Publications

Bioresorbable scaffolds (BRSs) may potentially overcome the many pitfalls related to drug eluting stents (DESs). Following CE mark approval, the rapid adoption of this novel treatment has led to its use in all comers with complex lesion morphology even without randomized comparison with the DESs. The only published randomized clinical study thus far is the ABSORB II. However, the current generation (ABBOTT Bioresorbable Vascular Scaffold, BVS™) still has a lot of limitations. The Mirage Microfiber Sirolimus Eluting Coronary Scaffold (MMSES™, Manli Cardiology™) is designed to address the concerns of BVSs, such as improved vessel wall conformability, reduced strut protrusion into lumen, fracture resistance allowing rapid deployment until rated burst pressure, excellent deliverability, faster degradation time, ability to store at ambient room temperature <25°C, and no restriction on size availability. In contrast to the BVSs, the MMSES struts are round and thinner with less protrusion into the lumen. This streamlined geometry results in lesser activation of coagulation cascade and better promotion of endothelialization. This feature is interesting, especially in view of recent reports of somewhat higher BVSs thrombosis as compared to DESs.

Background Intracoronary ultrasound (ICUS) imaging is potentially suitable to identify lesions at high risk of restenosis after percutaneous transluminal coronary angioplasty (PTCA), but it has not been studied systematically. Methods and Results We recruited 200 patients in whom ICUS studies were performed after successful PTCA and related their ICUS parameters to 6-month follow-up quantitative coronary angiography. This was performed in 164 patients (82%), yielding 170 lesions for analysis. The overall incidence of a ≥50% diameter stenosis at follow-up (categorical restenosis) was 29.4%. Quantitative ICUS parameters were weakly but significantly related to follow-up minimal luminal diameter on quantitative coronary angiography (lumen area: R 2 =.36, P =.0001; vessel area: R 2 =.29, P =.0002; plaque area: R 2 =−.18, P =.021; percent obstruction: R 2 =−.15, P =.05), but categorical restenosis was not significantly related to these parameters ( P =.63, .77, .38, and .08, respectively). There were no significant predictors of restenosis in ICUS parameters of plaque morphology: eccentric versus concentric ( P =1.0), plaque type (hard, soft, or calcific, P =.98), or the number of calcified quadrants ( P =.41). There were no significant predictors of restenosis in two predefined types of vessel-wall disruptions: (1) rupture: presence ( P =.79), depth (partial versus complete, P =.85), or extent in quadrants ( P =.6), and (2) dissection: presence ( P =.31), depth ( P =.82), or extent ( P =.38). Conclusions Qualitative ICUS parameters after PTCA did not predict restenosis. A larger lumen and vessel area and a smaller plaque area by ICUS were associated with a larger angiographic minimal lumen diameter at follow-up, but these parameters were not significantly related to categorical restenosis.

No abstract is provided for this article.

Recanalisation rates of coronary chronic total occlusions (CTO) remain sub-optimal. The retrograde technique was recently introduced to improve success rates.From February 2005 until December 2007, 175 patients were treated with this technique in seven European centres by highly experienced operators: in 84 (48%) as primary strategy, in 41 (23.5%) immediately after antegrade failure and in 50 (28.5%) as a repeat procedure after previous antegrade failure. Baseline characteristics revealed a mean age 61.4 +/- 10.8 years with 29.5% and 39% of patients having diabetes and a prior history of MI, respectively. The mean occlusion duration was 50.8 months (determined in 32% of patients). The target vessel was: LAD 21%, LCX 6.3%, RCA 71.4%. Epicardial collaterals were accessed in 20.6% and septal in 79.4% of the patients. Overall success rate was 83.4%. In 80.6% a wire crossed the collaterals and successfully delivered distal to the occlusion; success rate in this group was 91.5%. The technique implemented in the retrograde facilitated successful recanalisation was: retrograde wire/balloon crossing in 28%, CART in 34% and marker wire/"knuckle" technique in 48%. There was a great diversity between centres referring to the retrograde technique used. According to the initial strategy success rates were: primary 89.3%, immediately after antegrade failure 65.9% and repeat procedure after antegrade failure in 88%. In patients with failure to cross the collaterals success rate was 50%. Septal rupture/haematoma occurred in 6.9% of the patients, periprocedural myocardial infarction (CK-MB rise) in 4% and TIA in 0.6% and wire entrapment in 0.6%. Mean fluoroscopy time was 59.3 mn and the mean contrast used was 420.9 ml. Drug eluting stents were implanted in all successfully recanalised vessels.There is great diversity amongst European centres with respect to how the retrograde strategy has been adopted and adapted. The retrograde approach was used with high degree of success and safety and can thus be regarded as a valid contributor to the armamentarium of the modern day interventional cardiologist.

