease. Methods and Results— This observational hypothesis-generating analysis reports the results of a prespecified powered subgroup of 705 randomized patients who had LM disease among the 1800 patients with de novo 3-vessel disease and/or LM disease randomized to PCI with paclitaxel-eluting stents or CABG in the SYNTAX trial. Major adverse cardiac and cerebrovascular event rates at 1 year in LM patients were similar for CABG and PCI (13.7% versus 15.8%; Δ2.1% [95% confidence interval −3.2% to 7.4%]; P =0.44). At 1 year, stroke was significantly higher in the CABG arm (2.7% versus 0.3%; Δ−2.4% [95% confidence interval −4.2% to −0.1%]; P =0.009]), whereas repeat revascularization was significantly higher in the PCI arm (6.5% versus 11.8%; Δ5.3% [95% confidence interval 1.0% to 9.6%]; P =0.02); there was no observed difference between groups for other end points. When patients were scored for anatomic complexity, those with higher baseline SYNTAX scores had significantly worse outcomes with PCI than did patients with low or intermediate SYNTAX scores; outcomes for patients with CABG did not correlate with baseline SYNTAX score, but baseline EuroSCORE significantly predicted outcomes for both treatments. Conclusions— Patients with LM disease who had revascularization with PCI had safety and efficacy outcomes comparable to CABG at 1 year; longer follow-up is required to determine whether these 2 revascularization strategies offer comparable medium-term outcomes in this group of complex patients. Clinical Trial Registration— http://www.clinicaltrials.gov. Unique identifier: NCT00114972.

Background— Cardiac surgery is the reference treatment for patients with left main (LM) disease, although percutaneous coronary intervention with drug-eluting stents is emerging as a possible alternative. The objective of this registry was to evaluate the 2-year outcome of elective percutaneous coronary intervention for unprotected LM disease with paclitaxel-eluting stents. Methods and Results— A total of 291 patients were prospectively included from 4 centers. Acute myocardial infarction and cardiogenic shock were the only exclusion criteria. Patients were 69±11 years old, 29% were diabetic, and 25% had 3-vessel disease. For distal LM lesions (78%), the provisional side-branch T-stenting approach was used in 92% of cases and final kissing balloon inflation in 97%. Angiographic success was obtained in 99.7% of cases. At 2-year follow-up, the total cardiac death rate was 5.4% (1 EuroSCORE point was associated with a 15% [95% confidence interval 2.9% to 28.2%, P =0.013] higher risk of cardiac death), target-lesion revascularization was 8.7%, and incidence of Q-wave or non–Q-wave myocardial infarction was 0.9% and 3.1%, respectively. The combined end point occurred in 15.8% of cases and stroke in 0.7%. The incidence of definite and probable LM stent thrombosis was 0.7%, whereas the incidence of any stent thrombosis was 3.8%, with a higher risk in patients with side-branch stenting in the presence of LM bifurcation lesions (hazard ratio 9.6, 95% confidence interval 1.2 to 77.7, P =0.035). Conclusions— Unprotected LM stenting with paclitaxel-eluting stents, with a strategy of provisional side-branch T-stenting for distal lesions, provides excellent acute angiographic results and good mid-term clinical outcomes, with a 15.8% rate of major adverse cardiac events at 2-year follow-up.

Background— The outcome of resuscitated patients after cardiac arrest complicating acute myocardial infarction remains poor, primarily because of the relatively low success rates of cardiopulmonary resuscitation management. Existing data suggest potential beneficial effects of early myocardial reperfusion, but the predictors of survival in these patients remain unknown. Methods and Results— From 1995 to 2005, 186 patients (78% men; mean age, 60.4±13.8 years) underwent immediate percutaneous coronary intervention after successful resuscitation for cardiac arrest complicating acute myocardial infarction. Prompt prehospital management was performed by mobile medical care units in 154 of 186 patients, whereas 32 had in-hospital cardiac arrest. Infarct location was anterior in 105 patients (56%), and shock was present on admission in 96 (52%). Percutaneous coronary intervention (stenting rate 90%) was successful in 161 of 186 patients (87%). Six-month survival rate was 100 of 186 (54%), and 6-month survival free of neurological sequelae was 46%. By multivariate analysis, predictors of 6-month survival were a shorter interval between the onset of cardiac arrest and arrival of a first responder (odds ratio, 0.67; 95% CI, 0.54 to 0.84), a shorter interval between the onset of cardiac arrest and return of spontaneous circulation (odds ratio, 0.91; 95% CI, 0.87 to 0.96), and absence of diabetes (odds ratio, 7.30; 95% CI, 1.80 to 29.41). Conclusions— In patients with resuscitated cardiac arrest complicating acute myocardial infarction, prompt prehospital management and early revascularization were associated with a 54% survival rate at 6 months. A strategy including adequate prehospital management, early revascularization, and specific care in dedicated intensive care units should be strongly considered in resuscitated patients after cardiac arrest complicating acute myocardial infarction.

