Probal Roy

The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents

AIMS To assess the impact on clinical outcomes of intravascular ultrasound (IVUS) guidance during drug-eluting stent (DES) implantation. IVUS guidance during percutaneous coronary intervention (PCI) has been demonstrated to be useful in optimizing stent deployment. However, it is not proved that routine use of IVUS guidance with DES implantation can prevent stent thrombosis or restenosis. METHODS AND RESULTS The clinical outcomes of 884 patients undergoing IVUS-guided intracoronary DES implantation from April 2003 to May 2006 were compared with the outcomes of a propensity-score matched population undergoing DES implantation with angiographic guidance alone. The primary endpoint of the study was definite stent thrombosis at 12 months. The secondary endpoint was major adverse cardiac events (MACE). After propensity-score matching, the two groups were well matched for clinical and angiographic characteristics. Patients undergoing IVUS-guided DES implantation underwent less direct stenting, more post-dilation, and had greater cutting balloon and rotational atherectomy use. At 30 days and at 12 months, a higher rate of definite stent thrombosis was seen in the No IVUS group (0.5 vs. 1.4%; P = 0.046) and (0.7 vs. 2.0%; P = 0.014), respectively. There were no major differences in late stent thrombosis and MACE (14.5 vs. 16.2%; P = 0.33) at 12 month follow-up between the groups. Rates of death and Q-wave myocardial infarction were similar, and there was no significant difference between groups in target vessel revascularization. However, a trend was seen in favour of the IVUS group in target lesion revascularization (5.1 vs. 7.2%; P = 0.07). IVUS guidance was an independent predictor of freedom from cumulative stent thrombosis at 12 months (adjusted HR 0.5, CI 0.1-0.8; P = 0.02). CONCLUSION IVUS guidance during DES implantation has the potential to influence treatment strategy and reduce both DES thrombosis and the need for repeat revascularization.

Outcomes of Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention With Drug-Eluting Stents for Patients With Multivessel Coronary Artery Disease

Background— Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a “real-world” evaluation of current technology in the treatment of multivessel coronary artery disease. Methods and Results— A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). Conclusions— Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes. Coronary artery bypass surgery may be the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

Outcome differences with the use of drug-eluting stents for the treatment of in-stent restenosis of bare-metal stents versus drug-eluting stents.

Drug-eluting stent (DES) implantation is the standard treatment for patients with bare-metal stent (BMS) in-stent restenosis (ISR) and is associated with low rates of target-vessel revascularization. Outcomes in patients with DES ISR treated using repeated DES placement are less certain. A total of 119 patients who presented with BMS ISR and 119 patients with DES ISR matched for baseline characteristics were evaluated. Both groups of patients were treated using DESs and compared with regard to major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization, at 1 year. Baseline characteristics were similar between groups. Compared with patients with BMS ISR, those with DES ISR had similar 1-year rates of death (5.1% BMS ISR vs 3.5% DES ISR; p = 0.75) and myocardial infarction (2.6% BMS ISR vs 3.5% DES ISR; p = 0.72) when treated using DESs. However, at 1 year, patients with DES ISR experienced significantly higher rates of target-vessel revascularization (10.3% BMS ISR vs 22.2% DES ISR; p = 0.01), with a trend toward increased overall major adverse cardiac events, including death, myocardial infarction, and target-vessel revascularization (16.0% BMS ISR vs 25.2% DES ISR; p = 0.08). Stent thrombosis occurred with similar frequency in both groups (2.5% BMS ISR vs 0.8% DES ISR; p = 0.62). In conclusion, DES ISR continues to be a therapeutic challenge because patients with DES ISR treated using DESs experience higher rates of recurrence compared with patients with BMS ISR treated using DESs. The optimal treatment of patients with DES restenosis remains to be defined.

Temporal relation between Clopidogrel cessation and stent thrombosis after drug-eluting stent implantation.