No abstract is provided for this article.

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

Objectives The purpose of this study was to compare the 2-year safety and effectiveness of new- versus early-generation drug-eluting stents (DES) according to the severity of coronary artery disease (CAD) as assessed by the SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score. Background New-generation DES are considered the standard-of-care in patients with CAD undergoing percutaneous coronary intervention. However, there are few data investigating the effects of new- over early-generation DES according to the anatomic complexity of CAD. Methods Patient-level data from 4 contemporary, all-comers trials were pooled. The primary device-oriented clinical endpoint was the composite of cardiac death, myocardial infarction, or ischemia-driven target-lesion revascularization (TLR). The principal effectiveness and safety endpoints were TLR and definite stent thrombosis (ST), respectively. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated at 2 years for overall comparisons, as well as stratified for patients with lower (SYNTAX score ≤11) and higher complexity (SYNTAX score >11). Results A total of 6,081 patients were included in the study. New-generation DES (n = 4,554) compared with early-generation DES (n = 1,527) reduced the primary endpoint (HR: 0.75 [95% CI: 0.63 to 0.89]; p = 0.001) without interaction (p = 0.219) between patients with lower (HR: 0.86 [95% CI: 0.64 to 1.16]; p = 0.322) versus higher CAD complexity (HR: 0.68 [95% CI: 0.54 to 0.85]; p = 0.001). In patients with SYNTAX score >11, new-generation DES significantly reduced TLR (HR: 0.36 [95% CI: 0.26 to 0.51]; p < 0.001) and definite ST (HR: 0.28 [95% CI: 0.15 to 0.55]; p < 0.001) to a greater extent than in the low-complexity group (TLR pint = 0.059; ST pint = 0.013). New-generation DES decreased the risk of cardiac mortality in patients with SYNTAX score >11 (HR: 0.45 [95% CI: 0.27 to 0.76]; p = 0.003) but not in patients with SYNTAX score ≤11 (pint = 0.042). Conclusions New-generation DES improve clinical outcomes compared with early-generation DES, with a greater safety and effectiveness in patients with SYNTAX score >11.

The SYNTAX study compared PCI with TAXUS Express stents to CABG for the treatment of de novo 3-vessel and/or left main coronary disease. This study aimed to determine patient characteristics and five-year outcomes after a staged PCI strategy compared to single-session PCI.In the SYNTAX trial, staged procedures were discouraged but were allowed within 72 hours or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days (mean 9.8±18.1 days post initial procedure). A total of 125 (14%) patients underwent staged PCI. These patients had greater disease severity and/or required a more complex procedure. MACCE was significantly increased in staged patients (48.1% vs. 35.5%, p=0.004), as was the composite of death/stroke/MI (32.2% vs. 19%, p=0.0007). Individually, cardiac death and stroke occurred more frequently in the staged PCI group (p=0.03). Repeat revascularisation was significantly higher in staged patients (32.8% vs 24.8%, p=0.035), as was stent thrombosis (10.9% vs. 4.7%, p=0.005).There is a higher incidence of MACCE in patients undergoing staged compared to single-session PCI for 3-vessel and/or left main disease over the first five years of follow-up. However, these patients had more comorbidities and more diffuse disease.

No abstract is provided for this article.