Drug eluting stents in acute myocardial infarction

Routine stent-implantation in primary coronary intervention (PCI) for acute myocardial infarction (AMI) has been shown to have a better clinical outcome than balloon angioplasty mainly because of reduction in restenosis rate and reocclusion. Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stent (BMS) in elective procedures. Delayed endothelialization of these stents raises concern about a possible increase of thrombotic complications in the setting of AMI. Randomized studies with DES in the treatment of elective patients have shown at 9-12 months follow-up a thrombosis rate of 0-2% comparable to the one of BMS. Sirolimus eluting stents (SES) in AMI have been used in small series of consecutive pts not randomized or in registries with very high successful rate and a stent thrombosis varying between 0 and 4.7%. Paclitaxel eluting stent (PES) have also shown in small series a good immediate performance with a thrombosis rate between 0 and 4.8%. Predictors of acute and subacute stent thrombosis are the same than for BMS: residual dissection, long or overlapping stents, biforcation lesions and discontinuation of antiplatelets treatment. Providing effective mechanical reperfusion with similar results to the current therapeutic standard and decreasing the incidence of late complications, DES appear as an attractive approach for patients admitted with AMI.     

The impact of IVUS guided bare metal stent implantation for non-small vessel

Previous studies have shown larger target vessel or greater stent area contribute to reduced restenosis rate. Thus, intravascular ultrasound (IVUS)-guided bare metal stent (BMS) implantation for selected lesions might achieve drug-eluting stent-like outcomes. The aim was to examine the long-term outcomes of BMS using IVUS-guided optimization. METHODS: Consecutive 103 coronary artery lesions suitable for IVUS were enrolled. Using IVUS, final stent balloon size selected was 90 percent of media-to-media diameter at the lesion or distal reference. The balloon size was listed as follows: group A (3.0-3.5 mm, n = 15), group B (3.5-3.75 mm, n = 64), and group C (3.75-4.5 mm, n = 24). RESULTS: At post-intervention, average stent area increased by the balloon size (A: 7.2 +/- 1.4 mm2, B: 8.9 +/- 1.5 mm2, and C: 12.1 +/- 2.0 mm2, respectively p < 0.001). At 6 month follow up, the average lumen area increased by balloon size (A: 4.1 +/- 1.7 mm2, B: 5.7 +/- 1.2 mm2, and C: 8.1 +/- 2.0 mm2, respectively p < 0.001). Accordingly, group B and C revealed lower restenosis, compared to group A (A: 46.7%, B: 10.9%, C: 8.3%, A vs B: p = 0.001; C vs A: p = 0.015). Moreover, target lesion revascularization was less in group B and C than group A (A 26.6%, B 3.1%, C 0%, A vs B: p = 0.011; C vs A: p = 0.017). CONCLUSIONS: For non-small vessels, IVUS-guided BMS implantation showed less restenosis and target lesion revascularization compared to small vessels, mainly due to larger initial gain. These study results suggest that IVUS-guided optimal BMS implantation for selected lesions might result in favorable long-term outcomes similar to those seen using drug-eluting stents. For a decade, coronary stenting has become a standard therapy for coronary artery disease due to favorable long-term outcomes and simple treatment procedure. Furthermore, for the last two years, drug-eluting stents (DES), releasing antiproliferative agents from bare metal backbone, revealed the restenosis rates less than half of those seen using conventional bare metal stents (BMS). While target lesions especially suitable for DES continue to be identified, earlier BMS studies showed that larger target vessel or greater stent area contributed to less restenosis. Thus, optimal IVUS-guided BMS implantation for selected lesions might achieve DES-like long-term outcomes. This study was designed to examine the long-term outcomes of BMS with intravascular ultrasound (IVUS)-guided optimization, using coronary angiography and IVUS data.     

