Showing papers by "A. Pieter Kappetein published in 2012"

Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data.

Abstract: OBJECTIVE: To assess whether incomplete revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) has an effect on long-term outcomes. METHODS: During a heart team discussion to evaluate whether patients were eligible for randomization in the SYNTAX trial, both the cardiologist and surgeon agreed on which vessels needed revascularization. This statement was compared with the actual revascularization after treatment. Incomplete revascularization was defined as when a preoperatively identified vessel with a lesion was not revascularized. Outcomes were major adverse cardiac or cerebrovascular events (MACCE), the composite safety endpoint of death/ stroke/myocardial infarction (MI), and individual MACCE components death, MI and repeat revascularization at 3 years. Predictors of incomplete revascularization were explored. RESULTS: Incomplete revascularization was found in 43.3% (388/896) PCI and 36.8% (320/870) CABG patients. Patients with complete revascularization by PCI had lower rates of MACCE (66.5 versus 76.2%, P< 0.001), the composite safety endpoint (83.4 versus 87.9%, P = 0.05) and repeat revascularization (75.5 versus 83.9%, P< 0.001), but not death and MI. In the CABG group, no difference in outcomes was seen between incomplete and complete revascularization groups. Incomplete revascularization was identified as independent predictor of MACCE in PCI (HR = 1.55, 95% CI 1.15–2.08, P = 0.004) but not CABG patients. Independent predictors of incomplete revascularization by PCI were hyperlipidaemia (OR = 1.59, 95% CI 1.04–2.42, P = 0.031), a total occlusion (OR = 2.46, 95% CI 1.66–3.64, P < 0.001) and the number of vessels (OR = 1.58, 95% CI 1.41–1.77, P< 0.001). Independent predictors of incomplete revascularization by CABG were unstable angina (OR = 1.42, 95% CI 1.02–1.98, P= 0.038), diffuse disease or narrowed ( < 2 mm) segment distal to the lesion (OR = 1.87, 95% CI 1.31–2.69, P = 0.001) and the number of vessels (OR = 1.70, 95% CI 1.53–1.89, P < 0.001). CONCLUSIONS: Despite the hypothesis-generating nature of this data, this study demonstrates that incomplete revascularization is associated with adverse events during follow-up after PCI but not CABG.

Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical implications

Abstract: Surgical aortic valve replacement (SAVR) is currently the standard of care to treat patients with severe symptomatic aortic stenosis (AS) and is generally accepted to alleviate symptoms and prolong survival. Based on the results of randomized trials, transcatheter aortic valve implantation (TAVI) is the new standard of care for patients with symptomatic AS who are deemed 'inoperable'. Debatably, TAVI is also an alternative to SAVR in selected patients who are at high risk but operable. As we approach 10 years of clinical experience with TAVI, with over 50 000 implantations in 40 countries, a review of the current literature and clinical outcomes with this rapidly evolving technology is appropriate.

Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the

Abstract: Authors/Task Force Members: Alec Vahanian (Chairperson) (France)*, Ottavio Alfieri (Chairperson)* (Italy), Felicita Andreotti (Italy), Manuel J. Antunes (Portugal), Gonzalo Barón-Esquivias (Spain), Helmut Baumgartner (Germany), Michael Andrew Borger (Germany), Thierry P. Carrel (Switzerland), Michele De Bonis (Italy), Arturo Evangelista (Spain), Volkmar Falk (Switzerland), Bernard Iung (France), Patrizio Lancellotti (Belgium), Luc Pierard (Belgium), Susanna Price (UK), Hans-Joachim Schäfers (Germany), Gerhard Schuler (Germany), Janina Stepinska (Poland), Karl Swedberg (Sweden), Johanna Takkenberg (The Netherlands), Ulrich Otto Von Oppell (UK), Stephan Windecker (Switzerland), Jose Luis Zamorano (Spain), Marian Zembala (Poland)

Non-inferiority study design: lessons to be learned from cardiovascular trials

Abstract: The non-inferiority trial design has gained popularity within the last decades to compare a new treatment to the standard active control. In contrast to superiority trials, this design is complex and is based on assumptions that cannot be validated directly. Many readers and even investigators, therefore, have difficulty grasping the full methodological nature of non-inferiority trials. Non-inferiority margins are often arbitrarily chosen such that a favourable margin can bias a trial towards declaring non-inferiority. Pitfalls of non-inferiority trials are not fully appreciated, and without having identified these shortcomings, objective conclusions from non-inferiority trials cannot be made. This methodological review elaborates on what is a non-inferiority trial, why such a trial is performed, what the hazards are, and how conclusions from non-inferiority trials are derived, by providing examples of recent cardiovascular trials.