Background: Coronary chronic total occlusion (CTO) remains the lesion subtype in which angioplasty has the lowest success rate. Although many independent predictors of final procedural success have been identified, no studies have yet analyzed their combined impact on final procedural outcome. In order to obtain a scoring model to predict final CTO-PCI success, we analyzed a population of patients who underwent a percutaneous coronary intervention for a chronic total occlusion (CTO-PCI) at our institution. Methods: We included 1,657 consecutive patients who underwent a first-attempt CTO-PCI at ICPS from January 2004 to December 2013. Clinical, angiographic procedural and technical characteristics were prospectively collected. A backword stepwise logistic regression including clinical and angiographic variables was used to create a multivariable model of independent predictors of CTO-PCI success. Independent variables were then scored. Results: Overall procedural success rate was 72.5%. The backward logistic regression model showed that two clinical variables: previous CABG (OR2.28, 95%CI1.53-3.4), previous MI (1.56, 95%CI 1.19-2.0) and four angiographic variables: severe lesion calcification (OR 2.95, 95%CI 2.08-4.2), longer CTOs (≥20 mm: OR 2.04, 95%CI 1.62-2.58), non LAD location (OR 1.58, 95%CI 1.21-2-06) and blunt stump morphology (OR 1.57, 95%CI 1.24-1.99) were independent predictors of CTO-PCI failure. The OR values of these variables were used to create the Clinical and Angiographic Scoring System (CL-SCORE). CL-Score values of 0, 1-3, >3 and ≤5 and >5 indentified subgroups at high (class 0), intermediate (class 1), low (class 2), very low (class 3) probability of CTO-PCI success (80.3%, 64.2%, 49.4 and 29% respectively; p Conclusion: This clinical and angiographic score strongly predicted the final CTO-PCI procedural outcome of our study population. Further studies are required to validate this model.

Background— The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. Methods and Results— This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group ( P P =0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. Conclusions— Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.

Background— Incomplete stent apposition (ISA) has been previously documented after sirolimus-eluting stent (SES) implantation. The aim of this study was to investigate the long-term intravascular ultrasound (IVUS) findings of ISA in patients who received SES. Methods and Results— A total of 13 patients who received SES and showed ISA at follow-up IVUS (follow-up I) were investigated. IVUS was performed on all of these patients 12 months later (follow-up II). Quantitative ISA area measurement was also performed at follow-up I and II. No vascular remodeling was observed in the vessel segment with ISA; external elastic membrane area was 19.4±6.6 versus 19.5±6.4 mm 2 at follow-up I and II, respectively. There was also no significant change in external elastic membrane area between vessel segment with ISA and without ISA (+1.5% versus −3.0%, respectively; P =0.27) at late follow-up. The ISA area, either including (2.5±1.7 versus 3.8±6.3 mm 2 ; P =NS) or excluding (2.5±1.8 versus 2.4±1.7 mm 2 ; P =NS) a single patient with aneurysm formation, was not significantly different between follow-up I and II. One patient manifested a coronary aneurysm in the stented segment at late follow-up that was probably present at the initial follow-up but masked by thrombus. It was successfully treated with a covered stent. All patients were asymptomatic, and no patient experienced late thrombotic occlusion. Conclusions— Vessel dimensions and area of ISA did not change over time, except for 1 coronary aneurysm that became apparent. ISA after implantation of a SES was not associated with adverse events at late follow-up.

Background— The goal of this intravascular ultrasound investigation was to provide a more detailed morphological analysis of the local biological effects of the implantation of a sirolimus-eluting stent compared with an uncoated stent. Methods and Results— In the RAVEL trial, 238 patients with single de novo lesions were randomized to receive either an 18-mm sirolimus-eluting stent (Bx VELOCITY stent, Cordis) or an uncoated stent (Bx VELOCITY stent). In a subset of 95 patients (sirolimus-eluting stent=48, uncoated stent=47), motorized intravascular ultrasound pullback (0.5 mm/s) was performed at a 6-month follow-up. Stent volumes, total vessel volumes, and plaque-behind-stent volumes were comparable. However, the difference in neointimal hyperplasia (2±5 versus 37±28 mm 3 ) and percent of volume obstruction (1±3% versus 29±20%) at 6 months between the 2 groups was highly significant ( P P Conclusions— Sirolimus-eluting stents are effective in preventing neointimal hyperplasia without creating edge effect and without affecting the plaque burden behind the struts.