The risk of late thrombotic events and the need for prolonged dual antiplatelet therapy detract from the clinical advantage offered by drug-eluting stents (DESs). Short-term studies have shown premature clopidogrel cessation to be a strong predictor of stent thrombosis (ST) after DES implantation. Data pertaining to the utility of clopidogrel therapy and its optimal duration to prevent late ST remain limited. The study population consisted of 2,889 patients who underwent unrestricted intracoronary DES implantation from April 2003 to January 2007 for whom clopidogrel compliance data were available. Definite ST proved by angiography or autopsy within 12 months of the index procedure occurred in 61 patients. Comparisons of clinical and procedural characteristics in addition to outcomes (death and Q-wave myocardial infarction) were made between the ST and no-ST (2,828 patients) groups. Clopidogrel compliance was assessed at all follow-up time points. For patients in the ST group, clopidogrel compliance status for the remaining study period was defined as that at the time of ST. Logistic regression analysis was performed at 30 days, 6 months, and 12 months to identify independent predictors of cumulative ST. Patients with ST were more likely to have previous congestive heart failure and worse left ventricular ejection fraction. ST was associated with significantly higher mortality at 12 months (23.5% vs 3.2%, p <0.001). Clopidogrel compliance was 80.2% in the overall population and 73.8% in patients presenting with ST (82.6% in patients presenting with early ST and 43.8% in those with late ST). By logistic regression analysis, clopidogrel cessation was an independent predictor of cumulative ST at 30 days and 6 months but not at 12 months. In conclusion, high rates of clopidogrel compliance can be achieved in contemporary practice. Clopidogrel cessation by 12 months is no longer predictive of ST, thus suggesting the optimal duration of therapy for the prevention of ST to be 6 to 12 months.

Treatment of drug‐eluting stent restenosis with the same versus different drug‐eluting stent

The authors aimed to compare the clinical outcomes with repeat drug‐eluting stent (DES) implantation utilizing the same type versus an alternate DES type for in‐stent restenosis (ISR) of DES.

Prognostic value of the Syntax score in patients undergoing coronary artery bypass grafting for three-vessel coronary artery disease.

The Syntax score prognostic value has recently been highlighted in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary artery disease (CAD), however its prognostic value in patients undergoing coronary artery bypass grafting (CABG) for multivessel CAD is still unknown. The aim of this study was to evaluate the prognostic value of the Syntax score in patients undergoing CABG for 3‐vessel CAD.

Observations and Outcomes of Definite and Probable Drug-Eluting Stent Thrombosis Seen at a Single Hospital in a Four-Year Period

Stent thrombosis (ST) is a major safety concern after drug-eluting stent (DES) deployment, resulting in significant morbidity and mortality. The goal of this study was to examine the incidence, timing, clinical correlates, and outcomes after DES thrombosis in a real-world population. A retrospective analysis of 8,402 patients who underwent percutaneous coronary intervention and received a DES was performed. After DES implantation, 84 definite (DST) and 127 probable ST events occurred. The incidence of early DST was 0.8%, late DST was 0.4%, and very late DST was 0.4%. Multivariate analysis showed that a history of diabetes mellitus, myocardial infarction during admission, number of stents, and DES placement in a restenotic lesion were independently associated with DST. The incidence of early definite or probable ST (DPST) was 1.9%, late DPST was 1.4%, and very late DPST was 0.7%. Multivariate analysis showed that a history of diabetes, myocardial infarction during admission, cardiogenic shock, number of stents, and DES use in a restenotic lesion were independently associated with DPST. Both types of ST were associated with significantly higher rates of all-cause death, Q-wave myocardial infarction, and revascularization up to 24 months after DES implantation. In conclusion, ST after DES implantation in contemporary practice continues to occur from 30 days to 2 years at a rate > or =0.36%/year and is associated with high rates of morbidity and mortality. Diabetes mellitus, myocardial infarction, and DES use in a restenotic lesion were strongly associated with DST; therefore, careful consideration should apply when deploying a DES in these populations.

Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts.