药物支架治疗冠状动脉分叉病变9个月随访研究

目的：探讨应用国产药物洗脱支架（DES）治疗分叉病变及主支及分支血管均植入药物支架（Stent／Stent）和主支血管植人药物支架、分支血管球囊扩张（Stent/PTCA）两种方法的临床疗效。方法：自2003年9月至2007年1月在我中心因心绞痛、陈旧性心肌梗死、无痛性心肌缺血行冠状动脉造影证实为自身冠状动脉分叉病变的患者242例，248处病变。分又病变的标准根据Lefevre的标准进行分类，主支血管及分支血管的直径均大于2．5mm。分叉病变的类型为前降支／对角支105例（42．3％）．左冠状动脉主干分又病变70例（28．2％），回旋支／钝缘支42例（16．9％）．右冠状动脉远端分叉病变31例（12．5％），处分叉病变中采用Crush技术28例，“T”型支架置入23例；Reverse T支架置入25例，改良“Y”型支架置入3例；对吻支架置入11例；“V”型支架置入1例和Culotte技术置入5例。其余152例（64．7％）使用cross over技术，共植入药物支架384枚，其中Firebird支架（上海微创公司）327枚，占84．5％。术前常规应用阿司匹林及波力维，术中应用普通肝素或低分子肝索抗凝。术后用药氯吡格雷75mg／d至少服用6个月，长期服用阿司匹林100mg／d。主要研究终点为术后及9个月内的MACE事件（心源性死亡、急性心肌梗死、支架内血栓形成、再次靶血管重建术）。结果：手术成功率为100％，住院期间无死亡，住院期间心脏事件发生率为0％，所有病例均完成了9个月的临床随访，随访期间死亡3例，其中心源性死亡2例，非ST段抬高心肌梗死3例，再发心绞痛13例，主要心脏不良事件7．4％。118例完成9个月的造影随访，随访率为44．5％，其中双药物支架组51例，主支支架组67例。11例发生了支架内再狭窄．其中双药物支架组5例，主支支架组6例，发生率分别为9．8％和9．0％，P〉0．05，总再狭?     

Update on stents: recent studies on the TAXUS stent system in small vessels

Small vessel size (<3 mm) has been identified as an independent predictive factor of restenosis after percutaneous coronary intervention when using bare metal stents (BMS). It remains controversial whether BMS placement in small vessels has an advantage over balloon angioplasty in terms of angiographic and clinical outcomes. The advent of drug eluting stents (DES), either paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES), has strongly impacted interventional cardiology by significantly reducing restenosis and the need for repeat revascularization. Therefore, it was also expected that DES could substantially reduce restenosis in smaller vessels. However, even in the DES era, small vessel size remains an independent predictor of angiographic and clinical restenosis. To date, only a few studies systematically investigate the clinical effect of DES placement in small vessels. In addition, some potential issues with the use of DES have been raised, such as late stent thrombosis and late restenosis. In order to (i) establish the superiority of DES over BMS; (ii) verify the efficacy and safety of DES; and (iii) critically assess the superiority of one DES over the other in patients with small coronary arteries, further multicenter, randomized clinical trials with larger sample size are warranted.     

Drug-eluting stent: a review and update

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. However, neointimal hyperplasia occurring within the stent leading to in-stent restenosis is a main obstacle in the long-term success of percutaneous coronary intervention (PCI). The recent introduction of drug-eluting stents (DES) contributes a major breakthrough to interventional cardiology. Many large randomized clinical trials using DES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization when compared with bare metal stents. The results of these trials also appear to be supported by evidence from everyday practice and non-controlled clinical trials. However, the expanded applications of DES, especially in treating complex lesions such as left main trunk, bifurcation, saphenous vein graft lesions, or in-stent restenosis, are still under evaluation with ongoing studies. With the availability of different types of DES in the market, the issue of cost should not be a deterrent and DES will eventually be an economically viable option for all patients. The adoption of DES in all percutaneous coronary intervention may become a reality in the near future. In this review article, we summarize the recent development and progress of DES as well as compare and update the results of clinical trials.     

Engineering aspects of stents design and their translation into clinical practice

The implantation of coronary stents is a relevant part of interventional procedures for percutaneous revascularization. The wide acceptance of coronary stenting was based on the results of two highly significant trials which have shown the superiority of stenting over balloon angioplasty in terms of reduction of angiographic restenosis and need for repeated intervention in focal lesions and large coronary arteries. Since then, the growing use of stent market was impressive. A rapidly increasing number of different stent type with different material and designs has been introduced in the market both for bare metal stent and drug eluting stent. This review will summarize the different components of stent design that are important in term of biological response of the arterial wall and clinical outcome. In addition, new stent platforms, mainly represented by the biodegradable stent will be shortly reviewed since it may provide in the near future a more "physiological" answer to stent implantation, reducing vascular injury and accelerating vessel healing with consequent improving in clinical outcome.     