Background— Current guidelines recommend coronary artery bypass graft surgery (CABG) when treating significant de novo left main coronary artery (LM) stenosis; however, percutaneous coronary intervention (PCI) has a class IIa indication for unprotected LM disease in selected patients. This analysis compares 5-year clinical outcomes in PCI- and CABG-treated LM patients in the Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX) trial, the largest trial in this group to date. Methods and Results— The SYNTAX trial randomly assigned 1800 patients with LM or 3-vessel disease to receive either PCI (with TAXUS Express paclitaxel-eluting stents) or CABG. The unprotected LM cohort (N=705) was predefined and powered. Major adverse cardiac and cerebrovascular event rates at 5 years was 36.9% in PCI patients and 31.0% in CABG patients (hazard ratio, 1.23 [95% confidence interval, 0.95–1.59]; P =0.12). Mortality rate was 12.8% and 14.6% in PCI and CABG patients, respectively (hazard ratio, 0.88 [95% confidence interval, 0.58–1.32]; P =0.53). Stroke was significantly increased in the CABG group (PCI 1.5% versus CABG 4.3%; hazard ratio, 0.33 [95% confidence interval, 0.12–0.92]; P =0.03) and repeat revascularization in the PCI arm (26.7% versus 15.5%; hazard ratio, 1.82 [95% confidence interval, 1.28–2.57]; P Conclusions— At 5 years, no difference in overall major adverse cardiac and cerebrovascular events was found between treatment groups. PCI-treated patients had a lower stroke but a higher revascularization rate versus CABG. These results suggest that both treatments are valid options for LM patients. The extent of disease should accounted for when choosing between surgery and PCI, because patients with high SYNTAX scores seem to benefit more from surgery compared with those in the lower tertiles. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00114972.

Background Stenting reduces both acute complications of coronary angioplasty and restenosis rates but increases subacute thrombosis rates and hemorrhagic complications when used with coumadin anticoagulation. Methods and Results To simplify postcoronary stenting treatment and to reduce these drawbacks, we evaluated the 1-month outcome of a prospective registry of 2900 patients in whom successful coronary artery stenting was performed without coumadin anticoagulation. Patients received 100 mg/d aspirin and 250 mg/d ticlopidine for 1 month. Low-molecular-weight heparin (LMWH) treatment was progressively reduced in four consecutive stages, from 1-month treatment to none. Event-free outcome at 1 month was achieved in 2816 patients (97.1%). Major stent-related cardiac events were subacute closure in 51 patients (1.8%), including death in 12 (0.5%), acute myocardial infarction in 17 (0.6%), and coronary artery bypass graft surgery in 9 (0.3%). Stent thrombosis was more frequent with balloon size of P P P =.02). Bleeding complications that required transfusion, surgical repair, or both occurred in 55 patients (1.9%). Bleeding complications were related to female gender (4.0% versus 1.51%, P P P P P =.04). Conclusions These results suggest that poststenting treatment by ticlopidine/aspirin is an effective alternative to coumadin anticoagulation, achieving low rates of subacute closure and bleeding complications. LMWH treatment does not improve subacute reocclusion rates but increases bleeding complications. Furthermore, as bleeding complications were independently related to sheath size, we suggest that stenting with 6F guiding catheters may prevent local complications. Furthermore, the ticlopidine/aspirin combination allows a low-cost stenting strategy without ultrasound assessment of stent deployment and permits short in-hospital stay.