Transcatheter aortic valve implantation: 10-year anniversary. Part II: clinical implications

Abstract: Transcatheter aortic valve implantation (TAVI) has been increasingly recognized as a curative treatment for severe aortic stenosis (AS). Despite important improvements in current device technology and implantation techniques, specific complications still remain and warrant consideration. Vascular complications and peri-procedural neurological events were the first concerns to emerge with this new technology. Recently, significant post procedural para-valvular leak has been shown to be more frequent after TAVI than after surgical aortic valve replacement (SAVR), and its potential association with worse long-term prognostic has raised concerns. In moving toward treatment of lower risk populations, structural integrity and long-term durability of heat valve prosthesis are becoming of central importance. Emerging technologies and newer generations of devices seem promising in dealing with these matters.

The SURTAVI model: Proposal for a pragmatic risk stratification for patients with severe aortic stenosis

Abstract: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement (SAVR) for patients with symptomatic severe aortic stenosis (AS) and a high operative risk. Risk stratification plays a decisive role in the optimal selection of therapeutic strategies for AS patients. The accuracy of contemporary surgical risk algorithms for AS patients has spurred considerable debate especially in the higher risk patient population. Future trials will explore TAVI in patients at intermediate operative risk. During the design of the SURgical replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, a novel concept of risk stratification was proposed based upon age in combination with a fixed number of predefined risk factors, which are relatively prevalent, easy to capture and with a reasonable impact on operative mortality. Retrospective application of this algorithm to a contemporary academic practice dealing with clinically significant AS patients allocates about one-fourth of these patients as being at intermediate operative risk. Further testing is required for validation of this new paradigm in risk stratification. Finally, the Heart Team, consisting of at least an interventional cardiologist and cardiothoracic surgeon, should have the decisive role in determining whether a patient could be treated with TAVI or SAVR.

Economic outcomes of percutaneous coronary intervention with drug‐eluting stents versus bypass surgery for patients with left main or three‐vessel coronary artery disease: One‐year results from the SYNTAX trial

Abstract: Objectives: To evaluate the cost-effectiveness of alternative approaches to revascularization for patients with three-vessel or left main coronary artery disease (CAD). Background: Previous studies have demonstrated that, despite higher initial costs, long-term costs with bypass surgery (CABG) in multivessel CAD are similar to those for percutaneous coronary intervention (PCI). The impact of drug-eluting stents (DES) on these results is unknown. Methods: The SYNTAX trial randomized 1,800 patients with left main or three-vessel CAD to either CABG (n = 897) or PCI using paclitaxel-eluting stents (n = 903). Resource utilization data were collected prospectively for all patients, and cumulative 1-year costs were assessed from the perspective of the U.S. healthcare system. Results: Total costs for the initial hospitalization were $5,693/patient higher with CABG, whereas follow-up costs were $2,282/patient higher with PCI due mainly to more frequent revascularization procedures and higher outpatient medication costs. Total 1-year costs were thus $3,590/patient higher with CABG, while quality-adjusted life expectancy was slightly higher with PCI. Although PCI was an economically dominant strategy for the overall population, cost-effectiveness varied considerably according to angiographic complexity. For patients with high angiographic complexity (SYNTAX score > 32), total 1-year costs were similar for CABG and PCI, and the incremental cost-effectiveness ratio for CABG was $43,486 per quality-adjusted life-year gained. Conclusions: Among patients with three-vessel or left main CAD, PCI is an economically attractive strategy over the first year for patients with low and moderate angiographic complexity, while CABG is favored among patients with high angiographic complexity.