Results of coronary angioplasty in coronary bifurcation. Report of 61 cases

These are the results of 61 bifurcations treated by percutaneous coronary angioplasty in 50 patients (41 males, 9 females) between 1998 and 2003. Bifurcation stenosis, dominated by type I of bifurcation classification. Global restenosis rate was 20% and didn't concern any case of kissing balloon. Restenosis rate in bifunction angioplasty is similar to that of the other sites; besides, it's twice more important when we stent both of the principal and collateral arteries unless we did kissing balloon. Te interventional treatment of bifurcation stenosis is feasible, with restenosis rate similar to the other types of lesions if we proceed systematicaly to kissing balloon.     

Drug-eluting coronary stents

The first method of percutaneously treating a diseased vessel was developed by Dotter and Judkins in 1964. Andreas Grüntzig performed the first coronary angioplasty in 1977. In 1985 Palmaz et al. implanted the first balloon-mounted stent in a peripheral artery. Puel and Sigwart implanted the first human coronary stent in March 1986; it was a self-expanding mesh-like device. Schatz et al. applied some small modifications to the original Palmaz stent, which resulted in the first coronary stent available on the market, called Palmaz-Schatz stent. In 1987 Sigwart was the first to suggest the use of coronary stents in acute vessel occlusions during unsuccessful PTCA. Using the device it became possible to cover the intimal flap and to prevent elastic recoil. Because of the high incidence of subacute stent thromboses and the bleeding complications (aggressive anticoagulation regimens) these times the coronary stents were implanted only in order to avoid emergency CABG surgery. In 1993 BENESTENT and STRESS trials have proved that elective stent implantation can significantly reduce the incidence of restenosis. The dual antiplatelet therapy and the high pressure stent implantation technique dramatically reduced the incidence of subacute stent thrombosis. The treatment of coronary artery disease has undergone revolutionary changes in the past decade but remained the leading cause of mortality in the developed world. The most important limitation of PCI has been in-stent restenosis, which occurs in 20-40% of stent implantations. Clinically it results in recurrent ischemic episodes most often requiring repeat revascularisation (rePCI or CABG). With the use of drug-eluting stents the incidence of in-stent restenosis can be reduced dramatically, based on the currently available clinical trials it remains below 10%.     

Meta-analysis comparing clinical effectiveness of drug-eluting stents, bare metal stents and coronary artery bypass surgery

Objective To compare clinical outcomes among patients receiving drug-eluting stents, bare metal stents, or coronary artery bypass grafting surgery (CABG) to treat coronary artery disease. Data sources Randomised controlled trials were systematically selected from electronic database for head-to-head comparisons. The results from these head-to-head comparisons were used for an adjusted indirect comparison. Methods Published randomised controlled trials were reviewed for outcome data in patients treated for coronary artery disease with drug-eluting stents, bare metal stents, or CABG. Head-to-head comparisons were conducted for drug-eluting stents versus bare metal stents and for CABG versus bare metal stents. Adjusted indirect comparison was used to compare drug-eluting stents and CABG. Mid-term clinical outcomes (range: 6-12?months) were investigated and included rates of mortality, myocardial infarction, thrombosis, target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Results Systematic literature search identified 23 randomised controlled trials (15 for drug-eluting stents vs. bare metal stents, 8 for CABG vs. bare metal stents). Head-to-head comparisons for both single and multiple vessel disease demonstrated that compared with bare metal stents, drug-eluting stents had better outcomes for target lesion revascularisation, target vessel revascularisation, restenosis and major adverse cardiac events. Except target lesion revascularisation, data were similarly favourable for CABG when compared with bare metal stents. Adjusted indirect comparison between drug-eluting stents and CABG in single vessel disease failed to detect significant differences in any of the measured outcomes. Multiple vessel disease data analysis demonstrated that target vessel revascularisation (odds ratio 3.41 [95% CI 2.29-5.08]) and major adverse cardiac events (1.89 [1.28-2.79]) were superior to drug-eluting stents in patients undergoing CABG. Conclusions Drug-eluting stents and CABG were superior to bare metal stents in terms of target lesion revascularisation (drug-eluting stents only), target vessel revascularisation, restenosis and major adverse cardiac events. There was no difference in clinical outcomes when comparing CABG and drug-eluting stents in patients with single vessel disease, and CABG may be superior to drug-eluting stents for target vessel revascularisation and major adverse cardiac events in patients with multiple vessel disease. However, results may vary between subpopulations with different clinical or socioeconomic differences.     

Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V)

Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.     

The effects of drug-eluting coronary stents

(Drug-eluting stents substantially reduce the incidence of restenosis after percutaneous coronary interventions.) The cytostatic drugs however not only inhibit the proliferation of smooth muscle cell and neointima proliferation but also delay the endothelisation of the stent struts. It may result in persistent inflammatory reaction and also in stent thrombosis. The trials comparing the efficacy of drug-eluting and bare metal stents, and also that of the two drug-eluting stent brands are reviewed. The efficacy of the two brands of drug-eluting stents in prevention of restenosis is almost equal. Late stent thrombosis is more frequent after drug eluting, than after bare metal stents. This rare, but severe complication may develop if drug-eluting stents are used in off-label indications and anatomic situations. In order to avoid late stent thrombosis devices should be used as labelled, the platelet inhibitory treatment should be more efficacious and longlasting than these days. Thorough information about the importance of adherence to prescribed treatment should be delivered to the patients and to the medical community as well.     

Cost-effectiveness of drug-eluting coronary stents in Quebec, Canada

OBJECTIVES: The aim of this investigation was to assess the incremental cost-effectiveness of replacing bare metal coronary stents (BMS) with drug-eluting stents (DES) in the Province of Quebec, Canada. METHODS: The strategy used was a cost-effectiveness analysis from the perspective of the health-care provider, in the province of Quebec, Canada (population 7.5 million). The main outcome measure was the cost per avoided revascularization intervention. RESULTS: Based on the annual Quebec rate of 14,000 angioplasties with an average of 1.7 stents per procedure and a purchase cost of $2,600 Canadian dollar (CDN) for DES, 100 percent substitution of BMS with DES would require an additional $45.1 million CDN of funding. After the benefits of reduced repeat revascularization interventions are included, the incremental cost would be $35.2 million CDN. The cost per avoided revascularization intervention (18 percent coronary artery bypass graft, 82 percent percutaneous coronary intervention [PCI]) would be $23,067 CDN. If DES were offered selectively to higher risk populations, for example, a 20 percent subgroup with a relative restenosis risk of 2.5 times the current bare metal rate, the incremental cost of the program would be $4.9 million CDN at a cost of $7,800 per avoided revascularization procedure. Break-even costs for the program would occur at DES purchase cost of $1,161 for 100 percent DES use and $1,627 for selective 20 percent DES use for high-risk patients for restenosis (RR = 2.5). Univariate and Monte Carlo sensitivity analyses indicate that the parameters most affecting the analysis are the capacity to select patients at high risk of restenosis, the average number of stents used per PCI, baseline restenosis rates for BMS, the effectiveness ratio of restenosis prevention for DES versus BMS, the cost of DES, and the revascularization rate after initial PCI. Sensitivity analyses suggest little additional health benefits but escalating cost-effectiveness ratios once a DES penetration of 40 percent has been attained. CONCLUSIONS: Under current conditions in Quebec, Canada, selective use of DES in high-risk patients is the most acceptable strategy in terms of cost-effectiveness. Results of such an analysis would be expected to be similar in other countries with key model parameters similar to those used in this model. This model provides an example of how to evaluate the cost-effectiveness of selective use of a new technology in high-risk patients.     

Real-world cost-effectiveness of drug-eluting stents vs. bare-metal stents for coronary heart disease—A five-year follow-up study

Objective

To evaluate the cost-effectiveness of using drugeluting stents (DES) compared to bare-metal stents (BMS) for coronary heart disease (CHD).

