Claim: Drugs may make stents deadly, study says
Verdict: REFUTES

Retrieved passages:
title: Coronary stent
text: high risk is to give up smoking, to exercise regularly, and take "drugs to get blood pressure under control, drive cholesterol levels down and prevent blood clotting". Some cardiologists believe that stents are overused; however, in certain patient groups, such as the elderly, GRACE and other studies have found evidence of under-use. One cardiologist was convicted of billing patients for performing medically unnecessary stenting. Guidelines recommend a stress test before implanting stents, but most patients do not receive a stress test. While revascularisation (by stenting or bypass surgery) is of clear benefit in reducing mortality and morbidity in patients with

title: Drug-eluting stent
text: of thrombosis was shown after the first year, compared to bare-metal stents. Late stent thrombosis often causes myocardial infarction and sometimes death. In other analyses, the late thrombosis risk is offset by drug-eluting stents' markedly reduced risk of restenosis and its complications including myocardial infarction. A meta-analysis concluded the mortality risk associated with drug-eluting and bare-metal stents is similar. Drug-eluting stents generally consist of three parts - the stent platform, a polymer coating that binds the drug to the stent and releases drug (although stents have been tested that do without a coating), and the drug. The stent platform itself

title: Drug-eluting stent
text: narrowings, having lower rates of major adverse cardiac events (usually defined as a composite clinical endpoint of death + myocardial infarction + repeat intervention because of restenosis). The first drug-eluting stents to be approved in Europe and the U.S. were coated with paclitaxel or an mTOR inhibitor, such as sirolimus. Clinical trials have shown the benefits of coronary stenting with bare-metal stents over other methods of angioplasty, including balloon angioplasty and atherectomy. Drug-eluting stents (DES) have also been extensively studied, and are generally superior to bare-metal stents with respect to occurrence of major adverse cardiac events (MACE, generally defined as

title: Drug-eluting stent
text: York Times interviewed the study's main author, who said that more than half of patients with stable coronary artery disease were implanted with stents without even trying drug treatment and that he believed this happened because hospitals and doctors wanted to make more money. In 2013 the Times of India reported that DES were widely overused and that Indian distributors used profits from high markups on DES to bribe doctors to use them. In 2014 an investigation by the Maharashtra Food and Drug Administration found that high markups and bribery related to DES was still widespread. Drug-eluting stent A drug-eluting

title: Drug-eluting stent
text: has markedly decreased since the days of balloon angioplasty, such that in some communities, coronary stenting is permitted in hospitals without on-site cardiac surgery facilities, though this remains highly controversial in the United States, not the least because of the rare but largely unpredictable risk of coronary artery perforation. Rarely, a type of allergic reaction to the drug may occur; episodes of fatality have been reported. Although drug-eluting stents continue to represent a major medical advance for angioplasty, evidence has always shown new clot thrombosis formation with stents to be a problem, thus clotting suppressant agents are routinely given during

title: Drug-eluting stent
text: or both of these drugs after drug-eluting stenting markedly increases the risk of stent thrombosis and myocardial infarction. A recent histopathology study showed very late DES thrombosis is associated with histopathological signs of inflammation and intravascular ultrasound evidence of vessel remodeling. Compared with other causes of myocardial infarction, eosinophilic infiltrates are more common in thrombi harvested from very late DES thrombosis and correlate with the extent of stent malapposition. Whether drug-eluting stents are at higher risk than bare-metal stents for late thrombosis is intensely debated. In meta-analyses of the sirolimus- and paclitaxel-eluting stent trials, a small but statistically higher risk

title: Drug-eluting stent
text: death, myocardial infarction, or the need for a repeat revascularization procedure). Stents are indicated to improve the diameter of the coronary artery lumen, when narrowing (generally because of atherosclerosis) causes ischemia (reduced oxygen delivery to the muscle supplied by that artery). Drug-eluting stents also have been shown to be superior to bare-metal stents in reducing short-term complications of stenting in saphenous vein grafts; however, use in these bypass grafts is an example of an "off-label" use of drug-eluting stents. That is, this application has not been sufficiently examined by the Food and Drug Administration for that agency to recommend the