Do Differences in Repeat Revascularization Explain the Antianginal Benefits of Bypass Surgery Versus Percutaneous Coronary Intervention? Implications for Future Treatment Comparisons

Abstract: Background— Patients with multivessel coronary disease treated with coronary artery bypass graft (CABG) have less angina than those treated with percutaneous coronary intervention (PCI); however, there is uncertainty as to the mechanism of greater angina relief with CABG and whether more frequent repeat revascularization in patients treated with PCI could account for this treatment difference. Methods and Results— In the Synergy between percutaneous coronary intervention (PCI) with TAXUS and Cardiac Surgery trial, 1800 patients with 3-vessel or left main coronary artery disease were randomized to CABG or PCI with paclitaxel-eluting stents. Health status was assessed at baseline, 1, 6, and 12 months, using the Seattle Angina Questionnaire and the Medical Outcomes Study Short Form General Health Survey, and the association between repeat revascularization and health status during follow-up was assessed using longitudinal models. In adjusted analyses, patients who underwent repeat revascularization had worse angina frequency scores than patients who did not in both treatment groups, with differences of 8.5 points at 6 months and 3.1 points at 12 months in patients treated with PCI and 19.8 points at 6 months and 11.2 points at 12 months in patients with patients treated with CABG. Among patients who did not require repeat revascularization, the adjusted effect of CABG versus PCI on 12-month angina frequency scores was nearly identical to the overall benefit in the intention-to-treat analysis. Conclusions— Among patients with multivessel coronary artery disease treated with PCI or CABG, the occurrence of repeat revascularization during follow-up did not fully explain the antianginal benefit of CABG in the overall population. The differential association between repeat revascularization and anginal status, according to the type of initial revascularization procedure, suggests that this end point should play a limited role in any direct comparison of the 2 treatment strategies. Clinical Trial Registration— . Unique identifier: [NCT00114972][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00114972&atom=%2Fcirccvoq%2F5%2F3%2F267.atom

Towards excellence in revascularization for left main coronary artery disease

Abstract: Purpose of review The aim of this article is to review the current revascularization strategies in patients presenting with unprotected left main coronary artery disease (LMCAD). Recent findings Coronary artery bypass grafting (CABG) is the current standard of treatment for patients with LMCAD. The development and refinement of techniques increased the number of percutaneous coronary interventions (PCI) in LMCAD patients. Summary Although several observational studies show comparable results of CABG and/or PCI in patients with LMCAD, there is currently no convincing randomized evidence that either one of the two is associated with better long-term survival. Recent meta-analyses of four small randomized trials revealed a similar rate of 1-year major adverse cardiovascular and cerebrovascular events, higher rates of target vessel revascularization and lower stroke rates for PCI. Pooling randomized patients studies stratified by lesion complexity strengthened the hypothesis that CABG is better in more complex LMCAD patients. However, the randomized comparisons are affected by methodological limitations and lack power to be conclusive. The ongoing Evaluation of XIENCE V Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is expected to provide a better answer on the optimal treatment strategy for LMCAD patients. In the meantime, risk models need to be improved and the most appropriate revascularization strategy for the individual LMCAD patient should be chosen using a multidisciplinary heart team that considers not only risk models but also other clinical and economic facets.

What do we know about the natural history of severe symptomatic aortic valve stenosis

Abstract: Aortic valve stenosis (AS) is increasingly observed in the clinic. Although at present surgical valve replacement is the gold standard in patients with severe symptomatic AS, elderly patients experience higher morbidity and mortality compared with younger patients. The emergence of transcatheter aortic valve implantation offers an alternative for high-risk or inoperable patients. However, mortality and morbidity is high and long-term outcomes, particularly with respect to device durability, are not yet available. The life expectancy of patients with severe symptomatic AS who are not operated upon is reduced. Most of the reported data, however, date back to the presurgical and precatheterization era. The aim of this article is to outline the evidence of natural history with medical treatment to assist in optimal clinical decision making in the high-risk elderly population with severe symptomatic AS.