Usefulness of postmarket studies to evaluate long-term safety of coronary eluting stents (from the ENDEAVOR and PROTECT Programs).

Differences in enrollment criteria and protocol requirements are believed to affect patient representation and outcomes from premarket and postmarket surveillance (PMS) trials. These differences have not been assessed in studies evaluating coronary stenting. We aimed to assess differences in clinical profile and long-term outcomes in patients enrolled into premarket versus PMS trials assessing the Endeavor zotarolimus-eluting stent (E-ZES). We pooled patient-level data for 2,132 and 4,357 E-ZES-treated subjects enrolled into the ENDEAVOR program (premarket) and Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PMS), respectively. Follow-up data were available through 3 years. Baseline characteristics and outcomes of patients enrolled in the 2 groups were compared. Propensity score-adjusted Cox proportional hazards models were used to assess the effect of differences in baseline characteristics. We also adjusted for protocol-mandated repeat angiography to account for differences in follow-up requirements. Despite significant differences in baseline characteristics, the unadjusted 3-year rates of major adverse cardiac events, major adverse cardiac and cerebrovascular events, and target vessel failure were similar (premarket vs PMS: 11.9% vs 12.7%, p = 0.369; 12.7% vs 13.9%, p = 0.191; and 13.8% vs 13.4%, p = 0.667, respectively). However, PMS trials had significantly higher rates of myocardial infarctions (p = 0.005) and definite or probable stent thrombosis (p = 0.016). After propensity score adjustment, myocardial infarction rates remained significantly different (hazard ratio 0.53, 95% confidence interval 0.30 to 0.91). To conclude, premarket and PMS trials assessing E-ZES implantation enrolled different patients. PMS trials were shown to be essential for the detection of safety signals.

Imaging in Transcatheter Aortic Valve Replacement (TAVR): role of the radiologist.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a novel technique developed in the last decade to treat severe aortic stenosis in patients who are non-surgical candidates because of multiple comorbidities. METHODS: Since the technique is performed using a transvascular approach, pre-procedural assessment of the aortic valve apparatus, ascending aorta and vascular access is of paramount importance for both appropriate patient selection and correct device selection. This assessment is performed by a multi-disciplinary team with radiology being an integral and important part. RESULTS: Among imaging modalities, there is growing scientific evidence supporting the crucial role of MDCT in the assessment of the aortic valve apparatus, suitability of the iliofemoral or alternative pathway, and determination of appropriate coaxial angles. MDCT also plays an important role in post-procedure imaging in the assessment of valve integrity and position. CONCLUSION: This review outlines the principal aspects of TAVR, the multidisciplinary approach and utilisation of different imaging modalities, as well as a step-by-step approach to MDCT acquisition protocols, reconstruction techniques, pre-procedure measurements and post-procedure assessment. TEACHING POINTS: • TAVR is a new technique to treat severe aortic stenosis in high-risk and nonsurgical candidates. • MDCT assessment of the aortic annulus is important for appropriate patient and device selection. • Multidisciplinary approach is required for patient selection, procedure planning and performance. • MDCT is required for assessment of the aortic root, iliofemoral or alternative vascular pathway.

Risk assessment to predict arterial and venous events in patients undergoing percutaneous coronary intervention.

Atherosclerosis and venous thromboembolism (VTE) share common risk factors. We set to assess the strength of the association between atherosclerosis risk factors and disease manifestation, and VTE, in patients with coronary artery disease undergoing percutaneous coronary intervention. We pooled data from 6 global randomized controlled trials assessing coronary stenting (ENDEAVOR and SIRIUS programs), developed separate risk scores to predict major adverse cardiac and cerebrovascular events (MACCEs: cardiac death, myocardial infarction, and stroke) and VTE, and compared their performance. The 5-year rates of MACCE and VTE were 10.8% and 2.04%, respectively. Selected predictors for MACCE performed equally well in predicting VTE (area under the receiver-operating characteristic curve [AUC] 0.651 vs 0.672), and selected predictors for VTE performed equally well in predicting MACCE (AUC 0.699 vs 0.620). Ejection fraction and age were associated with both MACCE and VTE. These findings support the concept of overlapping pathophysiology of VTE and atherothrombosis.

Safety and efficacy metrics for primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis and critical examination of current methodologies.

BACKGROUND: The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta-analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings. METHODS AND RESULTS: We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve-month primary patency (PP) rate was reported in five trials. The meta-analytic 12-month PP rate was 71.6% (95% confidence interval [CI] 66.4-76.7%). The meta-analytic rate of 30-day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0-90.0%). CONCLUSION: Contemporary nitinol-based bare-metal stents performed well in controlled settings. Occurrence of the 1-month composite safety endpoint was extremely uncommon.

Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials.

OBJECTIVE: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM). BACKGROUND: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population. METHODS: Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression. RESULTS: Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES. CONCLUSIONS: Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

Role of Parenteral Agents in Percutaneous Coronary Intervention for Stable Patients.

Numerous agents are available for anticoagulation during percutaneous coronary intervention (PCI), and various antiplatelet agents are also used. With all of the medications available, an assessment must be made regarding the ischemic risk and risk of bleeding for an individual patient during elective PCI when selecting the optimal medical strategy to support PCI. Whether new antiplatelet medications will enhance or reduce complications when paired with various newer anticoagulant agents requires further investigation. This article summarizes existing data examining the benefits and limitations of the various anticoagulant and antiplatelet medications, and summarizes guidelines for their use.

Which antithrombin for whom? Identifying the patient population that benefits most from novel antithrombin agents.

Anticoagulation has proven to be a key component in the management of acute coronary syndromes (ACS). Pharmacological agents with various modes of action are utilized to reduce thrombus development by impairing thrombin formation, platelet activation, and platelet aggregation. The optimal management of these patients is to achieve maximal anti-ischemic benefit while avoiding bleeding complications. Synthetic "novel" agents have been developed to specifically target factor Xa or thrombin to achieve this goal. A growing amount of data show that these agents provide a net clinical benefit in the setting of stable ischemic heart disease, unstable angina, non-ST-elevation myocardial infarction (NSTEMI), and ST-elevation myocardial infarction (STEMI).