We thank Dr Uretsky for his interest in our study.1 He is correct that 248 of 705 patients who were visually assessed as having distal left main (LM) bifurcation disease by the site's Heart Team (interventional cardiologist, cardiothoracic surgeon, and study coordinator) were later determined by the core laboratory to not strictly meet the study protocol definition of LM disease (eg, the patients were determined to have B- [Medina type 0,1,0]- or E- [Medina type 0,0,1]-type distal LM bifurcation lesions). This discrepancy between the site and core laboratory determinations is typical of clinical trials that use a …

We thank Carnero-Alcazar and colleagues for their comments concerning our article.1 First, the readership should be reminded that the anatomic Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) score was designed before the SYNTAX trial as a tool to force the interventional cardiologist and cardiac surgeon to systematically analyze the coronary angiogram and agree that “equivalent anatomic revascularization” could be achieved on the basis of a vessel size of 1.5 mm. A vessel size of 1.5 mm was selected as this was the size of the vessel the cardiac surgeon stated they could revascularize. Before the SYNTAX trial, the SYNTAX score was tested in the Arterial Revascularization Therapies Study (ARTS) II Study.2 In the SYNTAX trial protocol, outcomes related to the SYNTAX score were prespecified. Since the SYNTAX trial, numerous studies have validated the SYNTAX score.3 Second, criticisms related to the reproducibility of the SYNTAX score appear excessive. The simple interpretation of a coronary angiogram, on which most contemporary …

Background . The risk of thrombosis which had been well described since the advent of stenting, is currently being re-addressed in the era of drug-eluting stents (DES). Among the predictors of thrombosis risk, there are some factors which may be favourably influenced by the operator. Indeed, the quality of stent deployment is crucial, which has been well demonstrated with IVUS. Inadequate deployment may be associated with numerous parameters. The time factor has never been explored accurately so far. Objectives. The purpose of this study was to analyse the relationship between the duration of stent balloon inflation and the quality of stent deployment as measured by StentBoost ™ in patients with de novo lesions. Methods. StentBoost ™ is a software developed by Philips on the flat panel detector, which averages frames, correcting for motion by using the balloon markers. This creates an enhanced image of the stent with an improved signal-to-noise ratio and allows precise measurements. Pressure of stent deployment was selected according to the reference diameter of the lesion and the diameter/pressure chart of the stent delivery system. A constant pressure was applied for 25 seconds and stent size measured at 5, 15, 25 sec., after deflation and post dilatation when performed. Primary endpoint was optimal stent expansion defined as minimal stent diameter/reference diameter at the lesion site > 80%. Results. Data were collected prospectively in 77 patients aged 67.8± 12.4 yrs, diabetic (38%), acute coronary syndrome (37 %), in whom 109 stents (length 18.7±6.4 mm; diameter 2.96±0.49 mm) were deployed at a mean pressure of 13.5±2.48 atm. Lesion reference diameter was 3.06±0.58 mm. Conclusion. Better stent implantation may be achieved by increasing the duration of stent deployment. This may influence the risk of stent thrombosis.

Purpose of the study . With increasing case complexity, radiation exposure is becoming a very important issue. One obvious element, which can result in dose reduction, is optimal placement of image receptor as close to the patient as possible. As part of the clinical workflow, even with best of intentions, the detector is often parked at a significant distance away from the patient and this may be improved by an automatic user-gantry interaction which automatically places the detector at an optimal distance from the patient surface. Methods . We determine the operator dose reduction impact of a patient contouring system which utilizes active sensors placed around the rim of the detector to optimally position the detector close to the patient surface compared to a conventional approach in the real world. On the cathlab platform Innova 2100 IQ (GE, Waukesha, WI), capacitive sensor elements are placed around the detector cover, which measures the minimal distance between the cover and the patient. Using a computer algorithm, the detector location is automatically controlled such that it rests at a preprogrammed distance of 7 cm from the patient surface with a fast response time of 20 deg/sec. Dose to the operator was recorded by an electronic dosimeter placed on the external side of the lead apron. Results . 250 consecutive patients admitted for coronary angiogram (n=234)or angioplasty (n=16) were randomly assigned for conventional approach (n=117) or patient contouring (n=133). The 2 patients populations were identical for age, indications, approach (radial or femoral), size, weight and body mass index. The operator effective dose was 5.71±6.34 μSv in the conventional group and 3.68±4.09 μSv in the patient contouring group (p = 0.0035), with an operator effective dose reduction of 35.5%. Conclusions . A simple technique of patient contouring may reduce operator effective dose by >30%.