title: Drug-eluting stent
text: use. For "on-label" applications, the FDA "believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications. These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year." Some concern has been expressed about overzealous use of stents in general. Two studies found about half of patients received stents for unapproved reasons, with worse outcomes for the patients in both studies. More recent data suggest off-label use of both bare-metal stents and drug-eluting stents have increased risks. However, drug-eluting stents seemed to have similar or improved rates

title: Coronary stent
text: that narrow arteries." Further, “...researchers say, most heart attacks do not occur because an artery is narrowed by plaque. Instead, they say, heart attacks occur when an area of plaque bursts, a clot forms over the area and blood flow is abruptly blocked. In 75 to 80 percent of cases, the plaque that erupts was not obstructing an artery and would not be stented or bypassed. The dangerous plaque is soft and fragile, produces no symptoms and would not be seen as an obstruction to blood flow.” A more permanent and successful way to prevent heart attacks in patients at

title: Drug-eluting stent
text: of a new endothelial layer over the new stent to inhibit clot formation. Endothelialization is a hallmark of vascular healing and is important for the prevention of thrombus formation. Lack of healing caused by antiproliferative drugs can make the stent an exposed surface on which a clot, sometimes life-threatening, can form. For drug-eluting stents (which, by design, delay formation of a new endothelium cover over the stent), the incidence of clot formation within the stent may persist for a longer period of time, perhaps as long as five years after treatment. Drug-eluting stents have been associated with delayed arterial healing

title: Percutaneous coronary intervention
text: stents, which utilize biodegradable polymers, are approved outside the U.S. However, in 2006, clinical trials showed a possible connection between drug-eluting stents and an event known as “late stent thrombosis” where the blood clotting inside the stent can occur one or more years after stent implantation. Late stent thrombosis occurs in 0.9% of patients and is fatal in about one-third of cases when the thrombosis occurs. Increased attention to antiplatelet medication duration and new generation stents (such as everolimus-eluting stents) have dramatically reduced concerns about late stent thrombosis. Newer-generation PCI technologies aim to reduce the risk of late stent thrombosis

title: Pharmacogenetics
text: world, however, it is known to warrant different responses among patients. GWAS studies have linked the gene CYP2C19 to those who cannot normally metabolize Plavix. Plavix is given to patients after receiving a stent in the coronary artery to prevent clotting. Stent clots almost always result in heart attack or sudden death, fortunately it only occurs in 1 or 2% of the population. That 1 or 2% are those with the CYP2C19 SNP. This finding has been applied in at least two hospitals, Scripps and Vanderbilt University, where patients who are candidates for heart stents are screened for the CYP2C19

title: Drug-eluting stent
text: drug-eluting stents to be licensed used durable coatings. The first generation coatings appear to have caused immunological reactions at times and some possibly led to thrombosis, which has driven experimentation and development of new coating approaches. The drug is mainly to inhibit neointimal growth (due to the proliferation of smooth muscle cells) that would cause restenosis. Much of the neointimal hyperplasia seems to be caused by inflammation. Hence, immunosuppressive and antiproliferative drugs are used. Sirolimus, paclitaxel, and everolimus were previously used for other medical applications and have been included in licensed DES. The first procedure to treat blocked coronary arteries

title: Drug-eluting stent
text: to bring a bioresorbable stent to market was Abbott Vascular which received a European marketing approval in September 2012; the second was Elixir which received its CE mark in May 2013. In 2017, Abbot pulled its bioabsorbable stent, Absorb, from the European market after negative press regarding the device. Boston Scientific also announced termination of its Renuvia bioresorbable coronary stent program as studies showed higher risk of serious adverse events. In 2012, a meta-analysis of clinical trial data was published, showing that, for people with stable coronary artery disease, DES has no benefit compared to treatment with drugs. The New