The Children of China

Abstract

Coronary artery disease is the primary cause of mortality in men and women in the United States. Transcatheter coronary intervention is the mainstay of treatment for patients with acute coronary artery disease presentations and patients with stable disease. Although percutaneous intervention initially only included balloon angioplasty, it now typically involves the placement of intracoronary stents. To overcome the limitations of bare-metal stents, namely in-stent restenosis, stents have been developed that remove pharmaceuticals that reduce neointimal hyperplasia and in-stent restenosis. However, these pharmaceutical agents also delay stent endothelialization, posing a prolonged risk of in situ thrombosis. Placement of an intracoronary stent (eg, bare-metal or drug-eluting stent) requires dual antiplatelet therapy to prevent the potentially life-threatening complication of stent thrombosis. The optimal duration of dual antiplatelet therapy following stent placement is unknown. This article discusses the factors to be considered when deciding when dual antiplatelet therapy can be safely discontinued. Unfortunately, in the hospital setting, this decision to interrupt dual antiplatelet therapy frequently must be made shortly after stent placement because of unanticipated surgical procedures or other unforeseen complications. The decision of when dual antiplatelet therapy can be safely interrupted needs to be individualized for each patient and involves factoring in the type of stent; the location and complexity of the lesion stented; post-stent lesion characteristics; the amount of time since stent placement; and the antiplatelet regimen currently in use, along with its implication for bleeding during the proposed procedure. Having a protocol in place, such as the protocol described in this article, can help guide this decision-making process and avoid confusion and potential error.     

Perioperative antiplatelet management in patients with coronary artery stenting

Coronary artery disease is the primary cause of mortality in men and women in the United States. Transcatheter coronary intervention is the mainstay of treatment for patients with acute coronary artery disease presentations and patients with stable disease. Although percutaneous intervention initially only included balloon angioplasty, it now typically involves the placement of intracoronary stents. To overcome the limitations of bare-metal stents, namely in-stent restenosis, stents have been developed that remove pharmaceuticals that reduce neointimal hyperplasia and in-stent restenosis. However, these pharmaceutical agents also delay stent endothelialization, posing a prolonged risk of in situ thrombosis. Placement of an intracoronary stent (eg, bare-metal or drug-eluting stent) requires dual antiplatelet therapy to prevent the potentially life-threatening complication of stent thrombosis. The optimal duration of dual antiplatelet therapy following stent placement is unknown. This article discusses the factors to be considered when deciding when dual antiplatelet therapy can be safely discontinued. Unfortunately, in the hospital setting, this decision to interrupt dual antiplatelet therapy frequently must be made shortly after stent placement because of unanticipated surgical procedures or other unforeseen complications. The decision of when dual antiplatelet therapy can be safely interrupted needs to be individualized for each patient and involves factoring in the type of stent; the location and complexity of the lesion stented; post-stent lesion characteristics; the amount of time since stent placement; and the antiplatelet regimen currently in use, along with its implication for bleeding during the proposed procedure. Having a protocol in place, such as the protocol described in this article, can help guide this decision-making process and avoid confusion and potential error.     

Developments in coronary artery stenting: primum non nocere

The occurrence of restenosis and acute vessel closure postballoon angioplasty was the driving force for the introduction of coronary artery stenting in the 1980s. Although the first generation of coronary artery stents were highly valuable and efficient in scaffolding (non-)threatened coronary vessels, they proved to be associated with iatrogenic side effects such as in-stent neointimal hyperplasia. The efforts to tackle these side-effects eventually lead to the most significant progress within the field of interventional cardiology in the past decennium, namely drug-eluting stents (DES). Analysts estimate that the total amount of DES implantations worldwide will be more than 5 million this year. Although this worldwide increase in percutaneous coronary interventions (PCI) is impressive, some pitfalls such as the incidence of neointimal hyperplasia, stent fracture and a local hypersensitivity reaction against the polymer coating are worrisome. According to critics, the possible causal relationship with higher rates of very-late stent thrombosis could be a ticking time bomb. These concerns paved the way for the development of novel stents, ranging from DES with biodegradable polymer coating to completely biodegradable stents. Like all progress in medical interventions, it is essential to not harm the patient throughout this complex evolvement process of coronary stents. The current review not only discusses the benefits and safety issues associated with currently utilized coronary stents but in particular highlights novel coronary stents that are being investigated in (pre-)clinical trials at this moment.     