Drug-eluting stents (DES) have reduced restenosis rate and are now emerging as an alternative to bypass surgery (CABG) for treating unprotected left main (ULM) stenosis. A prospective registry was set up in France to explore the role of DES in this setting. Consecutive patients (Pts) with de novo ULM stenosis undergoing PCI with Paclitaxel eluting stent (PES) in 4 French centers were prospectively included in this real world study. Acute MI and cardiogenic shock were the only criteria for exclusion. Pts had a loading dose (450 to 600 mg) of plavix before the procedure, aspirin (≥75 mg) and plavix (75 to 150 mg/day) for at least 6 months. Clinical outcome was planned up to 3 years and repeat angiography was strongly recommended at 6 months. Between March 2003 and June 2005, 291 Pts were included: 69±11 yrs old, 77% male, 29% diabetic, 5% renal failure, 17% previous or recent MI, 38% acute coronary syndrome and 25% 3-vessel disease. Euroscore was 4.8±3.4 (predicted in-hospital mortality in case of CABG 6.3±10.4). Provisional T stenting (distal LM in 78.4%) was used in 92% of cases and final kissing balloon in 96.8%. Angiographic success was obtained in 99.7%. Other lesions (1.2±0.9) were treated during the same hospitalization in 77%. Repeat angiogram was performed in 182 Pts (63%) at 7.0±4.0 months. Restenosis was observed in 8.7%. The clinical outcome is summarized below: By multivariate analysis Euroscore (OR 1.245; 95% CI 1.077–1.439; p=0.003), terminal renal failure with dialysis therapy (OR 0.018; 95% CI 0.002– 0.172; p=

Background— A sirolimus-eluting stent (Cypher, Cordis Corp) has been reported to markedly decrease restenosis in selected lesions; higher-risk lesions, including coronary bifurcations, have not been studied. Methods and Results— This prospective study evaluated the safety and efficacy of sirolimus-eluting stents for treatment of coronary bifurcation lesions. Patients were randomly assigned to either stenting of both branches (group A) or stenting of the main branch with provisional stenting of the side branch (SB) (group B). Eighty-five patients (86 lesions) were enrolled. There was 1 case of unsuccessful delivery of any device at the bifurcation site. Given the high crossover, more lesions were treated with 2 stents (n=63) than with stent/balloon (n=22). Clinical follow-up at 6 months was completed in all patients and angiographic follow-up in 53 patients in group A (85.5%) and 21 in group B (95.4%). One patient died suddenly 4.5 months after the procedure. There were 3 cases of stent thrombosis (3.5%). The total restenosis rate at 6 months was 25.7%, and it was not significantly different between the double-stenting (28.0%) and the provisional SB-stenting (18.7%) groups. Fourteen of the restenosis cases occurred at the ostium of the SB and were focal. Target lesion revascularization was performed in 7 cases; target vessel failure occurred in 15 cases (17.6%). Conclusions— These results are an improvement compared with historical controls using bare metal stents. Restenosis at the SB remains a problem. At this time, no statement can be made regarding the most appropriate technique to use when treating bifurcations with the Cypher stent.

Background— Treatment of lesions located in saphenous vein grafts (SVGs) is associated with increased procedural risk and a high rate of restenosis. Methods and Results— We conducted a randomized, multicenter trial to evaluate the usefulness of a polytetrafluoroethylene (PTFE)-covered stent compared with a bare stainless steel (SS) stent for prevention of restenosis and major adverse cardiac events (MACE) in patients undergoing SVG treatment. The primary end point was angiographic restenosis at 6 months. Secondary end points were 30-day and 6-month MACE rates, defined as the cumulative of death, myocardial infarction (MI), and target lesion revascularization. Between September 1999 and January 2002, 301 patients with SVG lesions were randomized to either the PTFE-covered JoStent coronary stent graft (PTFE group, n=156) or the SS JoFlex stent (control group, n=145). Angiographic and procedural success rates were similar between the 2 groups (97.4% versus 97.9% and 87.3% versus 93.8%, respectively). The incidence of 30-day MACE was higher in the PTFE group (10.9% versus 4.1%, P =0.047) and was mainly attributed to MI (10.3% versus 3.4%, P =0.037). The primary end point, the restenosis rate at 6-month follow-up, was similar between the 2 groups (24.2% versus 24.8%, P =0.237). Although the 6-month non–Q-wave MI rate was higher in the PTFE group (12.8% versus 4.1%, P =0.013), the cumulative MACE rate was not different (23.1% versus 15.9%, P =0.153). Conclusions— The study did not demonstrate a difference in restenosis rate and 6-month clinical outcome between the PTFE-covered stent and the SS stent for treatment of SVG lesions. However, a higher incidence of nonfatal myocardial infarctions was found in patients treated with the PTFE-covered stent.