title: Research on Adverse Drug Events and Reports
text: (drug eluting coronary arterial stents), pure red-cell aplasia (PRCA) (epoetin), vision changes (amiodarone, sildenafil, and tadalafil), late thrombotic events (drug eluting cardiac stents), leukemia (G-CSF), and interstitial pneumonitis (gemcitabine). For each individual ADR, the number of unique event reports collected by RADAR ranged from 0 to 96. Twenty-seven sADRs were associated with drugs and four were associated with a device. The success of the RADAR program has previously been largely based on the use of diverse data sources to identify, clarify, and verify ADRs. Databases, registries, clinical trials, referral centers, and case reports have all been utilized as sites of

title: Drug-eluting stent
text: small minority of patients with multiple-vessel coronary disease have been eligible for inclusion in the studies, and for most patients, clinical judgement by experienced operators suggest one or the other approach is preferred. Like all invasive medical procedures, implanting stents in the coronary arteries carries risk. For the newer drug-eluting stents, very-long-term results are not yet available; however, five years after implantation, sirolimus-eluting stents remained superior to bare-metal stents. Risks associated with cardiac catheterization procedures include bleeding, allergic reaction to the X-ray contrast agents used to visualize the coronary arteries, and myocardial infarction. With PCI, the requirement for emergency CABG

title: Sirolimus
text: in fewer repeat procedures. A sirolimus-eluting coronary stent was marketed by Cordis, a division of Johnson & Johnson, under the tradename Cypher. However, this kind of stent may also increase the risk of vascular thrombosis. Sirolimus is contraindicated in individuals with a known hypersensitivity to the drug. The most common adverse reactions (≥30% occurrence, leading to a 5% treatment discontinuation rate) observed with sirolimus in clinical studies of organ rejection prophylaxis in individuals with kidney transplants include: peripheral edema, hypercholesterolemia, abdominal pain, headache, nausea, diarrhea, pain, constipation, hypertriglyceridemia, hypertension, increased creatinine, fever, urinary tract infection, anemia, arthralgia, and thrombocytopenia. The

title: Heroic measure
text: to potentially cause serious or fatal side effects. Cardiopulmonary resuscitation is a particularly well-known heroic measure; vigorous chest compressions often result in fracturing one or more of the patient's ribs, but since the alternative is certain death, the technique is accepted as necessary. Patients with advanced AIDS and concomitant pneumocystis pneumonia (PCP) are in serious danger of acute respiratory distress syndrome (ARDS). A heroic rescue could use the chemotherapeutic drug trimetrexate, which would destroy bone marrow as well as the PCP, although leucovorin can protect the marrow. Heroic measure In medicine, heroic treatment or course of therapy is one which

title: Coronary stent
text: tendency for clots to form at the site where the stent damages the arterial wall. Since platelets are involved in the clotting process, patients must take dual antiplatelet therapy starting immediately before or after stenting: usually an ADP receptor antagonist (e.g. clopidogrel or ticagrelor) and aspirin for one year and aspirin indefinitely. In order to reduce the treatment, a new generation of stent has been developed with biodegradable polymer. However, the dual antiplatelet therapy may be insufficient to fully prevent clots that may result in stent thrombosis; these and the cell proliferation may cause the standard (“bare-metal”) stents to become

title: Drug-eluting stent
text: placement, and anticlotting agents should be continued; the question is for how long. Coronary arterial healing occurs after the placement of a drug-eluting stent, but complete healing of the vessel takes time. For drug-eluting stents, the time course of complete healing in humans is unknown. A stent is a foreign object in the body, and the body responds to the stent’s presence in a variety of ways. Macrophages accumulate around the stent, and nearby smooth muscle cells proliferate. These physiological changes, which can cause restenosis, are limited by the drugs released by the stent, but these drugs also limit formation