Sirolimus-eluting coronary stents: a review

The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and "high-risk" patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efficacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention.     

Cost effectiveness of sirolimus-eluting stents compared with bare metal stents in acute myocardial infarction

Background

Drug-eluting stents have been shown to reduce the rate of repeat revascularization after percutaneous coronary intervention for acute myocardial infarction (AMI) as compared with bare metal stents (BMS). A few studies have reported the cost effectiveness of sirolimus-eluting stents (SES) in several countries, but none in the particular setting of AMI in France.

Objectives

To assess the cost effectiveness of SES compared with BMS in a pre-specified subgroup of French patients with AMI in the randomized, multicentre TYPHOON trial.

Methods

A prospective economic evaluation was conducted for the 337 patients in the TYPHOON trial who were enrolled in the French centres. In the TYPHOON trial, patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain were randomized to undergo percutaneous coronary intervention with either SES or BMS. Data on clinical outcomes and resource use were collected prospectively over a 1-year follow-up period (from October 2003 to October 2005). Unit costs were applied to the resource utilization data. The main outcome measure was the incremental cost-effectiveness ratio (ICER) for additional cost per target-vessel revascularization (TVR) avoided. The perspective of the study was the French healthcare system and costs were expressed in 2007 values.

Results

SES significantly reduced the rate of TVR (6.6% vs 22.2% with BMS, p < 0.0001). There was no difference in the rate of death, recurrent myocardial infarction or stent thrombosis after 1 year of follow-up between the SES and BMS groups. Mean index admission costs, including the angioplasty procedure, were increased by €1282 per patient in the SES group, mostly driven by the price of the SES. Mean follow-up costs were €140 per patient lower in the SES group. Mean aggregate 1-year costs showed a €1142 per-patient increase in the SES group compared with the BMS group. The ICER was €7321 per TVR avoided.

Conclusion

In this pre-specified subgroup analysis of the TYPHOON trial, the use of SES in patients with AMI with ST-segment elevation less than 12 hours after the onset of chest pain reduced the rate of TVR compared with BMS. However, SES had a debatable ICER for the payer if it was based only on the specific benefit of TVR avoided.     

直接置入国产药物洗脱支架治疗急性心肌梗死的可行性研究

目的评价无球囊预扩张直接置入国产药物洗脱支架治疗急性心肌梗死（acute myocardial infarction,AMI）的安全性和有效性。方法将100例ST段抬高型AMI患者随机分为无球囊预扩张直接置入国产药物洗脱支架组（直接支架组）和球囊预扩张后置入冠状动脉内支架组（预扩张组）,应用心肌梗死溶栓治疗试验（thrombolysis in myocardial infarction,TIMI）血流分级、心肌呈色分级（myocardial blush grading,MBG）两种方法评价AMI患者的心肌灌注情况,并对主要不良心脏事件（major adverse cardiac events,MACE）及冠脉造影随访6个月。结果虽然两组术后即刻TIMI3级血流分级差异无统计学意义（94％ vs 90％,P〉0．05）,但直接支架组与预扩张组比较,术后即刻MBG分级2～3级明显增高（90％ vs 74％,P〈0．05）,无复流（no—reflow,NR）发生率明冠降低（10％ vs 26％,P〈0．05）。两组6个月MACE差异无统计学意义（6％ vs 10％,P〉0．05）,冠脉造影再狭窄发生率及支架内最小管腔直径、节段内最小管腔直径、支架内晚期管腔丢失、节段内晚期管腔丢失差异均无统计学意义[分别为5．5％VS7．7％,（2．91±0．25）mm vs（2．94±0．35）mm、（2．87±0．18）mm vs（2．84±0．25）mm、（0．12±0．09）mm vs（0．12±0,08）mm、（0,14±0．12）mm vs（0．13±0．10）mm,P值均〉0．05]。结论无球衰预扩张直接置入国产药物洗脱支架治疗AMI安全可行,可降低AMI血管再通后心肌无复流的发生。