Background — Although several randomized trials have demonstrated that coronary stenting improves angiographic and clinical outcomes for patients with acute myocardial infarction (AMI), the cost-effectiveness of this practice is unknown. The objective of the present study was to evaluate the long-term costs and cost-effectiveness (C/E) of coronary stenting compared with primary balloon angioplasty as treatment for AMI. Methods and Results — Between December 1996 and November 1997, 900 patients with AMI were randomized to undergo balloon angioplasty (PTCA, n=448) or coronary stenting (n=452). Detailed resource utilization and cost data were collected for each patient’s initial hospitalization and for 1 year after randomization. Compared with conventional PTCA, stenting increased procedural costs by ≈$2000 per patient ($6538±1778 versus $4561±1598, P P =0.03), overall 1-year costs remained ≈$1000/patient higher with stenting than with PTCA ($20 571±10 693 versus 19 595±10 990, P =0.02). The C/E ratio for stenting compared with PTCA was $10 550 per repeat revascularization avoided. In analyses that incorporated recent changes in stent technology and pricing, the 1-year cost differential fell to 0.2% compared with PTCA. Conclusions — As performed in Stent-PAMI, primary stenting for AMI increased 1-year medical care costs compared with primary PTCA. The overall cost-effectiveness of primary stenting depends on the societal value attributed to avoidance of symptomatic restenosis, as well as on the relative mortality rates of primary PTCA and stenting.

Background Stenting has been demonstrated to be superior to balloon angioplasty in de novo focal lesions located in large native vessels. However, in small vessels, the benefit of stenting remains questionable. Methods and Results A total of 381 symptomatic patients with de novo focal lesion located on a small coronary segment vessel (P =0.0001), resulting in a larger minimal lumen diameter (2.06±0.42 versus 1.70±0.46 mm, P =0.0001). At follow-up (obtained in 91% of patients), angiographic restenosis rate was 21% in the stent group versus 47% in the balloon group ( P =0.0001), a risk reduction of 55%. Repeat target lesion revascularization was less frequent in the stent group (13% versus 25%, P =0.0006). Conclusions Elective stent placement in small coronary arteries with focal de novo lesions is safe and associated with a marked reduction in restenosis rate and subsequent target lesion revascularization rate at 6 months.

Background — Whereas survival after lytic therapy for myocardial infarction is strongly dependent on early administration, it is unknown whether the otherwise excellent outcomes in patients undergoing primary PTCA for acute myocardial infarction, in whom TIMI-3 flow rates of >90% may be achieved, can be further improved by early reperfusion. Methods and Results — Among 2507 patients enrolled in 4 PAMI trials undergoing primary PTCA, spontaneous reperfusion (TIMI-3 flow) was present in 16% at initial angiography. Compared with patients without TIMI-3 flow, those with TIMI-3 flow before PTCA had greater left ventricular ejection fraction (57±10% versus 53±11%, P =0.003) and were less likely to present in heart failure (7.0% versus 11.6%, P =0.009). Patients with initial TIMI-3 flow had significantly lower in-hospital rates of mortality, new-onset heart failure, and hypotension and had a shorter hospital stay. Cumulative 6-month mortality was 0.5% in patients with initial TIMI-3 flow, 2.8% with TIMI-2 flow, and 4.4% with initial TIMI-0/1 flow ( P =0.009). By multivariate analysis, TIMI-3 flow before PTCA was an independent determinant of survival (odds ratio 2.1, P =0.04), even when corrected for by postprocedural TIMI-3 flow. Conclusions — Patients undergoing primary PTCA in whom TIMI-3 flow is present before angioplasty present with greater clinical and angiographic evidence of myocardial salvage, are less likely to develop complications related to left ventricular failure, and have improved early and late survival. These data warrant prospective randomized trials of pharmacological strategies to promote early reperfusion before definitive mechanical intervention in acute myocardial infarction.

To the Editor: We read with interest the editorial by Dr Baim, and we wish to provide a chronologically accurate summary with respect to the use of ticlopidine and aspirin after stent implantation. Dr Colombo has greatly contributed to the development of stenting by being the first to demonstrate that use of intravascular ultrasound (IVUS) could eliminate the need for anticoagulation treatment in stented patients.2 3 However, it does not seem necessary to attribute the introduction of poststenting treatment with ticlopidine and aspirin to Dr Colombo. Indeed, he does not claim credit for it. It was Dr Barragan who asserted, as early as 1992, that ticlopidine could prevent stent occlusion.4 Pursuant to this, the French registry “Stenting without Coumadin”5 …