Conflicting data exist regarding an advantage of drug-eluting stents (DES) over bare metal stents (BMS) in catheter-based treatment of saphenous vein graft (SVG) stenoses. This study was undertaken to compare the efficacy of these modalities in that lesion subset. The DES group consisted of 138 cases with 183 lesions (sirolimus-eluting stents, n = 117; paclitaxel-eluting stents, n = 66) and the BMS group consisted of 344 cases with 478 lesions that were followed to 1 year. We examined a composite end point that comprised death, Q-wave myocardial infarction, and target lesion revascularization. More BMS were deployed per patient (p <0.001) and the diameters of BMS deployed was significantly greater (p <0.001). Peak postprocedure values of creatine kinase-MB (p = 0.003) and troponin I (p = 0.05) were higher in BMS. At 1 year there was no significant superiority of DES over BMS with regard to hard end points (death and Q-wave myocardial infarction). In conclusion, this study indicates that both DES and BMS for SVG disease provide acceptably safe and efficacious results, but unlike the case in native coronary arteries, DES use does not reduce the frequency of the need for repeat revascularization.

Requirement for Emergent Coronary Artery Bypass Surgery Following Percutaneous Coronary Intervention in the Stent Era

Performance of percutaneous coronary intervention (PCI) at centers without cardiothoracic surgery is a contentious issue. Although this practice allows greater access to care, there are safety concerns. The aim was to assess the requirement for emergent coronary artery bypass grafting (CABG) after PCI and characterize patients at highest risk using independent predictors. The study population consisted of 21,957 unselected patients who underwent PCI from August 1994 (Food and Drug Administration stent approval) to January 2008 at a single medical center. Patients requiring emergent CABG (defined as within 24 hours of the index procedure) were identified. Logistic regression analysis was performed to assess for independent correlates of emergent CABG. Emergent CABG was required in 90 patients (cumulative incidence 0.41%). Indications for CABG included triple-vessel disease, dissection, acute closure, perforation, and failure to cross. These patients had significantly higher in-hospital cardiac death rates (7.8% vs 0.7%; p <0.01) and higher rates of Q-wave myocardial infarction, neurologic events, and renal insufficiency. Independent correlates of emergent CABG after PCI were acute ST-segment elevation myocardial infarction presentation, cardiogenic shock, triple-vessel disease, and type C lesion. Risk assessment based on these predictors identified 0.3% of the patient population to have a 9.3% cumulative incidence of emergent CABG. In conclusion, the need for emergent CABG after PCI in the stent era was low and was associated with poor in-hospital outcomes. Risk was nonuniform, with 0.3% of the study population, characterized by acute presentation and complex coronary disease, at heightened risk of emergent surgery.

Impact of optimal medical therapy and revascularization on outcome of patients with chronic kidney disease and on dialysis who presented with acute coronary syndrome.

Coronary artery disease is the main cause of death in patients with chronic kidney disease (CKD). The poor prognosis associated with acute coronary syndrome (ACS) in these patients has been related to therapeutic nihilism. This study included 2,357 patients with ACS who had percutaneous coronary intervention. According to their creatinine clearance and medical history, they were divided into 3 groups: dialysis (n = 73); CKD (n= 293); and control (n= 1,991). Rates of cardiovascular events were recorded during a 1-year follow-up period. Patients in all groups received similar contemporary therapy for ACS, including percutaneous coronary intervention and optimal medial therapy. On admission, patients with CKD and patients on dialysis more often presented with cardiogenic shock (p = 0.05 and 0.02, respectively). A graded increase in the rate of major adverse cardiovascular events at 1 year was observed with decreasing renal function (control 13%, CKD 22.9%, dialysis 45.2%, p <0.001 for all comparisons). In multivariate analysis, patients with CKD and on dialysis were significantly associated with 1-year major adverse cardiac events with adjusted hazard ratios of, respectively, 1.5 (95% confidence interval 1.1 to 2.1; p = 0.009) and 2.7 (95% confidence interval 1.7 to 4.1; p <0.001). In conclusion, despite optimal contemporary medical therapy and revascularization, the prognosis of patients with CKD and, in particular, of patients undergoing dialysis, remains poor.